DEPARTMENT OF VETERANS AFFAIRS Washington DC 20420 September 14, 2018 In Reply Refer To: 001B FOIA Request: 18-07426-F Daniel McGrath Staff Attorney American Oversight 1030 15th Street NW, Suite B255 Washington, DC 20005 foia@americanoversight.org Dear Mr. McGrath: This is the Partial Initial Agency Decision (IAD) to your Freedom of Information Act (FOIA) request to the Office of the Secretary, U.S. Dept. of Veterans Affairs (OSVA) dated May 4, 2018, received in this FOIA office on May 7, 2018, and assigned FOIA tracking number 1807426-F. You requested: “All records reflecting communications (including emails, email attachments, text messages, messages on messaging platforms (such as Slack, GChat or Google Hangouts, Lync, Skype, or WhatsApp), telephone call logs, calendar entries/invitations, meeting notices, meeting agendas, informational material, draft legislation, talking points, any handwritten or electronic notes taken during any oral communications, summaries of any oral communications, or other materials) between 1) political appointees and Senior Executive Service (SES) employees within the Office of the Secretary, the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer and, the Electronic Health Records Modernization (EHRM) Program Executive Office and 2) Isaac “Ike” Perlmutter, Bruce Moskowitz, or Jared Kushner” (emphasis in original). As a reminder, the VHA FOIA Office has responded to you separately for your VHA FOIA request 18-07460-F. The FOIA Office of Assistant Secretary for Information and Technology (OI&T) will respond to you separately for any potentially responsive OIT records (FOIA 1807440-F). VA Employees with Records After communicating with the OSVA Executive Assistant, OSVA believes the responsive records are located within the email boxes of the following VA employees: 1) Wilkie, Robert L., Jr., VA Secretary; 2) Shulkin, David, former VA Secretary; 3) O'Rourke, Peter M., former VA Acting Secretary; 4) Bowman, Thomas, former VA Deputy Secretary; 5) Hayes-Byrd, Jacquelyn, former VA Acting Chief of Staff; 6) Wright-Simpson, Vivieca, former VA Chief of Staff; 7) Selnick, Darin, former VA White House Senior Advisor; 8) Lukach, Michael, former VA White House Senior Advisor; 9) Leinenkugel, Jake, former VA White House Senior Advisor; and, 10) Spero, Casin D, former VA White House Liaison. Mr. McGrath Page 2 September 14, 2018 Partial IAD and May 8, 2018, 2018 Reasonable Search On May 8, 2018, our search cut-off date, we searched through former VA Secretary David Shulkin’s emails and calendars from February 14, 2017 (the date he became VA Secretary), to March 30, 2018 (the date he left VA). We searched through VA Secretary Robert Wilkie’s emails and calendars from April 1, 2018 (the date he became VA Acting Secretary) to May 8, 2018. We searched through former VA Acting Secretary Peter O’Rourke’s emails and calendars from February 15, 2018 (the date he became VA Acting Chief of Staff), to May 3, 2018. VA will conduct a follow-up search of former VA Acting Secretary Peter O’Rourke’s emails and calendars from May 4, 2018, to May 8, 2018. VA will conduct follow-up searches of email boxes and calendars of the other seven (7) identified VA employees. OSVA searched for any emails to or from Mr. Perlmutter, Dr. Moskowitz, and Mr. Kushner. Our search thus far yielded two hundred ninety-eight (298) pages, of which fifty-six (56) pages require consultation with the White House FOIA Liaison. After reviewing two hundred forty-two (242) pages, OSVA redacts some information with FOIA Exemptions 5, 6, 7(C), and 7(E). 5 U.S.C. § 552(b)(5) exempts from disclosure “inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency.” The government is entitled to redact confidential government information given "the sensitivity of the commercial secrets involved, and the harm that would be inflicted upon the Government by premature disclosure." Federal Open Market Committee v. Merrill, 443 U.S. 340, 363 (1979). Redacted information includes VA electronic mail server code usernames and government conference phone numbers and access codes. The release of this information would expose the VA, its employees, and its contractors to potential hacking and information technology security liabilities and risks. 5 U.S.C. § 552(b)(6) exempts from required disclosure "personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy." FOIA Exemption 6 permits VA to withhold a document or information within a document if disclosure of the information, either by itself or in conjunction with other information available to either the public or the FOIA requester, would result in an unwarranted invasion of an individual’s personal privacy without contributing significantly to the public’s understanding of the activities of the federal government. Specifically, the information being withheld, as indicated on the enclosed documents, under FOIA Exemption 6, consists of names, identities, email addresses, VA usernames, phone numbers, cellular numbers, facsimile numbers, and approximate resident addresses of federal employees and private citizens; we however release the names and VA email addresses of VA Senior Executives. Federal civilian employees and private citizens retain a significant privacy interest under certain circumstances, such as in instances where the release of their information could represent a threat to their well-being, harassment, or their ability to function within their sphere of employment. The federal civilian employees and private citizens whose information is at issue have a substantial privacy interest in their personal information. In weighing the private versus the public interest, except names and VA email addresses of VA Senior Executives, we find that there is no public interest in knowing the names, identities, email addresses, VA usernames, phone numbers, cellular numbers, facsimile numbers, and approximate resident addresses of federal civilian employees and private citizens. The coverage of FOIA Exemption 6 is absolute unless the FOIA requester can demonstrate a countervailing public interest in the requested information by demonstrating that the individual is in a position to provide the requested information to members of the Mr. McGrath Page 3 September 14, 2018 general public and that the information requested contributes significantly to the public’s understanding of the activities of the Federal government. Additionally, the requester must demonstrate how the public’s need to understand the information significantly outweighs the privacy interest of the person to whom the information pertains. Upon consideration of the records, I have not been able to identify a countervailing public interest of sufficient magnitude to outweigh the privacy interest of the individuals whose names are redacted. The protected information has been redacted and (b)(6) inserted. “Withholding a telephone number or e-mail address, alone, is not sufficient to protect that [privacy] interest; alternate means of contacting and harassing these employees would be readily discoverable on the Internet if this court ordered their names disclosed.” Long v. Immigration & Customs Enf’t, 2017 U.S. Dist. LEXIS 160719 (D.C. Cir. 2017). 5 U.S.C. § 552(b)(7)(C) exempts from required disclosure information law enforcement information the disclosure of which "could reasonably be expected to constitute an unwarranted invasion of personal privacy.” Redacted information includes names, email addresses, phone numbers, facsimile, and usernames of VA law enforcement employees or White House employees with security clearances, as well as the VA Secretary’s approximate resident address. The release of this information would risk impersonation of law enforcement personnel and White House employees and jeopardize the health and safety of not only law enforcement personnel, but those persons the law enforcement personnel protect. 5 U.S.C. § 552(b)(7)(E) exempts from required disclosure information that “would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law.” Redacted information includes the VA Secretary’s approximate resident address. The release of this information would compromise the safety of VA law enforcement personnel and VA employees. FOIA Mediation As part of the 2007 FOIA amendments, the Office of Government Information Services (OGIS) was created to offer mediation services to resolve disputes between FOIA requesters and Federal agencies as a non-exclusive alternative to litigation. Using OGIS services does not affect your right to pursue litigation. Under the provisions of the FOIA Improvement Act of 2016, the following contact information is provided to assist FOIA requesters in resolving disputes: VA Central Office FOIA Public Liaison: Name: John Buck Email Address: vacofoiaservice@va.gov Office of Government Information Services (OGIS) Email Address: ogis@nara.gov Fax: 202-741-5769 Mailing address: National Archives and Records Administration 8601 Adelphi Road College Park, MD 20740-6001 FOIA Appeal This concludes OSVA’s partial IAD response to request 18-07426-F. Please be advised that should you desire to do so, you may appeal the determination made in this response to: Mr. McGrath Page 4 September 14, 2018 Office of General Counsel (024) Department of Veterans Affairs 810 Vermont Avenue, NW Washington, DC 20420 If you should choose to file an appeal, please include a copy of this letter with your written appeal and clearly indicate the basis for your disagreement with the determination set forth in this response. Please be advised that in accordance with VA’s implementing FOIA regulations at 38 C.F.R. § 1.559, your appeal must be postmarked no later than ninety (90) days of the date of this letter. Sincerely, Richard Ha, JD, CIPP/G OSVA FOIA Officer Attachments - Two hundred forty-two (242) pages redacted emails and calendars From: To: Cc: Bcc: Subject: Date: Attachments: - DJS Ike Perlmutter <( @frenchangel59.com>; mbsherman <(b) b(6) gmail.com> (b) (6), (b) (5) ) ( 6) Updates Tue Mar 27 2018 10:43:42 CDT I spoke to Dr Hoyt this morning and I wanted to share the plan as he sees it now- to make sure that we are all comfortable with this- This is how we described the plan to meVA will get him a list of 15 potential sites for a site visit All 15 sites will complete the pre- survey assessment The College will then select 2-3 sites to visit to start The earliest he sees a site visit is late June or early July. I've let him know I want to do this asap so to ask for any help if there is a way to speed this up On the governance side we are working hard on a plan to restructure governance and incorporate assistance from our academic partners Please let me know if you have any feedback or suggestions at this time Thanks David Sent with Good (www.good.com) VA-18-0298-A-000001 From: To: Cc: Bcc: Subject: Date: Attachments: - DJS (b) (6), (b) (5) FW: NSO Survey Response and Appendix Wed Mar 07 2018 20:03:11 CST FYI Sent with Good (www.good.com) _____ From: Gunnar, William Sent: Wednesday, March 07, 2018 5:57:21 PM To: DJS Cc: (b) (6) .; Clancy, Carolyn Subject: RE: NSO Survey Response and Appendix Dr. Shulkin, Dave Hoyt responded that he is ready to move forward. He requested a conference call to discuss. I can arrange but wanted to know who from OGC should join to coordinate contract, etc. Bill From: DJS Sent: Wednesday, March 07, 2018 3:42 PM To: Gunnar, William Cc: (b) (6) .; Clancy, Carolyn Subject: RE: NSO Survey Response and Appendix Yes please do - we want to start asap Sent with Good (www.good.com) _____ VA-18-0298-A-000002 From: Gunnar, William Sent: Wednesday, March 07, 2018 12:41:11 PM To: DJS Cc: (b) (6) .; Clancy, Carolyn Subject: FW: NSO Survey Response and Appendix Dr. Shulkin, • (b) (6) requested an update. I have not heard back from the ACS (email receipt attached). Let me know if you would like me to follow-up with Dr. Hoyt. Bill From: Gunnar, William Sent: Monday, February 26, 2018 2:46 PM To: DJS Cc: Clancy, Carolyn Subject: FW: NSO Survey Response and Appendix Sec Shulkin, I am forwarding the survey response provided today to the American College of Surgeons and the appendix list of references. I can forward the additional 7 emails with referenced documents if you wish. Sincerely, Bill From: Gunnar, William Sent: Monday, February 26, 2018 2:12 PM To: Clancy, Carolyn; David Hoyt Cc: Clifford Ko Subject: NSO Survey Response and Appendix Dave, I have attached the VHA National Surgery Office response to the ACS “Red Book” Survey and the Appendix index of attached documents. The attached documents will be sent in a series of emails given document size. As discussed, Carolyn look forward to meeting following your review. Regards, VA-18-0298-A-000003 Bill William Gunnar, MD, JD, FACHE National Director of Surgery 810 Vermont Ave NW Washington, DC 20420 202-461-7148 VA-18-0298-A-000004 From: To: Cc: Bcc: Subject: Date: Attachments: - DJS (b) (6), (b) (5) FW: NSO Survey Response and Appendix Mon Feb 26 2018 15:50:00 CST Appendix02.26.18.pdf NSO Response.ACS Standards QM 02.26.18.pdf FYI Sent with Good (www.good.com) _____ From: Gunnar, William Sent: Monday, February 26, 2018 11:45:59 AM To: DJS Cc: Clancy, Carolyn Subject: FW: NSO Survey Response and Appendix Sec Shulkin, I am forwarding the survey response provided today to the American College of Surgeons and the appendix list of references. I can forward the additional 7 emails with referenced documents if you wish. Sincerely, Bill From: Gunnar, William Sent: Monday, February 26, 2018 2:12 PM To: Clancy, Carolyn; David Hoyt Cc: Clifford Ko Subject: NSO Survey Response and Appendix Dave, I have attached the VHA National Surgery Office response to the ACS “Red Book” Survey and the Appendix index of attached documents. VA-18-0298-A-000005 The attached documents will be sent in a series of emails given document size. As discussed, Carolyn look forward to meeting following your review. Regards, Bill William Gunnar, MD, JD, FACHE National Director of Surgery 810 Vermont Ave NW Washington, DC 20420 202-461-7148 VA-18-0298-A-000006 - Owner: DJS DJS On Feb 26, 2018, at 4:50 PM, DJS wrote: > > FYI > > > > Sent with Good (www.good.com) > > ________________________________ > From: Gunnar, William > Sent: Monday, February 26, 2018 11:45:59 AM > To: DJS > Cc: Clancy, Carolyn > Subject: FW: NSO Survey Response and Appendix > > Sec Shulkin, > I am forwarding the survey response provided today to the American College of Surgeons and the appendix list of references. I can forward the additional 7 emails with referenced documents if you wish. > Sincerely, > Bill > > From: Gunnar, William > Sent: Monday, February 26, 2018 2:12 PM > To: Clancy, Carolyn; David Hoyt > Cc: Clifford Ko > Subject: NSO Survey Response and Appendix > > Dave, > I have attached the VHA National Surgery Office response to the ACS “Red Book” Survey and the Appendix index of attached documents. > The attached documents will be sent in a series of emails given document size. > As discussed, Carolyn look forward to meeting following your review. > Regards, > Bill > > William Gunnar, MD, JD, FACHE > National Director of Surgery VA-18-0298-A-000054 > 810 Vermont Ave NW > Washington, DC 20420 > 202-461-7148 > > > > > > > VA-18-0298-A-000055 From: To: DJS ; Bruce Moskowitz <(b) (6) @mac.com>; Ike Perlmutter < @frenchangel59.com> (b) (6), (b) (5) (b) (6) Cc: Bcc: Subject: Date: Attachments: FW: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... Sat Feb 24 2018 14:26:02 CST See below- may be worth discussing on Tuesday David Sent with Good (www.good.com) _____ From: (b) (6) Sent: Saturday, February 24, 2018 11:56:47 AM To: Shulkin, David J., MD Cc: Blackburn, Scott R.; (b) (6) Subject: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... Secretary Shulkin, (b) (6) I am writing to share some exciting feedback. Yesterday afternoon, and I had the pleasure of joining Scott and the team to review the status of some of our recommendations from the Jan 5th gathering, particularly around open APIs and the opportunity to better align with community providers. We are pleased to report your team appears to have successfully designed a contract that will reap interop benefits far beyond the VA. Signing this agreement, and encouraging community providers to join you in a "standards acceleration" effort as previously noted as a "pledge", will: -make care safer for vets who receive both community care and direct services from the VA; -accelerate by years an open API-based data sharing network by inspiring community care providers and their EHR vendors to reciprocate what your team will do in making more EHR data accessible via APIs than are currently planned for production absent your intervention; -unleash a true “apps economy” that will compete to delight veterans, clinicians, and care coordination service providers in the use of longitudinal health information for care decisions. To complement the specific provisions your team has negotiated with Cerner, the standards acceleration initiative ("pledge") is critical to ensuring your trading partners in the private sector/community can reciprocate in data sharing at the pace the VA will set. Launching this collaborative, in time for a possible HIMSS announcement, might warrant your personal VA-18-0298-A-000056 attention in recruiting CEOs to serve as charter members of what will be an open process. (b) (6) I'll defer to and Scott on the roster of CEOs you might wish to call, but I've circulated a DRAFT of the acceleration effort with CIOs and CEOs who have participated in the Jan 5th gathering and one of the White House EHR listening sessions I attended a week or two ago. I'm confident, if asked, they will join: Mayo Hopkins Cleveland Clinic Geisinger Intermountain Fairview (MN) (b) (6) others to consider: U. Washington, Partners, Rush, UPMC (and anyone else Scott/ suggest). Congratulations on taking what I presume was a good contract, to something closer to great on account of the impact it will have in making open, standards-based interop a reality faster than if you hadn't made this a priority. Regards, (b) (6) President (703) 672-(b) (6) This email is intended only for the person or entity to which it is addressed and may contain information that is privileged, confidential or otherwise protected from disclosure. Dissemination, distribution, or copying of this email or the information herein by anyone other than the intended recipient, or an employee or agent responsible for delivering the message to the intended recipient, is prohibited. If you have received this email in error, please immediately notify us. VA-18-0298-A-000057 From: To: Cc: Bcc: Subject: Date: Attachments: DJS (b) (6), (b) (5) RE: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... Sat Feb 24 2018 14:56:04 CST Good- that's the reason we need to discuss- I'm still learning this stuff Thanks Sent with Good (www.good.com) _____ From: Bruce Moskowitz Sent: Saturday, February 24, 2018 12:41:09 PM To: DJS Cc: marcbsherman; Ike Perlmutter Subject: Re: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... Will discuss with everyone. Open API does not depend on signing the Cerner contract. Also this term is being tossed around without a full understanding of what it accomplishes. Sent from my iPad Bruce Moskowitz M.D. > On Feb 24, 2018, at 3:26 PM, DJS wrote: > > See below- may be worth discussing on Tuesday > > David > > > > Sent with Good (www.good.com) > > ________________________________ > From: (b) (6) > Sent: Saturday, February 24, 2018 11:56:47 AM > To: Shulkin, David J., MD > Cc: Blackburn, Scott R.; (b) (6) > Subject: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... > > Secretary Shulkin, > VA-18-0298-A-000058 (b) (6) > I am writing to share some exciting feedback. Yesterday afternoon, and I had the pleasure of joining Scott and the team to review the status of some of our recommendations from the Jan 5th gathering, particularly around open APIs and the opportunity to better align with community providers. > > We are pleased to report your team appears to have successfully designed a contract that will reap interop benefits far beyond the VA. Signing this agreement, and encouraging community providers to join you in a "standards acceleration" effort as previously noted as a "pledge", will: > > -make care safer for vets who receive both community care and direct services from the VA; > > -accelerate by years an open API-based data sharing network by inspiring community care providers and their EHR vendors to reciprocate what your team will do in making more EHR data accessible via APIs than are currently planned for production absent your intervention; > > -unleash a true “apps economy” that will compete to delight veterans, clinicians, and care coordination service providers in the use of longitudinal health information for care decisions. > > To complement the specific provisions your team has negotiated with Cerner, the standards acceleration initiative ("pledge") is critical to ensuring your trading partners in the private sector/community can reciprocate in data sharing at the pace the VA will set. > > Launching this collaborative, in time for a possible HIMSS announcement, might warrant your personal attention in recruiting CEOs to serve as charter members of what will be an open process. > (b) (6) > I'll defer to and Scott on the roster of CEOs you might wish to call, but I've circulated a DRAFT of the acceleration effort with CIOs and CEOs who have participated in the Jan 5th gathering and one of the White House EHR listening sessions I attended a week or two ago. I'm confident, if asked, they will join: > > Mayo > Hopkins > Cleveland Clinic > Geisinger > Intermountain > Fairview (MN) > (b) (6) > others to consider: U. Washington, Partners, Rush, UPMC (and anyone else Scott/ suggest). > > Congratulations on taking what I presume was a good contract, to something closer to great on account of the impact it will have in making open, standards-based interop a reality faster than if you hadn't made this a priority. > > Regards, > > (b) (6) > President > (703) 672-(b) (6) > > > [(b) (6) > > This email is intended only for the person or entity to which it is addressed and may contain information that is privileged, confidential or otherwise protected from disclosure. Dissemination, distribution, or copying of this email or the information herein by anyone other than the intended recipient, or an employee or agent responsible for delivering the message to the intended recipient, is prohibited. If you have received this email in error, please immediately notify us. VA-18-0298-A-000059 From: Bruce Moskowitz (b) (6) To: Cc: Bcc: Subject: Date: Attachments: @mac.com> DJS ; (b) (6) Ike Perlmutter @frenchangel59.com> (b) (6), (b) (5) Re: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... Sat Feb 24 2018 14:41:09 CST Will discuss with everyone. Open API does not depend on signing the Cerner contract. Also this term is being tossed around without a full understanding of what it accomplishes. Sent from my iPad Bruce Moskowitz M.D. > On Feb 24, 2018, at 3:26 PM, DJS wrote: > > See below- may be worth discussing on Tuesday > > David > > > > Sent with Good (www.good.com) > > ________________________________ > From: (b) (6) > Sent: Saturday, February 24, 2018 11:56:47 AM > To: Shulkin, David J., MD > Cc: Blackburn, Scott R.; (b) (6) > Subject: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... > > Secretary Shulkin, > (b) (6) > I am writing to share some exciting feedback. Yesterday afternoon, and I had the pleasure of joining Scott and the team to review the status of some of our recommendations from the Jan 5th gathering, particularly around open APIs and the opportunity to better align with community providers. > > We are pleased to report your team appears to have successfully designed a contract that will reap interop benefits far beyond the VA. Signing this agreement, and encouraging community providers to join you in a "standards acceleration" effort as previously noted as a "pledge", will: > > -make care safer for vets who receive both community care and direct services from the VA; > > -accelerate by years an open API-based data sharing network by inspiring community care providers and their EHR vendors to reciprocate what your team will do in making more EHR data accessible via APIs than are currently planned for production absent your intervention; > > -unleash a true “apps economy” that will compete to delight veterans, clinicians, and care coordination service providers in the use of longitudinal health information for care decisions. > VA-18-0298-A-000061 > To complement the specific provisions your team has negotiated with Cerner, the standards acceleration initiative ("pledge") is critical to ensuring your trading partners in the private sector/community can reciprocate in data sharing at the pace the VA will set. > > Launching this collaborative, in time for a possible HIMSS announcement, might warrant your personal attention in recruiting CEOs to serve as charter members of what will be an open process. > (b) (6) > I'll defer to and Scott on the roster of CEOs you might wish to call, but I've circulated a DRAFT of the acceleration effort with CIOs and CEOs who have participated in the Jan 5th gathering and one of the White House EHR listening sessions I attended a week or two ago. I'm confident, if asked, they will join: > > Mayo > Hopkins > Cleveland Clinic > Geisinger > Intermountain > Fairview (MN) > (b) (6) > others to consider: U. Washington, Partners, Rush, UPMC (and anyone else Scott/ suggest). > > Congratulations on taking what I presume was a good contract, to something closer to great on account of the impact it will have in making open, standards-based interop a reality faster than if you hadn't made this a priority. > > Regards, > > (b) (6) > President > (703) 672-(b) (6) > > > > (b) (6) > > This email is intended only for the person or entity to which it is addressed and may contain information that is privileged, confidential or otherwise protected from disclosure. Dissemination, distribution, or copying of this email or the information herein by anyone other than the intended recipient, or an employee or agent responsible for delivering the message to the intended recipient, is prohibited. If you have received this email in error, please immediately notify us. > VA-18-0298-A-000062 From: To: Cc: Bcc: Subject: Date: Attachments: DJS ; Bruce Moskowitz (b) (6) @mac.com>; (b) @gmail.com> (b) (6), (b) (5) (b) (6) (6) FW: VA collaborates with ACS to review VA Surgical Program Quality Wed Feb 14 2018 13:56:39 CST Optimal Resources for Surgical Quality and Safety booklet.pdf We're getting close Sent with Good (www.good.com) _____ From: Gunnar, William Sent: Wednesday, February 14, 2018 11:53:41 AM To: (b) (6) Cc: DJS; Clancy, Carolyn Subject: VA collaborates with ACS to review VA Surgical Program Quality (b) (6) Sec Shulkin asked me to reach out to David Hoyt, MD, Executive Director of the American College of Surgeons (ACS) today regarding a collaboration between the VA and ACS that will analyze the quality of surgical services provided by VHA Surgery Programs. The ACS has a newly established process for reviewing the delivery of surgical services (see attached). The current plan is for ACS to examine the VHA surgery programs through data analysis and site visits to the VHA Surgery Programs located at Houston VAMC and Milwaukee VAMC. Speaking with Dr. Hoyt today, he is committed to the project and will work with you and your staff to collaborate on a press release for as early as tomorrow. He asked that you contact him directly at (b) (6) @facs.org. His office number is 312-202-(b) (6) Additional information regarding ACS can be found at www.facs.org and the ACS executive staff at https://www.facs.org/about-acs/governance/execstaff Let me know if there is anything I can do to assist you. I will notify the MCD and Chief of Staff of the Houston VAMC and Milwaukee VAMC as a heads up. Feel free to call me if you need additional information. VA-18-0298-A-000063 Bill Owner: DJS (b) (6), (b) (5) FW: [EXTERNAL] AATB Follow-up to January 19th VA Meeting Fri Feb 02 2018 16:11:57 CST LeaveBehindVATissueTrackingFINAL20180202.pdf VALetterFINAL20180202pdf.pdf Bruce - what do you think of this? Sent with Good (www.good.com) _____ From: (b) (6) Sent: Friday, February 02, 2018 10:37:35 AM To: Shulkin, David J., MD Cc: Clancy, Carolyn; Hyduke, Barbara; Nechanicky, Penny L.; Christy, Phillip; Icardi, Michael S.; (SAC); (b) (6) @lifelinkfound.org (b) (6) Subject: [EXTERNAL] AATB Follow-up to January 19th VA Meeting Secretary Shulkin: Please find attached a letter from the American Association of Tissue Banks (AATB) and the AATB Tissue Policy Group (TPG) to thank the Department of Veterans Affairs (VA) for a very productive meeting on January 19, 2018. We found the exchange of key information regarding biological implants (including human tissue products) very informative. As noted during the meeting, the AATB and the TPG would like to a partner with the VA to assist in the development of appropriate systems for tracking and tracing all devices, including human tissue devices. Please do not hesitate to contact us should you require additional information. Cordially, (b) (6) American Association of Tissue Banks (AATB) (b) (6) 8200 Greensboro Drive, Suite 320 VA-18-0298-A-000073 McLean, VA 22102 Email: (b) (6) @aatb.org Office: (703) 229-(b) (6) Fax: (703) 992-(b) (6) ——— REGISTER TODAY! 2018 Quality & Donor Eligibility Workshop April 30-May 2, 2018 Hyatt Regency Baltimore Inner Harbor 2018 AATB Annual Meeting October 9-12, 2018 Hyatt Regency Dallas at Reunion Find an AATB Accredited Bank Confidentiality Notice: This e-mail transmission may contain confidential or legally privileged information. If you received this message in error and are not the intended recipient: any disclosure, copying, distribution or reliance on the contents of this e-mail and any attachment is strictly prohibited; please reply to the sender so that delivery to the intended recipient can be made; and promptly delete the message from your inbox and trash folder without further review of its contents. VA-18-0298-A-000074 Owner: DJS (b) (6), (b) (5) RE: [EXTERNAL] AATB Follow-up to January 19th VA Meeting Fri Feb 02 2018 16:59:40 CST Ok Sent with Good (www.good.com) _____ From: Bruce Moskowitz Sent: Friday, February 02, 2018 2:58:45 PM To: DJS Subject: Re: [EXTERNAL] AATB Follow-up to January 19th VA Meeting Should be part of meeting for device registry Sent from my iPhone > On Feb 2, 2018, at 5:11 PM, DJS wrote: > > Bruce - what do you think of this? > > > > Sent with Good (www.good.com) > > ________________________________ > From: (b) (6) > Sent: Friday, February 02, 2018 10:37:35 AM > To: Shulkin, David J., MD > Cc: Clancy, Carolyn; Hyduke, Barbara; Nechanicky, Penny L.; Christy, Phillip; Icardi, Michael S.; (SAC); (b) (6) @lifelinkfound.org (b) (6) > Subject: [EXTERNAL] AATB Follow-up to January 19th VA Meeting > > Secretary Shulkin: > > Please find attached a letter from the American Association of Tissue Banks (AATB) and the AATB Tissue Policy Group (TPG) to thank the Department of Veterans Affairs (VA) for a very productive meeting on January 19, 2018. We found the exchange of key information regarding biological implants (including human tissue products) very informative. > > As noted during the meeting, the AATB and the TPG would like to a partner with the VA to assist in VA-18-0298-A-000080 the development of appropriate systems for tracking and tracing all devices, including human tissue devices. > > Please do not hesitate to contact us should you require additional information. > > Cordially, > > (b) (6) > American Association of Tissue Banks (AATB) > (b) (6) > 8200 Greensboro Drive, Suite 320 > McLean, VA 22102 > Email: (b) (6) @aatb.org > Office: (703) 229-(b) (6) > Fax: (703) 992-(b) (6) > ——— > REGISTER TODAY! > 2018 Quality & Donor Eligibility Workshop April 30-May 2, 2018 Hyatt Regency Baltimore Inner Harbor > 2018 AATB Annual Meeting October 9-12, 2018 Hyatt Regency Dallas at Reunion > Find an AATB Accredited Bank > Confidentiality Notice: This e-mail transmission may contain confidential or legally privileged information. If you received this message in error and are not the intended recipient: any disclosure, copying, distribution or reliance on the contents of this e-mail and any attachment is strictly prohibited; please reply to the sender so that delivery to the intended recipient can be made; and promptly delete the message from your inbox and trash folder without further review of its contents. > > VA-18-0298-A-000081 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) @mac.com> DJS On Feb 2, 2018, at 5:11 PM, DJS wrote: > > Bruce - what do you think of this? > > > > Sent with Good (www.good.com) > > ________________________________ > From: (b) (6) > Sent: Friday, February 02, 2018 10:37:35 AM > To: Shulkin, David J., MD > Cc: Clancy, Carolyn; Hyduke, Barbara; Nechanicky, Penny L.; Christy, Phillip; Icardi, Michael S.; (SAC); (b) (6) @lifelinkfound.org (b) (6) > Subject: [EXTERNAL] AATB Follow-up to January 19th VA Meeting > > Secretary Shulkin: > > Please find attached a letter from the American Association of Tissue Banks (AATB) and the AATB Tissue Policy Group (TPG) to thank the Department of Veterans Affairs (VA) for a very productive meeting on January 19, 2018. We found the exchange of key information regarding biological implants (including human tissue products) very informative. > > As noted during the meeting, the AATB and the TPG would like to a partner with the VA to assist in the development of appropriate systems for tracking and tracing all devices, including human tissue devices. > > Please do not hesitate to contact us should you require additional information. > > Cordially, > > (b) (6) > American Association of Tissue Banks (AATB) > (b) (6) r > 8200 Greensboro Drive, Suite 320 > McLean, VA 22102 > Email: (b) (6) @aatb.org VA-18-0298-A-000082 > Office: (703) 229-(b) (6) > Fax: (703) 992-(b) (6) > ——— > REGISTER TODAY! > 2018 Quality & Donor Eligibility Workshop April 30-May 2, 2018 Hyatt Regency Baltimore Inner Harbor > 2018 AATB Annual Meeting October 9-12, 2018 Hyatt Regency Dallas at Reunion > Find an AATB Accredited Bank > Confidentiality Notice: This e-mail transmission may contain confidential or legally privileged information. If you received this message in error and are not the intended recipient: any disclosure, copying, distribution or reliance on the contents of this e-mail and any attachment is strictly prohibited; please reply to the sender so that delivery to the intended recipient can be made; and promptly delete the message from your inbox and trash folder without further review of its contents. > > VA-18-0298-A-000083 From: To: Cc: Bcc: Subject: Date: Attachments: DJS (b) (6), (b) (5) RE: [EXTERNAL] Re: IPA Update Tue Jan 02 2018 14:02:15 CST If you have time call me- I'm on a long car ride (b) (6) Sent with Good (www.good.com) _____ From: Bruce Moskowitz Sent: Tuesday, January 02, 2018 11:56:03 AM To: DJS Subject: [EXTERNAL] Re: IPA Update Will explain the big D problem we spoke about Sundayoff line and how it relates to this. Sent from my iPhone > On Jan 2, 2018, at 2:48 PM, DJS wrote: > > > > Sent with Good (www.good.com) > > ________________________________ > From: DJS > Sent: Tuesday, January 02, 2018 11:14:56 AM > To: brucemoskowitz > Subject: FW: IPA Update > > Bruce- this below is encouraging- it's using the IPA contract to get help from academic centers. I wanted you to be aware to make sure you know this is an available mechanism for us to use when we identify help. I'd be glad to discuss more if helpful > > > David > > > > Sent with Good (www.good.com) VA-18-0298-A-000084 > > ________________________________ > From: Zenooz, Ashwini > Sent: Tuesday, January 02, 2018 8:22:18 AM > To: DJS > Cc: Blackburn, Scott R. > Subject: IPA Update > > Hello Dr. Shulkin: > > Happy New Year. > > I am sending you a note on IPAs ahead of the session coming up on hiring. After our last roundtable with MITRE, you had asked all the university participants to think about sending experts to VA through IPAs. I followed up on that with several university dean’s offices and have received very positive responses. > > >· After your visit to Yale, I connected with Harlan Krumholz who was very inspired by his conversation with you and he offered to take the lead on the IPA Transformation Center. > >· We now have a plan to source experts from universities and hospitals around the country in a strategic way, and his team is willing to coordinate the search & maintenance of the program through Yale Medical School (similar to what he does with CMS, NIH ad FDA). > >· I have identified 6 core areas requiring experts who can fill leadership and other positions in VHA/EHR space and associated hospital systems where the experts would come from (slide below). > >· In addition, we also have additional interest in having a group work with us through Dr. Shrestha at Univ. Of Pittsburgh. > >· The goal is to give you a larger pool of external experts who will be embedded into our system, have in-depth understanding of the work, produce literature and can bring in change by leading from the inside. > > Please let me know if you would like more information, any changes, approve/disapprove. Thanks, ash > > [cid:image003.png@01D383BB.F2C583F0] > > Ashwini Zenooz, MD > EHR Modernization > Department of Veterans Affairs > O: (202) 461-5903 > Assistant: (b) (6) @va.gov > Web: https://vaww.ehrm.va.gov/ > > VA-18-0298-A-000085 From: DJS Cc: Bcc: Subject: Date: Attachments: FW: IPA Update Tue Jan 02 2018 13:48:13 CST image003.png Sent with Good (www.good.com) _____ From: DJS Sent: Tuesday, January 02, 2018 11:14:56 AM To: brucemoskowitz Subject: FW: IPA Update Bruce- this below is encouraging- it's using the IPA contract to get help from academic centers. I wanted you to be aware to make sure you know this is an available mechanism for us to use when we identify help. I'd be glad to discuss more if helpful David Sent with Good (www.good.com) _____ From: Zenooz, Ashwini Sent: Tuesday, January 02, 2018 8:22:18 AM To: DJS Cc: Blackburn, Scott R. Subject: IPA Update Hello Dr. Shulkin: Happy New Year. VA-18-0298-A-000086 I am sending you a note on IPAs ahead of the session coming up on hiring. After our last roundtable with MITRE, you had asked all the university participants to think about sending experts to VA through IPAs. I followed up on that with several university dean’s offices and have received very positive responses. ********* After your visit to Yale, I connected with Harlan Krumholz who was very inspired by his conversation with you and he offered to take the lead on the IPA Transformation Center. ********* We now have a plan to source experts from universities and hospitals around the country in a strategic way, and his team is willing to coordinate the search & maintenance of the program through Yale Medical School (similar to what he does with CMS, NIH ad FDA). ********* I have identified 6 core areas requiring experts who can fill leadership and other positions in VHA/EHR space and associated hospital systems where the experts would come from (slide below). ********* In addition, we also have additional interest in having a group work with us through Dr. Shrestha at Univ. Of Pittsburgh. ********* The goal is to give you a larger pool of external experts who will be embedded into our system, have in-depth understanding of the work, produce literature and can bring in change by leading from the inside. Please let me know if you would like more information, any changes, approve/disapprove. Thanks, ash Ashwini Zenooz, MD EHR Modernization Department of Veterans Affairs O: (202) 461-5903 Assistant: (b) (6) @va.gov Web: https://vaww.ehrm.va.gov/ VA-18-0298-A-000087 Owner: DJS DJS On Jan 2, 2018, at 2:48 PM, DJS wrote: > > > > Sent with Good (www.good.com) > > ________________________________ > From: DJS > Sent: Tuesday, January 02, 2018 11:14:56 AM > To: brucemoskowitz > Subject: FW: IPA Update > > Bruce- this below is encouraging- it's using the IPA contract to get help from academic centers. I wanted you to be aware to make sure you know this is an available mechanism for us to use when we identify help. I'd be glad to discuss more if helpful > > > David > > > > Sent with Good (www.good.com) > > ________________________________ > From: Zenooz, Ashwini > Sent: Tuesday, January 02, 2018 8:22:18 AM > To: DJS > Cc: Blackburn, Scott R. > Subject: IPA Update > > Hello Dr. Shulkin: > > Happy New Year. > > I am sending you a note on IPAs ahead of the session coming up on hiring. After our last roundtable with MITRE, you had asked all the university participants to think about sending experts to VA through IPAs. I followed up on that with several university dean’s offices and have received very positive responses. > VA-18-0298-A-000090 > >· After your visit to Yale, I connected with Harlan Krumholz who was very inspired by his conversation with you and he offered to take the lead on the IPA Transformation Center. > >· We now have a plan to source experts from universities and hospitals around the country in a strategic way, and his team is willing to coordinate the search & maintenance of the program through Yale Medical School (similar to what he does with CMS, NIH ad FDA). > >· I have identified 6 core areas requiring experts who can fill leadership and other positions in VHA/EHR space and associated hospital systems where the experts would come from (slide below). > >· In addition, we also have additional interest in having a group work with us through Dr. Shrestha at Univ. Of Pittsburgh. > >· The goal is to give you a larger pool of external experts who will be embedded into our system, have in-depth understanding of the work, produce literature and can bring in change by leading from the inside. > > Please let me know if you would like more information, any changes, approve/disapprove. Thanks, ash > > [cid:image003.png@01D383BB.F2C583F0] > > (b) (6) , MD > EHR Modernization > Department of Veterans Affairs > O: (202) 461-(b) (6) > Assistant:(b) (6) @va.gov > Web: https://vaww.ehrm.va.gov/ > > VA-18-0298-A-000091 From: To: Cc: Bruce Moskowitz <(b) (6) @mac.com> DJS ; Bowman, Thomas ; (b) (6) @gmail.com <(b) (6) @gmail.com>; Marc Sherman <(b) gmail.com> (b)(6)(6) (b) (6), (b) (5) (b) (6) (b) (6), (b) (5) Bcc: Subject: Date: Attachments: Re: [EXTERNAL] Shulkin Interview on FoxNews - Friday, October 20, 2017 Sun Oct 22 2017 08:29:18 CDT Well done! Sent from my iPad Bruce Moskowitz M.D. > On Oct 22, 2017, at 8:50 AM, DJS wrote: > > Thank you Ike- the President saw it as well and called me- he had you exact sentiments and asked about how you and Laurie are and said to pass on his regards (that was on my list to do today) > > David > > > > Sent with Good (www.good.com) > > ________________________________ > From: IP > Sent: Sunday, October 22, 2017 3:11:05 AM > To: DJS > Cc: Bowman, Thomas; (b) (6) @gmail.com; Marc Sherman; (b) (6) @mac.com' > Subject: [EXTERNAL] Shulkin Interview on FoxNews - Friday, October 20, 2017 > > David, > > I caught your interview Friday on Fox news and want to congratulate you. You were superb. Your responses that focused on the VA and the principal issue of veterans' care was right on point. That interview really did a great service to what you (and we) are doing to improve the quality of care for our veterans for the long term. > > Ike > > http://www.foxnews.com/transcript/2017/10/20/va-secretary-brave-soldiers-dont-deserve-to-bepoliticized.html > VA-18-0298-A-000092 From: To: Cc: Bcc: Subject: Date: Attachments: DJS (b) (6), (b) (5) RE: [EXTERNAL] Re: FW: VA issue - From Karen Donnelly Thu Sep 07 2017 10:55:16 CDT I agree thanks Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) @mac.com] Sent: Thursday, September 07, 2017 11:43 AM Eastern Standard Time To: Marc Sherman Cc: DJS; (b) (6) IP Subject: Re: [EXTERNAL] Re: FW: VA issue - From Karen Donnelly To the patient it should be that the VA person can steer him in the right direction regardless. Sent from my iPhone On Sep 7, 2017, at 11:34 AM, Marc Sherman <(b) (b)(6)(6) gmail.com> wrote: That was my first reaction when I read the story, but doubted myself when the problem was solved by someone in Building 10 at the VA hospital. Does that make sense? Ike, if this is a DOD problem/issue, perhaps you should pass this on to someone who can get it to the DOD. Marc Sherman (202) 758-(b) (6) On Sep 7, 2017 11:27 AM, "DJS" wrote: I think this is the department of defense and not VA Sent with Good (www.good.com) VA-18-0298-A-000093 -----Original Message----From: Marc Sherman [(b) gmail.com] (b)(6)(6) Sent: Thursday, September 07, 2017 10:07 AM Eastern Standard Time To: IP Cc: (b) (6) Bruce Moskowitz; DJS Subject: [EXTERNAL] Re: FW: VA issue - From Karen Donnelly David Assuming this email recounts the facts even somewhat accurately, i see huge implications...the system imposes hardships and anxiety that no one, especially someone hurting and crying for help, should have to endure. I would doubt that this is an isolated incident. Does it deserve a systemic examination of the existing policies and protocols and possible revamp (along with the ever-present required culture shock treatment) of the process? Marc Marc Sherman (202) 758-(b) (6) (b) (6) On Sep 7, 2017 9:47 AM, "IP" < @frenchangel59.com> wrote: David, I would like to share with you another real life example of the issues our great veterans are suffering with when trying to work with the VA. I know we are making very good progress, but this is an excellent reminder that we are also still very far away from achieving our goals. Thank you, Ike From: (b) (6) Sent: Tuesday, September 05, 2017 6:50 PM To: (b) (6) (b) (6) @gmail.com); IP Subject: FW: VA issue - From (b) (6) FYI From: (b) (6) [mailto:(b) (6) @fitegroup.co-m] VA-18-0298-A-000094 Sent: Tuesday, September 05, 2017 6:44 PM To: (b) (6) Subject: VA issue (b) (6) Ike wanted me to send him this info about my son and the trouble he had with trying to access his Military Medical Records: - (b) (6) (b) (6) VA-18-0298-A-000095 and From: To: Cc: DJS ; (b) (6) (b) (6) @mail.med.upenn.edu> Shulkin, David J., MD ; (b) (6) @hotmail.com>; (b) gmail.com (b)(6)(6) (b) (6) gmail.com>; IP < @frenchangel59.com>; (b) (6) (b) (6) (b) (6) @gmail.com> (b) (6), (b) (5) (b) (6), (b) (5) (b) (6) Bcc: Subject: Date: Attachments: RE: [EXTERNAL] Re: suicide efforts at Penn Thu Jun 01 2017 18:18:18 CDT I agree- thank you Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) @mac.com] Sent: Thursday, June 01, 2017 03:06 PM Eastern Standard Time To: (b) (6) Cc: Shulkin, David J., MD; (b) (6) ; Poonam Alaigh; (b) (6) Subject: [EXTERNAL] Re: suicide efforts at Penn gmail.com; IP; (b) (6) Thank you this is excellent Sent from my iPad Bruce Moskowitz M.D. On Jun 1, 2017, at 2:58 PM, (b) (6) @mail.med.upenn.edu> wrote: Dear Drs. Shulkin and Moskowitz, I just met with Dr. (b) (6) (Chairman of Psychiatry at the Philadelphia VAMC) and we will be pulling together a meeting of investigators to generate some ideas about suicide research in the VA, probably in collaboration with other VAMCs. We will be in touch soon. Cheers! (b) (6) (b) (6) , M.D., Ph.D. Professor and Chairman of Psychiatry Perelman School of Medicine, University of Pennsylvania VA-18-0298-A-000098 American Psychiatric Association, Immediate Past President International Academy of Suicide Research, President NOTE NEW E MAIL ADDRESS (b) (6) @mail.med.upenn.edu 3535 Market Street, Suite 200 Philadelphia, PA 19104-3309 Telephone: 215.662.(b) (6) Fax: 215.662.(b) (6) On May 30, 2017, at 4:31 PM, (b) (6) @mail.med.upenn.edu> wrote: (b) (6) (b) (6) , M.D., Ph.D. Professor and Chairman of Psychiatry Perelman School of Medicine, University of Pennsylvania American Psychiatric Association, Immediate Past President International Academy of Suicide Research, President NOTE NEW E MAIL ADDRESS (b) (6) @mail.med.upenn.edu 3535 Market Street, Suite 200 Philadelphia, PA 19104-3309 Telephone: 215.662.(b) (6) Fax: 215.662.(b) (6) VA-18-0298-A-000099 From: To: Bruce Moskowitz <(b) (6) @mac.com> ; DJS (b) (6) (b) (6), (b) (5) Cc: Bcc: Subject: Date: Attachments: (6) [EXTERNAL] Fwd: Call re: Veterans Medical Treatment Pilot Project Fri Apr 28 2017 06:26:42 CDT EAS (b) (6) will set up Sent from my iPad Bruce Moskowitz M.D. Begin forwarded message: From: "(b) (6) @Bruce Moskowitz,MD" (b) (6) @gmail.com> Date: April 27, 2017 at 3:26:14 PM EDT To: Bruce Moskowitz <(b) (6) @mac.com> Subject: Fwd: Call re: Veterans Medical Treatment Pilot Project FYI I scheduled the call for 6/14 @ 4:00pm ---------- Forwarded message ---------From: (b) (6) @vikings.nfl.net> Date: Thu, Apr 27, 2017 at 2:53 PM Subject: Call re: Veterans Medical Treatment Pilot Project To: (b) (6) @gmail.com" (b) (6) @gmail.com> Hi (b) (6) Thanks for your help in scheduling a call with Dr. Moskowitz and the Minnesota Vikings. It would be with (b) (6) , COO; (b) (6) , EVP of Public Affairs; and (b) (6) , VP of Legal and HR. 6/14 – 4:00 p.m. or 5:00 p.m. ET 6/15 – 12:00 p.m. ET 6/20 – 2:00 or 2:30 p.m. ET VA-18-0298-A-000100 Thanks again. (b) (6) Executive Assistant to Owners Minnesota Vikings Football, LLC 9520 Viking Drive Eden Prairie, Minnesota 55344 P: (952) 828-(b) (6) F: (952) 828-(b) (6) E: (b) (6) @vikings.nfl.net :IMAGES:Facebook.png _____ The information contained in this transmission may contain privileged and confidential information. It is intended only for the use of the person(s) named above. If you are not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message. To reply to our email administrator directly, please send an email to administrator-min@vikings.nfl.-net -- (b) (6) , MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Me Attachments: image001.jpg (3328 Bytes) image002.jpg (1293 Bytes) image003.jpg (1325 Bytes) image005.jpg (1146 Bytes) VA-18-0298-A-000101 Owner: Filename: Last Modified: Bruce Moskowitz <(b) (6) EAS Fri Apr 28 06:26:42 CDT 2017 @mac.com> VA-18-0298-A-000103 Dncment Attachmant Kama: EAS Locatur: :53. QTUT4 Vote?feti Action Fund VA'Batch 1 Dubs-David ShuJJ-Ein". ?134? dc44 ?164 ebb?i? gb?dd? de?d?48?b0?: Reason This ?le i5 empty (1.3-: its. length is. EEID bytes.) VA-1 8-0298-A-000104 (b) (6) Subject: Location: Phone Call with (b) (6) Phone Call: 888-204- (American College of Surgeons) per Dr. Bruce Moskowitz Access code: Start: End: Wed 2/15/2017 10:00 AM Wed 2/15/2017 10:30 AM Recurrence: (none) Organizer: Shulkin, David J., MD Categories: Yellow Category (b) (6), (b) (5) (b) (6), (b) (5)   (b) (6) MD, FACS CEO and Executive Medical Director Miami Cancer Institute 3rd Floor Executive Offices 8900 North Kendall Dr Miami, FL 33176 Office: 786 527(b) (6)   Cell: 617 543-(b) (6) 1 VA-18-0298-A-000105 (b) (6) From: Sent: To: Cc: Subject: (b) (6) Wednesday, February 08, 2017 8:16 AM 'Bruce Moskowitz' (b) (6) RE: [EXTERNAL] Re: Group meeting Dr. Bruce Moskowitz,     2/15 at 10am  works for Dr. Shulkin. Let us know if you would like for our team to send an invite.      (b) (6) Chief Administrative Officer Office of the Under Secretary for Health Veterans Health Administration 202-461-(b) (6) 202-834-(b) (Blackberry) (6)         From: Bruce Moskowitz [mailto:(b) (6) Sent: Wednesday, February 08, 2017 7:01 AM To: David Shulkin Cc: (b) (6) Subject: [EXTERNAL] Re: Group meeting @mac.com] Aware Politico said this week. Sent from my iPad Bruce Moskowitz M.D. On Feb 8, 2017, at 6:06 AM, David Shulkin <(b) (6) (b) (6) > wrote: Bruce- this was not the confirmation vote- it was a committee vote- we still need a floor vote (b) (6) can help arrange a call Sent from my iPad On Feb 8, 2017, at 6:00 AM, Bruce Moskowitz (b) (6) @mac.com> wrote: Congratulations I was unanimous. I will set up call with (b) (6) American College of Surgeons. Give me a good time for you. for Sent from my iPad 1 VA-18-0298-A-000106 Bruce Moskowitz M.D. On Feb 7, 2017, at 9:57 PM, David Shulkin <(b) (6) > wrote: I would like to echo Bruce's comments and in particular thank him, Ike, and (b) (6) I know how busy all of you are and having you be there in person, and so present, was truly a gift. I found the time that we spent, the focus that came out of our discussions, and the time we had with the President very meaningful. I think we all believe that we can and need to provide better care to our veterans and I am grateful for your involvement. David -----Original Message----From: Bruce Moskowitz <(b) (6) @mac.com> To: (b) (6) @partners.org>; (b) (6) @ccf.org>; (b) (6) @jhmi.edu>; (b) (6) @mayo.edu>;(b) (6) @mayo.edu>; (b) (6) @kp.org>; mbsherman (b) (6) @gmail.com>; (b) (6) @hopeunseen.com>; IP <( @frenchangel59.com>; (b) (6) b (b) (6) @gmail.com>; drshulkin Sent: Tue, Feb 7, 2017 1:44 pm ) Subject: Group meeting ( 6 I would like to thank everyone for )their dedication and very important insight so that we can transition from vision to reality. We do not need to meet in person monthly, but meet face to face only when necessary to respect everyone's valuable time. We will set up phone conference calls at a convenient time. Have a safe trip back. Sent from my iPad Bruce Moskowitz M.D. 2 VA-18-0298-A-000107 (b) (6) From: Sent: Cc: Subject: @Bruce Moskowitz,MD (b) (6) Wednesday, February 08, 2017 2:18 PM (b) (6) Re: [EXTERNAL] Re: Group meeting (b) (6) @gmail.com> Hi Everyone: Dr. Moskowitz wanted me to forward you the information for your call. (b) (6), The call in number is - 888-204-(b) (5) (b) (6), (b) (5) Access code is (b) (6) On Wed, Feb 8, 2017 at 8:24 AM, Bruce Moskowitz <(b) (6) @mac.com> wrote: Thank you (b) (6) will arrange call in info Sent from my iPhone On Feb 8, 2017, at 8:16 AM, (b) (6) . <(b) (6) @va.gov> wrote: Dr. Bruce Moskowitz,    2/15 at 10am  works for Dr. Shulkin. Let us know if you would like for our team to send an invite.     (b) (6) Chief Administrative Officer Office of the Under Secretary for Health Veterans Health Administration 202-461-(b) (6) 202-834-(b) (6) (Blackberry)     1 VA-18-0298-A-000108     From: Bruce Moskowitz [mailto(b) (6) Sent: Wednesday, February 08, 2017 7:01 AM To: David Shulkin Cc: (b) (6) Subject: [EXTERNAL] Re: Group meeting @mac.com] Aware Politico said this week. Sent from my iPad Bruce Moskowitz M.D. On Feb 8, 2017, at 6:06 AM, David Shulkin <(b) (6) > wrote: Bruce- this was not the confirmation vote- it was a committee vote- we still need a floor vote (b) (6) can help arrange a call Sent from my iPad On Feb 8, 2017, at 6:00 AM, Bruce Moskowitz <(b) (6) wrote: @mac.com> Congratulations I was unanimous. I will set up call with (b) (6) time for for American College of Surgeons. Give me a good you. Sent from my iPad Bruce Moskowitz M.D. On Feb 7, 2017, at 9:57 PM, David Shulkin <(b) (6) wrote: > I would like to echo Bruce's comments and in particular thank him, Ike, and (b) (6) I know how busy all of you are and having you be there in person, and so present, was truly a gift. I found the time that we spent, 2 VA-18-0298-A-000109 the focus that came out of our discussions, and the time we had with the President very meaningful. I think we all believe that we can and need to provide better care to our veterans and I am grateful for your involvement. David -----Original Message----From: Bruce Moskowitz <(b) (6) @mac.com> To: (b) (6) @partners.org>; (b) (6) @ccf.org>; (b) (6) @jhmi.edu>; (b) (6) @mayo.edu>; (b) (6) @mayo.edu>; (b) (6) @kp.org>; mbsherman <(b) (6) @gmail.com>; (b) (6) @hopeunseen.com>; (b ) @frenchangel59.com>; L Perl (b) (6) (6 @gmail.com>; drshulkin (b) (6) (b) ) (6) 7, 2017 1:44 pm Sent: Tue, Feb Subject: Group meeting I would like to thank everyone for their dedication and very important insight so that we can transition from vision to reality. We do not need to meet in person monthly, but meet face to face only when necessary to respect everyone's valuable time. We will set up phone conference calls at a convenient time. Have a safe trip back. Sent from my iPad Bruce Moskowitz M.D. -(b) (6) , MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x (b ) Fax: 561-833-(b) (6) (6) 3 VA-18-0298-A-000110 (b) (6) From: Sent: To: Cc: Subject: (b) (6) (b) (6) @baptisthealth.net> Wednesday, February 08, 2017 4:57 PM (b) (6) @Bruce Moskowitz,MD (b) (6) (b) (6) (b) (6) Re: [EXTERNAL] Re: Group meeting Pls make sure (b) (6) is on all calendar emails. Pls (b) (6) Sent from my iPhone On Feb 8, 2017, at 11:18 AM, (b) (6) @gmail.com> wrote: Hi Everyone: Dr. Moskowitz wanted me to forward you the information for your call. (b) (6), The call in number is - 888-204-(b) (5) (b) (6), (b) (5) Access code is (b) (6) On Wed, Feb 8, 2017 at 8:24 AM, Bruce Moskowitz <(b) (6) @mac.com> wrote: Thank you (b) (6) will arrange call in info Sent from my iPhone On Feb 8, 2017, at 8:16 AM, (b) (6) wrote: @va.gov> Dr. Bruce Moskowitz,    2/15 at 10am  works for Dr. Shulkin. Let us know if you would like for our team to send  an invite.     (b) (6) Chief Administrative Officer Office of the Under Secretary for Health Veterans Health Administration 1 VA-18-0298-A-000111 202-461-(b) (6) 202-834-(b) (6) (Blackberry)         From: Bruce Moskowitz [mailto:(b) (6) Sent: Wednesday, February 08, 2017 7:01 AM To: David Shulkin Cc: (b) (6) Subject: [EXTERNAL] Re: Group meeting @mac.com] Aware Politico said this week. Sent from my iPad Bruce Moskowitz M.D. On Feb 8, 2017, at 6:06 AM, David Shulkin <(b) (6) (b) (6) > wrote: Bruce- this was not the confirmation vote- it was a committee vote- we still need a floor vote (b) (6) can help arrange a call Sent from my iPad On Feb 8, 2017, at 6:00 AM, Bruce Moskowitz @mac.com> wrote: (b) (6) Congratulations I was unanimous. I will set up call with (b) (6) for American College of Surgeons. Give me a good time for you. Sent from my iPad 2 VA-18-0298-A-000112 Bruce Moskowitz M.D. On Feb 7, 2017, at 9:57 PM, David Shulkin (b) > wrote: (b) (6) (6) I would like to echo Bruce's comments and in particular thank him, Ike, and (b) (6) I know how busy all of you are and having you be there in person, and so present, was truly a gift. I found the time that we spent, the focus that came out of our discussions, and the time we had with the President very meaningful. I think we all believe that we can and need to provide better care to our veterans and I am grateful for your involvement. David -----Original Message----From: Bruce Moskowitz <(b) (6) @mac.com> To: (b) (6) partners.org>; (b) (6) @ccf.org>; (b) (6) @jhmi.edu>; (b) (6) @mayo.edu>; (b) @mayo.edu>; (6) (b) (6) @kp.org>; mbsherman @gmail.com>; (b) (6) @hopeunseen.com>; IP <( @frenchangel59.com>; (b) b (6) @gmail.com>; drshulkin (b) (b) ) (6) > (6) 7, 2017 1:44 pm Sent: Tue, Feb ( Subject: Group meeting 6 ) I would like to thank everyone for their dedication and very important insight so that we can transition from vision to reality. We do not need to meet in person monthly, but meet face to face only when necessary to respect everyone's valuable time. We will set up phone conference calls at a convenient time. Have a safe trip back. (b) (6) 3 VA-18-0298-A-000113 Sent from my iPad Bruce Moskowitz M.D. -(b) (6) , MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x (b ) Fax: 561-833-(b) (6) (6) This message originates from Baptist Health South Florida (BHSF). It contains information that may be confidential or privileged and is intended only for the individuals or entity named above. It is prohibited for anyone else to disclose, copy, distribute or use the contents of this message. This message may not be copied or distributed without this disclaimer. All personal messages express views solely of the sender, which are not to be attributed to BHSF. If you received this message in error, please notify us immediately at postmaster@baptisthealth.net. BHSF scanned this email for viruses, vandals and malicious content 4 VA-18-0298-A-000114 (b) (6) From: Sent: Cc: Subject: (b) (6) @Bruce Moskowitz,MD <(b) (6) Wednesday, February 08, 2017 2:18 PM (b) (6) Re: [EXTERNAL] Re: Group meeting @gmail.com> Hi Everyone: Dr. Moskowitz wanted me to forward you the information for your call. (b) (6), The call in number is - 888-204-(b) (5) (b) (6), (b) (5) Access code is (b) (6) On Wed, Feb 8, 2017 at 8:24 AM, Bruce Moskowitz <(b) (6) @mac.com> wrote: Thank you (b) (6) will arrange call in info Sent from my iPhone On Feb 8, 2017, at 8:16 AM, (b) (6) @va.gov> wrote: Dr. Bruce Moskowitz,    2/15 at 10am  works for Dr. Shulkin. Let us know if you would like for our team to send an invite.     (b) (6) Chief Administrative Officer Office of the Under Secretary for Health Veterans Health Administration 202-461-(b) (6) (b) (6) 202-834- (Blackberry)     1 VA-18-0298-A-000115     From: Bruce Moskowitz [mailto:(b) (6) Sent: Wednesday, February 08, 2017 7:01 AM To: David Shulkin Cc: (b) (6) Subject: [EXTERNAL] Re: Group meeting @mac.com] Aware Politico said this week. Sent from my iPad Bruce Moskowitz M.D. On Feb 8, 2017, at 6:06 AM, David Shulkin <(b) (6) > wrote: Bruce- this was not the confirmation vote- it was a committee vote- we still need a floor vote (b) (6) can help arrange a call Sent from my iPad On Feb 8, 2017, at 6:00 AM, Bruce Moskowitz (b) (6) wrote: @mac.com> Congratulations I was unanimous. I will set up call with (b) (6) time for for American College of Surgeons. Give me a good you. Sent from my iPad Bruce Moskowitz M.D. On Feb 7, 2017, at 9:57 PM, David Shulkin <(b) (6) wrote: > I would like to echo Bruce's comments and in particular thank him, Ike, and (b) (6) I know how busy all of you are and having you be there in person, and so present, was truly a gift. I found the time that we spent, 2 VA-18-0298-A-000116 the focus that came out of our discussions, and the time we had with the President very meaningful. I think we all believe that we can and need to provide better care to our veterans and I am grateful for your involvement. David -----Original Message----From: Bruce Moskowitz (b) (6) @mac.com> To: (b) (6) @partners.org>; (b) (6) @ccf.org>; (b) (6) @jhmi.edu>; (b) (6) @mayo.edu>; (b) (6) @mayo.edu>; (b) (6) @kp.org>; mbsherman (b) (6) @gmail.com>; (b) (6) @hopeunseen.com>; IP <( @frenchangel59.com>; (b) (6) b @gmail.com>; drshulkin (b) (b) ) (6) (6) 7, 2017 1:44 pm Sent: Tue, Feb ( Subject: Group meeting 6 ) I would like to thank everyone for their dedication and very important insight so that we can transition from vision to reality. We do not need to meet in person monthly, but meet face to face only when necessary to respect everyone's valuable time. We will set up phone conference calls at a convenient time. Have a safe trip back. Sent from my iPad Bruce Moskowitz M.D. -(b) (6) , MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x (b) (6) Fax: 561-833-(b) (6) 3 VA-18-0298-A-000117 (b) (6) From: Sent: To: Cc: Subject: Bruce Moskowitz <(b) (6) @mac.com> Wednesday, February 08, 2017 8:24 AM (b) (6) (b) (6) (b) (6) Re: [EXTERNAL] Re: Group meeting Thank you (b) (6) will arrange call in info Sent from my iPhone On Feb 8, 2017, at 8:16 AM, (b) (6) @va.gov> wrote: Dr. Bruce Moskowitz,    2/15 at 10am  works for Dr. Shulkin. Let us know if you would like for our team to send an invite.     (b) (6) Chief Administrative Officer Office of the Under Secretary for Health Veterans Health Administration 202-461-(b) (b) (6)(6) 202-834(Blackberry)         From: Bruce Moskowitz [mailto:(b) (6) Sent: Wednesday, February 08, 2017 7:01 AM To: David Shulkin Cc: (b) (6) . Subject: [EXTERNAL] Re: Group meeting @mac.com] Aware Politico said this week. Sent from my iPad Bruce Moskowitz M.D. On Feb 8, 2017, at 6:06 AM, David Shulkin <(b) (6) (b) (6) > wrote: Bruce- this was not the confirmation vote- it was a committee vote- we still need a floor vote (b) (6) can help arrange a call Sent from my iPad 1 VA-18-0298-A-000118 On Feb 8, 2017, at 6:00 AM, Bruce Moskowitz <(b) (6) wrote: @mac.com> Congratulations I was unanimous. I will set up call with (b) (6) time for for American College of Surgeons. Give me a good you. Sent from my iPad Bruce Moskowitz M.D. On Feb 7, 2017, at 9:57 PM, David Shulkin <(b) (6) wrote: (b) (6) > I would like to echo Bruce's comments and in particular thank him, Ike, and (b) (6) I know how busy all of you are and having you be there in person, and so present, was truly a gift. I found the time that we spent, the focus that came out of our discussions, and the time we had with the President very meaningful. I think we all believe that we can and need to provide better care to our veterans and I am grateful for your involvement. David -----Original Message----From: Bruce Moskowitz (b) (6) @mac.com> To: (b) (6) @partners.org>; (b) (6) @ccf.org>; (b) (6) @jhmi.edu>; (b) (6) @mayo.edu>; (b) (6) @mayo.edu>; (b) (6) @kp.org>; mbsherman <(b) (6) @gmail.com>; (b) (6) @hopeunseen.com>; IP <( @frenchangel59.com>; (b) (6) b @gmail.com>; drshulkin (b) (b) ) (6) (6) 7, 2017 1:44 pm Sent: Tue, Feb ( Subject: Group meeting 6 ) I would like to thank everyone for their dedication and very important insight so that we can transition from vision to reality. We do not need to meet in person monthly, but meet face to face only when necessary to respect everyone's valuable time. We will set up phone conference calls at a convenient time. Have a safe trip back. Sent from my iPad Bruce Moskowitz M.D. 2 VA-18-0298-A-000119 (b) (6) Subject: Location: Follow Up Call w/Johnson & Johnson SecVA Suite- we call Start: End: Mon 4/17/2017 2:00 PM Mon 4/17/2017 2:30 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category Dial‐in Information:  (6), US: 1‐866‐244‐(b) (b) (5)   (6), International: 719‐457‐(b) (b) (5)     Passcode: (b) (6), (b) (5) From: (b) (6) [mailto:(b) @frenchangel59.com] Sent: Friday, March 31, 2017(6) 4:58 PM To: (b) (6) .; (b) (6) Subject: [EXTERNAL] Follow up meeting - Johnson and Johnson ****Please let me know the dates and times that work for Secretary Shulkin****    Johnson and Johnson is looking to set‐up a 30 minute follow‐up conference call with the original group from  the February 28th call. The team agreed to talk again in 4‐6 weeks.   Please let me know if April 10th or 17th work for you and the best time.    Below are the dates and times J&J gave us:     April 10th: ((b) (6)  not available – but we can fill her in)  10:30 – 12:00 noon  1:00 – 2:00 p.m.   4:30 – 5:30 p.m.     April 17:  1:30 – 3:00 p.m.       Conference call with Johnson and Johnson    (b) (6) , Chairman and CEO      Official Titles:  (b) (6) , Vice President Federal Affairs  (b) (6) , Vice President Janssen Supply Chain  (heads the veterans group)  (b) (6) , Global TA Head, Neuroscience  1 VA-18-0298-A-000120   1. Ms. (b) (6) 2. Mr. (b) (6) 3. Dr. (b) (6)  – works in Government Affairs     – head of their Veterans Leadership Council    – works on veterans issues such as depression, PTSD, Traumatic Brain injury, etc.       Participants:  (b) (6) , Chairman and CEO (Johnson & Johnson), (b) (6) , (b) (6) Secretary David Shulkin (White House), Dr. Bruce Moskowitz, Marc Sherman, (b) (6) and Ike      and Dr. (b) (6)    (Chair, Mayo Clinic)    2 VA-18-0298-A-000121 (b) (6) Subject: Location: Conference Call w/Dr. Moskowitz (6), (b) (6), (b) (5) we call 1-888-204-(b) (b) (5) Start: End: Tue 5/23/2017 5:30 PM Tue 5/23/2017 6:00 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category 888-204-(b) (6), (b) (6), Access code: (b) (5) (b) (5) Conference call Shulkin/Alaigh/(b) /(b) (6) (6) /(b) (6) From: (b) (6) @Bruce Moskowitz,MD [mailto:(b) (6) Sent: Tuesday, May 16, 2017 8:43 AM To: (b) (6) Subject: Re: [EXTERNAL] Conference call /Moskowitz @gmail.com] Can you please hold May 23 @ 5:30 pm as I am still waiting to hear from one participant. Thanks! On Mon, May 15, 2017 at 10:42 AM, (b) (6) <(b) (6) @va.gov> wrote: May 23 5:30‐6:30pm May 24 4‐5pm   From: (b) (6) @Bruce Moskowitz,MD [mailto:(b) (6) Sent: Monday, May 15, 2017 10:15 AM @gmail.com] To: (b) (6) Subject: Re: [EXTERNAL] Conference call How about dates for the week of May 22? On Mon, May 15, 2017 at 10:12 AM, (b) (6) <(b) (6) @va.gov> wrote: 8‐9am on Friday.  He’ll be en route to the airport. 1 VA-18-0298-A-000122   From: (b) (6) @Bruce Moskowitz,MD [mailto:(b) (6) Sent: Monday, May 15, 2017 7:42 AM To: (b) (6) @gmail.com] Subject: Re: [EXTERNAL] Conference call (b) (6) Is it possible to get a few more dates as well, just in case May 18 doesn't work with everyone's schedule? Thanks! (b) (6) On Fri, May 12, 2017 at 3:48 PM, (b) (6) <(b) (6) @va.gov> wrote: The Secretary is doing a fair amount of traveling next week.  We could do on Thursday, May 18 at 5pm.  Does  this work for the group?  Thank you.   (b) (6)   From: (b) (6) @Bruce Moskowitz,MD [mailto:(b) (6) Sent: Wednesday, May 10, 2017 8:16 AM To: (b) (6) Cc: (b) (6) ; (b) (6) Subject: Re: [EXTERNAL] Conference call @gmail.com] Thanks so much! Next week (or later) will be fine as Dr. Moskowitz will be in NYC with his family this Thursday and Friday so I'm trying not to schedule anything on those days. 2 VA-18-0298-A-000123 I know Dr. Alaigh's schedule is pretty booked up as well, so don't hesitate to send me as many dates/times as possible. Thanks again! (b) (6) On Wed, May 10, 2017 at 8:06 AM, (b) (6) . <(b) (6) @va.gov> wrote: Good Morning (b) (6)   I know the Secretary has two hearings this week , but adding Ms. (b)  to see if she has time later this week. (6)   LPW   From: (b) (6) @Bruce Moskowitz,MD [mailto:(b) (6) Sent: Wednesday, May 10, 2017 8:01 AM To: (b) (6) . Subject: [EXTERNAL] Conference call Importance: High @gmail.com] Good Morning (b) (6) Dr. Moskowitz has asked me to set up a call with Secretary Shulkin, Dr. Alaigh, Dr. (b) (6) and Dr. (b) (6) If you could forward me some times that the Secretary is available, I will try and coordinate the call with the others. Thanks! 3 VA-18-0298-A-000124 (b) (6) -(b) (6) , MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x (b) (6) Fax: 561-833-(b) (6) -(b) (6) , MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x (b) (6) Fax: 561-833-(b) (6) -(b) (6) , MPA 4 VA-18-0298-A-000125 Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x (b) (6) Fax: 561-833-(b) (6) -(b) (6) , MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x (b) (6) Fax: 561-833-(b) (6) -(b) (6) , MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x (b) (6) 5 VA-18-0298-A-000126 Fax: 561?833- VA-18-0298-A-000127 (b) (6) Subject: Conference Call w/Alaigh/(b) (6) (6), /(b) (6) /Moskowitz - We dial 888-204-(b) (b) (5) (b) (6), (b) (5) Location: SecVA Suite Start: End: Tue 5/30/2017 4:00 PM Tue 5/30/2017 4:30 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category (b) (6) SecVA wanted to attend this if possible on his calendar Manage all your calendars in one place.  Download the Google Calendar app.           more details »     Conference call Alaigh/(b) (6) /(b) (6) /Moskowitz  (6), Call in number: 888‐204‐(b) (b) (5)   (b) (6), (b) (5) Access code:    When Tue May 30, 2017 4pm – 4:30pm Eastern Time (b) (6) Calendar @va.gov (b) (6) Who • @gmail.com - organizer  (b) (6) @mail.med.upenn.edu    (b) (6)  @va.gov     (b) (6) @va.gov     (b) (6) @mac.com    Going?   Yes    ‐ Maybe    ‐ No       more options »       1 VA-18-0298-A-000128 Invitation from Google Calendar You are receiving this courtesy email at the account (b) (6) @va.gov because you are an attendee of this event.  To stop receiving future updates for this event, decline this event. Alternatively you can sign up for a Google account at  https://www.google.com/calendar/ and control your notification settings for your entire calendar.  Forwarding this invitation could allow any recipient to modify your RSVP response. Learn More   .    2 VA-18-0298-A-000129 (b) (6) Subject: Location: WH Meeting on VA Health Care w/(b) (6), (b) (7)(C) WH Start: End: Wed 10/4/2017 9:30 AM Wed 10/4/2017 10:15 AM Recurrence: (none) Organizer: DJS Categories: White House Hi (b) (6)     (6), (b) Apologies for the delay. Wednesday at 130 works for (b)    (7)(C)   Thank you,    (b) (6)     From: (b) (6)  [mailto:(b) (6) @va.gov]   Sent: Thursday, September 28, 2017 2:44 PM  To: (b) (6), (b) (7)(C)  EOP/WHO <(b) (6), (b) (7)(C) @who.eop.gov>  (b) (6) (b) (6) Cc: @va.gov>;  @va.gov>  Subject: RE: [EXTERNAL] RE: VA Healthcare  @va.gov>; (b) (6)   Hi (b) (6)  just checking back with you.    From: (b) (6) . Sent: Wednesday, September 27, 2017 10:25 AM To: (b) (6) EOP/WHO Cc: (b) (6) ; (b) (6) ; (b) (6) Subject: RE: [EXTERNAL] RE: VA Healthcare Hi (b) (6)  –    Would any of the following times work for (b) (6)      next week?  Wednesday, October 4 from 1:30‐2:30pm ‐ 4:30‐5:30pm  Thursday, October 5 from 3‐5pm    Thanks,  (b) (6)        From: (b) (6), (b) (7)(C) EOP/WHO [mailto:(b) (6), (b) (7)(C) @who.eop.gov] Sent: Wednesday, September 27, 2017 10:18 AM To: (b) (6) .; (b) (6), (b) (7)(C) EOP/WHO; (b) (6), (b) (7)(C) 1 . EOP/WHO VA-18-0298-A-000130 Cc: (b) (6) ; (b) (6) ; (b) (6) Subject: RE: [EXTERNAL] RE: VA Healthcare (6), (b) +(b) (6)  who can help you with scheduling for (b)    (7)(C)   Kind regards,  (b) (6), (b)   (7)(C)   From: (b) (6)  [mailto:(b) (6) @va.gov]   Sent: Wednesday, September 27, 2017 10:14 AM  To: (b) (6), (b) (7)(C) . EOP/WHO < @who.eop.gov>; (b) (6), (b) (7)(C) . EOP/WHO  <(b) (6), (b) (7)(C) @who.eop.gov>  Cc: (b) (6) @va.gov>; (b) (6) @va.gov>; (b) (6) @va.gov>  Subject: FW: [EXTERNAL] RE: VA Healthcare  (b) (6), (b) (7) (C) Hi (b) and (b) (6) (6)   – (b) (6), (b) Can you share who would be best to work with setting a meeting up with (7)(C) Carolyn Clancy? Secretary Shulkin and Dr. (b) (6) From: (b) (6), (b) (7)(C) EOP/WHO Sent: Tuesday, September 26, 2017 1:24:00 PM To: DJS; 'IP' Cc: (b) (6), (b) (7)(C) EOP/WHO; (b) (6), (b) (7) EOP/WHO; (b) (6), (b) (7)(C) EOP/WHO; '(b) (6) @gmail.com'; (C) (b) (6) @gmail.com'; (b) (6) @mac.com'; Clancy, Carolyn; (b) (6), (b) (7)(C) EOP/WHO; (b) (6), (b) (7) EOP/WHO; (b) (6), (b) (7)(C) EOP/WHO (C) Subject: RE: [EXTERNAL] RE: VA Healthcare YES – we will make ourselves available to learn more and try to be helpful   From: DJS [mailto:vacodjs1@va.gov]   Sent: Tuesday, September 26, 2017 12:50 PM  (b) (6) @frenchangel59.com>  To: (b) (6), (b) (7)(C)  EOP/WHO <(b) (6), @who.eop.gov>; ' (b) (b) (6), (b) (7)(C) Cc:   EOP/WHO < @who.eop.gov>; (b) (6), (b) (7)  EOP/WHO <(b) (6), (b) (7) @who.eop.gov>;  (7) (C) (C) (C) (b) (6), (b) (7)(C) (b) (6)  EOP/WHO <(b) (6), (b) (7)(C) @who.eop.gov>;  @gmail.com'  (b) (6) @gmail.com>; (b) (6) @gmail.com' <(b) (6) @gmail.com>; '(b) (6) @mac.com'  (b) (6) < @mac.com>; Clancy, Carolyn   Subject: RE: [EXTERNAL] RE: VA Healthcare (b) (6), (b) (7) (C) (b) (6), (b) (7) (C) (b) (6) I do want to move forward with an independent evaluation of our quality comparison methodology. I'm adding Dr Carolyn Clancy (who will soon be acting undersecretary for health) who is one of the top quality experts in the country. She is prepared to review this methodology and make some recommendations on an independent review panel- Would it be helpful to have her meet with someone from your office to review where we are or do you have another suggestion to move forward? We also want to integrate Dr Moskowitz into this approach as he has some very useful approaches to this as well. David Shulkin 2 VA-18-0298-A-000131 Sent with Good (>>>www.good.com<<<) -----Original Message----From: (b) (6), (b) (7)(C) EOP/WHO [ @who.eop.gov] Sent: Sunday, September 24, 2017 06:04 PM Eastern Standard Time To: DJS; 'IP' Cc: (b) (6), (b) (7)(C) EOP/WHO; (b) (6), (b) (7)(C) EOP/WHO; (b) (6), (b) (7)(C) (b) (6) (b) @gmail.com'; ' (6) @gmail.com'; '(b) (6) @mac.com' Subject: RE: [EXTERNAL] RE: VA Healthcare (b) (6), (b) (7) (C) . EOP/WHO; Please let me know what we can do to help move this along. Good out of the box thinking…   From: DJS [mailto:vacodjs1@va.gov]  Sent: Sunday, September 24, 2017 5:18 PM  To: (b) (6), (b) (7)(C)  EOP/WHO < @who.eop.gov>; '(b) (6) @frenchangel59.com>  Cc: (b) (6), (b) (7)(C)  EOP/WHO < @who.eop.gov>; (b) (6), (b) (7)  EOP/WHO (b) (6), (b) (7) (C) (C) (b) (6), (b) (7)(C) (b) (6)  EOP/WHO <(b) (6), (b) (7)(C) @who.eop.gov>; ' @gmail.com'  (b) (6) @gmail.com>; '(b) (6) @gmail.com' <(b) (6) @gmail.com>; '(b) (6) (b) (6) @mac.com>  Subject: RE: [EXTERNAL] RE: VA Healthcare (b) (6), (b) (7) (C) (b) (6), (b) (7) (C) @who.eop.gov>;  @mac.com'  (b) (6) able -I agree with Ike and the team that measuring VA against private hospitals is critical - so while CMS is not to deliver this for months we have now developed our own tool to do this-we are fine tuning the model this week and can share it by friday. If it does not get us where we need to be then working quickly with an independent group would make a great deal of sense. David Sent with Good (>>>>www.good.com<<<<) -----Original Message----From: (b) (6), (b) (7)(C) EOP/WHO [ @who.eop.gov] Sent: Sunday, September 24, 2017 04:31 PM Eastern Standard Time To: IP Cc: (b) (6), (b) (7)(C) . EOP/WHO; (b) (6), (b) (7)(C) EOP/WHO; (b) (6), (b) (7)(C) (b) (6) (b) @gmail.com; (6) @gmail.com; '(b) (6) @mac.com' Subject: [EXTERNAL] RE: VA Healthcare (b) (6), (b) (7) (C) EOP/WHO; DJS; This is a creative i9dea to fast track the process – I think it could be worthwhile as a way of collecting the data quickly by  an independent group. If they can spend time with the other raters and get a sense for what they are looking for,  perhaps the data they are collecting can be used to help determine the star ratings   From: IP [mailto:( @frenchangel59.com]  b Sent: Monday, September 18, 2017 8:58 AM  ) (b) (6), (b) (7)(C) To:   EOP/WHO < @who.eop.gov>  ( 6 ) (b) (6), (b) (7) (C) 3 VA-18-0298-A-000132 Cc: (b) (6), (b) (7)(C) (b) (6), (b) (7) (C) . EOP/WHO < @who.eop.gov>; (b) (6), (b) (7)  EOP/WHO (b) (6), (b) (7) @who.eop.gov>;  (C) (C) (b) (6), (b) (7)(C) (b) (6)  EOP/WHO <(b) (6), (b) (7)(C) @who.eop.gov>; DJS ;  @gmail.com;  (b) (6) (b) (6) (b) (6) @gmail.com; ' @mac.com' < @mac.com>  Subject: VA Healthcare (b) (6), (b) (7)(C) We have been talking to Dr. Shulkin for many months about identifying the existence of healthcare delivery  issues at VA medical centers.  There is no doubt that issues exist in abundance and were created by decades of  historical federal government hiring practices, regulatory hiring rules and mismanagement.  We originally  were hoping that the hospitals could be rated (with the star rating system) by CMS, as they do with private  hospitals.  However, they recently advised that they would not be able to focus on the VA hospitals until  December 2018.  As an example, we think that some of the VA hospitals are delivering some specialty  healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better  option.  Not every VA hospital has both the breadth and depth of specialized medical expertise in every  specialty, which then creates risk to the patients and the system.  One idea discussed was to institute a self‐ rating program, but self‐ratings are rarely of any practical use. Our solution is to make use of the academic  medical centers and medical trade groups, both of whom have offered to send review teams to the VA  hospitals to help in this effort.  The purpose of this email is to see if you know of any impediments to taking  them up on this offer and to get your thoughts in general about this approach. All my Best, Ike     4 VA-18-0298-A-000133 (b) (6) Subject: Location: Phone Call w/Administrator (b) (6) and Dr. Bruce Moskowitz SecVA Suite Start: End: Mon 1/29/2018 1:00 PM Mon 1/29/2018 2:00 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category Access Information 1.      Please call the following number:           WebEx: 1‐877‐267‐ 2.      Follow the instructions you hear on the phone.   Your WebEx Meeting Number:           (b) (6), (b) (5) (b) (6), (b) (5) 1 VA-18-0298-A-000134 (b) (6) Subject: Location: Meet w/(b) (6) SecVA Suite re: Update on Medical Device Registry Summit Start: End: Wed 3/28/2018 10:00 AM Wed 3/28/2018 10:30 AM Recurrence: (none) Organizer: DJS From: (b) (6) (HOU) Sent: Tuesday, March 20, 2018 2:10 PM To: (b) (6) ; (b) (6) Subject:   Hi (b) (6)  and (b) (6)     Could I schedule a short meeting with Secretary Shulkin, whenever there’s an opening, to update on the Medical Device  Registry Summit/Bruce Moskowitz efforts? Thank you so much!      Hope you stay warm and dry in this snow weather!   ‐Srey    (b) (6) , MD    Special Advisor to the Secretary  Veterans Health Administration    Associate Chief of Staff   Quality, Safety & Value  Michael E. DeBakey VA Medical Center    810 Vermont Avenue, NW, #1069  Washington, DC 20420    Mobile:  713‐503‐(b) (6)   Office:  202‐461‐(b)       (6) 1 VA-18-0298-A-000135 (b) (6) Subject: Location: Phone Call re: VA Tech Transfer (Perlmutter, Moskowitz, Marc Sherman, and (b) (6) ) SecVA Suite Start: End: Tue 2/28/2017 12:00 PM Tue 2/28/2017 1:00 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category The last call I need to schedule is with (b) (6) … This is a call about the VA Tech Transfer Office. (b) (6) the most highly regarded authority on medical tech transfer and understands what is needed to fix the problem.    Tuesday (2/28) Noon to 1 pm EST    Participants will be – Ike Perlmutter, Dr. Bruce Moskowitz, Marc Sherman and (b) (6)   It will be great if  Secy Shulkin can join the call.   .    Thank you,    (b) (6)   1 VA-18-0298-A-000136  is  (b) (6) Subject: Location: Phone Call w/Mr. (b) (6) SecVA Suite Start: End: Fri 3/3/2017 1:00 PM Fri 3/3/2017 1:45 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category (Darin Selnick) Friday, March 3rd     1:00 PM – 2:00 PM EST    Dial‐in Information:  US: 1‐866‐244‐   International: 719‐457‐     Passcode:      Participants:  (b) (6)  (CEO Apple), (b) (6) , VP of Environment, Policy and Social Initiatives (Apple),   Secretary David Shulkin (White House), (b) (6)  Assistant to the President For Intragovernmental and Technology  Initiatives, (b) (6)  , Co‐founder of the United States Digital Service   (Chair, Mayo Clinic), (b) (6)  (Marketing Manager, Mayo Clinic), (b)   Dr. Moskowitz, Marc Sherman, (b) (6) (6)  (IT Tech Specialist, Mayo Clinic) and Ike Perlmutter     Thank you,  (b) (6)   (b) (6) (646) 201‐  (Cell)  (b) @frenchangel59.com  (6)   (b) (6), (b) (5) (b) (6), (b) (5) (b) (6), (b) (5)   1 VA-18-0298-A-000137 (b) (6) Subject: Location: Phone Call w/Mr. Bruce Moskowitz and Ike Ike will call SecVA Start: End: Sat 3/4/2017 4:00 PM Sat 3/4/2017 4:30 PM Recurrence: (none) Organizer: DJS FYA    ‐‐‐‐‐Original Message‐‐‐‐‐  (b) From: David shulkin [mailto:(b) (6) ]  (6) Sent: Friday, March 03, 2017 4:20 PM  To: IP  Cc: Bruce Moskowitz; (b) (6) .; (b) @frenchangel59.com  (6) Subject: [EXTERNAL] Re: RE:     610453(b) (6)     Sent from my iPhone    > On Mar 3, 2017, at 4:04 PM, IP <(b @frenchangel59.com> wrote:  ) >   (6 ) > 4:00 PM is perfect.  >   > David, please email me the best number for you tomorrow and I will   > call you and Bruce.  >   > We don't need an 800#.  >   > Thank you,  >   > Ike  >   > ‐‐‐‐‐Original Message‐‐‐‐‐  > From: Bruce Moskowitz [mailto(b) (6) @mac.com]  > Sent: Friday, March 03, 2017 3:57 PM  > To: David shulkin  > Cc: Ike Perlmutter; (b) (6)   > Subject: Re:  >   > Yes anytime  >   > Sent from my iPad  > Bruce Moskowitz M.D.  >   1 VA-18-0298-A-000138 (b) >> On Mar 3, 2017, at 3:55 PM, David shulkin <(b) (6) > wrote:  (6) >>   >> I would like to review the agenda I have prepared for the President   >> on  > Monday  >>   >> Would you have time on Saturday at either 1 pm or 4 pm?   >>   >> (b) (6)  can you send the Potus agenda out and set up a conference number?  >   >>   >> Sent from my iPhone  >     2 VA-18-0298-A-000139 (b) (6) Subject: Location: Breakfast w/Mr. Perlmutter The Willard- 1401 Pennsylvania Ave NW Start: End: Thu 4/27/2017 6:30 AM Thu 4/27/2017 8:00 AM Recurrence: (none) Organizer: DJS Categories: Special Events   1 VA-18-0298-A-000140 (b) (6) Subject: Location: Tour Walter Reed (w/Dr. (b) (6)Center Walter Reed Army Medical Start: End: Thu 4/27/2017 11:00 AM Thu 4/27/2017 1:00 PM Recurrence: (none) Organizer: DJS Categories: Special Events   Vivieca Wright  Ike Perlmultter  (b) (6)   Dr. Bruce Moskowitz  Mark Sherman          From: (b) (6) Sent: Tuesday, April 25, 2017 12:58 PM To: (b) (6) Cc: (b) (6) ; (b) (6) ; (b) (6) Subject: RE: Walter Reed Visit   ; (b) (6)   Hi (b) (6) Attached is the Distinguished Visitor Guest Packet for Secretary Shulkin. Included are the agenda for Thursday’s visit; bios of all the SMEs with whom he’ll engage; read-ahead on the clinical areas we will visit; a base map containing arrival, driving routes and parking guidance, and a Parking Placard for the dashboard of his vehicle. The last attachment is a quick reference VISN 5-Walter Reed profile sheet that our office put together. The Leadership Team will greet him upon arrival at the America Bldg. Arrangements have been made to have the vehicle remain posted at the America Bldg. Lastly, can you please provide a list of attendees and their titles? Also, can you please have the Security Detail contact Mrs. (b) (6) , Chief, Executive and Legislative Affairs, so they can work with the military police, and address any walkthroughs, considerations, etc? She can be reached at O: (301) 295-(b) (6) or Cell: (301) 655-(b) (6) 1 VA-18-0298-A-000141 Standing by if you have any questions or concerns. Best, (b) (6) (b) (6) Deputy Director, Office of VA/DoD Health Affairs (10P5) U.S. Department of Veterans Affairs 1575 I Street NW , Washington, DC 20420 O: (202) 461-(b) C: (202) 657-(b) (6) (6) 2 VA-18-0298-A-000142 (b) (6) Subject: Location: Apple Conference Call w/Dr. Bruce Moskowitz SecVA Suite Start: End: Wed 6/14/2017 11:00 AM Wed 6/14/2017 12:30 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category     United States: 1.866.244. (b) (6), (b) (5)   International: 719.457. Passcode:    (b) (6), (b) (5)   (b) (6), (b) (5) Participants:                           Bruce Moskowitz, M.D.                                                   Marc Sherman                                                  Ike Perlmutter      Apple:   (b) (6)  – Apple, Chief Executive Officer    (b) (6)  – Apple, Chief Operating Officer   (b) (6)  – Apple, Director of Global Government  (b) (6)  – Apple, Vice President for Public Policy and Government Affairs     Office of Veterans Affairs:   David Shulkin, M.D. – Secretary of Veterans Affairs  Poonam Alaigh, M.D. – Acting Under‐Secretary for Health  Darin Selnick – Senior Advisor to the Secretary  Rob C. Thomas II – Acting Assistant Secretary & Chief Information Officer  Department of Veterans Affairs  Patricia L. Wallace – Senior Advisor, Acting Under‐Secretary for Health, Department of  Veterans Affairs, Veterans Health Administration     Medical Institutions:  (b) (6)  – Chief Information Officer, Mayo Clinic  (b) (6) , M.D. – Associate Dean/Center for Connected Care, Mayo Clinic   (b) (6)  – Interim Chief Information Officer, Cleveland Clinic  1 VA-18-0298-A-000143 (b) (6) (b) (6) , M.D. – Associate Chief Information Officer, Cleveland Clinic   – Senior Vice President and CIO, Johns Hopkins Health System, Johns  Hopkins Medicine, Vice Provost and CIO, Johns Hopkins University  (b) (6)  – Senior Vice President, Care Delivery Technology Services, Kaiser  Permanente   (b) (6)  ‐ Cofounder, CEO ‐ Responsive Health  (b) (6) , M.D. – Co‐founder, Responsive Health/ Mount Sinai Health System  (b) (6)  – Payer Advisor, Responsive Health  (b) (6)  – Development Head, Responsive Health  (b) (6)  ‐ SME for Public Sector, Responsive Health  (b) (6)  – Biomedical Research & Education Foundation, Executive Director  (b) (6) , M.D. – Vice President, Connected Health   Partners HealthCare  (b) (6) , M.D. – Chief Information Officer and Vice President, Information  Systems, Brigham Health    Moderator:   (b) (6)  – Chair, Department of Public Affairs/Mayo Clinic   Agenda:     1) Introductions – (b) (6) , Moderator     2) Review/Discussion of Purpose of Call – All   Draft Meeting Objectives:     Consensus/endorsement of goals    Define roadmap and next steps   Determine core working team moving forward/ARCIV     3) Project Objectives/Status   Veteran’s Administration Perspective – David Shulkin, M.D.     4) Perspective of the Medical Experts – What Works/What Doesn’t –  Medical Experts    Status of portable medical record for the private sector    What will it take to get to “state of the art?”   o Preventive health/early detection of disease   o How does the medical record pick up that which may threaten health    What are medical centers working on that has been well received by patients?     5) Discussion of Digital/Veteran Platform Project Road Map – (b) (6)     6) Review/Discussion of Potential Project Requirements – All    Clinical needs re: obtaining information from the patient’s EMR  o Quick reference screen   Patient problem list   Medications   Allergies   Laboratory results    Diagnostic tests by specialty    Clinical notes by specialty    Dynamic vs. static EMR   2 VA-18-0298-A-000144      Early disease detection   Chart medication adherence   Laboratory results depicted by in graph form to permit lifestyle modification conversations   Alerts for follow‐up appointments/tests  Integration of clinical notes, lab and diagnostic text into integrated platform      7) Next steps Discussion:    Defining the core working team – ARCIV   Timeline       Thank you,  (b) (6)   212‐576‐  (Office)  (b) (6) (646) 201‐  (Cell)  (b) @frenchangel59.com  (6)   (b) (6)   -----Original Message----(b) From: David shulkin [(b) (6) ] (6) Sent: Thursday, May 25, 2017 01:38 PM Eastern Standard Time To: (b) (6) Subject: [EXTERNAL] Fwd: On Behalf of Doctor Bruce Moskowitz: Apple Conference Call scheduled for June 14, 2017 at 11:00 AM until 12:30 PM EST Only if i can Sent from my iPhone Begin forwarded message: From: "(b) (6) " <(b) @frenchangel59.com> (6) PM EDT Date: May 25, 2017 at 1:31:18 (b) (b) (6) To: "David shulkin" <(b) (6) > (6) Subject: On Behalf of Doctor Bruce Moskowitz: Apple Conference Call scheduled for June 14, 2017 at 11:00 AM until 12:30 PM EST Good 3 VA-18-0298-A-000145 Conference Call VA, Apple & Medical/Digital Experts Date: Wednesday June 14, 2017 Time: 11 a.m. – 12:30 p.m. ET/10 – 11:30 a.m. CT/8 – 9:30 a.m. PT Dial-in Information: United States: 1.866.244. (b) (6), (b) (5) International: 719.457. (b) (6), (b) (5) Passcode: Participants: (b) (6), (b) (5) Bruce Moskowitz, M.D. Marc Sherman Ike Perlmutter Apple: (b) (6) (b) (6) (b) (6) (b) (6) – Apple, Chief Executive Officer – Apple, Chief Operating Officer – Apple, Director of Global Government – Apple, Vice President for Public Policy and Government Affairs Office of Veterans Affairs: David Shulkin, M.D. – Secretary of Veterans Affairs Poonam Alaigh, M.D. – Acting Under-Secretary for Health Darin Selnick – Senior Advisor to the Secretary Rob C. Thomas II – Acting Assistant Secretary & Chief Information Officer Department of Veterans Affairs Patricia L. Wallace – Senior Advisor, Acting Under-Secretary for Health, Department of Veterans Affairs, Veterans Health Administration Medical Institutions: – Chief Information Officer, Mayo Clinic (b) (6) , M.D. – Associate Dean/Center for Connected Care, Mayo Clinic (b) (6) – Interim Chief Information Officer, Cleveland Clinic (b) (6) , M.D. – Associate Chief Information Officer, Cleveland Clinic (b) (6) – Senior Vice President and CIO, Johns Hopkins Health System, Johns (b) (6) Hopkins Medicine, Vice Provost and CIO, Johns Hopkins University – Senior Vice President, Care Delivery Technology Services, Kaiser Permanente (b) (6) Cofounder, CEO - Responsive Health (b) (6) , M.D. – Co-founder, Responsive Health/ Mount Sinai Health System (b) (6) – Payer Advisor, Responsive Health (b) (6) – Development Head, Responsive Health (b) (6) SME for Public Sector, Responsive Health (b) (6) – Biomedical Research & Education Foundation, Executive Director (b) (6) , M.D. – Vice President, Connected Health Partners HealthCare (b) (6) , M.D. – Chief Information Officer and Vice President, Information (b) (6) Systems, Brigham Health Moderator: – Chair, Department of Public Affairs/Mayo Clinic (b) (6) VA-18-0298-A-000146 Agenda: 1) Introductions – (b) (6) , Moderator 2) Review/Discussion of Purpose of Call – All Draft Meeting Objectives:  Consensus/endorsement of goals  Define roadmap and next steps  Determine core working team moving forward/ARCIV 3) Project Objectives/Status Veteran’s Administration Perspective – David Shulkin, M.D. 4) Perspective of the Medical Experts – What Works/What Doesn’t – Medical Experts  Status of portable medical record for the private sector  What will it take to get to “state of the art?” o Preventive health/early detection of disease o How does the medical record pick up that which may threaten health  What are medical centers working on that has been well received by patients? 5) Discussion of Digital/Veteran Platform Project Road Map – (b) (6) Digital Veteran Platform Experience.docx The attachment that reflects shared perspective of medical providers/Apple team. 6) Review/Discussion of Potential Project Requirements – All  Clinical needs re: obtaining information from the patient’s EMR o Quick reference screen  Patient problem list  Medications  Allergies  Laboratory results  Diagnostic tests by specialty  Clinical notes by specialty  Dynamic vs. static EMR  Early disease detection  Chart medication adherence  Laboratory results depicted by in graph form to permit lifestyle modification conversations  Alerts for follow-up appointments/tests  Integration of clinical notes, lab and diagnostic text into integrated platform 7) Next steps Discussion:  Defining the core working team – ARCIV  Timeline VA-18-0298-A-000147 This content should not be distributed outside of the participants of this call nor should it be published publicly. Digital Veteran Platform: Veteran-Mediated Data Exchange Background Improving the Veterans’ experience and enhancing strategic partnerships are two of the key focus areas for the 2015 myVA Transformational Plan. Recognizing that technology will be the foundation on which this transformation will occur, the VA has proposed a “Digital Veteran Platform.” The objective of this platform is to “build an ecosystem enabling external integration and innovation enabling transparency with Veterans and their care providers while expanding use of data with real-time analytics to support automated recommendations for care.” As a complement to this platform, the VA and the White House have proposed a collaboration with innovative health systems and Apple to work on four initiatives: 1. Care Finder: a mechanism for Veterans to discover an appropriate medical facility and/or physician based on available services and location. 2. Veteran Health Data Exchange (VHDE): the ability for Veterans to download and view health records from both the Veteran sector and private sector on a portable device. 3. Improve Medication Tracking: a technology solution for Veterans to view medications and be able to track medication compliance, preventing over-utilization of controlled substances, and preventing medication errors. 4. Transitions of Care: a system that facilitates Veteran compliance with discharge recommendations (e.g., prescription pick-up, medication compliance, follow-up appointments, home health services) and communicates status to the care team. This digital platform is being proposed at a time when the national health expenditure is rapidly increasing, representing 17.8% of GDP in 2015, or $3.2 trillion ($9,990 per person), a 5.8% rise compared to the previous year.i Despite these costs, the US remains well behind its peers in how efficiently that expenditure results in improved health and longevity.ii There is growing recognition that the fundamental changes required to reduce costs and improve outcomes in our healthcare system must begin with empowering the patient to take a greater role in her/his care. Initiatives such as Open Notes - which the VA helped to pioneer have shown that giving a patient full and transparent access to her/his health records improves safety as well as trust in the clinical relationship.iii Furthermore, evidence is mounting that empowering patients to care for themselves results in decreased costs and improved outcomes.iv However, patients today lack the ability to get an integrated view of their health data across a myriad of electronic health record (EHR) systems in the marketplace. Fortunately, private sector initiatives such as the Argonaut Projectv have proven that EHR vendors can align with the interests of patients and health systems to agree on a path forward involving standard application programming interfaces (APIs) for health. Additionally, bipartisan legislation such as the 21st-Century Cures Act has required health IT products to expose health data via APIs. These advances, when taken together, pave the way for a true 21st-Century Health IT System designed with the patient at the center.vi The National eHealth Exchange has also supported VA-18-0298-A-000148 health information exchange for clinicians, but this information is generally not directly available for patient viewing. It is within this rich milieu of health IT advancement that the VA and the White House have proposed this collaboration to identify solutions to problems for which the feasibility of a solution is only just becoming a reality. The VA has long been a pioneer in health IT innovation, which has been a necessity given their large and geographically diverse patient population. This is yet another opportunity for the VA to set an example for the rest of the country to follow, and it couldn’t come at a more critical time for our nation. Proposal In order to achieve the greatest benefit for our Veterans in the shortest amount of time, we propose that this set of initiatives should begin by leveraging the work of the standards community to enable Veteran health data exchange (initiative #2 above). Only after this is in place will we be able to explore the feasibility of improved medication tracking and seamless transitions of care. The ‘Care Finder’ functionality (initiative #1 above) represents an extension of the current VA tool found at vets.gov, however, a more patient-centric approach would likely improve Veteran engagement. The lack of a national health system, universal patient identifier, and common provider directory presents several challenges with respect to ensuring this resource is accurate and up to date. This concept and implementation will continue to be explored. Five health systems have agreed to participate in support of these initiatives: • • • • • Cleveland Clinic Johns Hopkins Medicine Kaiser Permanente Mayo Clinic Partners HealthCare The 5 selected health systems will implement APIs based on the Fast Healthcare Interoperability Resources (FHIR) standard, as outlined in the Argonaut Data Query Implementation Guide 1.0.0:vii All major EHR vendors, including Epic and Cerner, have implemented or are working on the implementation of this standard within their software. This is of critical importance given the recent announcement by U.S. Secretary of Veterans Affairs Dr. David J. Shulkin that the VA will adopt the Cerner EHR to replace their current VistA health records system.viii Once this is in place, Apple will enable the Veteran to access the following items from her/his health record: problems, medications, allergies, laboratory test results, immunizations, vital signs, and procedures. The health records of multiple institutions may be aggregated and harmonized into one ‘virtual’ master copy, available for viewing. This data will continue to reside within each organization, but be accessible to Veterans via APIs to present the information when requested. VA-18-0298-A-000149 Given the reality that many Veterans receive a portion of their care at non-VA health systems (a fact accelerated by the 2014 Choice Actix), this newfound data portability - with the patient at the center - will ensure that VA providers always have the most up-to-date information about a patient so that they can provide the most effective care. This work will begin as a limited pilot among patients who receive care at both the VA and one of the 5 health systems listed above. It will then be implemented across the VA and to any interested health system in the U.S. who has an EHR platform compatible with this open standard. Guiding Principles Healthcare is complex, and the challenges will be difficult to address. In order to succeed, all participants must be aligned according to a set of guiding principles. We propose to adhere to the following: 1. 2. 3. 4. We will act in the best interests of the Veteran. We will support the ability of the Veteran’s care team to provide the best care. We will identify and implement standards-based solutions, where possible. We will deploy solutions that can be leveraged and adopted by the healthcare industry more broadly. Next Steps Implementing the Veteran health data exchange functionality will require coordination across the health systems, the VA, and Apple. We propose that each entity select appropriate technical and business representatives to serve on an exploratory workgroup in order to define milestones, timelines, and priorities, and to have this workgroup in place by August 31, 2017. Additional members may be included as needed. This group should also identify any barriers, impediments or concerns that need to be addressed in order to further the work. The workgroup will be led by a designated representative from the VA. While the scope of this initiative will initially be constrained in order to provide something of value to Veterans in a relatively short period of time, we recognize that there are many problems in health care worth solving, and see this as a stepping stone to work more closely with the VA to identify and find sustainable solutions to their most pressing needs. It is hard to overstate the potential impact of this initiative; the nationwide implementation of a standards-based approach to patient-mediated data access and exchange across the VA and partner institutions will serve as a model for the future of healthcare, not only in the US, but around the world. It will set a standard by which all other health systems will be judged, and patients, once they realize the freedom and power it affords, will not settle for anything less. i https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-andreports/nationalhealthexpenddata/nationalhealthaccountshistorical.html ii https://www.bloomberg.com/news/articles/2016-09-29/u-s-health-care-system-ranks-as-one-of-the-least-efficient iii http://www.nejm.org/doi/full/10.1056/NEJMp1310132 iv https://hbr.org/2017/06/the-value-of-teaching-patients-to-administer-their-own-care VA-18-0298-A-000150 v http://argonautwiki.hl7.org/index.php?title=Main_Page http://www.nejm.org/doi/full/10.1056/NEJMp1700235 vii http://www.fhir.org/guides/argonaut/r2/ viii https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2914 ix https://www.va.gov/opa/choiceact/documents/choice-act-summary.pdf vi This content should not be distributed outside of the participants of this call nor should it be published publicly. VA-18-0298-A-000151 (b) (6) Subject: Meet w/Mr. Ike Perlmutter Start: End: Tue 2/27/2018 3:30 PM Tue 2/27/2018 6:30 PM Recurrence: (none) Organizer: DJS Categories: Green Category 1 VA-18-0298-A-000152 February 27, 2018 Tuesday February 2018 March 2018 SuMo TuWe Th Fr Sa SuMo TuWe Th Fr Sa 4 11 18 25 5 12 19 26 6 13 20 27 1 2 3 7 8 9 10 14 15 16 17 21 22 23 24 28 4 11 18 25 5 12 19 26 6 13 20 27 7 14 21 28 1 8 15 22 29 2 9 16 23 30 3 10 17 24 31 Tuesday 27 TRAVEL - West Palm Beach 7 am En route to Washington Hilton Hotel 8 00 9 00 SPEECH - American Legion Mid Winter Conference Washington Hilton Hotel, 1919 Connecticut Ave, NW, DC En Route to VACO 10 00 ERT DCA airport 11 00 12 pm 11:30am Wheels Up - PBI AA 1849, Flight time: 2hr 38min 1 00 2 00 ERT WPB VAMC Tour WPB VAMC MRI Suite 3 00 Tour Post-Deployment Clinic/Congressional office space ERT/Arrive at Mar-A-Lago hotel Meet w/Mr. Ike Perlmutter 4 00 5 00 6 00 7:50pm - 10:19pm 7:50pm Wheels up to DCA airport(AA 2756, Flight time: 2hr 29min) DJS 1 5/8/2018 9:07 AM VA-18-0298-A-000153 (b) (6) Subject: Location: Phone Call w/Marc Sherman - We dial 202-758SecVA Suite Start: End: Wed 2/15/2017 12:00 PM Wed 2/15/2017 12:30 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category (b) (6), (b) (5) 1 VA-18-0298-A-000154 (b) (6) Subject: Location: 9:30am - Phone Call with (b) (6) # SecVA Suite Start: End: Thu 2/23/2017 9:30 AM Thu 2/23/2017 10:15 AM Recurrence: (none) Organizer: DJS Categories: Yellow Category (CVS) - we call 1-866-244- (b) (6), (b) (5) Passcode Thursday, February 23rd       9:30 AM – 10:30 AM EST    Dial‐in Information:  US: 1‐866‐244‐   International: 719‐457‐     Passcode:      Participants:  (b) (6) , President and CEO of CVS Health, Secretary David Shulkin (WH), Dr. Bruce Moskowitz, (b) (6)   Marc Sherman (Will not be able to participate but Dr. Moskowitz will update him after the call)    Thank you,  (b) (6)   (646) 201‐(b) (6)  (Cell)  (b) @frenchangel59.com  (7)   (A   )  (b) (6), (b) (5) (b) (6), (b) (5) (b) (6), (b) (5) (b) (6), (b) (5) (b) (6)  and Ike   is able to do 9:15-10:15am EST on Thursday, 2/23rd - Is that OK?. We will probably just need 45 minutes but please block the hour.       From: (b) (6) mailto:(b) (6) @va.gov] Sent: Tuesday, February 21, 2017 2:41 PM To: '(b) (6) 'David shulkin'; 'Bruce Moskowitz'; (b) (6) @gmail.com; '(b) (6) 1 ' VA-18-0298-A-000155 Cc: (b) (6) ; (b) (6) ; (b) (6) Subject: RE: [EXTERNAL] CVS - (b) (6) , President and CEO   I am sorry – tomorrow doesn’t work.  We can do 9:15‐10:15am on Thursday.      From: (b) (6) [mailto:(b) @frenchangel59.com] Sent: Tuesday, February 21, (6) 2017 2:37 PM To: (b) (6) ; 'David shulkin'; 'Bruce Moskowitz'; (b) (6) (b) (6) Cc: (b) (6) ; (b) (6) Subject: RE: [EXTERNAL] CVS - (b) (6) , President and CEO @gmail.com; '(b) (6) '   (b) (6)     Any time at all tomorrow works?     (b)  can make 9‐11am on the 23rd but unfortunately he’s in a critical meeting at Noon on Thursday.   (6)   Thanks,  (b) (6)     From: (b) (6) [mailto:(b) (6) @va.gov] Sent: Tuesday, February 21, 2017 1:47 PM To: '(b) (6) '; David shulkin; Bruce Moskowitz; (b) (6) @gmail.com; (b) (6) Cc: (b) (6) ; (b) (6) ; (b) (6) . Subject: RE: [EXTERNAL] CVS - (b) (6) , President and CEO '   Unfortunately – tomorrow at noon does not work for the Secretary, he’ll be at a WH Meeting.      We could do the next day at noon‐1pm.      Thank you,    (b) (6)     From: (b) (6) [mailto:(b) @frenchangel59.com] Sent: Tuesday, February 21, (6) 2017 1:31 PM To: David shulkin; Bruce Moskowitz; (b) (6) @gmail.com; '(b) (6) (b) (6) Cc: Subject: [EXTERNAL] CVS - (b) (6) , President and CEO '   HI David, Bruce and Marc:    Are you available tomorrow Wednesday, February 22nd at 12:00 PM ‐ !:00 PM for a conference call with (b) (6) ?    Please let me know as soon as possible if we should invite anyone else and if the date and time works..     Participants:  (b) (6) . Secretary Shulkin,  (b) (6) , Dr. Moskowitz, Marc Sherman and Ike    Best,  (b) (5)   2 VA-18-0298-A-000156   VA-18-0298-A-000157 (b) (6) Subject: Location: Phone Call re: VA Tech Transfer (Perlmutter, Moskowitz, Marc Sherman, and (b) (6) ) SecVA Suite Start: End: Tue 2/28/2017 12:00 PM Tue 2/28/2017 1:00 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category The last call I need to schedule is with (b) (6) … This is a call about the VA Tech Transfer Office. (b) (6) the most highly regarded authority on medical tech transfer and understands what is needed to fix the problem.    Tuesday (2/28) Noon to 1 pm EST    Participants will be – Ike Perlmutter, Dr. Bruce Moskowitz, Marc Sherman and (b) (6)   It will be great if  Secy Shulkin can join the call.   .    Thank you,    (b) (6)   1 VA-18-0298-A-000158  is  (b) (6) Subject: Location: Meet w/Poonam & Sherman re: Fraud and Abuse SecVA Suite- 1-800-767- Start: End: Tue 4/11/2017 1:00 PM Tue 4/11/2017 2:00 PM Recurrence: (none) Organizer: DJS Categories: Special Events (b) (6), (b) (5) (b) (6), (b) (5) -----Original Message----From: David shulkin [(b) (6) Sent: Saturday, March 25, 2017 08:24 AM Eastern Standard Time To: (b) (6) Subject: Please add marc sherman and poonam alaigh on april 11 th at 1 m in the office on fraud and abuse and move the video taoing to 2 pm that day Thanks Sent from my iPhone 1 VA-18-0298-A-000159 (b) (6) Subject: Location: Copy: [EXTERNAL] VA - Call with (b) (6) Hospitals and Health Plan, Inc.) Conference Call Start: End: Show Time As: Wed 4/12/2017 2:00 PM Wed 4/12/2017 3:00 PM Free Recurrence: (none) Meeting Status: Not yet responded Organizer: (b) (6) , Chairman and CEO (Kaiser Foundation   Wednesday, April 12th        2:00 PM – 3:00 PM EST    Dial‐in Information:  US: 1‐866‐244‐   International: 719‐457‐     Passcode:      Participants:  (b) (6), (b) (5) (b) (6), (b) (5) (b) (6), (b) (5) (b) (6) , Secretary David Shulkin,  , Dr. Bruce Moskowitz, Marc Sherman and Ike  (b) (6)   Thank you,  (b) (6)   212‐576‐  (Office)  (b) (6) (646) 201‐  (Cell)  (b) (6) 1 VA-18-0298-A-000160 (b) (6) @frenchangel59.com        Wednesday, April 12th        2:00 PM – 3:00 PM EST    Dial‐in Information:  US: 1‐866‐244‐   International: 719‐457‐   Passcode:      Participants:  (b) (6), (b) (5) (b) (6), (b) (5)   (b) (6), (b) (5) (b) (6), (b) (7)(C) , Secretary David Shulkin, (b) (6) , Dr. Bruce Moskowitz, Marc Sherman and Ike    Thank you,  (b) (6)   212‐576‐(b) (6)  (Office)  (646) 201‐(b) (6)  (Cell)  (b) (6) @frenchangel59.com    2 VA-18-0298-A-000161 (b) (6) Subject: Location: Follow Up Call w/Johnson & Johnson SecVA Suite- we call Start: End: Mon 4/17/2017 2:00 PM Mon 4/17/2017 2:30 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category Dial‐in Information:  US: 1‐866‐244‐   International: 719‐457‐   Passcode:  (b) (6), (b) (5) (b) (6), (b) (5)   (b) (6), (b) (5) From: (b) (6) [mailto:(b) @frenchangel59.com] (6) Sent: Friday, March 31, 2017 4:58 PM To: (b) (6) Subject: [EXTERNAL] Follow up meeting - Johnson and Johnson ****Please let me know the dates and times that work for Secretary Shulkin****    Johnson and Johnson is looking to set‐up a 30 minute follow‐up conference call with the original group from  the February 28th call. The team agreed to talk again in 4‐6 weeks.   Please let me know if April 10th or 17th work for you and the best time.    Below are the dates and times J&J gave us:     April 10th: ((b) (6)  not available – but we can fill her in)  10:30 – 12:00 noon  1:00 – 2:00 p.m.   4:30 – 5:30 p.m.     April 17:  1:30 – 3:00 p.m.       Conference call with Johnson and Johnson    (b) (6) , Chairman and CEO      Official Titles:  (b) (6) , Vice President Federal Affairs  (b) (6) , Vice President Janssen Supply Chain  (heads the veterans group)  (b) (6) , Global TA Head, Neuroscience  1 VA-18-0298-A-000162   1. Ms. (b) (6) 2. Mr. (b) (6) 3. Dr.(b) (6)  – works in Government Affairs     – head of their Veterans Leadership Council    – works on veterans issues such as depression, PTSD, Traumatic Brain injury, etc.       Participants:  (b) (6) , Chairman and CEO (Johnson & Johnson), (b) (6) , (b) (6) Secretary David Shulkin (White House), Dr. Bruce Moskowitz, Marc Sherman, (b) (6) and Ike      and Dr. (b) (6)    (Chair, Mayo Clinic)    2 VA-18-0298-A-000163 (b) (6) Subject: Location: Dinner Marc sherman iRicchi 1220 19th St, NW Start: End: Mon 4/17/2017 6:00 PM Mon 4/17/2017 7:00 PM Recurrence: (none) Organizer: vacodjs (b) (6), (b) (5) 202‐835‐   1 VA-18-0298-A-000164 (b) (6) Subject: Location: Dinner w/Marc Sherman and Dr. Alaigh I Ricchi 1220 19th St, NW Start: End: Tue 5/30/2017 6:00 PM Tue 5/30/2017 7:30 PM Recurrence: (none) Organizer: DJS Categories: Special Events From: Poonam Alaigh <(b) (6) > Date: May 26, 2017 at 9:57:37 AM EDT @gmail.com> To: Marc Sherman (b) (6) Cc: David shulkin (b) (6) > Subject: Re: Tuesday dinner Perfect - yes!! Sent from my iPad On May 26, 2017, at 9:56 AM, Marc Sherman (b) (6) @gmail.com> wrote: Are we still on for dinner on Tuesday? If yes, we have a reservation at i Ricchi @ 6pm. Marc Sherman (202) 758-(b) (6) -----Original Message----From: Marc Sherman (b) (6) @gmail.com] Sent: Wednesday, May 17, 2017 07:14 AM Eastern Standard Time To: David shulkin 1 VA-18-0298-A-000165 Cc: (b) (6) ; (b) (6) Subject: [EXTERNAL] Re: Dinner Great. On Friday, I will ask my assistant to make a reservation. Is 6 pm ok? Do you have any recommendations? Marc Sherman (202) 758-(b) (6) On May 17, 2017 7:02 AM, "David shulkin" <(b) (6) Works for me > wrote: Sent from my iPhone > On May 17, 2017, at 4:10 AM, Poonam Alaigh <(b) (6) > wrote: > > May 30th works for me- David? > > Sent from my iPhone > >> On May 16, 2017, at 10:12 PM, Marc Sherman <(b) (6) @gmail.com> wrote: >> >> The only day I am in town and available for dinner in the next two weeks is Tuesday May 30. If that doesn't work, let me know and I will give you dates for the following week. Great talking to you both before. Safe travels back. >> >> Marc 2 VA-18-0298-A-000166 (b) (6) Subject: Location: Phone Call w/Dr. Moskowitz and Mr. Sherman - 1-866-244SecVA Suite Start: End: Fri 9/1/2017 10:00 AM Fri 9/1/2017 11:00 AM Recurrence: (none) Organizer: DJS Categories: Yellow Category (b) (6), (b) (5) From: "(b) (6) @frenchangel59.com>  Date: August 31, 2017 at 8:11:02 PM EDT  To: "Poonam Alaigh" (b) (6) >, <(b) (6) @gmail.com>, <(b) (6) @gmail.com>, "Bruce  (b) (6) (b Moskowitz" < @mac.com>, < @frenchangel59.com>  ) Subject: FRIENDLY REMINDER: Conference Call ‐ tomorrow Friday, September 1st  at 10:00 AM EST  (6 ) Poonam is available and will join the call.      Friday, September 1st           10:00 AM – 10:30 AM EST     Dial‐in Information:  US: 1‐866‐244‐   International: 719‐457‐      Passcode:       Participants:  Poonam Alaigh, Secretary David Shulkin, Dr. Bruce  Moskowitz, Marc Sherman and Ike  (b) (6), (b) (5) (b) (6), (b) (5) (b) (6), (b) (5) 1 VA-18-0298-A-000167    Thank you,  (b) (6)   (b) (6) 212‐576‐  (Office)  (b) (6) (646) 201‐  (Cell)  (b) (6) @frenchangel59.com                2 VA-18-0298-A-000168 (b) (6) Subject: Location: Phone Call w/Drs. (b) (6) TBD Start: End: Mon 12/18/2017 8:00 PM Mon 12/18/2017 9:00 PM Recurrence: (none) Organizer: DJS Categories: Yellow Category (W/Marc Sherman) Thank you so much, I will send a calendar outlook today.  If you wish to hold on his calendar until then here (below) are some of the details:    Conference call: continued discussion of FL DEC meeting Monday 18 DEC 2017 4:00 pm PDT 6:00 pm CDT 7:00 pm EDT (b) (6), (b) (5) Dial-in: 1-888-585Conference room code: 655 215 Hosted by: Dr. Hoyt’s office (b) (6), (b) (5) David J. Shulkin, United States Secretary of Veterans Affairs Dr. (b) (6) , Executive Director, American College of Surgeons Dr. (b) (6) , CEO and Executive Medical Director, Miami Cancer Institute Dr. (b) (6) , Director, Division of Research and Optimal Patient Care, American College of Surgeons Marc Sherman   Additional details, agenda to follow  From: (b) (6) [mailto:(b) (6) @facs.org] Sent: Friday, December 08, 2017 9:56 AM To: (b) (6) Subject: [EXTERNAL] RE: FW: [External] conference call with small group (b) (6)  – please call me at your earliest convenience.    I am aligning calendars and everyone has stated they will clear this date/time for this call  Monday 18 DEC 2017 6:00pm CDT 7:00 pm EDT  (Would be between 30‐45 minutes)  1 VA-18-0298-A-000169 Thank you.  (b) (6)   Executive Services Assistant  (312) 202‐(b) (6)   Or Dr. (b) (6)  direct line  312‐202‐(b) (6)         From: (b) (6) [mailto:(b) (6) @va.gov] Sent: Thursday, December 07, 2017 3:51 PM To: (b) (6) Cc: (b) (6) @baptisthealth.net; (b) (6) @gmail.com Subject: RE: FW: [External] conference call with small group I will get back to you all asap.  Thank you.    From: (b) (6) [mailto(b) (6) @facs.org] Sent: Thursday, December 07, 2017 3:05 PM To: (b) (6) Cc: (b) (6) @baptisthealth.net; (b) (6) @gmail.com Subject: [EXTERNAL] FW: FW: [External] conference call with small group (b) (6)     Would you be able to confirm if Dr. David Shulkin’s schedule could accommodate.    Monday 18 DEC 2017 6:00pm CDT 7:00 pm EDT      conference call with small group re: planning discussion from Florida meeting on Sat.2 DEC Dr. (b) (6) , Executive Director, American College of Surgeons Dr. (b) (6) , CEO and Executive Medical Director, Miami Cancer Institute Dr. (b) (6) , Director, Division of Research and Optimal Patient Care, American College of Surgeons Marc Sherman I would send you the call-in and Dr. (b) (6)   (b) (6)   would host the call. Executive Services Assistant  (312) 202‐(b) (6)     - (b) (6) is Dr (b) (6) ’s MAS and EA; (b) (6) is Dr. (b ’s EA )   (b) (6) (6 From: Marc Sherman [mailto: @gmail.com] ) Sent: Thursday, December 07, 2017 1:43 PM To: (b) (6) Cc: (b) (6) @baptisthealth.net; (b) (6) Subject: Re: FW: [External] conference call with small group Also, I assume you will send out a calendar appointment and dial in once the date and time are confirmed with all. 2 VA-18-0298-A-000170 On Thu, Dec 7, 2017 at 2:42 PM, Marc Sherman <(b) (6) @gmail.com> wrote: (b) (6) I will make Dr. (b) (6) availability work for me. However, this call is also going to include (if it is the same call I am thinking about - which you should confirm) the Secretary of the Department of Veterans Affairs, Dr. David Shulkin. So, if that is the case, you will need to confirm the Secretary's availability as well. Rather than my acting as an intermediary for his schedule, I spoke to his scheduling secretary and advised her that you would be reaching out to her for availability. SO, her name is (b) (6) and you can reach her at (b) (6) @va.gov She is expecting your email for this purpose. Marc Marc Sherman On Thu, Dec 7, 2017 at 2:20 PM, (b) (6) @facs.org> wrote: I spoke with Dr. (b) (6)  office, of the dates this would work for his schedule   Monday 18 DEC 2017 6:00pm CDT 7:00 pm EDT    I am holding this date and time (b) (6) Executive Services Assistant (312) 202‐(b) (6)       From: (b) (6) [mailto:(b) (6) @baptisthealth.net] Sent: Thursday, December 07, 2017 12:58 PM To: (b) (6) Subject: RE: [External] conference call with small group 3 VA-18-0298-A-000171 The 18th at 8 pm EST??? If so, yes for Dr. (b) (6) (b) (6) (b) (6) Manager, Administrative Services and Executive Assistant to (b) (6) , M.D., Chief Executive Officer and Executive Medical Director 8900 N. Kendall Drive, 3rd Floor Executive Office Miami, Florida 33176 (b) (6) Office Phone: 786.527. (b) (6) Mobile: 617.320. Ascom: (b) (6) From: (b) (6)    Sent: Thursday, December 07, 2017 1:53 PM  To: (b) (6) @facs.org>  Cc: (b) (6) @baptisthealth.net>  Subject: Re: [External] conference call with small group (b) (6) Can you include (b) (6) on calendar issues. 4 VA-18-0298-A-000172 Thank you (b) (6) (b) (6) MD FACS CEO and Executive Medical Director Miami Cancer Institute 3rd Floor Executive Offices 8900 North Kendall Drive Miami FL 33176 Office: (786) 527-(b) (6) Cell: (617) 543-(b) (6) On Dec 7, 2017, at 1:06 PM, (b) (6) Responding form the office of Dr. (b) (6) @facs.org> wrote: ;   Could I ask for possible consideration of a conference call with the group:   Monday 18 DEC 2017 6:00pm CDT   Wednesday 20 DEC 2017 8:00am CDT   Please respond at your earliest convenience. Thank you, 5 VA-18-0298-A-000173 (b) (6) Executive Services Assistant (312) 202‐(b) (6)       From: Marc Sherman [mailto:(b) (6) @gmail.com] Sent: Wednesday, December 06, 2017 10:24 AM To: (b) (6) Cc: (b) (6) Subject: Re: [External] Re: Mtg with Sec ; IP; Bruce Moskowitz; (b) (6) Also including my gang as a cc. Yes, I will be on the call. I am embarrassed to say that I forgot to talk about the contact person. But if we request Dr. Clancy, I am sure there will be no problem. I will talk to him about it before our call so you don't have to be the requester. On Wed, Dec 6, 2017 at 11:20 AM, (b) (6) I am copying (b) (6) (b) (6) @baptisthealth.net> wrote: and my office staff and his to get working on this call. Great to hear. Who from his office will Be contact person. And I assume you are also on the call. (b) (6) (b) (6) MD FACS CEO and Executive Medical Director Miami Cancer Institute 3rd Floor Executive Offices 8900 North Kendall Drive Miami FL 33176 Office: (786) 527-(b) (6) 6 VA-18-0298-A-000174 Cell: (617) 543-(b) (6) On Dec 6, 2017, at 11:17 AM, Marc Sherman (b) (6) @gmail.com> wrote: GREAT. He is ready to kick it off and is standing by for me to set up a call with you, David Hoyt, me and him to do so. Let me know several alternative times that work for the two of you for a call over the next week or two. I also mentioned about your having the inspections together with the Joint Commission and he liked that idea, AND he would love to get options from you for CIO and HR candidates. On Wed, Dec 6, 2017 at 11:09 AM, (b) (6) @baptisthealth.net> wrote: Mark, How did your lunch go with the Secretary (b) (6) (b) (6) MD, FACS CEO and Executive Medical Director Miami Cancer Institute 3rd Floor Executive Offices 8900 North Kendall Dr Miami, FL 33176 Office: 786 527-(b) (6) Cell: 617 543-(b) (6)   7 VA-18-0298-A-000175 (b) (6) Subject: Location: Mitre Meeting (Scott Blackburn) 7515 Colshire Drive, MITRE Bldg. 2, McLean VA 22102 Start: End: Fri 1/5/2018 1:30 PM Fri 1/5/2018 3:30 PM Recurrence: (none) Organizer: DJS Categories: Special Events MITRE Building 2 7515 Colshire Drive McLean, Virginia 22102 From: Blackburn, Scott R. Sent: Tuesday, January 02, 2018 9:18 AM To: (b) (6) Cc: '(b) (6) ' Subject: Friday afternoon     Hi (b) (6)  – Happy New Year once again.  Friday afternoon’s session will be at MITRE in McLean.  I am cc’ing (b)   (6)  for the exact address (they have a few different buildings and I don’t want to give you the wrong one).       We can be flexible around the Secretary’s calendar.  I am guessing 3pm would be optimal but I will let you work that out  with Jackie W.  Ideally 90 minutes on the ground (but we will take 60).  This is a pretty big meeting.  Below are some  more details.     All day Friday, MITRE will be convening a group of experts to weigh in on interoperability.  At the end of the day, we are  going to ask them to share what they are recommending directly to the Secretary.  We will also invite DepSec Bowman,  Dr. Clancy, John Windom and (b) (6)  (in place of me, I will be out with back surgery).  Below is the information I  already sent to the Secretary with a few updates in red.          1) January 5 MITRE expert panel.  MITRE has at least 7 experts coming in for a full day.  If you are available, I have  asked them to reserve 60‐90 minutes at the end for the experts to brief you on their recommendations at the  end of this day (I would include the 3 of you + Carolyn + John Windom).  This will be at MITRE in McLean.   The 7 experts are (with a few others possible):   (b) (6)    (b) (6) , CIO, Mayo Clinic  , President, HMMS   (b) (6) 1 VA-18-0298-A-000176          (b) (6) , Principal, Leavitt Partners, LLC (recommended by (b) (6) )  (b) (6) , MD, PhD, University of Washington (note: we are having conversations with him   about coming on board full‐time via IPA)  , MD, American College of Surgeons (recommended by Marc Sherman + (b)    (b) (6) (6) )   MD, MPH, Boston Children’s Hospital (was on the previous MITRE panel, also   (b) (6) one of the experts invited to the White House interoperability summit hosted by (b) (6), (b) (7)   (C) and (b) (6), (b) (7) )  (C)(6)  Dr. (b) , Massachusetts General Hospital (per suggestion of Bruce Moskowitcz and  Marc Sherman)     Possibly Dr. (b) (6) MITRE will basically be asking them 3 questions.     If they were us writing a contract with Cerner, what would they want included?     What is their perspective on what off‐the‐shelf solutions or emerging technologies for which we  need to build flexibility in the contract to include?  This will be their chance to weigh in on some  of the ideas that people reach out to you/I about.   What other big ideas do they have that we should consider incorporating into the contract (such  as the ones that (b) (6)  already sent us unsolicited)?  In addition to the outside experts – I have asked MITRE to also invite Camilo Sandoval, (b) (6)  from  ONC, and someone from CMS (I am working with (b) (6)  who is (b) (6)  senior advisor) as well as  (b) (6)  and (b) (6)  ((b)  is our guy behind the Digital Veterans Platform).  John Short and  (6) (b)  will be there is listen‐only mode.    (6) Scott Blackburn  Acting CIO & Executive‐in‐Charge, Office of Information & Technology  Department of Veterans Affairs             2 VA-18-0298-A-000177 (b) (6) From: To: IP @frenchangel59.com> O'Rourke, Peter M. image001.jpg Tue Apr 10 07:26:46 CDT 2018 VA-18-0298-A-000184 Owner: Filename: Last Modified: (b) (6) IP @frenchangel59.com> image002.jpg Tue Apr 10 07:26:46 CDT 2018 VA-18-0298-A-000186 Owner: Filename: Last Modified: (b) (6) IP @frenchangel59.com> image003.jpg Tue Apr 10 07:26:46 CDT 2018 VA-18-0298-A-000188 Owner: Filename: Last Modified: (b) (6) IP @frenchangel59.com> image004.jpg Tue Apr 10 07:26:46 CDT 2018 VA-18-0298-A-000190 >2 .1 Owner: Filename: Last Modified: (b) (6) IP @frenchangel59.com> image005.jpg Tue Apr 10 07:26:46 CDT 2018 VA-18-0298-A-000192 ted Item: 1 (Attachment 5 of 6) -000193 Owner: Filename: Last Modified: (b) (6) IP image006.jpg Tue Apr 10 07:26:46 CDT 2018 VA-18-0298-A-000194 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) @mac.com> O'Rourke, Peter M. ; (b) (6) (HOU) [EXTERNAL] Device registry Wed Mar 28 2018 06:05:52 CDT I confirmed with (b) (6) who has worked with (b) (6) for many years that indeed all of the essentials are done and ready to go including the barcoding, scanners and EMR configuration. The extraction of data from having a registry has been vetted also. Starting a pilot project will allow us to get the “kinks out”. We firmly believe there will be no cost to the VA but huge savings on inventory management. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298-A-000196 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) @mac.com> O'Rourke, Peter M. VA-18-0298-A-000198 Requested Names.pdf for Printed Item: 9 ( Attachment 1 of 1) Brian Gamble - a former private-sector health care executive who has been working at the Orlando, Fla VA hospital. According to a different media report, Dr. W. Bryan Gamble, a retired Army brigadier general. He recently deactivated his LinkedIn profile. I couldn’t find anything else. Andrew Bartlett – Couldn’t find any reliable information online. Christina White - https://www.linkedin.com/in/christina-white-147a385/ Chris Vojta - https://www.va.gov/directory/guide/manager.asp?pnum=30323 VA-18-0298-A-000199 Requested Names.pdf for Printed Item: 9 ( Attachment 1 of 1) Fabricio-Fernandez-Reid - https://www.linkedin.com/in/fabricio-fernandez-reid-7b282847/ VA-18-0298-A-000200 Requested Names.pdf for Printed Item: 9 (Attachment 1 of 1) ("In Me. HI II Faculty Group Practice Administrative Operations Leader NYU Langone Medical Center Oct 2012 ?Jul 2016 3 10 mos Greater New York City Area I Led a multidisciplinary team of 18 staff members (all levels of employees) alongside supporting a faculty of 13 world?renowned dermatologists (including directors, associate directors. chairman, and vice chairman) with a variety of specialties and practice requirements. Created a world?class experience for patients, doctors, administrators, and external vendors by leading with diplomacy, tact, compassion, a focus on efficiency, and enthusiasm while offering timely and thoughtful service. I Specialized in conflict management communications (via inaperson, email, and telephone}. Successfully diffused difficult situations among high?level physicians, patients, and staff disagreements while protecting patient and employee confidentiality. I Proactively managed team's daily office operations and identi?ed prime opportunities for improvement within procedures and guidelines, always keeping a focus on patient experience, operational efficiency, and driving for results via creative and data?informed solutions. Created and implemented policies that resulted in a streamlined check?in process and reduced system queries by 50%. I Drafted, reviewed, and revised communications, memorandums to staff, other miscellaneous correspondence for practice administrators, chairmen, and physicians. I Efficiently set priorities to manage physician practice and on?call calendar schedules, balancing patient demand and academic responsibilities. I Used complex medical electronic records and other record databases to collect data, report trends, and present practice data findings when necessary. I Coliaborated with department admins, faculty heads, and other key stakeholders on new medical treatment projects, implementation and training of software initiatives, and government regulation rollouts, in order to advance practice competitiveness, compliance, and effectiveness. Requested Names.pdf for Printed Item: 9 (Attachment 1 of 1) ?lm/{a Project Manager Clinilabs May 2008? Oct 2012 - 4 6 mos Greater New York City Area I Successfully managed over 10 domestic and global clinical sleep trials as the directly responsible individual, maintaining superb data quality and upholding standard operating procedures. Sponsor audits showed no major queries thus ensuring the scientific integrity of the studies under my management. I Drafted, formatted, proofread for grammar, and distributed official study documents/correspondence (containing confidential information) including: Standard Operating Procedures, subject eligibilityXineligibility notifications, communication plans, status reports, data reports. data graphs. study presentations, meeting minute transcriptions, meeting agendas, and email. I Represented the department heads by presenting standard procedures, data collection techniques, and data findings to study sponsors. I Repeatedly exceeded rigorous data collection, complex electronic data transfer goals, customer service goals, and industry policies/procedures set by external and internal stakeholders. I Entered, evaluated, analyzed, and data submitted by 100+ sleep sites to ensure subject eligibility and protocol adherence using proprietary applications and MS Office. I Progressed data query and collection skills by controlling/monitoring multiple databases containing 20,000+ data entries. I When challenged to pilot program to expand scope of study types, led data services to execute EKG and dim?light studies, resulting in increased business. I Created a user friendly experience by training sleep?site staff on data collection/transfer according to industry policies and standard operating procedures. I Efficiently and courteously communicated [via imperson, telephone, email, mail) with all levels of sponsor/internal contacts to build relationships, facilitating project interactions and high morale. Requested Names.pdf for Printed Item: 9 (Attachment 1 of 1) Education The George Washington University GW Bachelor of Science, Biological Sciences 2003 7 Volunteer Experience Field Volunteer Hillary for America Jul 2016 Nov 20i6 - 5 mos Politics From: To: Cc: O'Rourke, Peter M. Sandoval, Camilo J. ; IP < @frenchangel59.com> (b) (6) Bcc: Subject: Date: Attachments: RE: [EXTERNAL] Re: Apple vs Cerner Thu Mar 08 2018 06:14:42 CST I'll have my scheduler set something up for Friday if that works for you all. Pete -----Original Message----From: Bruce Moskowitz [mailto:(b) (6) Sent: Thursday, March 08, 2018 7:08 AM To: O'Rourke, Peter M. Cc: Sandoval, Camilo J.; Marc Sherman; IP Subject: Re: [EXTERNAL] Re: Apple vs Cerner @mac.com] Thank you for your quick response. When convenient for you, let’s set up a call to determine what can be done to rescue this very important initiative. Sent from my iPad Bruce Moskowitz M.D. > On Mar 8, 2018, at 7:04 AM, O'Rourke, Peter M. wrote: > > Bruce, > > What can I do to salvage that group's work and expertise and apply what we can to the developing product? > > Pete > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) @mac.com] > Sent: Thursday, March 08, 2018 6:45 AM > To: Sandoval, Camilo J. > Cc: Marc Sherman; IP; O'Rourke, Peter M. > Subject: [EXTERNAL] Re: Apple vs Cerner > > Thank you and after reviewing, we had an excellent group assembled on the call with Tim Cook, his staff and our five Academic centers and the VA to proceed with an EMR that would have solved many of the problems faced by the choice system, Telemedicine and of equal importance a platform for mental health. > > Instead of taking the excellent resources from the five Academic centers donating their time to the VA-18-0298-A-000204 VA, the VA dropped all contact and proceeded on its own. So now we have a product of limited value. > > Sent from my iPad > Bruce Moskowitz M.D. > >> On Mar 7, 2018, at 10:46 PM, Sandoval, Camilo J. wrote: >> >> Bruce/Marc, >> >> Apparently I was suppose to share this Attachment with you last month per John’s note below. >> >> My apologies if I didn’t. I will update the tracker, and please do let me know if this helps answers questions around Apple’s efforts or if additional clarification is required. >> >> Thank you. >> Camilo >> >> >> ________________________________ >> From: Windom, John H. >> Sent: Wednesday, March 07, 2018 7:26:08 PM >> To: Sandoval, Camilo J. >> Subject: FW: Apple vs Cerner >> >> >> >> Sent with Good (www.good.com) >> >> ________________________________ >> From: Windom, John H. >> Sent: Tuesday, March 06, 2018 6:18:26 AM >> To: Blackburn, Scott R. >> Cc: Short, John (VACO); Zenooz, Ashwini >> Subject: FW: Apple vs Cerner >> >> Sir, >> As you can see, I also shared with Cam who readily saw the difference and was to convey the message down South. Here you go. >> Vr >> John >> >> John H. Windom, Senior Executive Service (SES) Program Executive for >> Electronic Health Record Modernization (PEO EHRM) Special Advisor to >> the Under Secretary for Health >> 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 >> John.Windom@va.gov >> Office: (202) 461-5820 >> Mobile: (202) 794-4911 >> Executive Assistant: Ms.(b) (6) – Appointments and Scheduling >> (b) (6) @va.gov Office: (202) 461-(b) (6) >> >> >> >> >> From: Windom, John H. >> Sent: Friday, January 26, 2018 3:24 PM VA-18-0298-A-000205 >> To: Blackburn, Scott R.; Sandoval, Camilo J.; Zenooz, Ashwini; Short, >> John (VACO); (b) (6) (VACO) >> Subject: Apple vs Cerner >> >> Apple will not produce an EHR/EMR. It is a health record electronic file cabinet and will likely ultimately align to a commercial EHR. Apple will deliver less than 1% of commercial EHR capabilities. Please don’t let people confuse the two. These draft charts may help you with your messaging. >> Vr >> John >> >> John H. Windom, Senior Executive Service (SES) Program Executive for >> Electronic Health Record Modernization (PEO EHRM) Special Advisor to >> the Under Secretary for Health >> 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 >> John.Windom@va.gov >> Office: (202) 461-5820 >> Mobile: (202) 794-4911 >> Executive Assistant: (b) (6) – Appointments and Scheduling >> (b) (6) @va.gov Office: (202) 461-(b) (6) >> >> >> >> >> > Questions _final.docx> VA-18-0298-A-000206 From: COS-PMO O'Rourke, Peter M. wrote: Pete, You beat me to it-- just sat down to email all to you... It was truly a pleasure and honor to meet you yesterday. Please feel free to contact any of us at anytime.... I thought it was an extremely productive meeting yesterday and look forward to achieving the goals discussed. Warm regards.....(b) (6) On Wed, Feb 28, 2018 at 6:58 AM, COS-PMO wrote: (b) (6) I didn’t type your email right the first time, please see the original email below. Thank you, Pete Sent with Good (www.good.com) VA-18-0298-A-000208 ________________________________ From: COS-PMO Sent: Wednesday, February 28, 2018 3:37:19 AM To: (b) (6) ; ip; mbsherman; brucemoskowitzmd Subject: Contact information All, It was an honor to meet you all yesterday. I want to ensure that you have my VA and personal contact information. VA cell: 202-823-(b) (6) Personal cell: 202-997-(b) (6) Direct VA email: CoS-PMO@va.gov Personal email: (b) (6) I will protect our conversations from yesterday and as instructed by the Secretary last night, not discuss the content with any of the individuals what were mentioned. Thank you for your support of the President, the VA, and me as we work to make the VA great. Pete Sent with Good (www.good.com) VA-18-0298-A-000209 From: To: Cc: Bcc: Subject: Date: Attachments: COS-PMO O'Rourke, Peter M. FW: [EXTERNAL] Re: Contact information Wed Feb 28 2018 05:44:01 CST _____ From: Marc Sherman Sent: Wednesday, February 28, 2018 3:43:46 AM (UTC-08:00) Pacific Time (US & Canada) To: COS-PMO Cc: (b) (6) IP; Bruce Moskowitz Subject: [EXTERNAL] Re: Contact information Pete It was great to meet you and be able to spend the afternoon with you (and of course the Secretary) discussing mutual passions to help improve healthcare for our veterans. We are always excited to provide each of our thoughts to you and the Secretary as you both move forward in making decisions on how to best run and improve the veterans healthcare delivery system. Best Marc Marc Sherman (202) 758-(b) (6) On Feb 28, 2018 6:37 AM, "COS-PMO" wrote: All, It was an honor to meet you all yesterday. I want to ensure that you have my VA and personal contact information. VA cell: 202-823-(b) (6) Personal cell: 202-997-(b) (6) Direct VA email: CoS-PMO@va.gov Personal email: (b) (6) I will protect our conversations from yesterday and as instructed by the Secretary last night, not discuss the content with any of the individuals what were mentioned. Thank you for your support of the President, the VA, and me as we work to make the VA great. VA-18-0298-A-000210 Pete Sent with Good 1 From: To: Cc: Bcc: Subject: Date: Attachments: COS-PMO O'Rourke, Peter M. On Feb 28, 2018, at 6:37 AM, COS-PMO wrote: > > All, > > It was an honor to meet you all yesterday. I want to ensure that you have my VA and personal contact information. > > VA cell: 202-823-(b) (6) > Personal cell: 202-997-(b) (6) > Direct VA email: CoS-PMO@va.gov > Personal email: (b) (6) > > I will protect our conversations from yesterday and as instructed by the Secretary last night, not discuss the content with any of the individuals what were mentioned. > > Thank you for your support of the President, the VA, and me as we work to make the VA great. > > Pete > > > > Sent with Good (www.good.com) VA-18-0298-A-000212 From: To: Cc: Bcc: Subject: Date: Attachments: COS-PMO O'Rourke, Peter M. wrote: Sent from my iPad Bruce Moskowitz M.D. Begin forwarded message: From: Bruce Moskowitz (b) (6) @mac.com> Date: February 28, 2018 at 6:25:54 AM EST To: David Shulkin (b) (6) >, "Peter M. O'Rourke" Cc:(b) (6) @gmail.com, IP < @frenchangel59.com>,(b) (6) @gmail.com Subject: Mental Health (b) (6) The emergency “committee” is mental health and that should be the first one to get right and move VA-18-0298-A-000213 ASAP. I need to know all existing committees and initiatives on a chart. I have to pull in a significant number of assets to get boots on the ground to actually give timely care. I will need you to contact besides our academic partners, the following, U of PENN, U. OfChicago,UCLA, U of SanFrancisco, Stanford, Columbia, the Mack Center of technological innovation, the Bloomberg school of public health and Ondrea Gleason MD head of American Association of Chairs of Psychiatry. This committee will need a direct working relationship with Telemedicine, the Choice Program to get the job done. They will need the authority to seep away any beuqacratic process that slows the initiative. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298-A-000214 From: To: Cc: Bcc: Subject: Date: Attachments: COS-PMO O'Rourke, Peter M. wrote: Pete It was great to meet you and be able to spend the afternoon with you (and of course the Secretary) discussing mutual passions to help improve healthcare for our veterans. We are always excited to provide each of our thoughts to you and the Secretary as you both move forward in making decisions on how to best run and improve the veterans healthcare delivery system. Best Marc Marc Sherman (202) 758-(b) (6) On Feb 28, 2018 6:37 AM, "COS-PMO" wrote: All, It was an honor to meet you all yesterday. I want to ensure that you have my VA and personal contact information. VA-18-0298-A-000215 VA cell: 202-823-(b) (6) Personal cell: 202-997-(b) (6) Direct VA email: CoS-PMO@va.gov Personal email: (b) (6) I will protect our conversations from yesterday and as instructed by the Secretary last night, not discuss the content with any of the individuals what were mentioned. Thank you for your support of the President, the VA, and me as we work to make the VA great. Pete Sent with Good (www.good.com) VA-18-0298-A-000216 From: COS-PMO O'Rourke, Peter M. ((b) (6) @gmail.com); l(b) (6) @gmail.com Subject: [EXTERNAL] RE: Contact information Pete, I enjoyed meeting with you and the Secretary yesterday. I feel confident that you will be a terrific asset moving forward to get things accomplished. I am here 24/7 to help.....Best...Ike -----Original Message----From: COS-PMO [mailto:COS-PMO@va.gov] Sent: Wednesday, February 28, 2018 6:37 AM To: (b) (6) ; IP; mbsherman; brucemoskowitzmd Subject: Contact information All, It was an honor to meet you all yesterday. I want to ensure that you have my VA and personal contact information. VA cell: 202-823-(b) (6) Personal cell: 202-997-(b) (6) Direct VA email: CoS-PMO@va.gov Personal email: (b) (6) I will (b) (5) Thank you for your support of the President, the VA, and me as we work to make the VA great. Pete VA-18-0298-A-000217 Sent with Good 8 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) @mac.com> David Shulkin (b) (6) >; O'Rourke, Peter M. ; IP < @frenchangel59.com>; @gmail.com (b) (6) (b) (6) @gmail.com> (b) (6) [EXTERNAL] Mental Health Wed Feb 28 2018 05:25:54 CST The emergency “committee” is mental health and that should be the first one to get right and move ASAP. I need to know all existing committees and initiatives on a chart. I have to pull in a significant number of assets to get boots on the ground to actually give timely care. I will need you to contact besides our academic partners, the following, U of PENN, U. OfChicago,UCLA, U of SanFrancisco, Stanford, Columbia, the Mack Center of technological innovation, the Bloomberg school of public health and Ondrea Gleason MD head of American Association of Chairs of Psychiatry. This committee will need a direct working relationship with Telemedicine, the Choice Program to get the job done. They will need the authority to seep away any beuqacratic process that slows the initiative. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298-A-000219 From: To: Cc: Bcc: Subject: Date: Attachments: O'Rourke, Peter M. ; Sandoval, Camilo J. ; IP < @frenchangel59.com> (b) (6) RE: [EXTERNAL] Re: Apple vs Cerner Thu Mar 08 2018 06:04:39 CST Bruce, What can I do to salvage that group's work and expertise and apply what we can to the developing product? Pete -----Original Message----From: Bruce Moskowitz [mailto:(b) (6) Sent: Thursday, March 08, 2018 6:45 AM To: Sandoval, Camilo J. Cc: Marc Sherman; IP; O'Rourke, Peter M. Subject: [EXTERNAL] Re: Apple vs Cerner @mac.com] Thank you and after reviewing, we had an excellent group assembled on the call with Tim Cook, his staff and our five Academic centers and the VA to proceed with an EMR that would have solved many of the problems faced by the choice system, Telemedicine and of equal importance a platform for mental health. Instead of taking the excellent resources from the five Academic centers donating their time to the VA, the VA dropped all contact and proceeded on its own. So now we have a product of limited value. Sent from my iPad Bruce Moskowitz M.D. > On Mar 7, 2018, at 10:46 PM, Sandoval, Camilo J. wrote: > > Bruce/Marc, > > Apparently I was suppose to share this Attachment with you last month per John’s note below. > > My apologies if I didn’t. I will update the tracker, and please do let me know if this helps answers questions around Apple’s efforts or if additional clarification is required. > > Thank you. > Camilo > > > ________________________________ VA-18-0298-A-000220 > From: Windom, John H. > Sent: Wednesday, March 07, 2018 7:26:08 PM > To: Sandoval, Camilo J. > Subject: FW: Apple vs Cerner > > > > Sent with Good (www.good.com) > > ________________________________ > From: Windom, John H. > Sent: Tuesday, March 06, 2018 6:18:26 AM > To: Blackburn, Scott R. > Cc: Short, John (VACO); Zenooz, Ashwini > Subject: FW: Apple vs Cerner > > Sir, > As you can see, I also shared with Cam who readily saw the difference and was to convey the message down South. Here you go. > Vr > John > > John H. Windom, Senior Executive Service (SES) Program Executive for > Electronic Health Record Modernization (PEO EHRM) Special Advisor to > the Under Secretary for Health > 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 > John.Windom@va.gov > Office: (202) 461-5820 > Mobile: (202) 794-4911 > Executive Assistant: Ms. (b) (6) – Appointments and Scheduling > (b) (6) @va.gov Office: (202) 461-(b) (6) > > > > > From: Windom, John H. > Sent: Friday, January 26, 2018 3:24 PM > To: Blackburn, Scott R.; Sandoval, Camilo J.; Zenooz, Ashwini; Short, > John (VACO); (b) (6) (VACO) > Subject: Apple vs Cerner > > Apple will not produce an EHR/EMR. It is a health record electronic file cabinet and will likely ultimately align to a commercial EHR. Apple will deliver less than 1% of commercial EHR capabilities. Please don’t let people confuse the two. These draft charts may help you with your messaging. > Vr > John > > John H. Windom, Senior Executive Service (SES) Program Executive for > Electronic Health Record Modernization (PEO EHRM) Special Advisor to > the Under Secretary for Health > 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 > John.Windom@va.gov > Office: (202) 461-5820 > Mobile: (202) 794-4911 > Executive Assistant: (b) (6) – Appointments and Scheduling >(b) (6) @va.gov Office: (202) 461-(b) (6) VA-18-0298-A-000221 > > > > > Questions _final.docx> VA-18-0298-A-000222 From: Bruce Moskowitz (b) (6) To: Cc: @mac.com> O'Rourke, Peter M. ; IP < @frenchangel59.com> (b) (6) (b) (6) Bcc: Subject: Date: Attachments: Re: [EXTERNAL] Re: Apple vs Cerner Thu Mar 08 2018 06:08:06 CST Thank you for your quick response. When convenient for you, let’s set up a call to determine what can be done to rescue this very important initiative. Sent from my iPad Bruce Moskowitz M.D. > On Mar 8, 2018, at 7:04 AM, O'Rourke, Peter M. wrote: > > Bruce, > > What can I do to salvage that group's work and expertise and apply what we can to the developing product? > > Pete > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) @mac.com] > Sent: Thursday, March 08, 2018 6:45 AM > To: Sandoval, Camilo J. > Cc: Marc Sherman; IP; O'Rourke, Peter M. > Subject: [EXTERNAL] Re: Apple vs Cerner > > Thank you and after reviewing, we had an excellent group assembled on the call with Tim Cook, his staff and our five Academic centers and the VA to proceed with an EMR that would have solved many of the problems faced by the choice system, Telemedicine and of equal importance a platform for mental health. > > Instead of taking the excellent resources from the five Academic centers donating their time to the VA, the VA dropped all contact and proceeded on its own. So now we have a product of limited value. > > Sent from my iPad > Bruce Moskowitz M.D. > >> On Mar 7, 2018, at 10:46 PM, Sandoval, Camilo J. wrote: >> >> Bruce/Marc, >> >> Apparently I was suppose to share this Attachment with you last month per John’s note below. >> VA-18-0298-A-000223 >> My apologies if I didn’t. I will update the tracker, and please do let me know if this helps answers questions around Apple’s efforts or if additional clarification is required. >> >> Thank you. >> Camilo >> >> >> ________________________________ >> From: Windom, John H. >> Sent: Wednesday, March 07, 2018 7:26:08 PM >> To: Sandoval, Camilo J. >> Subject: FW: Apple vs Cerner >> >> >> >> Sent with Good (www.good.com) >> >> ________________________________ >> From: Windom, John H. >> Sent: Tuesday, March 06, 2018 6:18:26 AM >> To: Blackburn, Scott R. >> Cc: Short, John (VACO); Zenooz, Ashwini >> Subject: FW: Apple vs Cerner >> >> Sir, >> As you can see, I also shared with Cam who readily saw the difference and was to convey the message down South. Here you go. >> Vr >> John >> >> John H. Windom, Senior Executive Service (SES) Program Executive for >> Electronic Health Record Modernization (PEO EHRM) Special Advisor to >> the Under Secretary for Health >> 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 >> John.Windom@va.gov >> Office: (202) 461-5820 >> Mobile: (202) 794-4911 >> Executive Assistant: Ms. (b) (6) – Appointments and Scheduling >> (b) (6) @va.gov Office: (202) 461-(b) (6) >> >> >> >> >> From: Windom, John H. >> Sent: Friday, January 26, 2018 3:24 PM >> To: Blackburn, Scott R.; Sandoval, Camilo J.; Zenooz, Ashwini; Short, >> John (VACO); Cox, Tim (VACO) >> Subject: Apple vs Cerner >> >> Apple will not produce an EHR/EMR. It is a health record electronic file cabinet and will likely ultimately align to a commercial EHR. Apple will deliver less than 1% of commercial EHR capabilities. Please don’t let people confuse the two. These draft charts may help you with your messaging. >> Vr >> John >> >> John H. Windom, Senior Executive Service (SES) Program Executive for VA-18-0298-A-000224 >> Electronic Health Record Modernization (PEO EHRM) Special Advisor to >> the Under Secretary for Health >> 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 >> John.Windom@va.gov >> Office: (202) 461-5820 >> Mobile: (202) 794-4911 >> Executive Assistant: Ms. (b) (6) – Appointments and Scheduling >> (b) (6) @va.gov Office: (202) 461-(b) (6) >> >> >> >> >> > Questions _final.docx> VA-18-0298-A-000225 From: To: Cc: O'Rourke, Peter M. (b) (6) Sandoval, Camilo J. ; IP < @frenchangel59.com>; (b) (6) (b) (6) On Mar 8, 2018, at 7:14 AM, O'Rourke, Peter M. wrote: > > I'll have my scheduler set something up for Friday if that works for you all. > > Pete > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) @mac.com] > Sent: Thursday, March 08, 2018 7:08 AM > To: O'Rourke, Peter M. > Cc: Sandoval, Camilo J.; Marc Sherman; IP > Subject: Re: [EXTERNAL] Re: Apple vs Cerner > > Thank you for your quick response. When convenient for you, let’s set up a call to determine what can be done to rescue this very important initiative. > > Sent from my iPad > Bruce Moskowitz M.D. > >> On Mar 8, 2018, at 7:04 AM, O'Rourke, Peter M. wrote: >> >> Bruce, VA-18-0298-A-000226 >> >> What can I do to salvage that group's work and expertise and apply what we can to the developing product? >> >> Pete >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) d@mac.com] >> Sent: Thursday, March 08, 2018 6:45 AM >> To: Sandoval, Camilo J. >> Cc: Marc Sherman; IP; O'Rourke, Peter M. >> Subject: [EXTERNAL] Re: Apple vs Cerner >> >> Thank you and after reviewing, we had an excellent group assembled on the call with Tim Cook, his staff and our five Academic centers and the VA to proceed with an EMR that would have solved many of the problems faced by the choice system, Telemedicine and of equal importance a platform for mental health. >> >> Instead of taking the excellent resources from the five Academic centers donating their time to the VA, the VA dropped all contact and proceeded on its own. So now we have a product of limited value. >> >> Sent from my iPad >> Bruce Moskowitz M.D. >> >>> On Mar 7, 2018, at 10:46 PM, Sandoval, Camilo J. wrote: >>> >>> Bruce/Marc, >>> >>> Apparently I was suppose to share this Attachment with you last month per John’s note below. >>> >>> My apologies if I didn’t. I will update the tracker, and please do let me know if this helps answers questions around Apple’s efforts or if additional clarification is required. >>> >>> Thank you. >>> Camilo >>> >>> >>> ________________________________ >>> From: Windom, John H. >>> Sent: Wednesday, March 07, 2018 7:26:08 PM >>> To: Sandoval, Camilo J. >>> Subject: FW: Apple vs Cerner >>> >>> >>> >>> Sent with Good (www.good.com) >>> >>> ________________________________ >>> From: Windom, John H. >>> Sent: Tuesday, March 06, 2018 6:18:26 AM >>> To: Blackburn, Scott R. >>> Cc: Short, John (VACO); Zenooz, Ashwini >>> Subject: FW: Apple vs Cerner >>> >>> Sir, >>> As you can see, I also shared with Cam who readily saw the difference and was to convey the VA-18-0298-A-000227 message down South. Here you go. >>> Vr >>> John >>> >>> John H. Windom, Senior Executive Service (SES) Program Executive for >>> Electronic Health Record Modernization (PEO EHRM) Special Advisor to >>> the Under Secretary for Health >>> 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 >>> John.Windom@va.gov >>> Office: (202) 461-5820 >>> Mobile: (202) 794-4911 >>> Executive Assistant: Ms. (b) (6) – Appointments and Scheduling >>> (b) (6) @va.gov Office: (202) 461-(b) (6) >>> >>> >>> >>> >>> From: Windom, John H. >>> Sent: Friday, January 26, 2018 3:24 PM >>> To: Blackburn, Scott R.; Sandoval, Camilo J.; Zenooz, Ashwini; >>> Short, John (VACO); (b) (6) (VACO) >>> Subject: Apple vs Cerner >>> >>> Apple will not produce an EHR/EMR. It is a health record electronic file cabinet and will likely ultimately align to a commercial EHR. Apple will deliver less than 1% of commercial EHR capabilities. Please don’t let people confuse the two. These draft charts may help you with your messaging. >>> Vr >>> John >>> >>> John H. Windom, Senior Executive Service (SES) Program Executive for >>> Electronic Health Record Modernization (PEO EHRM) Special Advisor to >>> the Under Secretary for Health >>> 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 >>> John.Windom@va.gov >>> Office: (202) 461-5820 >>> Mobile: (202) 794-4911 >>> Executive Assistant: Ms. (b) (6) – Appointments and Scheduling >>> (b) (6) @va.gov Office: (202) 461-(b) (6) >>> >>> >>> >>> >>> >> Questions _final.docx> VA-18-0298-A-000228 From: Bruce Moskowitz (b) (6), (b) (5) To: Cc: @mac.com> O'Rourke, Peter M. ; IP < @frenchangel59.com> (b) (6) (b) (6) Bcc: Subject: Date: Attachments: Re: [EXTERNAL] Re: Apple vs Cerner Thu Mar 08 2018 06:15:56 CST Thank you I have noon or after 4 or before 7 am. It will probably just be me on the call Sent from my iPad Bruce Moskowitz M.D. > On Mar 8, 2018, at 7:14 AM, O'Rourke, Peter M. wrote: > > I'll have my scheduler set something up for Friday if that works for you all. > > Pete > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) @mac.com] > Sent: Thursday, March 08, 2018 7:08 AM > To: O'Rourke, Peter M. > Cc: Sandoval, Camilo J.; Marc Sherman; IP > Subject: Re: [EXTERNAL] Re: Apple vs Cerner > > Thank you for your quick response. When convenient for you, let’s set up a call to determine what can be done to rescue this very important initiative. > > Sent from my iPad > Bruce Moskowitz M.D. > >> On Mar 8, 2018, at 7:04 AM, O'Rourke, Peter M. wrote: >> >> Bruce, >> >> What can I do to salvage that group's work and expertise and apply what we can to the developing product? >> >> Pete >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) @mac.com] >> Sent: Thursday, March 08, 2018 6:45 AM >> To: Sandoval, Camilo J. >> Cc: Marc Sherman; IP; O'Rourke, Peter M. >> Subject: [EXTERNAL] Re: Apple vs Cerner VA-18-0298-A-000229 >> >> Thank you and after reviewing, we had an excellent group assembled on the call with Tim Cook, his staff and our five Academic centers and the VA to proceed with an EMR that would have solved many of the problems faced by the choice system, Telemedicine and of equal importance a platform for mental health. >> >> Instead of taking the excellent resources from the five Academic centers donating their time to the VA, the VA dropped all contact and proceeded on its own. So now we have a product of limited value. >> >> Sent from my iPad >> Bruce Moskowitz M.D. >> >>> On Mar 7, 2018, at 10:46 PM, Sandoval, Camilo J. wrote: >>> >>> Bruce/Marc, >>> >>> Apparently I was suppose to share this Attachment with you last month per John’s note below. >>> >>> My apologies if I didn’t. I will update the tracker, and please do let me know if this helps answers questions around Apple’s efforts or if additional clarification is required. >>> >>> Thank you. >>> Camilo >>> >>> >>> ________________________________ >>> From: Windom, John H. >>> Sent: Wednesday, March 07, 2018 7:26:08 PM >>> To: Sandoval, Camilo J. >>> Subject: FW: Apple vs Cerner >>> >>> >>> >>> Sent with Good (www.good.com) >>> >>> ________________________________ >>> From: Windom, John H. >>> Sent: Tuesday, March 06, 2018 6:18:26 AM >>> To: Blackburn, Scott R. >>> Cc: Short, John (VACO); Zenooz, Ashwini >>> Subject: FW: Apple vs Cerner >>> >>> Sir, >>> As you can see, I also shared with Cam who readily saw the difference and was to convey the message down South. Here you go. >>> Vr >>> John >>> >>> John H. Windom, Senior Executive Service (SES) Program Executive for >>> Electronic Health Record Modernization (PEO EHRM) Special Advisor to >>> the Under Secretary for Health >>> 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 >>> John.Windom@va.gov >>> Office: (202) 461-5820 >>> Mobile: (202) 794-4911 >>> Executive Assistant: (b) (6) – Appointments and Scheduling VA-18-0298-A-000230 >>> (b) (6) @va.gov Office: (202) 461-(b) (6) >>> >>> >>> >>> >>> From: Windom, John H. >>> Sent: Friday, January 26, 2018 3:24 PM >>> To: Blackburn, Scott R.; Sandoval, Camilo J.; Zenooz, Ashwini; Short, >>> John (VACO); Cox, Tim (VACO) >>> Subject: Apple vs Cerner >>> >>> Apple will not produce an EHR/EMR. It is a health record electronic file cabinet and will likely ultimately align to a commercial EHR. Apple will deliver less than 1% of commercial EHR capabilities. Please don’t let people confuse the two. These draft charts may help you with your messaging. >>> Vr >>> John >>> >>> John H. Windom, Senior Executive Service (SES) Program Executive for >>> Electronic Health Record Modernization (PEO EHRM) Special Advisor to >>> the Under Secretary for Health >>> 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 >>> John.Windom@va.gov >>> Office: (202) 461-5820 >>> Mobile: (202) 794-4911 >>> Executive Assistant: Ms. (b) (6) – Appointments and Scheduling >>> (b) (6) @va.gov Office: (202) 461-(b) (6) >>> >>> >>> >>> >>> >> Questions _final.docx> VA-18-0298-A-000231 Ha, Richard From: Sent: To: Subject: RLW Monday, April 23, 2018 11:09 AM (b) (6) ; COS-PMO; (b) (6) @aol.com; (b) (6) (b) (6) RE: [EXTERNAL] From & Ike Perlmutter Bruce Moskowitz; Marc Sherman I was honored to visit with you.  No matter how long I am here,  there is a template in place based on your efforts to  move this institution out of the Industrial Age.    Thank you again for taking time to see me.    Very Respectfully,    Robert Wilkie    From: (b) (6) Sent: Saturday, April 21, 2018 1:49:02 PM To: RLW; COS-PMO; (b) (6) @aol.com; (b) (6) Subject: [EXTERNAL] From (b) (6) & Ike Perlmutter  ; Bruce Moskowitz; Marc Sherman Hello all,  Ike and I believe we speak for all of us when we say our meeting was  extremely productive. For the first time in 1 1/2 years we feel everyone  is on the same page. Everybody "gets it."  With all  of you, led by Rob and Pete‐‐ our Veterans cannot lose.  Again, please know we are available and want to help any possible way  24/7.  Thank you for an amazing meeting.    Warmest regards ...(b) (6)  & Ike  1 VA-18-0298-A-000232 Ha, Richard From: Sent: To: Cc: Subject: RLW Monday, April 23, 2018 11:18 AM Bruce Moskowitz; (b) (6) IP; (b) (6) @gmail.com; (b) (6) RE: [EXTERNAL] Meeting follow up @gmail.com Sir it was my honor.  Thank you for taking time and I look forward to seeing you soon.    Very Respectfully,    Robert Wilkie    From: Bruce Moskowitz Sent: Saturday, April 21, 2018 1:41:42 PM To: RLW; (b) (6) Cc: IP; (b) (6) @gmail.com; (b) (6) @gmail.com Subject: [EXTERNAL] Meeting follow up  I am sure that I speak for the group,  that both you and Peter astounded all of us on how quickly and accurately you assessed the key  problems and more importantly the solutions that will be needed to finally move the VA in the right direction. Thank you again for a  very productive meeting.      Sent from my iPad  Bruce Moskowitz M.D.  1 0224 VA-18-0298-A-000233 FOR OFFICIAL USE ONLY – DO NOT DISTRIBUTE FINAL 2 THE HONORABLE ROBERT WILKIE U.S. ACTING SECRETARY OF VETERANS AFFAIRS TRAVEL ITINERARY FAYETTEVILLE, NC – WEST PALM BEACH, FL APRIL 17-20, 2018 TRAVELING PARTY: The Honorable Robert Wilkie Peter O’Rourke, Chief of Staff (WPB only) Colonel (b) (6) , Special Assistant (b) (6) , Deputy Press Secretary 202-823-(b) (6) 202-870-(b) (6) 202-897-(b) (6) SECURITY: (b) (6), (b) (7)(C) , Detail Leader (b) (6), (b) (7) , Advance (C) 202-391-(b) (6), 202-657-(b) POCs: (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) , Executive Editor, Fayetteville Observer , Braxton Bragg Chapter, AUSA , Sr. Dir. of Events, Crown Complex , EA to Director/Facility Planner, FVAMC (dinner) , Office of the Governor , Exec. Officer, Womack Medical Center, Ft. Bragg , EA, Office of President, Methodist University (MU) Ph.D., MU Director of University Relations, MU Acting Asst. Dir., WPB VAMC SCHEDULING POCs: , Special Assistant, OSVA (Advance NC only) Travel Coordinator, OSVA (b) (6) (b) (6) Tuesday, April 17, 2018 Weather: Washington, DC Fayetteville, NC (b) (6), (7) (b) (C) (7) 910-916-(b) (C) 910-396-(b) /910-624-(b)(6)(6) (6) /910-824-(b) (6) 910-438-(b) 910-488-2120 (b)(6)(6) /910-797-(b) (6) 910-797-(b) (b) 919-814-(6) (b) (b) 910-907/910-849- (6)(6) (6) 910-630-(b) (b) 910-630/910-987-(b)(6)(6) (6) (b) 910-630/910-309-(b) (6) (6) 561-422-(b) /606-571-(b) (6) (6) 202-461-(b) /202-384-(b) (6) (6) (b) /202-281-(b) 202-461(6) (6) Attire: Casual H-53°; L-39° – Partly Sunny H-67°; L-50° – Sunny 1500-1600 DEPART U.S. CAPITOL ERT/ARRIVE TO DULLES AIRPORT (IAD) 1730 WHEELS UP TO FAYETTEVILLE, NC AIRPORT (FAY) United 3915, Flight Time: 1hr 34min 1904 ARRIVE AT FAY AIRPORT 1915-1940 ERT/ARRIVE RESIDENCE – RON (6), (b) (7)(E), Drive Time: (b) (b) (7)(C) Last Update: 4/19/2018 9:50 AM 1 VA-18-0298-A-000234 FOR OFFICIAL USE ONLY – DO NOT DISTRIBUTE FINAL 2 Wednesday, April 18, 2018 Weather: Fayetteville, NC Attire: Business (day) H-84°; L-65° – Mostly Sunny Casual (dinner) golf shirt/sweater/slacks BREAKFAST ON OWN 0930-0945 ERT/ARRIVE FAYETTEVILLE OBSERVER 458 Whitfield Street, Fayetteville, NC (Visitor Entrance) Drive Time: 3.4mil / 15mins Greeted by: Matt Leclercq, Executive Editor, FO Drew Brook, Military Editor, FO Tim White, Editorial Page Editor, FO 1000-1015 INTERVIEW W/WRAL-TV ANCHOR DAVID CRABTREE Location: WRAL Studio area Topics: - Eastern North Carolina & Fayetteville’s importance to National Security How Fort Bragg fits into the National Security Strategy Veteran’s Affairs – items of interest to Fayetteville & surrounding areas 1015-1025 PRINT INTERVIEW W/FAYETTEVILLE OBSERVER Location: Conference Room Topics: same as above Drew Brook, Military Editor, FO Tim White, Editorial Page Editor, FO 1030-1045 ERT/ARRIVE AT CROWN COLISEUM 1960 Coliseum Dr., Fayetteville NC 28314 (arrive West VIP Entrance) Drive Time: 2.1mil / 15mins Greeted by: Andrew McFolwer, President Braxton Chapter, Association of United Army 1045-1130 HOLD ROOM – ESPN Radio, Upper Deck 1130-1300 REMARKS AT ASSOCIATION OF UNITED STATES ARMY (AUSA) Location: Ballroom (Hospitality Room) PRESS: open (190-200 attendees business leaders, community & Veterans) - Emcee - MG Rodney Anderson (USA Ret.) - Welcome, Invocation, Pledge of Allegiance, All American Chorus - Lunch served - Community Partner’s Recognition (4 companies) - Introduction of ASECVA – MG Anderson - Remarks – ASECVA (Q&A optional) - Remarks - General Carter Ham, Pres. & CEO, AUSA - Raffle for computer analysis - Closing Remarks/Benediction Last Update: 4/19/2018 9:50 AM 2 VA-18-0298-A-000235 FOR OFFICIAL USE ONLY – DO NOT DISTRIBUTE FINAL 2 1300-1325 ERT/ARRIVE AT FAYETTEVILLE VA HEALTH CARE CENTER (FVAHHC) 7300 S. Raeford Road, Fayetteville, NC 28304 Drive Time 9.5mil / 25mins Greeted by: (b) (6) , VISN 6 Network Director (b) (6) Fayetteville Medical Center Director 1330-1415 FACILITY BRIEFING / LEADERSHIP OVERVIEW Location: Briefing Room 3117 - Introduction of Executive Leadership Team - Fayetteville Market Analysis Overview - Overview of Fayetteville Enterprise - Review of Successes o Access/Wait Time Improvement o Improved Quality Rating o DoD Relationship o Opioid Reduction Efforts o Veterans Court - Discussion of Challenges o Infrastructure o Population Growth & Staff Recruiting o Approval Speed for Local Leases o Choice Authorization Bill & Impacts o Support VISN 6 and FVAMC as the fastest growing VISN in VA Attendees: (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) 1415-1500 , VISN 6 ND , Director FVAMC Associate Director, FVAMC , Chief of Staff, FVAMC , Associate Director for Patient Care Services, FVAMC Executive Assistant to the Director TOUR FAYETTEVILLE HCC 3rd Floor Optometry – (b) (6) Audiology – (b) (6) Prosthetics – (b) (6) Physical Medicine & Rehabilitation – (b) (6) - 2nd Floor Surgery – (b) (6) st 1 Floor - Imaging – (b) (6) Chapel Women’s Health – (b) (6) Attendees: - same meeting participants Last Update: 4/19/2018 9:50 AM 3 VA-18-0298-A-000236 FOR OFFICIAL USE ONLY – DO NOT DISTRIBUTE FINAL 2 1500-1525 ERT/ARRIVE RESIDENCE (6), (b) (7)(E), Drive Time: (b) (b) (7)(C) 1525-1700 EXECUTIVE TIME 1720-1730 ERT/ARRIVE CHRIS STEAKHOUSE Drive Time: 1.6mil / 10mins 1730 DINNER AT CHRIS STEAKHOUSE 2620 Raeford Rd Fayetteville, NC 28303 910-485-2948 Attendees: 1) (b) (6) , FORSCOM CG (b) (6) 2) 3) (b) (6) AUSA Exec Director (b) (6) 4) , AUSA President, Braxton Bragg Chapter 5) (b) (6) , FORSCOM, DCG 6) (b) (6) , FIRSCOM, CSM 7) (b) (6) President, Systel 8) (b) (6) , Momentum Aerospace Group 9) (b) (6) , Director, Crown Coliseum 10) (b) (6) , President Allegra (b) (6) 11) , Chair, Allegra 12) (b) (6) Barnhill Contracting (b) (6) 13) , Area Manager, Barnhill, Contracting 14) (b) (6) , CPA (b) (6) 15) , Retired XVIII ABN Corps CSM 16) (b) (6) , teacher (b) (6) 17) , CASA – NC 18) (b) (6) , Gen Mgr. Master Tow Manufacturing 19) (b) (6) local manager, General Dynamics (b) (6) 20) , Freefall Instructor 21) (b) (6) Dean of Health Sciences, FTCC (b) (6) 22) , Director of Innovation, Entrepreneurship, and Small Business ERT/ARRIVE AT RESIDENCE - RON Last Update: 4/19/2018 9:50 AM 4 VA-18-0298-A-000237 FOR OFFICIAL USE ONLY – DO NOT DISTRIBUTE FINAL 2 Thursday, April 19, 2018 Weather: Fayetteville, NC Raleigh, NC Attire: Business H-80°; L-47° – Mostly Sunny H-75°; L-44° – Mostly Sunny BREAKFAST ON OWN 0530-0725 ERT/ARRIVE AT N.C. EXECUTIVE MANSION 200 N. Blount Street, Raleigh, NC 27601 Drive Time: 67mil / 1hr 25mins 0730-0815 MEETING W/GOVERNOR ROY COOPER Location: Library Attendees: (b) (6) , NC Secretary of Military & Veterans Affairs (b) (6) , Director of Inter-governmental Affairs, Governor’s Office (b) (6) Colonel , Special Assistant to the Secretary of VA 0815-0940 ERT/ARRIVE AT RESIDENCE (6), (b) (7)(E), (b) (7) Drive Time: (b) (C) 0835-0855 PHONE INTERVIEW W/ 640 WFNC RADIO JEFF GOLDBERG “GOLDY” Call in: 910.864.(b) (6) Goldberg, 910-401-(b) (6) 301-706-(b) (6) POC: Jeff "Goldy" Topics: - Eastern North Carolina & Fayetteville’s importance to National Security - How Fort Bragg fits into the National Security Strategy - Veteran’s Affairs – items of interest to Fayetteville & surrounding areas 0940-1030 EXECUTIVE TIME 1035-1100 ERT/ARRIVE WOMACK ARMY MEDICAL CENTER 2817 Reilly Road, Fort Bragg, NC 28310 Drive Time: 8.2mil / 25mins Greeted by: Commander Melton 1100-1200 MEETING W/COMMANDER OF WOMACK ARMY MEDICAL CENTER COLONEL JOHN MELTON Location: Commander’s Office, 1st Floor Attendees: Colonel (b) (6) , Special Assistant to the Secretary of VA 1200-1215 ERT/ARRIVE AT RESIDENCE (6), (b) (7)(E), (b) Drive Time: (b) (7)(C) 1215-1410 EXECUTIVE TIME – LUNCH ON OWN Last Update: 4/19/2018 9:50 AM 5 VA-18-0298-A-000238 FOR OFFICIAL USE ONLY – DO NOT DISTRIBUTE FINAL 2 1410-1445 ERT/ARRIVE AT METHODIST UNIVERSITY 5400 Ramsey Street, Fayetteville, NC 28311 Berns Student Center Drive Time: 9.8mil / 35mins Greeted by: Dr. Ben Hancock, Jr, President Director of University Relations 1445-1450 COUTESY CALL W/METHODIST UNIVERSITY PRES. DR. BEN HANCOCK Location: President’s Dining Room, Berns Student Center 1450-1520 RECEPTION HOSTED BY PRESIDENT HANCOCK Location: Alumni Dining Room, Berns Student Center Attendees (20): , Chair, Dept. of Political Science , Director of University Relations MU Trustees Student Government Association Officers 1520-1525 MOVE TO MARGARET & WALTER CLARK HALL 1530-1630 REMARKS / Q&A AT METHODIST UNIVERSITY Location: Yarborough Auditorium PRESS: Media Release (150 students & faculty) Topic: "The New U.S. National Defense Strategy" --Introduction of ASECVA – Dr. Ziegler, Chair, Dept. of Political Science 1630-1705 ERT/ARRIVE AT RESIDENCE - RON (6), (b) (7)(E), (b) Drive Time: (b) (7)(C) DINNER ON OWN Last Update: 4/19/2018 9:50 AM 6 VA-18-0298-A-000239 FOR OFFICIAL USE ONLY – DO NOT DISTRIBUTE FINAL 2 Friday, April 20, 2018 Weather: Fayetteville, NC West Palm Beach, FL Washington, DC Attire: Business H-69°; L-45° – Sunny H-84°; L-72° – Mostly Sunny H-58°; L-40° - Sunny 0430-0500 ERT/ARRIVE AT FAY AIRPORT Drive time: 12mil / 30min 0600 WHEELS UP TO CHARLOTTE, NC AIRPORT (CLT) American 5259, Flight time: 54min 0654 ARRIVE AT CLT AIRPORT (Layover 41min) 0735 WHEELS UP TO PALM BEACH INTERNATIONAL AIRPORT (PBI) American 0764, Flight time: 1hr 53mn 0928 ARRIVE AT PBI AIRPORT 0940-0955 ERT/ARRIVE AT WEST PALM BEACH VA MEDICAL CENTER *East Main Entrance 7305 N. Military Trail West Palm Beach, FL 33410 Dive time: 10mil / 15min Greeted by: Miguel Lapuz, MD, VISN8 Network Director Donna Katen-Bahensky, Medical Center Director 1000-1045 LEADERSHIP BRIEFING Location: Medical Center Conference Room 2C-149 -Introduction of Leadership Team -Review of Successes • High Risk Population Strategies • Community Partnerships • Primary Care Access • Blind Rehabilitation Program • Whole Health -Discussion of Challenges • Federal Acquisitions Constraints • Competitive Recruitment and Retention Process • Choice and Community Partnerships Attendees: Peter O’Rourke, Chief of Staff Miguel Lapuz, MD, VISN8 Network Director Donna Katen-Bahensky, Medical Center Director (b) (6) , Acting Chief of Staff (b) (6) , Acting Associate Medical Center Director (b) (6) , Associate Director for Patient Care Services Last Update: 4/19/2018 9:50 AM 7 VA-18-0298-A-000240 FOR OFFICIAL USE ONLY – DO NOT DISTRIBUTE FINAL 2 (b) (6) , Acting Asst. Medical Center Director 1045-1130 FACILITY TOUR Primary Care Clinical Area-9th Floor Blind Rehabilitation Unit-7B Cancer Center 1130-1150 ERT/ARRIVE AT MAR-A-LAGO HOTEL 1100 South Ocean Boulevard, Palm Beach, Florida 33480 Drive time: 11mil / 20min 1200-1600 EXECUTIVE TIME 1600-1615 ERT/ARRIVE AT WEST PALM BEACH AIRPORT (PBI) Drive time: 5mil / 15min 1735 WHEELS UP TO REAGAN AIRPORT (DCA) American 0632, Flight time: 2hr 27min 2002 ARRIVE AT DCA AIRPORT 2015 ERT/ARRIVE RESIDENCE - MC Last Update: 4/19/2018 9:50 AM 8 VA-18-0298-A-000241 (b) (6) Subject: Location: Meet w/Marc Sherman SecVA Suite Start: End: Mon 4/2/2018 4:30 PM Mon 4/2/2018 5:00 PM Recurrence: (none) Organizer: RLW   1 VA-18-0298-A-000242 From: To: Cc: Subject: Date: American Oversight FOIA Short, Jacqueline VACO FOIA Service Inbox [EXTERNAL] Re: FOIA Request 18-07476-F (McGrath) Tuesday, May 08, 2018 11:44:56 AM Ms. Short, Thank you for your message. While we believe our request is reasonably described as submitted, as an accommodation to VA, we agree to limit the search to political appointees and career SES employees in the offices noted in our request: the Office of the Secretary, the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer, or the Electronic Health Records Modernization (EHRM) Program Executive Office. The amended request would essentially read as follows: All records reflecting communications (including emails, email attachments, text messages, messages on messaging platforms (such as Slack, GChat or Google Hangouts, Lync, Skype, or WhatsApp), telephone call logs, calendar entries/invitations, meeting notices, meeting agendas, informational material, draft legislation, talking points, any handwritten or electronic notes taken during any oral communications, summaries of any oral communications, or other materials) between 1) political appointees[1] and Senior Executive Service (SES) employees within the Office of the Secretary, the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer and, the Electronic Health Records Modernization (EHRM) Program Executive Office and 2) Isaac "Ike" Perlmutter, Bruce Moskowitz, or Jared Kushner. Please provide all responsive records from May 15, 2017, to the date of the search. [1] "Political appointee" should be understood as any person who is a Presidential Appointee with Senate Confirmation (PAS), a Presidential Appointee (PA), a Non-career SES, any Schedule C employees, or any persons hired under Temporary Non-career SES Appointments, Limited Term SES Appointments, or Temporary Transitional Schedule C Appointments. Sincerely, Daniel McGrath Staff Attorney American Oversight foia@americanoversight.org | 202.897.4213 www.americanoversight.org | @weareoversight FOIA: VA-18-0298 On May 8, 2018, at 11:11 AM, Short, Jacqueline wrote: Dear Mr. Grath, This is in response to your Freedom of Information Act (FOIA) request dated May 4, 2018 in which you asked for a copy of "all records reflecting communications (including emails, email attachments, text messages, messages on messaging platforms (such as Slack, GChat or Google Hangouts, Lync, Skype, or WhatsApp), telephone call logs, calendar entries/invitations, meeting notices, meeting agendas, informational material, draft legislation, talking points, any handwritten or electronic notes taken during any oral communications, summaries of any oral communications, or other materials) between 1) the Office of the Secretary, the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer, or the Electronic Health Records Modernization (EHRM) Program Executive Office and 2) Isaac "Ike" Perlmutter, Bruce Moskowitz, or Jared Kushner". Your request was received in this office on May 8, 2018. We have assigned FOIA Tracking Number 18-07426-F to your request. Please refer to it whenever communicating with VA about your request. Please be advised that your request, as written, is overly broad in its scope and would impose an inordinate and unreasonable search burden on agency resources. Therefore, we require that you redefine the scope of your request by more specifically identifying the program, office, or other delineating factor that will more reasonably describe the records sought so that a Department of Veterans Affairs (VA) employee familiar with the subject matter concerned would be able to locate the records with a reasonable amount of effort. Failure to do so will result in our inability to process your request. If you would like assistance with reformulating your request, please call me at 202-632-7426. Sincerely, Jacqueline (Jackie) Short VACO FOIA Service Quality, Privacy, and Risk (QPR) Office of Information and Technology (OI&T) Office: (202) 632-7426 / Fax: (202) 632-7581 vacofoiaservice@va.gov FOIA Service Hotline: 1-877-750-3642 Please take a moment and let us know how we did by completing a quick evaluation: Got a minute? Rate Our Service! QPR's Mission Statement: "To instill and promote a culture of quality, privacy and risk management in collaboration with our business partners to enable a better Veteran experience." From: American Oversight FOIA [mailto:foia@americanoversight.org] Sent: Friday, May 04, 2018 3:59 PM To: VACO FOIA Service Inbox Subject: [EXTERNAL] FOIA Request (VA-18-0298) Dear FOIA Officer: Please find attached a request for records under the Freedom of Information Act. Sincerely, Daniel McGrath Staff Attorney American Oversight foia@americanoversight.org | 202.897.4213 www.americanoversight.org | @weareoversight FOIA: VA-18-0298 DEPARTMENT OF VETERANS AFFAIRS Washington DC 20420 November 20, 2018 In Reply Refer To: 001B FOIA Request: 18-07426-F Daniel McGrath Staff Attorney American Oversight 1030 15th Street NW, Suite B255 Washington, DC 20005 foia@americanoversight.org Dear Mr. McGrath: This is the Second Partial Initial Agency Decision (IAD) to your Freedom of Information Act (FOIA) request to the Office of the Secretary, U.S. Dept. of Veterans Affairs (OSVA) dated May 4, 2018, received in this FOIA office on May 7, 2018, and assigned FOIA tracking number 1807426-F. Per your attached amended FOIA request dated May 8, 2018, you requested: "All records reflecting communications (including emails, email attachments, text messages, messages on messaging platforms (such as Slack, GChat or Google Hangouts, Lync, Skype, or WhatsApp), telephone call logs, calendar entries/invitations, meeting notices, meeting agendas, informational material, draft legislation, talking points, any handwritten or electronic notes taken during any oral communications, summaries of any oral communications, or other materials) between 1) political appointees and Senior Executive Service (SES) employees within the Office of the Secretary, the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer and, the Electronic Health Records Modernization (EHRM) Program Executive Office and 2) Isaac "Ike" Perlmutter, Bruce Moskowitz, or Jared Kushner" (emphasis in original). The VHA FOIA Office has responded to you separately for your VHA FOIA request 18-07460-F. The FOIA Office of Assistant Secretary for Information and Technology (OI&T) will respond to you separately for any potentially responsive OIT records (FOIA 18-07440-F). OSVA Employees with Records After communicating with the OSVA Executive Assistant, OSVA believes the responsive records are located within the email boxes of the following VA employees: 1) Wilkie, Robert L., Jr., VA Secretary; 2) Shulkin, David, former VA Secretary; 3) O'Rourke, Peter M., former VA Acting Secretary; 4) Bowman, Thomas, former VA Deputy Secretary; 5) Hayes-Byrd, Jacquelyn, former VA Acting Chief of Staff; 6) Wright-Simpson, Vivieca, former VA Chief of Staff; 7) Selnick, Darin, former VA White House Senior Advisor; 8) Lukach, Michael, former VA White House Senior Advisor; 9) Leinenkugel, Jake, former VA White House Senior Advisor; and, 10) Spero, Casin D, former VA White House Liaison. Reasonable Searches Dated May 8, 2018, September 18, 2018, October 12, 2018, October 16, 2018, October 18, 2018, and November 15, 2018 On October 12, 2018, and October 16, 2018, the OSVA FOIA office searched though former VA Acting Secretary Peter O'Rourke's emails and calendars from May 4, 2018, to June 22, 2018. Mr. McGrath Page 2 November 20, 2018 The OSVA FOIA office used the search terms Sherman, Perlmutter, Moskowitz, @frenchangel59.com, and Kushner. These October 12, 2018, and October 16, 2018, searches yielded forty-four (44) pages, which the VA now releases redacted as pages Bates-numbered 243-286. On September 18, 2018, and October 16, 2018, the OSVA FOIA office searched through former VA Acting Chief of Staff Jacquelyn Hayes-Byrd's emails and calendars from November 8, 2016, to June 22, 2018. OSVA used the search terms Sherman, Perlmutter, Moskowitz, @frenchangel59.com, and Kushner. This search yielded two hundred fifty-five (255) pages, which OSVA now releases redacted as pages Bates-numbered 287-541. On October 18, 2018, the OSVA FOIA office searched through the email boxes and calendars, from January 20, 2017, to June 22, 2018, of: 1) Bowman, Thomas, former VA Deputy Secretary; 2) Wright-Simpson, Vivieca, former VA Chief of Staff; 3) Selnick, Darin, former VA White House Senior Advisor; 4) Lukach, Michael, former VA White House Senior Advisor; 5) Leinenkugel, Jake, former VA White House Senior Advisor; and 6) Spero, Casin D, former VA White House Liaison. The OSVA FOIA office used the search terms Sherman, Perlmutter, Moskowitz, @frenchangel59.com, and Kushner. This search yielded two hundred seventy-two (272) pages, which OSVA now releases redacted as pages Bates-numbered 542-813. On November 15, 2018, the OSVA FOIA office searched through the email boxes and calendars from June 23, 2018, to September 6, 2018, of: 1) Wilkie, Robert L., Jr., VA Secretary; 2) O'Rourke, Peter M., former VA Acting Secretary; 3) Bowman, Thomas, former VA Deputy Secretary; 4) Hayes-Byrd, Jacquelyn, former VA Acting Chief of Staff; 5) Wright-Simpson, Vivieca, former VA Chief of Staff; 6) Selnick, Darin, former VA White House Senior Advisor; 7) Lukach, Michael, former VA White House Senior Advisor; 8) Leinenkugel, Jake, former VA White House Senior Advisor; and, 9) Spero, Casin D, former VA White House Liaison. The November 15, 2018, search yielded two pages, which the VA now releases redacted as pages Bates-numbered 814-815. As a reminder, our May 8, 2018 (our search cut-off date) search yielded fifty-six (56) pages of email communication to or from Jared Kushner. OSVA now releases these fifty-six (56) pages redacted as pages Bates-numbered 814-871. After reviewing six hundred twenty-nine (629) pages Bates-numbered 243-871, OSVA redacts some information with FOIA Exemptions 4, 5, 6, and 7(C). 5 U.S.C. ? 552(b)(4) exempts from disclosure "trade secrets and commercial or financial information obtained from a person and privileged or confidential." "[F]ormulae, designs, drawings, research data, etc.," can be "significant . . . items of valuable property." Attorney General's Memorandum on the Public Information Section of the Administrative Procedure Act (1967), at 34, reprinted in Freedom of Information Act Source Book: Legislative Materials, Cases, Articles, 93d Cong., 2d Sess. 233 (1974). Redacted "intrinsically valuable" information includes internal contractor and Apple phone numbers and conference codes, which contractors and Apple, Inc. voluntarily released to the VA. The release of this "intrinsically valuable" information would likely lead to impairing the flow of such information to the Government. Mr. McGrath Page 3 November 20, 2018 5 U.S.C. ? 552(b)(5) exempts from disclosure "inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency." The government is entitled to redact confidential government information given "the sensitivity of the commercial secrets involved, and the harm that would be inflicted upon the Government by premature disclosure." Federal Open Market Committee v. Merrill, 443 U.S. 340, 363 (1979). Redacted information includes VA electronic mail server code usernames and government conference phone numbers and access codes. The release of this information would expose the VA, its employees, and its contractors to potential hacking and information technology security liabilities and risks. Releasing even a single VA username reveals the pattern to ascertain VA usernames that VA employees use to log into VA Systems of Records. Releasing VA usernames exposes the VA, its employees, and its contractors to potential hacking and information technology security liabilities and risks. Exemption 5 protects interagency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency. Moreover, this exemption permits an agency to withhold material reflecting the thoughts, opinions, and recommendations of federal officials and consultants reviewing an issue. Under the deliberative process privilege and FOIA Exemption 5, OSVA redacts internal government deliberations, thoughts, opinions, recommendations, and proposed solutions from federal employees and consultants reviewing VA programs in their professional capacities, analyses of alleged wrongdoing, unsubstantiated allegations from federal reviewing VA programs, and portions of non-final or draft documents. The information contained in the responsive records is both predecisional and deliberative because it reflects preliminary opinions, proposed solutions, recommendations, analyses of alleged wrongdoing, and unsubstantiated allegations, which do not reflect VA's final decision. Exposure of premature discussions before a final decision is made could create undue public confusion. The release of the redacted information would negatively impact the ability of federal employees to openly and frankly consider issues amongst themselves when deliberating, discussing, reviewing, proposing changes to, making recommendations on VA programs, analyzing alleged wrongdoing, and making complaints on alleged violations of VA policies or laws. The information reveals the thoughts, deliberations, opinions, analyses of, and complaints that, if released, would have a chilling effect on the ability of federal and White House employees and consultants to discuss, opine, recommend or be forthcoming about the agency's issues which require full and frank assessment. Here, the disclosure of the withheld information is likely to compromise the integrity of this deliberative or decision-making process. Moreover, the predecisional character of a document is not altered by the passage of time. Bruscino v. BOP, No. 94-1955, 1995 WL 444406 at *5 (D.D. C. May 15, 1995), aff'd in part, No. 95-5212, 1996 WL 393101 (D.C. Cir. June 24, 1996). 5 U.S.C. ? 552(b)(6) exempts from required disclosure "personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy." FOIA Exemption 6 permits VA to withhold a document or information within a document if disclosure of the information, either by itself or in conjunction with other information available to either the public or the FOIA requester, would result in an unwarranted invasion of an individual's personal privacy without contributing significantly to the public's understanding of the activities of the federal government. Specifically, the information being withheld, as indicated on the enclosed documents, under FOIA Exemption 6, consists of names, identities, personal profiles, email addresses, VA usernames, phone numbers, cellular numbers, and facsimile numbers of private citizens and federal and White House employees with security clearances; we however release the names and VA email addresses of VA Senior Executives. Private citizens and Federal and White House employees with security clearances retain a Mr. McGrath Page 4 November 20, 2018 significant privacy interest under certain circumstances, such as in instances where the release of their information could represent a threat to their well-being, harassment, or their ability to function within their sphere of employment. The private citizens and federal and White House employees with security clearances whose information is at issue have a substantial privacy interest in their personal information. In weighing the private versus the public interest, except names and VA email addresses of VA Senior Executives, we find that there is no public interest in knowing the names, identities, personal profiles, email addresses, VA usernames, phone numbers, cellular numbers, and facsimile numbers of private citizens and federal and White House employees with security clearances. The coverage of FOIA Exemption 6 is absolute unless the FOIA requester can demonstrate a countervailing public interest in the requested information by demonstrating that the FOIA requester is in a position to provide the requested information to members of the general public and that the information requested contributes significantly to the public's understanding of the activities of the Federal government. Additionally, the requester must demonstrate how the public's need to understand the information significantly outweighs the privacy interest of the person to whom the information pertains. Upon consideration of the records, I have not been able to identify a countervailing public interest of sufficient magnitude to outweigh the privacy interest of the individuals whose names are redacted. The protected information has been redacted and (b)(6) inserted. "Withholding a telephone number or e-mail address, alone, is not sufficient to protect that [privacy] interest; alternate means of contacting and harassing these employees would be readily discoverable on the Internet if this court ordered their names disclosed." Long v. Immigration & Customs Enf't, 2017 U.S. Dist. LEXIS 160719 (D.C. Cir. 2017). 5 U.S.C. ? 552(b)(7)(C) exempts from required disclosure information law enforcement information the disclosure of which "could reasonably be expected to constitute an unwarranted invasion of personal privacy." Redacted information includes names and email addresses of White House employees with security clearances. The release of this information would risk impersonation of these White House employees with security clearances also working on national security and law enforcement matters, as well as jeopardizing their health and safety and those the White House employees are charged with protecting. September 14, 2018, Partial IAD and May 8, 2018, Reasonable Search On May 8, 2018, our search cut-off date, we searched through former VA Secretary David Shulkin's emails and calendars from February 14, 2017 (the date he became VA Secretary), to March 30, 2018 (the date he left VA). We searched through VA Secretary Robert Wilkie's emails and calendars from April 1, 2018 (the date he became VA Acting Secretary) to May 8, 2018. We searched through former VA Acting Secretary Peter O'Rourke's emails and calendars from February 15, 2018 (the date he became VA Acting Chief of Staff), to May 3, 2018. OSVA searched for any emails to or from Mr. Perlmutter, Dr. Moskowitz, and Mr. Kushner. The May 8, 2018 search yielded two hundred ninety-eight (298) pages. Of the two hundred ninety-eight (298) pages, OSVA released two hundred forty-two (242) pages redacted as pages Bates-numbered 1-242 on September 14, 2018. Of the other fifty-six (56) pages, OSVA just released redacted as pages Bates-numbered 816-871. For the two hundred forty-two (242) pages, OSVA redacted some information with FOIA Exemptions 5, 6, 7(C), and 7(E). 5 U.S.C. ? 552(b)(7)(E) exempts from required disclosure information that "would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions Mr. McGrath Page 5 November 20, 2018 if such disclosure could reasonably be expected to risk circumvention of the law." Redacted information includes the VA Secretary's approximate resident address. The release of this information would compromise the safety of VA law enforcement personnel and VA employees. FOIA Mediation As part of the 2007 FOIA amendments, the Office of Government Information Services (OGIS) was created to offer mediation services to resolve disputes between FOIA requesters and Federal agencies as a non-exclusive alternative to litigation. Using OGIS services does not affect your right to pursue litigation. Under the provisions of the FOIA Improvement Act of 2016, the following contact information is provided to assist FOIA requesters in resolving disputes: VA Central Office FOIA Public Liaison: Name: John Buck Email Address: vacofoiaservice@va.gov Office of Government Information Services (OGIS) Email Address: ogis@nara.gov Fax: 202-741-5769 Mailing address: National Archives and Records Administration 8601 Adelphi Road College Park, MD 20740-6001 FOIA Appeal This concludes OSVA's second partial IAD and OSVA's response to request 18-07426-F. Please be advised that should you desire to do so, you may appeal the determination made in this response to: Office of General Counsel (024) Department of Veterans Affairs 810 Vermont Avenue, NW Washington, DC 20420 If you should choose to file an appeal, please include a copy of this letter with your written appeal and clearly indicate the basis for your disagreement with the determination set forth in this response. Please be advised that in accordance with VA's implementing FOIA regulations at 38 C.F.R. ? 1.559, your appeal must be postmarked no later than ninety (90) days of the date of this letter. Sincerely, Richard Ha, JD, CIPP/G OSVA FOIA Officer Attachments - Six hundred twenty-nine (629) pages Bates-numbered 243-871 - Amended May 8, 2018 FOIA request - From: DJS ; (b) (6), (b) (7)(C) (C) < who.eop.gov> (b) (6), (b) (7)(C) EOP/WHO (b)(b) (6),(6), who.eop.gov> (b)(b) (7)(7)(C) To: Cc: Bcc: Subject: Date: Attachments: (C) RE: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... Sun Feb 25 2018 11:49:34 CST Absolutely Sent with Good (www.good.com) _____ (b) (6), (b) (7)(C) From: /WHO Sent: Sunday, February 25, 2018 7:51:19 AM (b) (6), (b) (7)(C) To: DJS; EOP/WHO (b) (6), (b) (7)(C) Cc: EOP/WHO Subject: RE: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... (b) (5) (b) (5) -----Original Message----From: DJS [mailto:vacodjs1@va.gov] Sent: Saturday, February 24, 2018 3:25 PM (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) To: EOP/WHO < who.eop.gov> (b) (6), (b) (7)(C) (b)(b) (6),(6), Cc: EOP/WHO (b)(b)(7)(7)(C) who.eop.gov> Subject: FW: [EXTERNAL] Closing(C)the loop on Jan 5th MITRE recommendations... - (b) (6), (b) (7)(C) - (b) (6), (b) (7) this is pretty exciting and of course without your help (and (C) not be anywhere as far along as we are. Thank you David on the standards we would Sent with Good (>www.good.com<) ________________________________ (b) (6) From: VA-18-0298 and 18-0299-B-000001 Sent: Saturday, February 24, 2018 11:56:47 AM To: Shulkin, David J., MD (b) (6) Cc: Blackburn, Scott R.; Subject: [EXTERNAL] Closing the loop on Jan 5th MITRE recommendations... Secretary Shulkin, ? (b) (6) I am writing to share some exciting feedback. Yesterday afternoon, and I had the pleasure of joining Scott and the team to review the status of some of our recommendations from the Jan 5th gathering, (b) (5) particularly around (b) (5) (b) (5) Regards, (b) (6) (b) (6) (b) (6) (703) 672- | CareJourney.com<>https://carejourney.com<> VA-18-0298 and 18-0299-B-000002 [CareJourney] This email is intended only for the person or entity to which it is addressed and may contain information that is privileged, confidential or otherwise protected from disclosure. Dissemination, distribution, or copying of this email or the information herein by anyone other than the intended recipient, or an employee or agent responsible for delivering the message to the intended recipient, is prohibited. If you have received this email in error, please immediately notify us. VA-18-0298 and 18-0299-B-000003 From: - DJS To: Cc: Bcc: Subject: Date: Attachments: (C) RE: [EXTERNAL] FW: Follow up from 12/12/17 White House Interoperability Meeting Mon Jan 08 2018 12:53:42 CST I'm around if you get a moment to call - (b) (6) Or if it's after hours (b) (6) David Sent with Good (www.good.com) _____ (b) (6), (b) (7)(C) From: EOP/WHO Sent: Sunday, January 07, 2018 1:53:58 PM To: DJS (b) (6), (b) (7)(C) Cc: EOP/WHO Subject: Re: [EXTERNAL] FW: Follow up from 12/12/17 White House Interoperability Meeting (b) (6), (b) (7) (C) (b) (5) Sent from my iPhone On Jan 7, 2018, at 3:03 PM, DJS wrote: (b) (5) - (b) (6), (b) (7)(C) (b) (5) https://www.politico.com/story/2018/01/05/shulkin-delay-in-cerner-contract-could-benefit-patientsoutside-va-326370< VA-18-0298 and 18-0299-B-000004 Thanks David Sent with Good (>www.good.com<) ________________________________ (b) (6), (b) (7)(C) From: EOP/WHO Sent: Sunday, January 07, 2018 7:57:35 AM (b) (6), (b) (7)(C) To: DJS; EOP/WHO Subject: [EXTERNAL] FW: Follow up from 12/12/17 White House Interoperability Meeting FYI only... (b) (6) -- (b) (6) From: [mailto: sequoiaproject.org] Sent: Thursday, January 4, 2018 1:21 PM (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b)(b) (6),(6), (b) (6), (b) (7)(C) To: EOP/WHO (b)(b)(7)(7)(C) who.eop.gov>; EOP/WHO < (C) who.eop.gov> (b) (6) (b) (6) (b)(b) (6)(6) Cc: troutmansanders.com) troutmansanders.com>; (b) (6), Office of American Innovation <(b) (7) @who.eop.gov> Subject: [EXTERNAL] Follow up(C)from 12/12/17 White House Interoperability Meeting Mr. - - (b) (6), (b) (7)(C) It was a pleasure meeting you at the December 12th White House electronic health record interoperability listening session. We had an opportunity to chat briefly at the end of the meeting regarding a significant issue which limits the VA's ability to share Veteran health data with private sector healthcare providers. (b) (5) We would be happy to discuss this further with your team. Given the timing of the legislation aimed to correct this problem, it may be advantageous to talk as soon as practicable. Thank you for your consideration. With kind regards, (b) (6) The Sequoia Project (b) (6) Office: 571-327(b) (6) Cell: 703-623(b) (6) (b) (6) sequoiaproject.org - (b) (6), (6) From: Office of American Innovation [mailto:(b) (7) @who.eop.gov] Sent: Friday, December 22, 2017 8:11 AM (C) VA-18-0298 and 18-0299-B-000005 (b) (6) (b) (6) To: (b) (6) (b) (6) Cc: Subject: RE: Thank you Ms. - sequoiaproject.org> (b)(b) (6)(6) troutmansanders.com) troutmansanders.com> (b) (6) We appreciated your contribution at the event! (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (5), (b) (7)(C) (b) (6), (b) (7) (C) (b) (6), (b) (7) (7)(C) (C) Kind regards and Happy Holidays, The Office of American Innovation (b) (6) - (b) (6) From: [mailto: sequoiaproject.org] Sent: Thursday, December 21, 2017 8:05 PM (b) (6), (b) (6), To: Office of American Innovation <(b) (7) @who.eop.gov> (b) (6) (b) (6) (b)(6) (6) (C) (C) (b) Cc: troutmansanders.com) troutmansanders.com>; (b) (6) (b) (6) (b) (b)(6) (6) sequoiaproject.org> Subject: [EXTERNAL] RE: Thank you Thank you so much for inviting me to participate in the listening session on December 12th. I thoroughly enjoyed the interactive dialogue and appreciated the opportunity to also share real-world perspectives based upon Sequoia's experiences supporting national-level interoperability initiatives. (b) (5), (b) (b) (6), (6), (b) (b) (7) (7)(C) (C) (b) (6), (b) (7) (C) Thank you again for the opportunity to participate in the interoperability dialogue. I am very interested in remaining actively engaged and look forward to future discussions. Thank you and Happy Holidays! (b) (6) (b) (6) The Sequoia Project (b) (6) Office: 571-327(b) (6) Cell: 703-623(b) (6) (b) (6) sequoiaproject.org - - (b) (6), (6) From: Office of American Innovation [mailto:(b) (7) @who.eop.gov] (C) Sent: Thursday, December 21, 2017 6:13 PM (b) (6) (b) (6) (b) (6) To: sequoiaproject.org> Thank you for participating in last week's electronic health records interoperability listening session. We had robust conversations about the role government can play with advancing this initiative, the VA-18-0298 and 18-0299-B-000006 technical standards and authentication issues surrounding the technology, the importance of engagement with patients and physicians, and the ways the government can partner with the private sector. We have formed an internal working team to process all the feedback and use it in our plans for next year. We are excited about the opportunity to make a positive impact and are embarking on the detailed work necessary to appropriately approach. We hope that we can continue to engage with you in the New Year as we progress toward our mutual goals. Sincerely, (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6) (b) (6) , CMS VA-18-0298 and 18-0299-B-000007 (b) (6), (b) (7)(C) From: EOP/WHO who.eop.gov> DJS (b)(b) (6),(6), (b)(b) (7)(7)(C) (C) To: Cc: Bcc: Subject: Date: Attachments: - [EXTERNAL] FW: Follow up from 12/12/17 White House Interoperability Meeting Sun Jan 07 2018 09:57:35 CST Sequoia-VA Consent Memo for White House_2018Jan3-FINAL.pdf FYI only... (b) (6) -- (b) (6) From: [mailto: sequoiaproject.org] Sent: Thursday, January 4, 2018 1:21 PM (b) (6), (b) (7)(C) (b)(b) (6),(6), (b) (6), (b) (7)(C) (b)(b) (6),(6), (b)(b) (7)(C) (7)(C) To: EOP/WHO (b)(b)(7)(7)(C) who.eop.gov>; EOP/WHO (C) who.eop.gov> (b) (6) (b) (6) (b)(b) (6)(6) Cc: troutmansanders.com) troutmansanders.com>; (b) (6), Office of American Innovation <(b) (7) @who.eop.gov> Subject: [EXTERNAL] Follow up(C)from 12/12/17 White House Interoperability Meeting Mr. - - (b) (6), (b) (7)(C) It was a pleasure meeting you at the December 12th White House electronic health record interoperability listening session. We had an opportunity to chat briefly at the end of the meeting regarding a significant issue which limits the VA's ability to share Veteran health data with private sector healthcare providers. (b) (5) We would be happy to discuss this further with your team. Given the timing of the legislation aimed to correct this problem, it may be advantageous to talk as soon as practicable. Thank you for your consideration. With kind regards, VA-18-0298 and 18-0299-B-000008 (b) (6) - (b) (6) The Sequoia Project (b) (6) Office: 571-327- (b) (6) Cell: 703-623- (b) (6) sequoiaproject.org - (b) (6), From: Office of American Innovation [mailto:(b) (7) @who.eop.gov] Sent: Friday, December 22, 2017 8:11 AM (C) (b) (6) (b) (6) To: sequoiaproject.org> (b) (6) (b) (6) (b)(b) (6)(6) Cc: troutmansanders.com) Subject: RE: Thank you Ms. troutmansanders.com> - (b) (6) We appreciated your contribution at the event! (b) (6), (b) (7)(C) (b) (5), (b) (6), (b) (7)(C) (b) (6), (b) (7) (C) (b) (6), (b) (7)(C) Kind regards and Happy Holidays, The Office of American Innovation (b) (6) - (b) (6) From: [mailto: sequoiaproject.org] Sent: Thursday, December 21, 2017 8:05 PM (b) (6), To: Office of American Innovation <(b) (7) @who.eop.gov> (b) (6) (b) (6) (b) (6) (C) Cc: troutmansanders.com) < (b) (6) (b) (6) sequoiaproject.org> Subject: [EXTERNAL] RE: Thank you troutmansanders.com>; Thank you so much for inviting me to participate in the listening session on December 12th. VA-18-0298 and 18-0299-B-000009 I thoroughly enjoyed the interactive dialogue and appreciated the opportunity to also share real-world perspectives based upon Sequoia's experiences supporting national-level interoperability initiatives. (b) (5), (b) (b) (6), (6), (b) (b) (7) (7)(C) (C) (b) (6), (b) (7) (C) Thank you again for the opportunity to participate in the interoperability dialogue. I am very interested in remaining actively engaged and look forward to future discussions. Thank you and Happy Holidays! (b) (6) - (b) (6) The Sequoia Project (b) (6) Office: 571-327- (b) (6) Cell: 703-623- (b) (6) sequoiaproject.org - (b) (6), From: Office of American Innovation [mailto:(b) (7) @who.eop.gov] (C) Sent: Thursday, December 21, 2017 6:13 PM (b) (6) (b) (6) To: sequoiaproject.org> Subject: Thank you Dear Ms. - (b) (6) Thank you for participating in last week's electronic health records interoperability listening session. We had robust conversations about the role government can play with advancing this initiative, the VA-18-0298 and 18-0299-B-000010 technical standards and authentication issues surrounding the technology, the importance of engagement with patients and physicians, and the ways the government can partner with the private sector. We have formed an internal working team to process all the feedback and use it in our plans for next year. We are excited about the opportunity to make a positive impact and are embarking on the detailed work necessary to appropriately approach. We hope that we can continue to engage with you in the New Year as we progress toward our mutual goals. Sincerely, (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6) (b) (6) CMS VA-18-0298 and 18-0299-B-000011 Owner: Filename: Last Modified: (b) (6), (b) (7)(C) -----(b)(b) (6), EOP/WHO (6),(b) (7)(C) who.eop.gov> (b) Sequoia-VA Consent Memo for (7) White House_2018Jan3-FINAL.pdf (C) Sun Jan 07 09:57:35 CST 2018 VA-18-0298 and 18-0299-B-000012 Sequoia-VA Consent Memo for White House_2018Jan3-FINAL.pdf for Printed Item: 3 ( Attachment 1 of 1) January 3, 2018 Mr. (b) (6), (b) (7)(C) Office of American Innovation Executive Office of the President The White House 1600 Pennsylvania Avenue NW Washington, D.C. 20500 RE: Issue Impeding Provider Access to Veteran's Records (6), (b) (7) Dear Mr. (b) (C) Thank you for inviting me to participate in the White House Electronic Health Records Interoperability Listening Session on December 12th. It was a pleasure meeting you and CMS (b) (6) . I thoroughly enjoyed the interactive dialogue and appreciated the opportunity to also share real-world perspectives based upon Sequoia's experiences supporting national-level interoperability initiatives. I especially appreciate your focus on seeking innovative solutions for electronic health record exchange on behalf of Veterans. (b) (5) (b) (5) (b) (5) I would welcome an opportunity to meet and provide additional information regarding the practical impact this is having today, as well as the opportunity to improve the accessibility of Veteran health information to better treat Veterans and coordinate their care. Sincerely, (b) (6) - (b) (6) The Sequoia Project sequoiaproject.org C: 703-623-(b) (6) (b) (6) 8300 Boone Blvd STE 500 | Vienna, VA 22182| 571.327.3640 | sequoiaproject.org 33495578v1 VA-18-0298 and 18-0299-B-000013 Sequoia-VA Consent Memo for White House_2018Jan3-FINAL.pdf for Printed Item: 3 ( Attachment 1 of 1) Background Information: Veteran Consent and Impact on Interoperability Purpose (b) (5) About the eHealth Exchange and Our Work with VHA (b) (5) (b) (5) (b) (5) (b) (5) Veteran Authorization (b) (5) (b) (5) 8300 Boone Blvd STE 500 | Vienna, VA 22182| 571.327.3640 | sequoiaproject.org 33495578v1 VA-18-0298 and 18-0299-B-000014 Sequoia-VA Consent Memo for White House_2018Jan3-FINAL.pdf for Printed Item: 3 ( Attachment 1 of 1) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) Legislation Attempted to Address Consent Barriers (b) (5) (b) (5) (b) (5) 8300 Boone Blvd STE 500 | Vienna, VA 22182| 571.327.3640 | sequoiaproject.org 33495578v1 VA-18-0298 and 18-0299-B-000015 Sequoia-VA Consent Memo for White House_2018Jan3-FINAL.pdf for Printed Item: 3 ( Attachment 1 of 1) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) . Recommended Solutions: (b) (5) 8300 Boone Blvd STE 500 | Vienna, VA 22182| 571.327.3640 | sequoiaproject.org 33495578v1 VA-18-0298 and 18-0299-B-000016 Sequoia-VA Consent Memo for White House_2018Jan3-FINAL.pdf for Printed Item: 3 ( Attachment 1 of 1) (b) (5) (b) (5) n. (b) (5) (b) (5) (b) (5) (b) (5) : (b) (5) 8300 Boone Blvd STE 500 | Vienna, VA 22182| 571.327.3640 | sequoiaproject.org 33495578v1 VA-18-0298 and 18-0299-B-000017 Sequoia-VA Consent Memo for White House_2018Jan3-FINAL.pdf for Printed Item: 3 ( Attachment 1 of 1) (b) (5) (b) (5) (b) (5) (b) (5) (b) (5) Conclusion: (b) (5) (b) (5) 8300 Boone Blvd STE 500 | Vienna, VA 22182| 571.327.3640 | sequoiaproject.org 33495578v1 VA-18-0298 and 18-0299-B-000018 From: - DJS To: Cc: Bcc: Subject: Date: Attachments: (C) RE: [EXTERNAL] FW: Follow up from 12/12/17 White House Interoperability Meeting Sun Jan 07 2018 14:03:32 CST (b) (5) - (b) (6), (b) (7)(C) (b) (5) https://www.politico.com/story/2018/01/05/shulkin-delay-in-cerner-contract-could-benefit-patientsoutside-va-326370 Thanks David Sent with Good (www.good.com) _____ (b) (6), (b) (7)(C) From: EOP/WHO Sent: Sunday, January 07, 2018 7:57:35 AM (b) (6), (b) (7)(C) To: DJS; EOP/WHO Subject: [EXTERNAL] FW: Follow up from 12/12/17 White House Interoperability Meeting FYI only... (b) (6) -- (b) (6) From: [mailto: sequoiaproject.org] Sent: Thursday, January 4, 2018 1:21 PM (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) To: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov> (b) (6) (b) (6) (b) (6) Cc: ( troutmansanders.com) < troutmansanders.com>; (b) (6), Office of American Innovation <(b) (7) @who.eop.gov> Subject: [EXTERNAL] Follow up(C)from 12/12/17 White House Interoperability Meeting Mr. - - - (b) (6), (b) (7)(C) VA-18-0298 and 18-0299-B-000019 It was a pleasure meeting you at the December 12th White House electronic health record interoperability listening session. We had an opportunity to chat briefly at the end of the meeting regarding a significant issue which limits the VA's ability to share Veteran health data with private sector healthcare providers. (b) (5) We would be happy to discuss this further with your team. Given the timing of the legislation aimed to correct this problem, it may be advantageous to talk as soon as practicable. Thank you for your consideration. With kind regards, (b) (6) - (b) (6) The Sequoia Project (b) (6) Office: 571-327- (b) (6) Cell: 703-623- (b) (6) sequoiaproject.org - (b) (6), From: Office of American Innovation [mailto:(b) (7) @who.eop.gov] Sent: Friday, December 22, 2017 8:11 AM (C) (b) (6) (b) (6) To: < sequoiaproject.org> (b) (6) (b) (6) (b) (6) Cc: ( troutmansanders.com) < Subject: RE: Thank you Ms. troutmansanders.com> - (b) (6) VA-18-0298 and 18-0299-B-000020 We appreciated your contribution at the event! (b) (6), (b) (7)(C) (b) (5), (b) (6), (b) (7)(C) (b) (6), (b) (7) (C) (b) (6), (b) (7)(C) Kind regards and Happy Holidays, The Office of American Innovation - (b) (6) (b) (6) From: [mailto: sequoiaproject.org] Sent: Thursday, December 21, 2017 8:05 PM (b) (6), To: Office of American Innovation <(b) (7) @who.eop.gov> (b) (6) (b) (6) (b) (6) (C) Cc: ( troutmansanders.com) < (b) (6) (b) (6) < sequoiaproject.org> Subject: [EXTERNAL] RE: Thank you troutmansanders.com>; Thank you so much for inviting me to participate in the listening session on December 12th. I thoroughly enjoyed the interactive dialogue and appreciated the opportunity to also share real-world perspectives based upon Sequoia's experiences supporting national-level interoperability initiatives. (b) (5), (b) (b) (6), (6), (b) (b) (7) (7)(C) (C) (b) (6), (b) (7) (C) Thank you again for the opportunity to participate in the interoperability dialogue. I am very interested in remaining actively engaged and look forward to future discussions. Thank you and Happy Holidays! (b) (6) - (b) (6) The Sequoia Project (b) (6) Office: 571-327- (b) (6) Cell: 703-623- VA-18-0298 and 18-0299-B-000021 (b) (6) sequoiaproject.org - (b) (6), From: Office of American Innovation [mailto:(b) (7) @who.eop.gov] (C) Sent: Thursday, December 21, 2017 6:13 PM (b) (6) (b) (6) To: < sequoiaproject.org> Subject: Thank you Dear Ms. - - (b) (6) Thank you for participating in last week's electronic health records interoperability listening session. We had robust conversations about the role government can play with advancing this initiative, the technical standards and authentication issues surrounding the technology, the importance of engagement with patients and physicians, and the ways the government can partner with the private sector. We have formed an internal working team to process all the feedback and use it in our plans for next year. We are excited about the opportunity to make a positive impact and are embarking on the detailed work necessary to appropriately approach. We hope that we can continue to engage with you in the New Year as we progress toward our mutual goals. Sincerely, (b) (6), (b) (b) (6), (b) (7) (7)(C) (C) (b) (6), (b) (7)(C) (b) (6) (b) (6) , CMS VA-18-0298 and 18-0299-B-000022 (b) (6), (b) (7)(C) From: EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> DJS To: Cc: Bcc: Subject: Date: Attachments: - Re: [EXTERNAL] FW: Follow up from 12/12/17 White House Interoperability Meeting Sun Jan 07 2018 15:53:58 CST (b) (6), (b) (7) (C) (b) (5), (b) (6), (b) (7)(C) ! (b) (5) Sent from my iPhone On Jan 7, 2018, at 3:03 PM, DJS wrote: (b) (5) - (b) (5) (b) (6), (b) (7)(C) (b) (5) https://www.politico.com/story/2018/01/05/shulkin-delay-in-cerner-contract-could-benefit-patientsoutside-va-326370< Thanks David Sent with Good (>www.good.com<) ________________________________ (b) (6), (b) (7)(C) From: EOP/WHO Sent: Sunday, January 07, 2018 7:57:35 AM (b) (6), (b) (7)(C) To: DJS; EOP/WHO Subject: [EXTERNAL] FW: Follow up from 12/12/17 White House Interoperability Meeting FYI only... (b) (6) - (b) (6) From: [mailto: sequoiaproject.org] Sent: Thursday, January 4, 2018 1:21 PM VA-18-0298 and 18-0299-B-000023 To: - (b) (6), (b) (7)(C) (b) (6), - (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov> (b) (6) (b) (6) (b) (6) Cc: ( troutmansanders.com) < troutmansanders.com>; (b) (6), Office of American Innovation <(b) (7) @who.eop.gov> Subject: [EXTERNAL] Follow up(C)from 12/12/17 White House Interoperability Meeting Mr. - (b) (6), (b) (7)(C) - It was a pleasure meeting you at the December 12th White House electronic health record interoperability listening session. We had an opportunity to chat briefly at the end of the meeting regarding a significant issue which limits the VA's ability to share Veteran health data with private sector healthcare providers. (b) (5) We would be happy to discuss this further with your team. Given the timing of the legislation aimed to correct this problem, it may be advantageous to talk as soon as practicable. Thank you for your consideration. With kind regards, (b) (6) (b) (6) The Sequoia Project (b) (6) Office: 571-327(b) (6) Cell: 703-623(b) (6) (b) (6) sequoiaproject.org (b) (6), From: Office of American Innovation [mailto:(b) (7) @who.eop.gov] Sent: Friday, December 22, 2017 8:11 AM (C) (b) (6) (b) (6) To: < sequoiaproject.org> (b) (6) (b) (6) (b) (6) Cc: ( troutmansanders.com) < Subject: RE: Thank you Ms. - troutmansanders.com> (b) (6) We appreciated your contribution at the event! (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7) (C) (b) (6), (b) (5), (b) (7)(C) (b) (6), (b) (7) (C) Kind regards and Happy Holidays, The Office of American Innovation (b) (6) (b) (6) From: [mailto: sequoiaproject.org] Sent: Thursday, December 21, 2017 8:05 PM (b) (6), (b) (6), To: Office of American Innovation <(b) (7) @who.eop.gov> (b) (6) (b) (6) (C) (C) (b) (6) Cc: ( troutmansanders.com) < troutmansanders.com>; (b) (6) (b) (6) (b) (6) < sequoiaproject.org> Subject: [EXTERNAL] RE: Thank you VA-18-0298 and 18-0299-B-000024 Thank you so much for inviting me to participate in the listening session on December 12th. I thoroughly enjoyed the interactive dialogue and appreciated the opportunity to also share real-world perspectives based upon Sequoia's experiences supporting national-level interoperability initiatives. (b) (6), (b) (b) (6), (5), (b) (b) (7) (7)(C) (C) (b) (6), (b) (7) (C) Thank you again for the opportunity to participate in the interoperability dialogue. I am very interested in remaining actively engaged and look forward to future discussions. Thank you and Happy Holidays! (b) (6) (b) (6) The Sequoia Project (b) (6) Office: 571-327(b) (6) Cell: 703-623(b) (6) (b) (6) sequoiaproject.org - - (b) (6), From: Office of American Innovation [mailto:(b) (7) @who.eop.gov] (C) Sent: Thursday, December 21, 2017 6:13 PM (b) (6) (b) (6) (b) (6) To: < sequoiaproject.org> Thank you for participating in last week's electronic health records interoperability listening session. We had robust conversations about the role government can play with advancing this initiative, the technical standards and authentication issues surrounding the technology, the importance of engagement with patients and physicians, and the ways the government can partner with the private sector. We have formed an internal working team to process all the feedback and use it in our plans for next year. We are excited about the opportunity to make a positive impact and are embarking on the detailed work necessary to appropriately approach. We hope that we can continue to engage with you in the New Year as we progress toward our mutual goals. Sincerely, (b) (6), (b) (b) (6), (b) (7) (7)(C) (C) (b) (6), (b) (7)(C) (b) (6) (b) (6) , CMS VA-18-0298 and 18-0299-B-000025 (b) (6), (b) (7)(C) From: EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) EOP/WHO (b) (6), (b) (7)(C) < who.eop.gov> (b) (6), (b) (7)(C) EOP/WHO (b) (6), (b) (7)(C) < who.eop.gov>; DJS Subject: RE: Followup - - (b) (6), (b) (7)(C) (b) (5) (b) (6), (b) (7)(C), (b) (5) I . -----Original Message----(b) (6), (b) (7)(C) From: EOP/WHO Sent: Tuesday, January 2, 2018 12:15 PM (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) To: EOP/WHO < who.eop.gov> (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; .M.Dumbauld@who.eop.gov> Subject: FW: Followup - (b) (6), (b) (7)(C) - EOP/WHO (b) (6), (b) (7)(C) (b) (6), Cc: EOP/WHO <(b) (7)(C) who.eop.gov> Subject: Followup - (b) (6), (b) (7)(C) (b) (5) VA-18-0298 and 18-0299-B-000026 (b) (5), (b) (6), (b) (7)(C) (b) (6), (b) (7)(C), (b) (5) (b) (5), (b) (6), (b) (7)(C) (b) (6), (b) (5), (b) (7)(C) (b) (6) - (b) (5), (b) (6), (b) (7)(C) Thanks again David Sent with Good (>www.good.com<) VA-18-0298 and 18-0299-B-000027 From: To: Cc: (b) (6), (b) (7)(C) (b) (6), (b) (7) (b) (C) (7) (b) (6), (b) (b) (6), (b) (7)(C) (C) (7)(C) < Bcc: Subject: Date: Attachments: - (b) (6), (b) (7)(C) - DJS . who.eop.gov> Followup Tue Jan 02 2018 09:49:26 CST (b) (5) (b) (5), (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6) (b) (6) Thanks again David Sent with Good (www.good.com) VA-18-0298 and 18-0299-B-000028 (b) (6), (b) (7)(C) From: EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> Blackburn, Scott R. (b) (6), (b) (7)(C) EOP/WHO (b) (6), (b) (7)(C) < who.eop.gov>; Windom, John H. ; DJS ; EOP/WHO (b) (6), (b) (7)(C) < who.eop.gov> To: Cc: Bcc: Subject: Date: Attachments: [EXTERNAL] Re: VA CIO advisory support for Cerner contract Fri Oct 27 2017 04:35:32 CDT (b) (5) (b) (5) . ? (b) (b) (5) (6), (b) (7)(C) Sent from my iPhone On Oct 27, 2017, at 1:56 AM, Blackburn, Scott R. wrote: (b) (6), (b) (7)(C) - (b) (5) (b) (5), (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) VA-18-0298 and 18-0299-B-000029 (b) (5) (b) (5) . Scott (b) (5) (b) (5) I (b) (5) Scott Blackburn VA-18-0298 and 18-0299-B-000030 Scott Blackburn Acting CIO & Executive in Charge, Office of Information & Technology US Department of Veterans Affairs VA-18-0298 and 18-0299-B-000031 From: To: Cc: (b) (6), (b) (7)(C) EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> DJS (b) (6), (b) (7)(C) EOP/WHO (b) (6), (b) (6), (b) (7)(C) <(b) (7)(C) who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) < who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6) < who.eop.gov>; gmail.com (b) (6) (b) (6) < gmail.com>; gmail.com (b) (6) (b) (6) < gmail.com>; mac.com (b) (6) < mac.com>; Clancy, Carolyn ; (7)(C) (b) (6), (b) (7)(C) EOP/WHO < who.eop.gov>; (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) EOP/WHO < who.eop.gov>; (b) (6), (b) (7)(C) (b) (6), EOP/WHO <(b) (7)(C) who.eop.gov> - - Bcc: Subject: Date: Attachments: RE: [EXTERNAL] RE: VA Healthcare Tue Sep 26 2017 15:24:00 CDT YES - we will make ourselves available to learn more and try to be helpful From: DJS [mailto:vacodjs1@va.gov] Sent: Tuesday, September 26, 2017 12:50 PM (b) (6), (b) (7)(C) (b) (6), (b) (6) To: EOP/WHO <(b) (7)(C) who.eop.gov>; 'IP' < frenchangel59.com> (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; (b) (6) (b) (6) (b) (6) (b) (6) ' gmail.com' < gmail.com>; ' gmail.com' < gmail.com>; (b) (6) (b) (6) ' mac.com' < mac.com>; Clancy, Carolyn Subject: RE: [EXTERNAL] RE: VA Healthcare - - (b) (6), (b) (7)(C) I do want to move forward with an independent evaluation of our quality comparison methodology. I'm adding Dr Carolyn Clancy (who will soon be acting undersecretary for health) who is one of the top quality experts in the country. She is prepared to review this methodology and make some recommendations on an independent review panel- Would it be helpful to have her meet with someone from your office to review where we are or do you have another suggestion to move forward? We also want to integrate Dr Moskowitz into this approach as he has some very useful approaches to this as well. David Shulkin VA-18-0298 and 18-0299-B-000032 Sent with Good (>www.good.com<) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 06:04 PM Eastern Standard Time To: DJS; 'IP' (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO; EOP/WHO; (b) (6) (b) (6) (b) (6) ' gmail.com'; ' gmail.com'; ' mac.com' Subject: RE: [EXTERNAL] RE: VA Healthcare EOP/WHO; Please let me know what we can do to help move this along. Good out of the box thinking... From: DJS [mailto:vacodjs1@va.gov] Sent: Sunday, September 24, 2017 5:18 PM (b) (6), (b) (7)(C) (b) (6), (b) (6) To: EOP/WHO <(b) (7)(C) who.eop.gov>; 'IP' < frenchangel59.com> (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; (b) (6) (b) (6) (b) (6) (b) (6) ' gmail.com' < gmail.com>; ' gmail.com' < gmail.com>; (b) (6) (b) (6) ' mac.com' < mac.com> Subject: RE: [EXTERNAL] RE: VA Healthcare - - (b) (6), (b) (7)(C) -I agree with Ike and the team that measuring VA against private hospitals is critical - so while CMS is not able to deliver this for months we have now developed our own tool to do this-we are fine tuning the model this week and can share it by friday. If it does not get us where we need to be then working quickly with an independent group would make a great deal of sense. David Sent with Good (>>www.good.com<<) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 04:31 PM Eastern Standard Time To: IP (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO; EOP/WHO; (b) (6) (b) (6) (b) (6) DJS; gmail.com; gmail.com; ' mac.com' Subject: [EXTERNAL] RE: VA Healthcare EOP/WHO; This is a creative i9dea to fast track the process - I think it could be worthwhile as a way of collecting the data quickly by an independent group. If they can spend time with the other raters and get a sense for what they are looking for, perhaps the data they are collecting can be used to help determine the star ratings VA-18-0298 and 18-0299-B-000033 (b) (b) (6) From: IP [mailto(6) frenchangel59.com] Sent: Monday, September 18, 2017 8:58 AM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; DJS (b) (6) (b) (6) (b) (6) ; gmail.com; gmail.com; ' mac.com' (b) (6) < mac.com> Subject: VA Healthcare - - (b) (6), (b) (7)(C) We have been talking to Dr. Shulkin for many months about identifying the existence of healthcare delivery issues at VA medical centers. There is no doubt that issues exist in abundance and were created by decades of historical federal government hiring practices, regulatory hiring rules and mismanagement. We originally were hoping that the hospitals could be rated (with the star rating system) by CMS, as they do with private hospitals. However, they recently advised that they would not be able to focus on the VA hospitals until December 2018. As an example, we think that some of the VA hospitals are delivering some specialty healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better option. Not every VA hospital has both the breadth and depth of specialized medical expertise in every specialty, which then creates risk to the patients and the system. One idea discussed was to institute a self-rating program, but self-ratings are rarely of any practical use. Our solution is to make use of the academic medical centers and medical trade groups, both of whom have offered to send review teams to the VA hospitals to help in this effort. The purpose of this email is to see if you know of any impediments to taking them up on this offer and to get your thoughts in general about this approach. All my Best, Ike VA-18-0298 and 18-0299-B-000034 From: To: Cc: Bcc: Subject: Date: Attachments: - DJS ; IP < frenchangel59.com> (b) (6), (b) (7)(C) EOP/WHO (b) (6), (b) (6), (b) (7)(C) <(b) (7)(C) who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) < who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6) < who.eop.gov>; gmail.com (b) (6) (b) (6) < gmail.com>; gmail.com (b) (6) (b) (6) < gmail.com>; mac.com (b) (6) < mac.com>; Clancy, Carolyn RE: [EXTERNAL] RE: VA Healthcare Tue Sep 26 2017 11:49:34 CDT - (b) (6), (b) (7)(C) I do want to move forward with an independent evaluation of our quality comparison methodology. I'm adding Dr Carolyn Clancy (who will soon be acting undersecretary for health) who is one of the top quality experts in the country. She is prepared to review this methodology and make some recommendations on an independent review panel- Would it be helpful to have her meet with someone from your office to review where we are or do you have another suggestion to move forward? We also want to integrate Dr Moskowitz into this approach as he has some very useful approaches to this as well. David Shulkin Sent with Good (www.good.com) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 06:04 PM Eastern Standard Time To: DJS; 'IP' (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO; EOP/WHO; (b) (6) (b) (6) (b) (6) ' gmail.com'; ' gmail.com'; ' mac.com' Subject: RE: [EXTERNAL] RE: VA Healthcare EOP/WHO; Please let me know what we can do to help move this along. Good out of the box thinking... From: DJS [mailto:vacodjs1@va.gov] Sent: Sunday, September 24, 2017 5:18 PM (b) (6), (b) (7)(C) (b) (6), (b) (6) To: EOP/WHO <(b) (7)(C) who.eop.gov>; 'IP' < frenchangel59.com> - - VA-18-0298 and 18-0299-B-000035 Cc: (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) - (b) (6), (b) (7)(C) EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; (b) (6) (b) (6) (b) (6) (b) (6) ' gmail.com' < gmail.com>; ' gmail.com' < gmail.com>; (b) (6) (b) (6) ' mac.com' < mac.com> Subject: RE: [EXTERNAL] RE: VA Healthcare (b) (6), (b) (7)(C) - (b) (6), (b) (7)(C) -I agree with Ike and the team that measuring VA against private hospitals is critical - so while CMS is not able to deliver this for months we have now developed our own tool to do this-we are fine tuning the model this week and can share it by friday. If it does not get us where we need to be then working quickly with an independent group would make a great deal of sense. David Sent with Good (>www.good.com<) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 04:31 PM Eastern Standard Time To: IP (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO; EOP/WHO; (b) (6) (b) (6) (b) (6) DJS; gmail.com; gmail.com; ' mac.com' Subject: [EXTERNAL] RE: VA Healthcare EOP/WHO; This is a creative i9dea to fast track the process - I think it could be worthwhile as a way of collecting the data quickly by an independent group. If they can spend time with the other raters and get a sense for what they are looking for, perhaps the data they are collecting can be used to help determine the star ratings (b) (6) From: IP [mailto: frenchangel59.com] Sent: Monday, September 18, 2017 8:58 AM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; DJS (b) (6) (b) (6) (b) (6) ; gmail.com; gmail.com; ' mac.com' (b) (6) < mac.com> Subject: VA Healthcare - - (b) (6), (b) (7)(C) We have been talking to Dr. Shulkin for many months about identifying the existence of healthcare delivery issues at VA medical centers. There is no doubt that issues exist in abundance and were created by decades of historical federal government hiring practices, regulatory hiring rules and mismanagement. We originally were hoping that the hospitals could be rated (with the star rating system) by CMS, as they do with private hospitals. However, they recently advised that they would not VA-18-0298 and 18-0299-B-000036 be able to focus on the VA hospitals until December 2018. As an example, we think that some of the VA hospitals are delivering some specialty healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better option. Not every VA hospital has both the breadth and depth of specialized medical expertise in every specialty, which then creates risk to the patients and the system. One idea discussed was to institute a self-rating program, but self-ratings are rarely of any practical use. Our solution is to make use of the academic medical centers and medical trade groups, both of whom have offered to send review teams to the VA hospitals to help in this effort. The purpose of this email is to see if you know of any impediments to taking them up on this offer and to get your thoughts in general about this approach. All my Best, Ike VA-18-0298 and 18-0299-B-000037 From: To: Cc: Bcc: Subject: Date: Attachments: (b) (6), (b) (7)(C) EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> (b) (6) IP < frenchangel59.com> (b) (6), (b) (7)(C) EOP/WHO (b) (6), (b) (6), (b) (7)(C) <(b) (7)(C) who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) < who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) < who.eop.gov>; DJS ; gmail.com (b) (6) (b) (6) < gmail.com>; mac.com (b) (6) < mac.com> [EXTERNAL] RE: VA Healthcare Sun Sep 24 2017 15:31:04 CDT This is a creative i9dea to fast track the process - I think it could be worthwhile as a way of collecting the data quickly by an independent group. If they can spend time with the other raters and get a sense for what they are looking for, perhaps the data they are collecting can be used to help determine the star ratings (b) (6) From: IP [mailto: frenchangel59.com] Sent: Monday, September 18, 2017 8:58 AM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; DJS (b) (6) (b) (6) (b) (6) ; gmail.com; gmail.com; ' mac.com' (b) (6) < mac.com> Subject: VA Healthcare - - (b) (6), (b) (7)(C) We have been talking to Dr. Shulkin for many months about identifying the existence of healthcare delivery issues at VA medical centers. There is no doubt that issues exist in abundance and were created by decades of historical federal government hiring practices, regulatory hiring rules and mismanagement. We originally were hoping that the hospitals could be rated (with the star rating system) by CMS, as they do with private hospitals. However, they recently advised that they would not be able to focus on the VA hospitals until December 2018. As an example, we think that some of the VA hospitals are delivering some specialty healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better option. Not every VA hospital has both the breadth and depth of specialized medical expertise in every specialty, which then creates risk to the patients and the system. One idea discussed was to institute a self-rating program, but self-ratings are rarely of any practical use. Our solution is to make use of the academic medical centers and medical trade groups, both of whom have offered to send review teams to the VA hospitals to help in this effort. The purpose of this email is to see if you know of any impediments to taking them up on this offer and to get your thoughts in general about this approach. All my Best, VA-18-0298 and 18-0299-B-000038 Ike and 18-0299-B-000039 From: To: Cc: Bcc: Subject: Date: Attachments: - DJS ; IP < frenchangel59.com> (b) (6), (b) (7)(C) EOP/WHO (b) (6), (b) (6), (b) (7)(C) <(b) (7)(C) who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) < who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6) < who.eop.gov>; gmail.com (b) (6) (b) (6) < gmail.com>; gmail.com (b) (6) (b) (6) < gmail.com>; mac.com (b) (6) < mac.com> RE: [EXTERNAL] RE: VA Healthcare Sun Sep 24 2017 16:17:52 CDT - (b) (6), (b) (7)(C) -I agree with Ike and the team that measuring VA against private hospitals is critical - so while CMS is not able to deliver this for months we have now developed our own tool to do this-we are fine tuning the model this week and can share it by friday. If it does not get us where we need to be then working quickly with an independent group would make a great deal of sense. David Sent with Good (www.good.com) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 04:31 PM Eastern Standard Time To: IP (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO; EOP/WHO; (b) (6) (b) (6) (b) (6) DJS; gmail.com; gmail.com; ' mac.com' Subject: [EXTERNAL] RE: VA Healthcare EOP/WHO; This is a creative i9dea to fast track the process - I think it could be worthwhile as a way of collecting the data quickly by an independent group. If they can spend time with the other raters and get a sense for what they are looking for, perhaps the data they are collecting can be used to help determine the star ratings (b) (6) From: IP [mailto: frenchangel59.com] Sent: Monday, September 18, 2017 8:58 AM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; DJS (b) (6) (b) (6) (b) (6) ; gmail.com; gmail.com; ' mac.com' (b) (6) < mac.com> Subject: VA Healthcare - VA-18-0298 and 18-0299-B-000040 - (b) (6), (b) (7)(C) We have been talking to Dr. Shulkin for many months about identifying the existence of healthcare delivery issues at VA medical centers. There is no doubt that issues exist in abundance and were created by decades of historical federal government hiring practices, regulatory hiring rules and mismanagement. We originally were hoping that the hospitals could be rated (with the star rating system) by CMS, as they do with private hospitals. However, they recently advised that they would not be able to focus on the VA hospitals until December 2018. As an example, we think that some of the VA hospitals are delivering some specialty healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better option. Not every VA hospital has both the breadth and depth of specialized medical expertise in every specialty, which then creates risk to the patients and the system. One idea discussed was to institute a self-rating program, but self-ratings are rarely of any practical use. Our solution is to make use of the academic medical centers and medical trade groups, both of whom have offered to send review teams to the VA hospitals to help in this effort. The purpose of this email is to see if you know of any impediments to taking them up on this offer and to get your thoughts in general about this approach. All my Best, Ike VA-18-0298 and 18-0299-B-000041 From: To: Cc: Bcc: Subject: Date: Attachments: (b) (6), (b) (7)(C) EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> DJS (b) (6), (b) (7)(C) EOP/WHO (b) (6), (b) (6), (b) (7)(C) <(b) (7)(C) who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) < who.eop.gov>; EOP/WHO (b) (6), (b) (7)(C) (b) (6) < who.eop.gov>; gmail.com (b) (6) (b) (6) < gmail.com>; gmail.com (b) (6) (b) (6) < gmail.com>; mac.com (b) (6) < mac.com> - RE: [EXTERNAL] RE: VA Healthcare Sun Sep 24 2017 17:03:20 CDT Please let me know what we can do to help move this along. Good out of the box thinking... From: DJS [mailto:vacodjs1@va.gov] Sent: Sunday, September 24, 2017 5:18 PM (b) (6), (b) (7)(C) (b) (6), (b) (6) To: EOP/WHO <(b) (7)(C) who.eop.gov>; 'IP' < frenchangel59.com> (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; (b) (6) (b) (6) (b) (6) (b) (6) ' gmail.com' < gmail.com>; ' gmail.com' < gmail.com>; (b) (6) (b) (6) ' mac.com' < mac.com> Subject: RE: [EXTERNAL] RE: VA Healthcare - - (b) (6), (b) (7)(C) -I agree with Ike and the team that measuring VA against private hospitals is critical - so while CMS is not able to deliver this for months we have now developed our own tool to do this-we are fine tuning the model this week and can share it by friday. If it does not get us where we need to be then working quickly with an independent group would make a great deal of sense. David Sent with Good (>www.good.com<) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 04:31 PM Eastern Standard Time To: IP (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO; EOP/WHO; (b) (6) (b) (6) (b) (6) DJS; gmail.com; gmail.com; ' mac.com' Subject: [EXTERNAL] RE: VA Healthcare EOP/WHO; VA-18-0298 and 18-0299-B-000042 This is a creative i9dea to fast track the process - I think it could be worthwhile as a way of collecting the data quickly by an independent group. If they can spend time with the other raters and get a sense for what they are looking for, perhaps the data they are collecting can be used to help determine the star ratings (b) (6) From: IP [mailto: frenchangel59.com] Sent: Monday, September 18, 2017 8:58 AM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; DJS (b) (6) (b) (6) (b) (6) ; gmail.com; gmail.com; ' mac.com' (b) (6) < mac.com> Subject: VA Healthcare - - (b) (6), (b) (7)(C) We have been talking to Dr. Shulkin for many months about identifying the existence of healthcare delivery issues at VA medical centers. There is no doubt that issues exist in abundance and were created by decades of historical federal government hiring practices, regulatory hiring rules and mismanagement. We originally were hoping that the hospitals could be rated (with the star rating system) by CMS, as they do with private hospitals. However, they recently advised that they would not be able to focus on the VA hospitals until December 2018. As an example, we think that some of the VA hospitals are delivering some specialty healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better option. Not every VA hospital has both the breadth and depth of specialized medical expertise in every specialty, which then creates risk to the patients and the system. One idea discussed was to institute a self-rating program, but self-ratings are rarely of any practical use. Our solution is to make use of the academic medical centers and medical trade groups, both of whom have offered to send review teams to the VA hospitals to help in this effort. The purpose of this email is to see if you know of any impediments to taking them up on this offer and to get your thoughts in general about this approach. All my Best, Ike VA-18-0298 and 18-0299-B-000043 From: To: Cc: Bcc: Subject: Date: Attachments: And (b) (6), (b) (7)(C) EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> DJS ; 'IP' < frenchangel59.com> (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; (b) (6) (b) (6) (b) (6) (b) (6) ' gmail.com' < gmail.com>; ' gmail.com' < gmail.com>; (b) (6) (b) (6) ' mac.com' < mac.com> Subject: RE: [EXTERNAL] RE: VA Healthcare - - (b) (6), (b) (7)(C) -I agree with Ike and the team that measuring VA against private hospitals is critical - so while CMS is not able to deliver this for months we have now developed our own tool to do this-we are fine tuning the model this week and can share it by friday. If it does not get us where we need to be then working quickly with an independent group would make a great deal of sense. David Sent with Good (>www.good.com<) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 04:31 PM Eastern Standard Time To: IP (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO; EOP/WHO; (b) (6) (b) (6) (b) (6) DJS; gmail.com; gmail.com; ' mac.com' Subject: [EXTERNAL] RE: VA Healthcare EOP/WHO; This is a creative i9dea to fast track the process - I think it could be worthwhile as a way of collecting the data quickly by an independent group. If they can spend time with the other raters and get a sense for what they are looking for, perhaps the data they are collecting can be used to help determine the star ratings VA-18-0298 and 18-0299-B-000044 (b) (6) From: IP [mailto: frenchangel59.com] Sent: Monday, September 18, 2017 8:58 AM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; DJS (b) (6) (b) (6) (b) (6) ; gmail.com; gmail.com; ' mac.com' (b) (6) < mac.com> Subject: VA Healthcare - - (b) (6), (b) (7)(C) We have been talking to Dr. Shulkin for many months about identifying the existence of healthcare delivery issues at VA medical centers. There is no doubt that issues exist in abundance and were created by decades of historical federal government hiring practices, regulatory hiring rules and mismanagement. We originally were hoping that the hospitals could be rated (with the star rating system) by CMS, as they do with private hospitals. However, they recently advised that they would not be able to focus on the VA hospitals until December 2018. As an example, we think that some of the VA hospitals are delivering some specialty healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better option. Not every VA hospital has both the breadth and depth of specialized medical expertise in every specialty, which then creates risk to the patients and the system. One idea discussed was to institute a self-rating program, but self-ratings are rarely of any practical use. Our solution is to make use of the academic medical centers and medical trade groups, both of whom have offered to send review teams to the VA hospitals to help in this effort. The purpose of this email is to see if you know of any impediments to taking them up on this offer and to get your thoughts in general about this approach. All my Best, Ike VA-18-0298 and 18-0299-B-000045 From: - DJS To: Cc: Bcc: Subject: Date: Attachments: RE: [EXTERNAL] RE: VA Healthcare Sun Sep 24 2017 19:14:16 CDT - (b) (6), (b) You too (7)(C) (b) (5) Thanks David Sent with Good (www.good.com) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 06:04 PM Eastern Standard Time To: DJS Subject: RE: [EXTERNAL] RE: VA Healthcare And (b) (6) From: DJS [mailto:vacodjs1@va.gov] Sent: Sunday, September 24, 2017 5:18 PM (b) (6), (b) (7)(C) (b) (6), (b) (6) To: EOP/WHO <(b) (7)(C) who.eop.gov>; 'IP' < frenchangel59.com> (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; (b) (6) (b) (6) (b) (6) (b) (6) ' gmail.com' < gmail.com>; ' gmail.com' < gmail.com>; (b) (6) (b) (6) ' mac.com' < mac.com> Subject: RE: [EXTERNAL] RE: VA Healthcare - - (b) (6), (b) (7)(C) -I agree with Ike and the team that measuring VA against private hospitals is critical - so while CMS is not able to deliver this for months we have now developed our own tool to do this-we are fine tuning the model this week and can share it by friday. If it does not get us where we need to be then working quickly with an independent group would make a great deal of sense. David VA-18-0298 and 18-0299-B-000046 Sent with Good (>www.good.com<) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, September 24, 2017 04:31 PM Eastern Standard Time To: IP (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO; EOP/WHO; (b) (6) (b) (6) (b) (6) DJS; gmail.com; gmail.com; ' mac.com' Subject: [EXTERNAL] RE: VA Healthcare EOP/WHO; This is a creative i9dea to fast track the process - I think it could be worthwhile as a way of collecting the data quickly by an independent group. If they can spend time with the other raters and get a sense for what they are looking for, perhaps the data they are collecting can be used to help determine the star ratings (b) (6) From: IP [mailto: frenchangel59.com] Sent: Monday, September 18, 2017 8:58 AM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) (b) (6), (b) (6), (b) (7)(C) Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; EOP/WHO < (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) who.eop.gov>; EOP/WHO < who.eop.gov>; DJS (b) (6) (b) (6) (b) (6) ; gmail.com; gmail.com; ' mac.com' (b) (6) < mac.com> Subject: VA Healthcare - - (b) (6), (b) (7)(C) We have been talking to Dr. Shulkin for many months about identifying the existence of healthcare delivery issues at VA medical centers. There is no doubt that issues exist in abundance and were created by decades of historical federal government hiring practices, regulatory hiring rules and mismanagement. We originally were hoping that the hospitals could be rated (with the star rating system) by CMS, as they do with private hospitals. However, they recently advised that they would not be able to focus on the VA hospitals until December 2018. As an example, we think that some of the VA hospitals are delivering some specialty healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better option. Not every VA hospital has both the breadth and depth of specialized medical expertise in every specialty, which then creates risk to the patients and the system. One idea discussed was to institute a self-rating program, but self-ratings are rarely of any practical use. Our solution is to make use of the academic medical centers and medical trade groups, both of whom have offered to send review teams to the VA hospitals to help in this effort. The purpose of this email is to see if you know of any impediments to taking them up on this offer and to get your thoughts in general about this approach. All my Best, Ike VA-18-0298 and 18-0299-B-000047 and 18-0299-B-000048 From: To: Cc: Bcc: Subject: Date: Attachments: - DJS Bastille Day July 14 Wed Jun 28 2017 19:13:10 CDT (6), (b) (6), (b) (7)(C) (b) (5), (7)(C) (b) (5) Thanks David Shulkin Sent with Good (www.good.com) VA-18-0298 and 18-0299-B-000049 (b) (6), (b) (7)(C) From: EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> DJS ; (b) (6), <(b) (7)(C) who.eop.gov> - To: Cc: Bcc: Subject: Date: Attachments: EOP/WHO [EXTERNAL] RE: Bastille Day July 14 Thu Jun 29 2017 07:19:26 CDT (b) (5) -----Original Message----From: DJS [mailto:vacodjs1@va.gov] Sent: Wednesday, June 28, 2017 8:13 PM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> Subject: Bastille Day July 14 (b) (6), (b) (7)(C) (b) (5) - Thanks David Shulkin Sent with Good (www.good.com) VA-18-0298 and 18-0299-B-000050 From: To: Cc: (b) (6), (b) (7)(C) EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> DJS ; (b) (6), <(b) (7)(C) who.eop.gov> Bcc: Subject: Date: Attachments: - (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) EOP/WHO [EXTERNAL] Re: Sun Apr 09 2017 15:58:40 CDT (b) (5) (b) (5) (b) . (6), - (b) (5) (b) (7)(C) Sent from my iPad > On Apr 3, 2017, at 9:52 AM, DJS wrote: > (b) (5) (b) (6), (b) > (7)(C) > > David Shulkin > > > > Sent with Good (www.good.com) VA-18-0298 and 18-0299-B-000051 From: - DJS To: (b) (6), (b) (7)(C) Cc: (b) (6), (b) (7)(C) < who.eop.gov>; (b) (6), <(b) (7)(C) who.eop.gov> Bcc: Subject: Date: Attachments: - (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) EOP/WHO RE: [EXTERNAL] Re: Sun Apr 09 2017 17:52:11 CDT (b) (5) ? (b) (b) (5) (6), (b) (7)(C) David Sent with Good (www.good.com) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, April 09, 2017 04:59 PM Eastern Standard Time To: DJS (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO Subject: [EXTERNAL] Re: (b) (5) (b) . (6), - (b) (5) (b) (7)(C) Sent from my iPad > On Apr 3, 2017, at 9:52 AM, DJS wrote: > (b) (5) (b) (6), (b) > (7)(C) > > David Shulkin > > > > Sent with Good (www.good.com) VA-18-0298 and 18-0299-B-000052 and 18-0299-B-000053 (b) (6), (b) (7)(C) From: EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> DJS ; (b) (6), <(b) (7)(C) who.eop.gov> Bcc: Subject: Date: Attachments: (b) (6), (b) (7)(C) EOP/WHO Re: [EXTERNAL] Re: Sun Apr 09 2017 22:18:59 CDT Thank you! Sent from my iPhone On Apr 9, 2017, at 3:52 PM, DJS wrote: - (b) (6), (b) (7)(C) (b) (5) (b) (b) (5) (6), (b) (7)(C) David Sent with Good (www.good.com) - -----Original Message----(b) (6), (b) (7)(C) (b) (6), From: EOP/WHO [(b) (7)(C) who.eop.gov] Sent: Sunday, April 09, 2017 04:59 PM Eastern Standard Time To: DJS (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) Cc: EOP/WHO Subject: [EXTERNAL] Re: (b) (5) (b) (6), (b) (7)(C) - (b) (5) Sent from my iPad > On Apr 3, 2017, at 9:52 AM, DJS wrote: > (b) (5) (b) (6), (b) > (7)(C) VA-18-0298 and 18-0299-B-000054 David and 18-0299-B-000055 From: (b) (6), (b) (7)(C) Cc: EOP/WHO (b) (6), <(b) (7)(C) who.eop.gov> DJS ; Wright, Vivieca (Simpson) ; (b) (6) . ; (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) EOP/WHO < who.eop.gov> Bcc: Subject: Date: Attachments: [EXTERNAL] RE: Invitation on Tuesday Fri Apr 21 2017 17:54:27 CDT To: - (b) (5) From: DJS [mailto:vacodjs1@va.gov] Sent: Friday, April 21, 2017 11:22 AM (b) (6), (b) (7)(C) (b) (6), To: EOP/WHO <(b) (7)(C) who.eop.gov> (b) (6), (b) (7)(C) (b) (6), Cc: EOP/WHO <(b) (7)(C) who.eop.gov>; Wright, Vivieca (Simpson) ; @va.gov> Subject: Invitation on Tuesday - (b) (6), (b) (7)(C) (b) (5), (b) (6), (b) (7)(C) (b) (6), (b) (7)(C) David VA-18-0298 and 18-0299-B-000056 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin - FW: VA and Apple Fri Apr 28 2017 09:53:01 CDT Hi Marc It was great meeting you yesterday at VA. If you are available next week, I would like to discuss with you what VA is looking to do with Apple and the 5 Centers. I am happy to meet at your office. Please let me know when you are available. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) VA-18-0298 and 18-0299-B-000057 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> (b) (6) Poonam Alaigh < hotmail.com> (b) (6) aol.com <(b) (6) aol.com>; Selnick, Darin ; < gmail.com>; (b)) (6) gmail.com <(b) (6) gmail.com> (6 -) [EXTERNAL] Apple Tue May 02 2017 06:36:39 CDT I think the number one priority with Apple will be to have what they are already working on, portable health records available to Veterans. If they choose the choice program then we need to know in realtime what the evaluation and treatment is, not was or the cost can be prohibitive. Also the health provider needs important data from the VA records The 5 CEO's have committed resources also to get this done. We will need their assistance to have a patient centric program for preventive medicine that can also tract progress Tracking mechanism for opioid prescriptions within and outside of the VA Organize mental health early detection and treatment strategies. Currently there are too many unorganized initiatives and no feed back on effectiveness. Approved Choice services geotagged to the Veterans location hospitals, providers walk in clinics etc. The CEO's want to have their teams work with Apple for strategies to reduce health care costs. This is very important and we need to take advantage of everyone's intellectual capital. I am available to discuss 24/7 and the academic team is ready to move now. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000058 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) gmail.com <(b) (6) gmail.com>; (b) (6) Selnick, Darin ; (b) (6) On May 3, 2017, at 3:41 PM, Selnick, Darin wrote: > > Hi Bruce > > Thanks for the emaiI, it was great meeting you last week and I am looking forward to working with you on the partnership. I wanted to let you and Marc know that we have just completed and signed the NDA with Apple. Going forward I recommend that we set up a conference call with Apple to discuss the path forward and partnership of VA, Apple and the 5 Centers. The call would include you, Marc, from VA myself and (b) (6) and our Apple points of contact. > > In preparation for that call, I would like to have a call with you and Marc so that I can get you up to speed on the past initial discussions VA has had with Apple. We had discussed three broad health IT areas to explore and a process to do it. > > Please let know when you and Marc are available for a call. > > Best regards > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Tuesday, May 02, 2017 7:37 AM > To: Poonam Alaigh > Cc: (b) (6) aol.com; Selnick, Darin; IP; (b) (6) (b) (6) gmail.com > Subject: [EXTERNAL] Apple > > I think the number one priority with Apple will be to have what they are already working on, portable - - - VA-18-0298 and 18-0299-B-000061 8 health records available to Veterans. If they choose the choice program then we need to know in realtime what the evaluation and treatment is, not was or the cost can be prohibitive. Also the health provider needs important data from the VA records The 5 CEO's have committed resources also to get this done. > > We will need their assistance to have a patient centric program for preventive medicine that can also tract progress > > Tracking mechanism for opioid prescriptions within and outside of the VA > > Organize mental health early detection and treatment strategies. Currently there are too many unorganized initiatives and no feed back on effectiveness. > > Approved Choice services geotagged to the Veterans location hospitals, providers walk in clinics etc. > > The CEO's want to have their teams work with Apple for strategies to reduce health care costs. This is very important and we need to take advantage of everyone's intellectual capital. > > I am available to discuss 24/7 and the academic team is ready to move now. > > > > > > > Sent from my iPad > Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000062 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) gmail.com <(b) (6) gmail.com>; (b) (6) On May 3, 2017, at 3:41 PM, Selnick, Darin wrote: > > Hi Bruce > > Thanks for the emaiI, it was great meeting you last week and I am looking forward to working with you on the partnership. I wanted to let you and Marc know that we have just completed and signed the NDA with Apple. Going forward I recommend that we set up a conference call with Apple to discuss the path forward and partnership of VA, Apple and the 5 Centers. The call would include you, Marc, from VA myself and (b) (6) and our Apple points of contact. > > In preparation for that call, I would like to have a call with you and Marc so that I can get you up to speed on the past initial discussions VA has had with Apple. We had discussed three broad health IT areas to explore and a process to do it. > > Please let know when you and Marc are available for a call. VA-18-0298 and 18-0299-B-000063 > > Best regards > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Tuesday, May 02, 2017 7:37 AM > To: Poonam Alaigh > Cc: (b) (6) aol.com; Selnick, Darin; IP; (b) (6) (b) (6) gmail.com > Subject: [EXTERNAL] Apple > > I think the number one priority with Apple will be to have what they are already working on, portable health records available to Veterans. If they choose the choice program then we need to know in realtime what the evaluation and treatment is, not was or the cost can be prohibitive. Also the health provider needs important data from the VA records The 5 CEO's have committed resources also to get this done. - - - > > We will need their assistance to have a patient centric program for preventive medicine that can also tract progress > > Tracking mechanism for opioid prescriptions within and outside of the VA > > Organize mental health early detection and treatment strategies. Currently there are too many unorganized initiatives and no feed back on effectiveness. > > Approved Choice services geotagged to the Veterans location hospitals, providers walk in clinics etc. > > The CEO's want to have their teams work with Apple for strategies to reduce health care costs. This is very important and we need to take advantage of everyone's intellectual capital. > > I am available to discuss 24/7 and the academic team is ready to move now. > > > > > > > Sent from my iPad > Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000064 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin ; (b) (6) On May 3, 2017, at 4:02 PM, Selnick, Darin wrote: > > Great, how about 4:30pm ET on Monday, May 8. > > Best > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Wednesday, May 03, 2017 3:47 PM > To: Selnick, Darin > Cc: (b) (6) gmail.com; (b) (6) > Subject: Re: [EXTERNAL] Apple > > I can do usually a noon or 430 > > Sent from my iPhone > >> On May 3, 2017, at 3:41 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> Thanks for the emaiI, it was great meeting you last week and I am looking forward to working with you on the partnership. I wanted to let you and Marc know that we have just completed and signed the NDA with Apple. Going forward I recommend that we set up a conference call with Apple to discuss the path forward and partnership of VA, Apple and the 5 Centers. The call would include you, Marc, from VA myself and (b) (6) and our Apple points of contact. - VA-18-0298 and 18-0299-B-000065 >> >> In preparation for that call, I would like to have a call with you and Marc so that I can get you up to speed on the past initial discussions VA has had with Apple. We had discussed three broad health IT areas to explore and a process to do it. >> >> Please let know when you and Marc are available for a call. >> >> Best regards >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Tuesday, May 02, 2017 7:37 AM >> To: Poonam Alaigh >> Cc: (b) (6) aol.com; Selnick, Darin; IP; (b) (6) (b) (6) gmail.com >> Subject: [EXTERNAL] Apple >> >> I think the number one priority with Apple will be to have what they are already working on, portable health records available to Veterans. If they choose the choice program then we need to know in realtime what the evaluation and treatment is, not was or the cost can be prohibitive. Also the health provider needs important data from the VA records The 5 CEO's have committed resources also to get this done. - - - >> >> We will need their assistance to have a patient centric program for preventive medicine that can also tract progress >> >> Tracking mechanism for opioid prescriptions within and outside of the VA >> >> Organize mental health early detection and treatment strategies. Currently there are too many unorganized initiatives and no feed back on effectiveness. >> >> Approved Choice services geotagged to the Veterans location hospitals, providers walk in clinics etc. >> >> The CEO's want to have their teams work with Apple for strategies to reduce health care costs. This is very important and we need to take advantage of everyone's intellectual capital. >> >> I am available to discuss 24/7 and the academic team is ready to move now. >> >> >> >> >> >> >> Sent from my iPad VA-18-0298 and 18-0299-B-000066 Bruce Moskowitz MD. and From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) gmail.com <(b) (6) gmail.com>; (b) (6) On May 3, 2017, at 4:02 PM, Selnick, Darin wrote: > > Great, how about 4:30pm ET on Monday, May 8. > > Best > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > - VA-18-0298 and 18-0299-B-000068 > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Wednesday, May 03, 2017 3:47 PM > To: Selnick, Darin > Cc: (b) (6) gmail.com; (b) (6) > Subject: Re: [EXTERNAL] Apple > > I can do usually a noon or 430 > > Sent from my iPhone > >> On May 3, 2017, at 3:41 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> Thanks for the emaiI, it was great meeting you last week and I am looking forward to working with you on the partnership. I wanted to let you and Marc know that we have just completed and signed the NDA with Apple. Going forward I recommend that we set up a conference call with Apple to discuss the path forward and partnership of VA, Apple and the 5 Centers. The call would include you, Marc, from VA myself and (b) (6) and our Apple points of contact. >> >> In preparation for that call, I would like to have a call with you and Marc so that I can get you up to speed on the past initial discussions VA has had with Apple. We had discussed three broad health IT areas to explore and a process to do it. >> >> Please let know when you and Marc are available for a call. >> >> Best regards >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Tuesday, May 02, 2017 7:37 AM >> To: Poonam Alaigh >> Cc: (b) (6) aol.com; Selnick, Darin; IP; (b) (6) (b) (6) gmail.com >> Subject: [EXTERNAL] Apple >> >> I think the number one priority with Apple will be to have what they are already working on, portable health records available to Veterans. If they choose the choice program then we need to know in realtime what the evaluation and treatment is, not was or the cost can be prohibitive. Also the health provider needs important data from the VA records The 5 CEO's have committed resources also to get this done. - - - >> >> We will need their assistance to have a patient centric program for preventive medicine that can also tract progress >> VA-18-0298 and 18-0299-B-000069 >> Tracking mechanism for opioid prescriptions within and outside of the VA >> >> Organize mental health early detection and treatment strategies. Currently there are too many unorganized initiatives and no feed back on effectiveness. >> >> Approved Choice services geotagged to the Veterans location hospitals, providers walk in clinics etc. >> >> The CEO's want to have their teams work with Apple for strategies to reduce health care costs. This is very important and we need to take advantage of everyone's intellectual capital. >> >> I am available to discuss 24/7 and the academic team is ready to move now. >> >> >> >> >> >> >> Sent from my iPad >> Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000070 From: Bruce Moskowitz <(b) (6) mac.com> (b) (6) To: <(b) (6) kp.org>; (b) (6) <(b) (6) jhu.edu>; (b) (6) < jhmi.edu>; <(b) (6) mayo.edu>; (b) (6) <(b) (6) ccf.org>; (b) (6) (b) (6) ccf.org < ccf.org>; (b) (6) <(b) (6) kp.org>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) (b) (6) < mayo.edu> (b) (6) <(b) (6) mayo.edu>; (b) (6) gmail.com <(b) (6) gmail.com>; Selnick, Darin jhu.edu> jha.edu mayo.edu Dr. (b) (6) (b) (6) - mayo.edu (b) (6) (b) (6) kp. org (b) (6) (b) (6) ccf.org (b) (6) (b) (6) ccf.org (b) (6) (b) (6) ccf.org VA-18-0298 and 18-0299-B-000071 (b) (6) (b) (6) - mayo.edu Cleveland Clinic Acting CIO ccf.org (216) 469-(b) (6) (b) (6) (b) (6) (216) 445 (b) (6) To: <(b) (6) kp.org>; (b) (6) <(b) (6) jhu.edu>; (b) (6) < jhmi.edu>; <(b) (6) mayo.edu>; (b) (6) <(b) (6) ccf.org>; (b) (6) (b) (6) ccf.org < ccf.org>; (b) (6) <(b) (6) kp.org>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) (b) (6) < mayo.edu> (b) (6) <(b) (6) mayo.edu>; (b) (6) gmail.com <(b) (6) gmail.com>; Selnick, Darin (b) (6) gmail.com <(b) (6) gmail.com>; (b) (6) On May 3, 2017, at 4:02 PM, Selnick, Darin wrote: > > Great, how about 4:30pm ET on Monday, May 8. > > Best > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Wednesday, May 03, 2017 3:47 PM > To: Selnick, Darin > Cc: (b) (6) gmail.com; (b) (6) > Subject: Re: [EXTERNAL] Apple > > I can do usually a noon or 430 > > Sent from my iPhone > >> On May 3, 2017, at 3:41 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> Thanks for the emaiI, it was great meeting you last week and I am looking forward to working with you on the partnership. I wanted to let you and Marc know that we have just completed and signed the NDA with Apple. Going forward I recommend that we set up a conference call with Apple to discuss the path forward and partnership of VA, Apple and the 5 Centers. The call would include you, Marc, from VA myself and (b) (6) and our Apple points of contact. - >> >> In preparation for that call, I would like to have a call with you and Marc so that I can get you up to speed on the past initial discussions VA has had with Apple. We had discussed three broad health IT areas to explore and a process to do it. >> >> Please let know when you and Marc are available for a call. >> VA-18-0298 and 18-0299-B-000078 >> Best regards >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Tuesday, May 02, 2017 7:37 AM >> To: Poonam Alaigh (b) (6) (b) (6) >> Cc: (b) (6) aol.com; Selnick, Darin; (b) gmail.com (6) >> Subject: [EXTERNAL] Apple >> >> I think the number one priority with Apple will be to have what they are already working on, portable health records available to Veterans. If they choose the choice program then we need to know in realtime what the evaluation and treatment is, not was or the cost can be prohibitive. Also the health provider needs important data from the VA records The 5 CEO's have committed resources also to get this done. - - ?- >> >> We will need their assistance to have a patient centric program for preventive medicine that can also tract progress >> >> Tracking mechanism for opioid prescriptions within and outside of the VA >> >> Organize mental health early detection and treatment strategies. Currently there are too many unorganized initiatives and no feed back on effectiveness. >> >> Approved Choice services geotagged to the Veterans location hospitals, providers walk in clinics etc. >> >> The CEO's want to have their teams work with Apple for strategies to reduce health care costs. This is very important and we need to take advantage of everyone's intellectual capital. >> >> I am available to discuss 24/7 and the academic team is ready to move now. >> >> >> >> >> >> >> Sent from my iPad >> Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000079 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin ; (b) (6) On May 8, 2017, at 3:24 PM, Selnick, Darin wrote: > > Hi Bruce and Marc > > Just confirming we are on for the call at 4:30pm. > > FYI - In the couple phone calls Apple had with VHA staff, these are the three broad areas they were looking to focus on. > > * Credentialing/authenticating > * Patient mediated data exchange and analytics > * Development of a research type app related to suicide prevention. > > Best > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Selnick, Darin > Sent: Wednesday, May 03, 2017 4:30 PM > To: 'Bruce Moskowitz' > Cc: (b) (6) gmail.com; (b) (6) > Subject: RE: [EXTERNAL] Apple > > Great, here is the conference call in number and instructions for May 8 at 4:30pm ET. > (6), > Dial 800-767-(b) and follow the voice prompts. When asked, please enter the Moderator Code (b) (5) - VA-18-0298 and 18-0299-B-000080 - (b) (6), (b) (5) followed by the # key > > Best > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Wednesday, May 03, 2017 4:13 PM > To: Selnick, Darin > Cc: (b) (6) gmail.com; (b) (6) > Subject: Re: [EXTERNAL] Apple > > Ok > > Sent from my iPad > Bruce Moskowitz M.D. > >> On May 3, 2017, at 4:02 PM, Selnick, Darin wrote: >> >> Great, how about 4:30pm ET on Monday, May 8. >> >> Best >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Wednesday, May 03, 2017 3:47 PM >> To: Selnick, Darin >> Cc: (b) (6) gmail.com; (b) (6) >> Subject: Re: [EXTERNAL] Apple >> >> I can do usually a noon or 430 >> >> Sent from my iPhone >> >>> On May 3, 2017, at 3:41 PM, Selnick, Darin wrote: >>> >>> Hi Bruce >>> >>> Thanks for the emaiI, it was great meeting you last week and I am looking forward to working with you on the partnership. I wanted to let you and Marc know that we have just completed and signed the NDA with Apple. Going forward I recommend that we set up a conference call with Apple to discuss the path forward and partnership of VA, Apple and the 5 Centers. The call would include you, Marc, from - - VA-18-0298 and 18-0299-B-000081 VA myself and (b) (6) and our Apple points of contact. >>> >>> In preparation for that call, I would like to have a call with you and Marc so that I can get you up to speed on the past initial discussions VA has had with Apple. We had discussed three broad health IT areas to explore and a process to do it. >>> >>> Please let know when you and Marc are available for a call. >>> >>> Best regards >>> >>> Darin >>> >>> Darin Selnick >>> Senior Advisor to the Secretary >>> Cell 202-390-(b) (6) >>> >>> >>> -----Original Message---->>> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >>> Sent: Tuesday, May 02, 2017 7:37 AM >>> To: Poonam Alaigh >>> Cc: (b) (6) aol.com; Selnick, Darin; IP; (b) (6) (b) (6) gmail.com >>> Subject: [EXTERNAL] Apple >>> >>> I think the number one priority with Apple will be to have what they are already working on, portable health records available to Veterans. If they choose the choice program then we need to know in realtime what the evaluation and treatment is, not was or the cost can be prohibitive. Also the health provider needs important data from the VA records The 5 CEO's have committed resources also to get this done. - - - >>> >>> We will need their assistance to have a patient centric program for preventive medicine that can also tract progress >>> >>> Tracking mechanism for opioid prescriptions within and outside of the VA >>> >>> Organize mental health early detection and treatment strategies. Currently there are too many unorganized initiatives and no feed back on effectiveness. >>> >>> Approved Choice services geotagged to the Veterans location hospitals, providers walk in clinics etc. >>> >>> The CEO's want to have their teams work with Apple for strategies to reduce health care costs. This is very important and we need to take advantage of everyone's intellectual capital. >>> >>> I am available to discuss 24/7 and the academic team is ready to move now. >>> >>> >>> >>> >>> VA-18-0298 and 18-0299-B-000082 Sent from my iPad Bruce Moskowitz MD. and From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) gmail.com <(b) (6) gmail.com>; (b) (6) On May 8, 2017, at 3:24 PM, Selnick, Darin wrote: > > Hi Bruce and Marc > > Just confirming we are on for the call at 4:30pm. > > FYI - In the couple phone calls Apple had with VHA staff, these are the three broad areas they were looking to focus on. > > * Credentialing/authenticating > * Patient mediated data exchange and analytics > * Development of a research type app related to suicide prevention. > > Best > > Darin VA-18-0298 and 18-0299-B-000084 > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Selnick, Darin > Sent: Wednesday, May 03, 2017 4:30 PM > To: 'Bruce Moskowitz' > Cc: (b) (6) gmail.com; (b) (6) > Subject: RE: [EXTERNAL] Apple > > Great, here is the conference call in number and instructions for May 8 at 4:30pm ET. > (6), > Dial 800-767-(b) and follow the voice prompts. When asked, please enter the Moderator Code (b) (5) (b) (6), followed by the # key (b) (5) - - - > > Best > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Wednesday, May 03, 2017 4:13 PM > To: Selnick, Darin > Cc: (b) (6) gmail.com; (b) (6) > Subject: Re: [EXTERNAL] Apple > > Ok > > Sent from my iPad > Bruce Moskowitz M.D. > >> On May 3, 2017, at 4:02 PM, Selnick, Darin wrote: >> >> Great, how about 4:30pm ET on Monday, May 8. >> >> Best >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Wednesday, May 03, 2017 3:47 PM - - VA-18-0298 and 18-0299-B-000085 >> To: Selnick, Darin >> Cc: (b) (6) gmail.com; (b) (6) >> Subject: Re: [EXTERNAL] Apple >> >> I can do usually a noon or 430 >> >> Sent from my iPhone >> >>> On May 3, 2017, at 3:41 PM, Selnick, Darin wrote: >>> >>> Hi Bruce >>> >>> Thanks for the emaiI, it was great meeting you last week and I am looking forward to working with you on the partnership. I wanted to let you and Marc know that we have just completed and signed the NDA with Apple. Going forward I recommend that we set up a conference call with Apple to discuss the path forward and partnership of VA, Apple and the 5 Centers. The call would include you, Marc, from VA myself and (b) (6) and our Apple points of contact. >>> >>> In preparation for that call, I would like to have a call with you and Marc so that I can get you up to speed on the past initial discussions VA has had with Apple. We had discussed three broad health IT areas to explore and a process to do it. >>> >>> Please let know when you and Marc are available for a call. >>> >>> Best regards >>> >>> Darin >>> >>> Darin Selnick >>> Senior Advisor to the Secretary >>> Cell 202-390-(b) (6) >>> >>> >>> -----Original Message---->>> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >>> Sent: Tuesday, May 02, 2017 7:37 AM >>> To: Poonam Alaigh >>> Cc: (b) (6) aol.com; Selnick, Darin; IP; (b) (6) (b) (6) gmail.com >>> Subject: [EXTERNAL] Apple >>> >>> I think the number one priority with Apple will be to have what they are already working on, portable health records available to Veterans. If they choose the choice program then we need to know in realtime what the evaluation and treatment is, not was or the cost can be prohibitive. Also the health provider needs important data from the VA records The 5 CEO's have committed resources also to get this done. - - - >>> >>> We will need their assistance to have a patient centric program for preventive medicine that can also tract progress >>> >>> Tracking mechanism for opioid prescriptions within and outside of the VA >>> >>> Organize mental health early detection and treatment strategies. Currently there are too many VA-18-0298 and 18-0299-B-000086 unorganized initiatives and no feed back on effectiveness. >>> >>> Approved Choice services geotagged to the Veterans location hospitals, providers walk in clinics etc. >>> >>> The CEO's want to have their teams work with Apple for strategies to reduce health care costs. This is very important and we need to take advantage of everyone's intellectual capital. >>> >>> I am available to discuss 24/7 and the academic team is ready to move now. >>> >>> >>> >>> >>> >>> >>> Sent from my iPad >>> Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000087 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) gmail.com> Selnick, Darin - Marc Sherman [EXTERNAL] Apple Agenda Tue May 09 2017 05:42:07 CDT The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000088 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) - Marc Sherman RE: [EXTERNAL] Apple Agenda Tue May 09 2017 05:44:56 CDT Great, thanks Darin Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) gmail.com] Sent: Tuesday, May 09, 2017 06:42 AM Eastern Standard Time To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. VA-18-0298 and 18-0299-B-000089 Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000090 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) - Marc Sherman RE: [EXTERNAL] Apple Agenda Thu May 11 2017 10:04:56 CDT Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. VA-18-0298 and 18-0299-B-000091 We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000092 From: Bruce Moskowitz <(b) (6) gmail.com> Selnick, Darin ; (b) (6) <(b) (6) To: - Cc: Bcc: Subject: Date: Attachments: - Ok (b) (6) Marc Sherman gmail.com> Re: [EXTERNAL] Apple Agenda Thu May 11 2017 10:16:21 CDT will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] VA-18-0298 and 18-0299-B-000093 The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000094 Marc Sherman <(b) (6) gmail.com> Bruce Moskowitz <(b) (6) gmail.com> Selnick, Darin From: To: Cc: Bcc: Subject: Date: Attachments: - Re: [EXTERNAL] Apple Agenda Thu May 11 2017 10:20:11 CDT -- I am good at 4pm on the 19th. On Thu, May 11, 2017 at 11:16 AM, Bruce Moskowitz <(b) (6) - Ok (b) (6) gmail.com> wrote: will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) VA-18-0298 and 18-0299-B-000095 From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000096 From: Selnick, Darin ; Bruce Moskowitz <(b) (6) gmail.com> (b) (6) - To: Cc: Bcc: Subject: Date: Attachments: RE: [EXTERNAL] Apple Agenda Thu May 11 2017 10:34:05 CDT - 4pm on 5/19 works for VA. Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Marc Sherman [mailto:(b) (6) gmail.com] Sent: Thursday, May 11, 2017 11:20 AM To: Bruce Moskowitz (b) (6) Cc: Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - I am good at 4pm on the 19th. On Thu, May 11, 2017 at 11:16 AM, Bruce Moskowitz <(b) (6) - Ok (b) (6) gmail.com> wrote: will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: VA-18-0298 and 18-0299-B-000097 Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the VA-18-0298 and 18-0299-B-000098 medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000099 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) gmail.com> Selnick, Darin ; (b) (6) - Re: [EXTERNAL] Apple Agenda Thu May 11 2017 10:50:16 CDT - That won't work I have a call with Mayo and Poonam at that time Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:34 AM, Selnick, Darin wrote: 4pm on 5/19 works for VA. Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Marc Sherman [mailto:(b) (6) gmail.com] Sent: Thursday, May 11, 2017 11:20 AM To: Bruce Moskowitz (b) (6) Cc: Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - I am good at 4pm on the 19th. On Thu, May 11, 2017 at 11:16 AM, Bruce Moskowitz <(b) (6) gmail.com> wrote: VA-18-0298 and 18-0299-B-000100 - Ok (b) (6) will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. VA-18-0298 and 18-0299-B-000101 We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000102 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin Marc Sherman <(b) (6) gmail.com>; (b) (6) - RE: [EXTERNAL] Apple Agenda Thu May 11 2017 10:57:00 CDT - Bruce We are available anytime on 5/19. If that day does not work for you, please let us know a date and time that will. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Thursday, May 11, 2017 11:50 AM To: Selnick, Darin (b) (6) Cc: Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda gmail.com] - That won't work I have a call with Mayo and Poonam at that time Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000103 On May 11, 2017, at 11:34 AM, Selnick, Darin wrote: 4pm on 5/19 works for VA. Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Marc Sherman [mailto:(b) (6) gmail.com] Sent: Thursday, May 11, 2017 11:20 AM To: Bruce Moskowitz (b) (6) Cc: Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - I am good at 4pm on the 19th. On Thu, May 11, 2017 at 11:16 AM, Bruce Moskowitz <(b) (6) - Ok (b) (6) gmail.com> wrote: will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin VA-18-0298 and 18-0299-B-000104 Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000105 From: To: Cc: Bruce Moskowitz <(b) (6) mac.com> (b) (6) David shulkin < aol.com> Selnick, Darin On May 11, 2017, at 6:26 PM, David shulkin <(b) (6) aol.com> wrote: > > Bruce- did Darin or (b) (6) reach out to you yet to set up > A call regarding Apple? > > Sent from my iPhone VA-18-0298 and 18-0299-B-000106 From: Selnick, Darin (b) (6) ; (b) (6) <(b) (6) - To: Cc: Bcc: Subject: Date: Attachments: Marc Sherman gmail.com> RE: [EXTERNAL] Apple Agenda Thu May 11 2017 21:37:29 CDT Great, I think Thursday May 18 at 4pm could work as well. Best Darin Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) gmail.com] Sent: Thursday, May 11, 2017 10:34 PM Eastern Standard Time To: Selnick, Darin Cc: (b) (6) Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - Ok (b) (6) - will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best VA-18-0298 and 18-0299-B-000107 Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000108 and 18-0299-B-000109 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin ; IP <(b @frenchangel59.com>; ) (b) (6) aol.com <(b) (6) aol.com>; Poonam Alaigh (6 (b) (6) ) < hotmail.com> - [EXTERNAL] Apple Fri May 12 2017 13:10:25 CDT --- (b) (6) There are 4 more experts to have on the apple call they are (b) (6) , (b) (6) and All with responsive health.org. I met with them today and they are experts on the tough part of the agenda. To make the call effective we plan to have two to Three from our side speak and the rest are available to answer technical questions. All of the group have different areas of expertise. (b) (6) Sent from my iPhone VA-18-0298 and 18-0299-B-000110 From: Selnick, Darin (b) (6) gmail.com <(b) (6) gmail.com>; IP <(b @frenchangel59.com>; ) (b) (6) aol.com <(b) (6) aol.com>; Poonam Alaigh (6 (b) (6) ) < hotmail.com> - To: Cc: Bcc: Subject: Date: Attachments: RE: [EXTERNAL] Apple Fri May 12 2017 13:26:10 CDT Bruce Sounds great. Best Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - -----Original Message----From: Bruce Moskowitz [mailto:(b) (6) Sent: Friday, May 12, 2017 2:10 PM To: Selnick, Darin Cc: (b) (6) gmail.com; IP; (b) (6) Subject: [EXTERNAL] Apple - mac.com] aol.com; Poonam Alaigh --- (b) (6) There are 4 more experts to have on the apple call they are (b) (6) , (b) (6) and All with responsive health.org. I met with them today and they are experts on the tough part of the agenda. To make the call effective we plan to have two to Three from our side speak and the rest are available to answer technical questions. All of the group have different areas of expertise. (b) (6) Sent from my iPhone VA-18-0298 and 18-0299-B-000111 From: bruce moskowitz <(b) (6) gmail.com> Selnick, Darin ; Marc Sherman <(b) (6) gmail.com>; (b) (6) wrote: Just to confirm, how long will the call be. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 3:11 PM To: Selnick, Darin Cc: Bruce Moskowitz; Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda gmail.com] Great! I will send out a calendar invite. VA-18-0298 and 18-0299-B-000112 On Fri, May 12, 2017 at 3:08 PM, Selnick, Darin wrote: Let's go with Thursday, May 18 at 4pm. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 2:35 PM To: Selnick, Darin Cc: Bruce Moskowitz; Marc Sherman; (b) (6) Subject: RE: [EXTERNAL] Apple Agenda gmail.com] Dr. Moskowitz is not available until 5:00 pm EDT on May 19. I had suggested Thursday, May 18 at 4 pm or Monday, May 22 at 4 pm, but Mr. Sherman is not available at those times, however he indicated that the date works for everyone else, you could proceed without him. Do you have a preference? On May 12, 2017 2:27 PM, "Selnick, Darin" wrote: - Hi (b) (6) No there has not been a consensus at this point. The last email from Bruce was the possibility of checking on 4pm on 5/19. We are open all day on 5/19 and most of the day on 5/22. Best Darin VA-18-0298 and 18-0299-B-000113 Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 1:51 PM To: Marc Sherman Cc: Bruce Moskowitz; Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda gmail.com] Good afternoon everyone! I'm just checking in to see if there has been any consensus on a date for the conference call that is convenient for all of the participants? On May 11, 2017 11:40 PM, "Marc Sherman" <(b) (6) gmail.com> wrote: I am not available on Thursday May 18 or Monday May 22. Proceed without me if those are the only times available for everyone. - Marc Sherman (202) 758-(b) (6) - On May 11, 2017 12:06 PM, "(b) (6) Bruce Moskowitz,MD" <(b) (6) gmail.com> wrote: Dr, Moskowitz would be available at 5:00 on Friday, May 19 or he is available at 4:00 pm on Thursday, May 18 or 4:00 pm on Monday, May 22. On Thu, May 11, 2017 at 11:57 AM, Selnick, Darin wrote: Bruce We are available anytime on 5/19. If that day does not work for you, please let us know a date and time that will. VA-18-0298 and 18-0299-B-000114 Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Thursday, May 11, 2017 11:50 AM To: Selnick, Darin (b) (6) Cc: Marc Sherman; (b) (6) gmail.com] - Subject: Re: [EXTERNAL] Apple Agenda That won't work I have a call with Mayo and Poonam at that time Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:34 AM, Selnick, Darin wrote: 4pm on 5/19 works for VA. Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Marc Sherman [mailto:(b) (6) gmail.com] Sent: Thursday, May 11, 2017 11:20 AM To: Bruce Moskowitz (b) (6) Cc: Selnick, Darin; (b) (6) - VA-18-0298 and 18-0299-B-000115 Subject: Re: [EXTERNAL] Apple Agenda I am good at 4pm on the 19th. On Thu, May 11, 2017 at 11:16 AM, Bruce Moskowitz <(b) (6) - Ok (b) (6) gmail.com> wrote: will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma VA-18-0298 and 18-0299-B-000116 center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. -(b) (6) MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 - Phone: 561-833-(b) (6) Fax: 561-833-(b) (6) -- VA-18-0298 and 18-0299-B-000117 (b) (6) MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 - Phone: 561-833-(b) (6) Fax: 561-833-(b) (6) VA-18-0298 and 18-0299-B-000118 From: (b) (6) gmail.com gmail.com> (b) (6) gmail.com <(b) (6) gmail.com>; Selnick, Darin ; (b) (6) mac.com <(b) (6) mac.com> <(b) (6) To: Cc: Bcc: Subject: [EXTERNAL] Invitation: Conference call Selnick/(b) (6) 2017 4pm - 4:30pm (EDT) (darin.selnick@va.gov) Date: Fri May 12 2017 15:35:25 CDT Attachments: invite.ics - Moskowitz @ Thu May 18, StartTime: Thu May 18 15:00:00 Central Daylight Time 2017 EndTime: Thu May 18 15:30:00 Central Daylight Time 2017 Location: Recurring: No ShowReminder: No Accepted: Yes AcceptedTime: Mon May 15 09:37:00 Central Daylight Time 2017 Manage all your calendars in one place. Download the Google Calendar app. more details >> - Conference call Selnick/(b) (6) Moskowitz (6), 888-204-(b) (b) (5) (6), (b) Access code: (b) (5) WhenThu May 18, 2017 4pm - 4:30pm Eastern Time Calendardarin.selnick@va.gov Whoo(b) (6) gmail.com - organizer odarin.selnick@va.gov o(b) (6) baptisthealth.net o(b) (6) mac.com Going? Yes - Maybe - No more options >> Invitation from Google Calendar You are receiving this courtesy email at the account darin.selnick@va.gov because you are an attendee of this event. To stop receiving future updates for this event, decline this event. Alternatively you can sign up for a Google account at https://www.google.com/calendar/ and control your notification settings for your entire calendar. Forwarding this invitation could allow any recipient to modify your RSVP response. Learn More. VA-18-0298 and 18-0299-B-000119 Owner: Filename: Last Modified: (b) (6) gmail.com <(b) (6) gmail.com> invite.ics Fri May 12 15:35:25 CDT 2017 VA-18-0298 and 18-0299-B-000120 invite.ics for Printed Item: 26 ( Attachment 1 of 1) (b) (6) Conference call Selnick/ Moskowitz 20170518T200000Z CONFIRMED PRODID -//Google Inc//Google Calendar 70.9054//EN Version 2.0 CALSCALE GREGORIAN METHOD REQUEST Start Date/Time 20170518T200000Z End Date/Time 20170518T203000Z DTSTAMP 20170512T203525Z ORGANIZER ( CN=(b) (6) mailto:(b) (6) gmail.com ) gmail.com UID u28m6cbgnnr3ubeslgopjmfls8@google.com Attendee mailto:darin.selnick@va.gov Role REQ-PARTICIPANT RSVP TRUE Attendee mailto:(b) (6) Role REQ-PARTICIPANT RSVP TRUE gmail.com ---------Attendee mailto:(b) (6) baptisthealth.net Role REQ-PARTICIPANT RSVP TRUE Attendee mailto:(b) (6) Role REQ-PARTICIPANT RSVP TRUE mac.com CREATED 20170512T203525Z - Description 888-204-(b) (6), (b) (5) VA-18-0298 and 18-0299-B-000121 invite.ics for Printed Item: 26 ( Attachment 1 of 1) - Access code: (b) (6), (b) (5)at View your event https://www.google.com/calendar/event?action=VIEW&eid=dTI4bTZjYmdubnIzdWJlc2xnb3BqbWZsczgg ZGFyaW4uc2Vsbmlja0B2YS5nb3Y&tok=MjIjY2Fyb2x5bnM5MzAwQGdtYWlsLmNvbTQ0ZGQ2ZDFhYm NkOWZkOGVhNmUzNzc3ZTA3NjU5MmY3OTkzNDQ5N2M&ctz=America/New_York&hl=en. Last Modified 20170512T203525Z Location Sequence Number 0 Status CONFIRMED - Summary Conference call Selnick/(b) (6) Time Transparency OPAQUE Moskowitz VA-18-0298 and 18-0299-B-000122 From: To: (b) (6) gmail.com <(b) (6) gmail.com> Selnick, Darin ; (b) (6) mac.com <(b) (6) mac.com> Cc: Bcc: Subject: [EXTERNAL] Invitation: Conference call Selnick/(b) (6) 2017 4pm - 4:30pm (EDT) (darin.selnick@va.gov) Date: Fri May 12 2017 15:35:25 CDT Attachments: invite.ics - Moskowitz @ Thu May 18, Manage all your calendars in one place. Download the Google Calendar app. more details >> - Conference call Selnick/(b) (6) Moskowitz (6), 888-204-(b) (b) (5) (6), (b) Access code: (b) (5) WhenThu May 18, 2017 4pm - 4:30pm Eastern Time Calendardarin.selnick@va.gov Whoo(b) (6) gmail.com - organizer odarin.selnick@va.gov o(b) (6) baptisthealth.net o(b) (6) mac.com Going? Yes - Maybe - No more options >> Invitation from Google Calendar You are receiving this courtesy email at the account darin.selnick@va.gov because you are an attendee of this event. To stop receiving future updates for this event, decline this event. Alternatively you can sign up for a Google account at https://www.google.com/calendar/ and control your notification settings for your entire calendar. Forwarding this invitation could allow any recipient to modify your RSVP response. Learn More. VA-18-0298 and 18-0299-B-000123 Owner: Filename: Last Modified: (b) (6) gmail.com <(b) (6) gmail.com> invite.ics Fri May 12 15:35:25 CDT 2017 VA-18-0298 and 18-0299-B-000124 invite.ics for Printed Item: 28 ( Attachment 1 of 1) Conference call Selnic(b) (6) e/Moskowitz 20170518T200000Z CONFIRMED PRODID -//Google Inc//Google Calendar 70.9054//EN Version 2.0 CALSCALE GREGORIAN METHOD REQUEST Start Date/Time 20170518T200000Z End Date/Time 20170518T203000Z DTSTAMP 20170512T203525Z ORGANIZER ( CN=(b) (6) mailto:(b) (6) gmail.com ) gmail.com UID u28m6cbgnnr3ubeslgopjmfls8@google.com Attendee mailto:darin.selnick@va.gov Role REQ-PARTICIPANT RSVP TRUE Attendee mailto(b) (6) @gmail.com Role REQ-PARTICIPANT RSVP TRUE mailto(b) (6) baptisthealth.net REQ-PARTICIPANT RSVP TRUE Attendee ------------,----Role Attendee mailto(b) (6) Role REQ-PARTICIPANT RSVP TRUE @mac.com CREATED 20170512T203525Z - Description 888-204-(b) (6), (b) (5) VA-18-0298 and 18-0299-B-000125 invite.ics for Printed Item: 28 ( Attachment 1 of 1) - Access code: (b) (6), (b) (5)at View your event https://www.google.com/calendar/event?action=VIEW&eid=dTI4bTZjYmdubnIzdWJlc2xnb3BqbWZsczgg ZGFyaW4uc2Vsbmlja0B2YS5nb3Y&tok=MjIjY2Fyb2x5bnM5MzAwQGdtYWlsLmNvbTQ0ZGQ2ZDFhYm NkOWZkOGVhNmUzNzc3ZTA3NjU5MmY3OTkzNDQ5N2M&ctz=America/New_York&hl=en. Last Modified 20170512T203525Z Location Sequence Number 0 Status CONFIRMED - Summary Conference call Selnick/(b) (6) Time Transparency OPAQUE Moskowitz VA-18-0298 and 18-0299-B-000126 From: Bruce Moskowitz <(b) (6) mac.com> (b) (6) To: <(b) (6) baptisthealth.net> gmail.com <(b) (6) gmail.com>; Selnick, Darin wrote: Hello, Just confirming that this invitation was meant for Dr. Michael Zinner???? It may have been sent to me in error. Thanks. (b) (6) - (b) (6) Executive Assistant to (b) (6) M.D., Chief Executive Officer and Executive Medical Director and Manager, Administrative Services, Miami Cancer Institute - Executive Office 8900 N. Kendall Drive, 3rd Floor Executive Office Miami, Florida 33176 Office Phone: 786.527.(b) (6) Mobile: 617.320.(b) (6) Ascom: (b) (6) -- -----Original Appointment----From: (b) (6) gmail.com [mailto:(b) (6) gmail.com] Sent: Friday, May 12, 2017 4:35 PM (b) (6) To: (b) (6) gmail.com; darin.selnick@va.gov; (b) (6) mac.com (b) (6) Subject: [External] Invitation: Conference call Selnick/ Moskowitz @ Thu May 18, 2017 4pm - 4: 30pm (EDT) ((b) (6) baptisthealth.net) When: Thursday, May 18, 2017 4:00 PM-4:30 PM (UTC-05:00) Eastern Time (US & Canada). Where: - VA-18-0298 and 18-0299-B-000127 Manage all your calendars in one place. Download the Google Calendar app. more details >> - Conference call Selnick/(b) (6) Moskowitz (6), 888-204-(b) (b) (5) (6), (b) Access code: (b) (5) When Thu May 18, 2017 4pm - 4:30pm Eastern Time (b) (6) Calendar baptisthealth.net (b) (6) Who o gmail.com - organizer o darin.selnick@va.gov (b) (6) o baptisthealth.net (b) (6) o mac.com Going? Yes - Maybe - No more options >> Invitation from Google Calendar You are receiving this courtesy email at the account (b) (6) baptisthealth.net because you are an attendee of this event. To stop receiving future updates for this event, decline this event. Alternatively you can sign up for a Google account at https://www.google.com/calendar/ and control your notification settings for your entire calendar. Forwarding this invitation could allow any recipient to modify your RSVP response. Learn More. << File: invite.ics >> - _____ This message originates from Baptist Health South Florida (BHSF). It contains information that may be confidential or privileged and is intended only for the individuals or entity named above. It is prohibited for anyone else to disclose, copy, distribute or use the contents of this message. This message may not be copied or distributed without this disclaimer. All personal messages express views solely of the sender, which are not to be attributed to BHSF. If you received this message in error, please notify us immediately at postmaster@baptisthealth.net. BHSF scanned this email for viruses, vandals and malicious content VA-18-0298 and 18-0299-B-000128 From: To: Cc: Bcc: Subject: Date: Attachments: docx Selnick, Darin (b) (6) Bruce Moskowitz,MD <(b) (6) gmail.com>; Marc Sherman <(b) (6) gmail.com>; (b) (6) wrote: Just to confirm, how long will the call be. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) gmail.com] VA-18-0298 and 18-0299-B-000130 Sent: Friday, May 12, 2017 3:11 PM To: Selnick, Darin Cc: Bruce Moskowitz; Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda Great! I will send out a calendar invite. On Fri, May 12, 2017 at 3:08 PM, Selnick, Darin wrote: Let's go with Thursday, May 18 at 4pm. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 2:35 PM To: Selnick, Darin Cc: Bruce Moskowitz; Marc Sherman; (b) (6) Subject: RE: [EXTERNAL] Apple Agenda gmail.com] Dr. Moskowitz is not available until 5:00 pm EDT on May 19. I had suggested Thursday, May 18 at 4 pm or Monday, May 22 at 4 pm, but Mr. Sherman is not available at those times, however he indicated that the date works for everyone else, you could proceed without him. Do you have a preference? On May 12, 2017 2:27 PM, "Selnick, Darin" wrote: - Hi (b) (6) No there has not been a consensus at this point. The last email from Bruce was the possibility of checking on 4pm on 5/19. We are open all day on 5/19 and most of the day on 5/22. VA-18-0298 and 18-0299-B-000131 Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 1:51 PM To: Marc Sherman Cc: Bruce Moskowitz; Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda gmail.com] Good afternoon everyone! I'm just checking in to see if there has been any consensus on a date for the conference call that is convenient for all of the participants? On May 11, 2017 11:40 PM, "Marc Sherman" <(b) (6) gmail.com> wrote: I am not available on Thursday May 18 or Monday May 22. Proceed without me if those are the only times available for everyone. - Marc Sherman (202) 758-(b) (6) - On May 11, 2017 12:06 PM, "(b) (6) Bruce Moskowitz,MD" <(b) (6) gmail.com> wrote: Dr, Moskowitz would be available at 5:00 on Friday, May 19 or he is available at 4:00 pm on Thursday, May 18 or 4:00 pm on Monday, May 22. VA-18-0298 and 18-0299-B-000132 On Thu, May 11, 2017 at 11:57 AM, Selnick, Darin wrote: Bruce We are available anytime on 5/19. If that day does not work for you, please let us know a date and time that will. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Thursday, May 11, 2017 11:50 AM To: Selnick, Darin (b) (6) Cc: Marc Sherman; (b) (6) gmail.com] - Subject: Re: [EXTERNAL] Apple Agenda That won't work I have a call with Mayo and Poonam at that time Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:34 AM, Selnick, Darin wrote: 4pm on 5/19 works for VA. Darin Darin Selnick VA-18-0298 and 18-0299-B-000133 Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Marc Sherman [mailto:(b) (6) gmail.com] Sent: Thursday, May 11, 2017 11:20 AM To: Bruce Moskowitz (b) (6) Cc: Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - I am good at 4pm on the 19th. On Thu, May 11, 2017 at 11:16 AM, Bruce Moskowitz <(b) (6) - Ok (b) (6) gmail.com> wrote: will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM gmail.com] VA-18-0298 and 18-0299-B-000134 To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. -(b) (6) MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 - Phone: 561-833-(b) (6) VA-18-0298 and 18-0299-B-000135 - Fax: 561-833-(b) (6) -(b) (6) MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 - Phone: 561-833-(b) (6) Fax: 561-833-(b) (6) VA-18-0298 and 18-0299-B-000136 - Owner: Selnick, Darin Selnick, Darin ; Marc Sherman <(b) (6) gmail.com>; (b) (6) ; < gmail.com> ) - I (6 - ) Re: [EXTERNAL] Apple Agenda Thu May 18 2017 06:08:34 CDT Before you consider the phrase you do not believe it is appropriate to do due diligence. We now have approximately 20 in our group that already have an available platform to solve the two issues you believe can not be solved. Also Apple technology is more than apps, platforms that get the job done are equally important. Sent from my iPad Bruce Moskowitz M.D. On May 16, 2017, at 1:45 PM, Selnick, Darin wrote: Hi Bruce For the Thursday call, here are the VA thoughts in blue based on the agenda items you had sent me. If I get additional questions I will send them: 1. The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. a. We suggest a modified use case: A telehealth provider wants to direct their patient to a nearby healthcare resource (e.g. urgent care center or call 911 for patient). The app should be able to send to the patient and the patient's telehealth providers, the location of the patient and the healthcare resources that are nearby to the patient. For example, the closest VA location, closest pharmacy, closest urgent care center, and closest contact center phone number. 2. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. a. This is the FHIR Patient-Mediated data exchange concept. Please see attached FHIR concept paper. VA-18-0298 and 18-0299-B-000159 3. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. a. This is a problem but we do not believe that this is something that can be solved with an app. 4. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. a. This is a problem but we do not believe that this is something that can be solved with an app. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: bruce moskowitz [mailto:(b) (6) gmail.com] Sent: Friday, May 12, 2017 3:52 PM To: Selnick, Darin Cc: (b) (6) Bruce Moskowitz,MD; Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - - Darin call my cell to discuss length 561346(b) (6) Sent from my iPhone On May 12, 2017, at 3:34 PM, Selnick, Darin wrote: Just to confirm, how long will the call be. Thanks Darin VA-18-0298 and 18-0299-B-000160 Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 3:11 PM To: Selnick, Darin Cc: Bruce Moskowitz; Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda gmail.com] Great! I will send out a calendar invite. On Fri, May 12, 2017 at 3:08 PM, Selnick, Darin wrote: Let's go with Thursday, May 18 at 4pm. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 2:35 PM To: Selnick, Darin Cc: Bruce Moskowitz; Marc Sherman; (b) (6) Subject: RE: [EXTERNAL] Apple Agenda gmail.com] Dr. Moskowitz is not available until 5:00 pm EDT on May 19. I had suggested Thursday, May 18 at 4 pm or Monday, May 22 at 4 pm, but Mr. Sherman is not available at those times, however he indicated that the date works for everyone else, you could proceed without him. Do you have a preference? VA-18-0298 and 18-0299-B-000161 On May 12, 2017 2:27 PM, "Selnick, Darin" wrote: - Hi (b) (6) No there has not been a consensus at this point. The last email from Bruce was the possibility of checking on 4pm on 5/19. We are open all day on 5/19 and most of the day on 5/22. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 1:51 PM To: Marc Sherman Cc: Bruce Moskowitz; Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda gmail.com] Good afternoon everyone! I'm just checking in to see if there has been any consensus on a date for the conference call that is convenient for all of the participants? On May 11, 2017 11:40 PM, "Marc Sherman" <(b) (6) gmail.com> wrote: I am not available on Thursday May 18 or Monday May 22. Proceed without me if those are the only times available for everyone. VA-18-0298 and 18-0299-B-000162 - Marc Sherman (202) 758-(b) (6) - On May 11, 2017 12:06 PM, "(b) (6) Bruce Moskowitz,MD" <(b) (6) gmail.com> wrote: Dr, Moskowitz would be available at 5:00 on Friday, May 19 or he is available at 4:00 pm on Thursday, May 18 or 4:00 pm on Monday, May 22. On Thu, May 11, 2017 at 11:57 AM, Selnick, Darin wrote: Bruce We are available anytime on 5/19. If that day does not work for you, please let us know a date and time that will. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Thursday, May 11, 2017 11:50 AM To: Selnick, Darin (b) (6) Cc: Marc Sherman; (b) (6) gmail.com] - Subject: Re: [EXTERNAL] Apple Agenda That won't work I have a call with Mayo and Poonam at that time Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000163 On May 11, 2017, at 11:34 AM, Selnick, Darin wrote: 4pm on 5/19 works for VA. Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Marc Sherman [mailto:(b) (6) gmail.com] Sent: Thursday, May 11, 2017 11:20 AM To: Bruce Moskowitz (b) (6) Cc: Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - I am good at 4pm on the 19th. On Thu, May 11, 2017 at 11:16 AM, Bruce Moskowitz <(b) (6) - Ok (b) (6) gmail.com> wrote: will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin VA-18-0298 and 18-0299-B-000164 Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. -(b) (6) MPA Patient Care Coordinator VA-18-0298 and 18-0299-B-000165 Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 - Phone: 561-833-(b) (6) Fax: 561-833-(b) (6) -(b) (6) MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 - Phone: 561-833-(b) (6) Fax: 561-833-(b) (6) VA-18-0298 and 18-0299-B-000166 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) Bruce Moskowitz,MD <(b) (6) gmail.com>; Marc Sherman <(b) (6) gmail.com>; (b) (6) ; < gmail.com> ) - I (6 - ) RE: [EXTERNAL] Apple Agenda Thu May 18 2017 06:19:00 CDT Hi Bruce I agree with your comments. The VA staff has limited knowledge and experience, which is why you and the Centers are so important to help the VA move forward. Looking forward to the discussion today. Best Darin Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) gmail.com] Sent: Thursday, May 18, 2017 07:08 AM Eastern Standard Time To: Selnick, Darin Cc: (b) (6) Bruce Moskowitz,MD; Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - - IP; (b) (6) Before you consider the phrase you do not believe it is appropriate to do due diligence. We now have approximately 20 in our group that already have an available platform to solve the two issues you believe can not be solved. Also Apple technology is more than apps, platforms that get the job done are equally important. Sent from my iPad Bruce Moskowitz M.D. On May 16, 2017, at 1:45 PM, Selnick, Darin wrote: Hi Bruce VA-18-0298 and 18-0299-B-000167 For the Thursday call, here are the VA thoughts in blue based on the agenda items you had sent me. If I get additional questions I will send them: 1. The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. a. We suggest a modified use case: A telehealth provider wants to direct their patient to a nearby healthcare resource (e.g. urgent care center or call 911 for patient). The app should be able to send to the patient and the patient's telehealth providers, the location of the patient and the healthcare resources that are nearby to the patient. For example, the closest VA location, closest pharmacy, closest urgent care center, and closest contact center phone number. 2. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. a. This is the FHIR Patient-Mediated data exchange concept. Please see attached FHIR concept paper. 3. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. a. This is a problem but we do not believe that this is something that can be solved with an app. 4. Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. a. This is a problem but we do not believe that this is something that can be solved with an app. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) VA-18-0298 and 18-0299-B-000168 From: bruce moskowitz [mailto:(b) (6) gmail.com] Sent: Friday, May 12, 2017 3:52 PM To: Selnick, Darin Cc: (b) (6) Bruce Moskowitz,MD; Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - - Darin call my cell to discuss length 561346(b) (6) Sent from my iPhone On May 12, 2017, at 3:34 PM, Selnick, Darin wrote: Just to confirm, how long will the call be. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 3:11 PM To: Selnick, Darin Cc: Bruce Moskowitz; Marc Sherman; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda gmail.com] Great! I will send out a calendar invite. On Fri, May 12, 2017 at 3:08 PM, Selnick, Darin wrote: Let's go with Thursday, May 18 at 4pm. Thanks VA-18-0298 and 18-0299-B-000169 Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 2:35 PM To: Selnick, Darin Cc: Bruce Moskowitz; Marc Sherman; (b) (6) Subject: RE: [EXTERNAL] Apple Agenda gmail.com] Dr. Moskowitz is not available until 5:00 pm EDT on May 19. I had suggested Thursday, May 18 at 4 pm or Monday, May 22 at 4 pm, but Mr. Sherman is not available at those times, however he indicated that the date works for everyone else, you could proceed without him. Do you have a preference? On May 12, 2017 2:27 PM, "Selnick, Darin" wrote: - Hi (b) (6) No there has not been a consensus at this point. The last email from Bruce was the possibility of checking on 4pm on 5/19. We are open all day on 5/19 and most of the day on 5/22. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) - From: (b) (6) Bruce Moskowitz,MD [mailto:(b) (6) Sent: Friday, May 12, 2017 1:51 PM gmail.com] VA-18-0298 and 18-0299-B-000170 To: Marc Sherman Cc: Bruce Moskowitz; Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda Good afternoon everyone! I'm just checking in to see if there has been any consensus on a date for the conference call that is convenient for all of the participants? On May 11, 2017 11:40 PM, "Marc Sherman" <(b) (6) gmail.com> wrote: I am not available on Thursday May 18 or Monday May 22. Proceed without me if those are the only times available for everyone. - Marc Sherman (202) 758-(b) (6) - On May 11, 2017 12:06 PM, "(b) (6) Bruce Moskowitz,MD" <(b) (6) gmail.com> wrote: Dr, Moskowitz would be available at 5:00 on Friday, May 19 or he is available at 4:00 pm on Thursday, May 18 or 4:00 pm on Monday, May 22. On Thu, May 11, 2017 at 11:57 AM, Selnick, Darin wrote: Bruce We are available anytime on 5/19. If that day does not work for you, please let us know a date and time that will. Thanks Darin Darin Selnick VA-18-0298 and 18-0299-B-000171 Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Thursday, May 11, 2017 11:50 AM To: Selnick, Darin (b) (6) Cc: Marc Sherman; (b) (6) gmail.com] - Subject: Re: [EXTERNAL] Apple Agenda That won't work I have a call with Mayo and Poonam at that time Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:34 AM, Selnick, Darin wrote: 4pm on 5/19 works for VA. Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Marc Sherman [mailto:(b) (6) gmail.com] Sent: Thursday, May 11, 2017 11:20 AM To: Bruce Moskowitz (b) (6) Cc: Selnick, Darin; (b) (6) Subject: Re: [EXTERNAL] Apple Agenda - I am good at 4pm on the 19th. On Thu, May 11, 2017 at 11:16 AM, Bruce Moskowitz <(b) (6) gmail.com> wrote: VA-18-0298 and 18-0299-B-000172 - Ok (b) (6) will check possibly 4 Sent from my iPad Bruce Moskowitz M.D. On May 11, 2017, at 11:04 AM, Selnick, Darin wrote: Hi Bruce We have all the VA staff identified for the 2 hour conference call meeting we discussed. How does next week look, Friday May 19. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Tuesday, May 09, 2017 6:42 AM To: Selnick, Darin Cc: (b) (6) Marc Sherman Subject: [EXTERNAL] Apple Agenda gmail.com] The following is the correct agenda I accidentally sent an earlier version The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We will need the ability for Veterans to download the records from both the Veteran sector (Veterans have access to a portable record) and private sector on their portable device. It should have the feature that would prevent duplication of tests at the time of ordering at the point of contact and the ability to send information back to their primary doctor in real time. It should also have a feature to prevent unnecessary testing and over utilization. We need a technology solution for tracking medication compliance, prevention of over utilization of controlled substances and prevention of medication errors. VA-18-0298 and 18-0299-B-000173 Currently the medical discharge everywhere is antiquated. Patients are discharged by a floor nurse with a list of medication. We need a system that automatically checks that the patient picked up the medication and does not confuse it with medication at home. Second, track follow up appointments, health care services for home care and distributes all information to the health care team. Sent from my iPad Bruce Moskowitz M.D. -(b) (6) MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 - Phone: 561-833-(b) (6) Fax: 561-833-(b) (6) -(b) (6) MPA Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Ferris Medical Building 1411 North Flagler Drive VA-18-0298 and 18-0299-B-000174 Suite 7100 West Palm Beach, FL 33401 - Phone: 561-833-(b) (6) Fax: 561-833-(b) (6) VA-18-0298 and 18-0299-B-000175 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) gmail.com> Selnick, Darin ; IP <(b @frenchangel59.com>; (b) (6) ) (b) (6) < gmail.com> (6 - - I ) [EXTERNAL] Agenda item 4 Thu May 18 2017 08:12:39 CDT - Yes it can be solved with an app but those at the VA who felt it could not this article should be reviewed. Our group will make it better and more comprehensive. I thought you would be interested in the following story from The Wall Street Journal. Why Your Pharmacy May Be Texting You https://www.wsj.com/article_email/why-your-pharmacy-may-be-texting-you-1494986940lMyQjAxMTE3NDE0ODQxOTgzWj/ Download the Wall Street Journal app here: WSJ. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000176 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin ; (b) (6) ; IP <(b @frenchangel59.com>; (b) (6) ) <(b) (6) gmail.com> (6 - I - ) RE: [EXTERNAL] Agenda item 4 Thu May 18 2017 08:35:44 CDT Bruce Thanks for the article, I will pass it to the VA staff. Best Darin Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) gmail.com] Sent: Thursday, May 18, 2017 09:13 AM Eastern Standard Time To: Selnick, Darin; (b) (6) Cc: (b) (6) gmail.com; IP; (b) (6) Subject: [EXTERNAL] Agenda item 4 -- Yes it can be solved with an app but those at the VA who felt it could not this article should be reviewed. Our group will make it better and more comprehensive. I thought you would be interested in the following story from The Wall Street Journal. Why Your Pharmacy May Be Texting You https://www.wsj.com/article_email/why-your-pharmacy-may-be-texting-you-1494986940lMyQjAxMTE3NDE0ODQxOTgzWj/ Download the Wall Street Journal app here: WSJ. VA-18-0298 and 18-0299-B-000177 Sent from my iPad Bruce Moskowitz MD. and 1 8-0299-B-000178 From: Selnick, Darin ; (b) (6) - To: Cc: Bcc: Subject: Date: Attachments: RE: [EXTERNAL] Agenda item 4 Thu May 18 2017 18:04:32 CDT Hi Bruce - Great call today, here are the names of the VA staff on the call besides myself and (b) (6) (b) (6) Ricci Mulligan (b) (6) (b) (6) Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Thursday, May 18, 2017 9:13 AM To: Selnick, Darin; (b) (6) Cc: (b) (6) gmail.com; IP; (b) (6) Subject: [EXTERNAL] Agenda item 4 gmail.com] -- VA-18-0298 and 18-0299-B-000179 Yes it can be solved with an app but those at the VA who felt it could not this article should be reviewed. Our group will make it better and more comprehensive. I thought you would be interested in the following story from The Wall Street Journal. Why Your Pharmacy May Be Texting You https://www.wsj.com/article_email/why-your-pharmacy-may-be-texting-you-1494986940lMyQjAxMTE3NDE0ODQxOTgzWj/ Download the Wall Street Journal app here: WSJ. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000180 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin (6) I - [EXTERNAL] Attendees Fri May 19 2017 12:22:34 CDT Mr Perlmutter's assistant needs the list of Apple attendees and your attendees. Thank you Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000181 From: To: Cc: Bcc: Subject: Date: Attachments: (b) (6) - <(b) (6) frenchangel59.com> Bruce Moskowitz <(b) (6) mac.com>; Selnick, Darin (b) (6) (b) (6) < frenchangel59.com> Selnick, Darin On May 19, 2017, at 3:30 PM, (b) (6) <(b) (6) frenchangel59.com> wrote: > > Bruce - David gave me names for the VA and I am working with Apple directly > for their participants names. > > Is that OK? > > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Friday, May 19, 2017 1:23 PM > To: Darin Selnick > Cc: (b) (6) frenchangel59.com > Subject: Attendees > > Mr Perlmutter's assistant needs the list of Apple attendees and your > attendees. Thank you > > Sent from my iPad > Bruce Moskowitz M.D. > - VA-18-0298 and 18-0299-B-000183 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin ; (b) (6) (b) (6) < frenchangel59.com> (b) (6) apple.com <(b) (6) apple.com> RE: [EXTERNAL] Re: Attendees Fri May 19 2017 14:58:38 CDT Hi Bruce - My main Apple contacts are (b) (6) and (b) (6) I talked to (b) (6) and they would like to have a conference call with you and me next week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. That way they can ensure they have the right people on the call. To facilitate setting up the call I have cc: (b) (6) Can you let me know a couple of days/time you are available next week for a call. - Thanks Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - -----Original Message----From: Bruce Moskowitz [mailto:(b) (6) Sent: Friday, May 19, 2017 3:34 PM To: (b) (6) Cc: Selnick, Darin Subject: [EXTERNAL] Re: Attendees mac.com] Good Sent from my iPad Bruce Moskowitz M.D. - > On May 19, 2017, at 3:30 PM, (b) (6) <(b) (6) frenchangel59.com> wrote: > > Bruce - David gave me names for the VA and I am working with Apple > directly for their participants names. > > Is that OK? > > > > -----Original Message----- VA-18-0298 and 18-0299-B-000184 > From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Friday, May 19, 2017 1:23 PM > To: Darin Selnick > Cc: (b) (6) frenchangel59.com > Subject: Attendees > > Mr Perlmutter's assistant needs the list of Apple attendees and your > attendees. Thank you > > Sent from my iPad > Bruce Moskowitz M.D. > - VA-18-0298 and 18-0299-B-000185 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin ; (b) (6) (b) (6) < frenchangel59.com> - RE: [EXTERNAL] Re: Attendees Mon May 22 2017 13:22:22 CDT Centers and VA Partnership Call revised notes.docx Hi Bruce In preparation for the next partnership call I have attached the comments and requirements from the VA OIT, I expect the VHA clinician side to have theirs later this week. Also, my Apple contacts (b) (6) and (b) (6) would like to have a prep conference call with you and me this week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. Please let me know if you are available for that. Thanks Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - -----Original Message----From: Selnick, Darin Sent: Friday, May 19, 2017 3:59 PM To: 'Bruce Moskowitz'; (b) (6) Cc: '(b) (6) apple.com' Subject: RE: [EXTERNAL] Re: Attendees - Hi Bruce - My main Apple contacts are (b) (6) and (b) (6) I talked to (b) (6) and they would like to have a conference call with you and me next week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. That way they can ensure they have the right people on the call. To facilitate setting up the call I have cc: (b) (6) Can you let me know a couple of days/time you are available next week for a call. - Thanks Darin VA-18-0298 and 18-0299-B-000186 Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - -----Original Message----From: Bruce Moskowitz [mailto:(b) (6) Sent: Friday, May 19, 2017 3:34 PM To: (b) (6) Cc: Selnick, Darin Subject: [EXTERNAL] Re: Attendees mac.com] Good Sent from my iPad Bruce Moskowitz M.D. - > On May 19, 2017, at 3:30 PM, (b) (6) <(b) (6) frenchangel59.com> wrote: > > Bruce - David gave me names for the VA and I am working with Apple > directly for their participants names. > > Is that OK? > > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Friday, May 19, 2017 1:23 PM > To: Darin Selnick > Cc: (b) (6) frenchangel59.com > Subject: Attendees > > Mr Perlmutter's assistant needs the list of Apple attendees and your > attendees. Thank you > > Sent from my iPad > Bruce Moskowitz M.D. > - VA-18-0298 and 18-0299-B-000187 - Owner: Selnick, Darin Selnick, Darin ; (b) (6) David Shulkin < aol.com> To: Cc: Bcc: Subject: Date: Attachments: - Re: [EXTERNAL] Re: Attendees Mon May 22 2017 15:07:33 CDT Both Ike and Secretary Shulkin want to proceed with a call with everyone on it instead of separate calls. If they need a further explanation of the agenda on the Apple side I and Marc Sherman will be available to speak with them since we have all the information from the academic centers and an understanding of their skill sets. Thank you. Sent from my iPad Bruce Moskowitz M.D. > On May 22, 2017, at 2:22 PM, Selnick, Darin wrote: > > Hi Bruce > > In preparation for the next partnership call I have attached the comments and requirements from the VA OIT, I expect the VHA clinician side to have theirs later this week. > > Also, my Apple contacts (b) (6) and (b) (6) would like to have a prep conference call with you and me this week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. > > Please let me know if you are available for that. > > Thanks > > Darin > > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > -----Original Message----> From: Selnick, Darin > Sent: Friday, May 19, 2017 3:59 PM > To: 'Bruce Moskowitz'; (b) (6) > Cc: '(b) (6) apple.com' > Subject: RE: [EXTERNAL] Re: Attendees > > Hi Bruce > > My main Apple contacts are (b) (6) and (b) (6) I talked to (b) (6) and they would like to have a conference call with you and me next week so that they can get more clarity on the - - - VA-18-0298 and 18-0299-B-000192 - partnership and the skill sets needed for the upcoming VA/Centers/Apple call. That way they can ensure they have the right people on the call. To facilitate setting up the call I have cc: (b) (6) > > Can you let me know a couple of days/time you are available next week for a call. > > Thanks > > Darin > > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Friday, May 19, 2017 3:34 PM > To: (b) (6) > Cc: Selnick, Darin > Subject: [EXTERNAL] Re: Attendees > > Good > > Sent from my iPad > Bruce Moskowitz M.D. > >> On May 19, 2017, at 3:30 PM, (b) (6) <(b) (6) frenchangel59.com> wrote: >> >> Bruce - David gave me names for the VA and I am working with Apple >> directly for their participants names. >> >> Is that OK? >> >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Friday, May 19, 2017 1:23 PM >> To: Darin Selnick >> Cc: (b) (6) frenchangel59.com >> Subject: Attendees >> >> Mr Perlmutter's assistant needs the list of Apple attendees and your >> attendees. Thank you >> >> Sent from my iPad >> Bruce Moskowitz M.D. >> > - - - VA-18-0298 and 18-0299-B-000193 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) <(b) (6) frenchangel59.com>; David Shulkin <(b) (6) aol.com> - RE: [EXTERNAL] Re: Attendees Mon May 22 2017 15:18:23 CDT Hi Bruce Yes, my Apple contacts wanted the further explanation of the agenda from you and Marc. When would you be available to do that? Thanks Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - -----Original Message----From: Bruce Moskowitz [mailto:(b) (6) Sent: Monday, May 22, 2017 4:08 PM To: Selnick, Darin Cc: (b) (6) David Shulkin Subject: Re: [EXTERNAL] Re: Attendees mac.com] Both Ike and Secretary Shulkin want to proceed with a call with everyone on it instead of separate calls. If they need a further explanation of the agenda on the Apple side I and Marc Sherman will be available to speak with them since we have all the information from the academic centers and an understanding of their skill sets. Thank you. Sent from my iPad Bruce Moskowitz M.D. > On May 22, 2017, at 2:22 PM, Selnick, Darin wrote: > > Hi Bruce > > In preparation for the next partnership call I have attached the comments and requirements from the VA OIT, I expect the VHA clinician side to have theirs later this week. > > Also, my Apple contacts (b) (6) and (b) (6) would like to have a prep conference call with you and me this week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. > > Please let me know if you are available for that. VA-18-0298 and 18-0299-B-000194 > > Thanks > > Darin > > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > -----Original Message----> From: Selnick, Darin > Sent: Friday, May 19, 2017 3:59 PM > To: 'Bruce Moskowitz'; (b) (6) > Cc: '(b) (6) apple.com' > Subject: RE: [EXTERNAL] Re: Attendees > > Hi Bruce > > My main Apple contacts are (b) (6) and (b) (6) I talked to (b) (6) and they would like to have a conference call with you and me next week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. That way they can ensure they have the right people on the call. To facilitate setting up the call I have cc: (b) (6) > > Can you let me know a couple of days/time you are available next week for a call. > > Thanks > > Darin > > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Friday, May 19, 2017 3:34 PM > To: (b) (6) > Cc: Selnick, Darin > Subject: [EXTERNAL] Re: Attendees > > Good > > Sent from my iPad > Bruce Moskowitz M.D. > >> On May 19, 2017, at 3:30 PM, (b) (6) <(b) (6) frenchangel59.com> wrote: >> >> Bruce - David gave me names for the VA and I am working with Apple >> directly for their participants names. >> >> Is that OK? >> >> - - - - - - VA-18-0298 and 18-0299-B-000195 >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Friday, May 19, 2017 1:23 PM >> To: Darin Selnick >> Cc: (b) (6) frenchangel59.com >> Subject: Attendees >> >> Mr Perlmutter's assistant needs the list of Apple attendees and your >> attendees. Thank you >> >> Sent from my iPad >> Bruce Moskowitz M.D. >> > - VA-18-0298 and 18-0299-B-000196 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin ; (b) (6) David Shulkin < aol.com> - Re: [EXTERNAL] Re: Attendees Mon May 22 2017 15:20:25 CDT - Yes give them my cell 561-(b) (6) Sent from my iPad Bruce Moskowitz M.D. and email anytime. > On May 22, 2017, at 4:18 PM, Selnick, Darin wrote: > > Hi Bruce > > Yes, my Apple contacts wanted the further explanation of the agenda from you and Marc. When would you be available to do that? > > Thanks > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Monday, May 22, 2017 4:08 PM > To: Selnick, Darin > Cc: (b) (6) David Shulkin > Subject: Re: [EXTERNAL] Re: Attendees > > Both Ike and Secretary Shulkin want to proceed with a call with everyone on it instead of separate calls. If they need a further explanation of the agenda on the Apple side I and Marc Sherman will be available to speak with them since we have all the information from the academic centers and an understanding of their skill sets. Thank you. > > Sent from my iPad > Bruce Moskowitz M.D. > >> On May 22, 2017, at 2:22 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> In preparation for the next partnership call I have attached the comments and requirements from the - VA-18-0298 and 18-0299-B-000197 VA OIT, I expect the VHA clinician side to have theirs later this week. >> >> Also, my Apple contacts (b) (6) and (b) (6) would like to have a prep conference call with you and me this week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. >> >> Please let me know if you are available for that. >> >> Thanks >> >> Darin >> >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> -----Original Message---->> From: Selnick, Darin >> Sent: Friday, May 19, 2017 3:59 PM >> To: 'Bruce Moskowitz'; (b) (6) >> Cc: '(b) (6) apple.com' >> Subject: RE: [EXTERNAL] Re: Attendees >> >> Hi Bruce >> >> My main Apple contacts are (b) (6) and (b) (6) I talked to (b) (6) and they would like to have a conference call with you and me next week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. That way they can ensure they have the right people on the call. To facilitate setting up the call I have cc: (b) (6) >> >> Can you let me know a couple of days/time you are available next week for a call. >> >> Thanks >> >> Darin >> >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Friday, May 19, 2017 3:34 PM >> To: (b) (6) >> Cc: Selnick, Darin >> Subject: [EXTERNAL] Re: Attendees >> >> Good >> >> Sent from my iPad >> Bruce Moskowitz M.D. >> >>> On May 19, 2017, at 3:30 PM, (b) (6) <(b) (6) frenchangel59.com> wrote: - - - - - - VA-18-0298 and 18-0299-B-000198 >>> >>> Bruce - David gave me names for the VA and I am working with Apple >>> directly for their participants names. >>> >>> Is that OK? >>> >>> >>> >>> -----Original Message---->>> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >>> Sent: Friday, May 19, 2017 1:23 PM >>> To: Darin Selnick >>> Cc: (b) (6) frenchangel59.com >>> Subject: Attendees >>> >>> Mr Perlmutter's assistant needs the list of Apple attendees and your >>> attendees. Thank you >>> >>> Sent from my iPad >>> Bruce Moskowitz M.D. >>> >> - VA-18-0298 and 18-0299-B-000199 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin - RE: [EXTERNAL] Re: Attendees Mon May 22 2017 15:56:24 CDT I will send them an email with your information now. Thanks Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - -----Original Message----From: Bruce Moskowitz [mailto:(b) (6) Sent: Monday, May 22, 2017 4:20 PM To: Selnick, Darin Cc: (b) (6) David Shulkin Subject: Re: [EXTERNAL] Re: Attendees mac.com] - Yes give them my cell 561-346(b) (6) and email anytime. Sent from my iPad Bruce Moskowitz M.D. > On May 22, 2017, at 4:18 PM, Selnick, Darin wrote: > > Hi Bruce > > Yes, my Apple contacts wanted the further explanation of the agenda from you and Marc. When would you be available to do that? > > Thanks > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) mac.com] > Sent: Monday, May 22, 2017 4:08 PM - VA-18-0298 and 18-0299-B-000200 > To: Selnick, Darin > Cc: (b) (6) David Shulkin > Subject: Re: [EXTERNAL] Re: Attendees > > Both Ike and Secretary Shulkin want to proceed with a call with everyone on it instead of separate calls. If they need a further explanation of the agenda on the Apple side I and Marc Sherman will be available to speak with them since we have all the information from the academic centers and an understanding of their skill sets. Thank you. > > Sent from my iPad > Bruce Moskowitz M.D. > >> On May 22, 2017, at 2:22 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> In preparation for the next partnership call I have attached the comments and requirements from the VA OIT, I expect the VHA clinician side to have theirs later this week. >> >> Also, my Apple contacts (b) (6) and (b) (6) would like to have a prep conference call with you and me this week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. >> >> Please let me know if you are available for that. >> >> Thanks >> >> Darin >> >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> -----Original Message---->> From: Selnick, Darin >> Sent: Friday, May 19, 2017 3:59 PM >> To: 'Bruce Moskowitz'; (b) (6) >> Cc: '(b) (6) apple.com' >> Subject: RE: [EXTERNAL] Re: Attendees >> >> Hi Bruce >> >> My main Apple contacts are (b) (6) and (b) (6) I talked to (b) (6) and they would like to have a conference call with you and me next week so that they can get more clarity on the partnership and the skill sets needed for the upcoming VA/Centers/Apple call. That way they can ensure they have the right people on the call. To facilitate setting up the call I have cc: (b) (6) >> >> Can you let me know a couple of days/time you are available next week for a call. >> >> Thanks >> >> Darin >> >> >> Darin Selnick - - - - VA-18-0298 and 18-0299-B-000201 - >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >> Sent: Friday, May 19, 2017 3:34 PM >> To: (b) (6) >> Cc: Selnick, Darin >> Subject: [EXTERNAL] Re: Attendees >> >> Good >> >> Sent from my iPad >> Bruce Moskowitz M.D. >> >>> On May 19, 2017, at 3:30 PM, (b) (6) <(b) (6) frenchangel59.com> wrote: >>> >>> Bruce - David gave me names for the VA and I am working with Apple >>> directly for their participants names. >>> >>> Is that OK? >>> >>> >>> >>> -----Original Message---->>> From: Bruce Moskowitz [mailto:(b) (6) mac.com] >>> Sent: Friday, May 19, 2017 1:23 PM >>> To: Darin Selnick >>> Cc: (b) (6) frenchangel59.com >>> Subject: Attendees >>> >>> Mr Perlmutter's assistant needs the list of Apple attendees and your >>> attendees. Thank you >>> >>> Sent from my iPad >>> Bruce Moskowitz M.D. >>> >> - - VA-18-0298 and 18-0299-B-000202 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin ; Marc Sherman <(b) (6) - gmail.com> [EXTERNAL] Re: VA/Centers/Apple call Mon May 22 2017 16:59:06 CDT Thank you I am available anytime Sent from my iPhone On May 22, 2017, at 5:10 PM, Selnick, Darin wrote: - Hi (b) (6) Bruce and Marc would be happy to provide further explanation of the agenda for the upcoming VA/Centers/Apple partnership call. - Bruce can be reached at cell 561-346-(b) (6) I am happy to assist anyway I can. Best Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) VA-18-0298 and 18-0299-B-000203 and 18-0299-B-000204 From: To: Cc: Bcc: Subject: Date: Attachments: - (b) (6) apple.com <(b) (6) apple.com> on behalf of (b) (6) <(b) (6) apple.com> Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin [EXTERNAL] Re: VA/Centers/Apple call Tue May 23 2017 12:45:39 CDT Dr. Moskowitz and Mr. Sherman, It's a pleasure to meet you. (b) (6) next steps. and I look forward to connecting on a brief call to discuss Here are some times that work for us this week: Today - 3:30 - 4:30 PM ET Thursday - 9:30-11 AM ET, 12:15-1 PM ET, 4:30-5:30 PM ET Please let me know which works best for you, and we will send a dial-in number. - Many thanks, (b) (6) Confidential Commercial Information - Exempt from Disclosure under FOIA ? 552(b)(4) This submission contains trade secret and confidential commercial or financial information. This information is exempt from public disclosure under the Freedom of Information Act, 5 U.S.C. ? 552(b) (4), and may not be disclosed without the prior written authorization of Apple Inc. Such disclosure is prohibited by the U.S. Criminal Code, 18 U.S.C. ? 1905. If the Department of Veterans Affairs receives an FOIA request for this information, the Department must comply with 38 C.F.R. ? 1.558(c) and (d), by providing Apple Inc. with timely advance notice at: 1 Infinite Loop, Cupertino, CA 95014, Attention: General Counsel, and a meaningful opportunity to object before making the disclosure. The Department should either specifically identify the business information requested or provide a copy of any specific records that have been requested. On May 22, 2017, at 2:59 PM, Bruce Moskowitz <(b) (6) mac.com> wrote: Thank you I am available anytime Sent from my iPhone On May 22, 2017, at 5:10 PM, Selnick, Darin wrote: VA-18-0298 and 18-0299-B-000205 - Hi (b) (6) Bruce and Marc would be happy to provide further explanation of the agenda for the upcoming VA/Centers/Apple partnership call. - Bruce can be reached at cell 561-346-(b) (6) I am happy to assist anyway I can. Best Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - VA-18-0298 and 18-0299-B-000206 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> (b) (6) (b) (6) < apple.com> Selnick, Darin Marc Sherman [EXTERNAL] Re: VA/Centers/Apple call Tue May 23 2017 12:54:10 CDT Thank you can we do 345 today? If so would you like me to call you if not call my cell Sent from my iPad Bruce Moskowitz M.D. On May 23, 2017, at 1:45 PM, (b) (6) - <(b) (6) apple.com> wrote: Dr. Moskowitz and Mr. Sherman, It's a pleasure to meet you. (b) (6) next steps. and I look forward to connecting on a brief call to discuss Here are some times that work for us this week: Today - 3:30 - 4:30 PM ET Thursday - 9:30-11 AM ET, 12:15-1 PM ET, 4:30-5:30 PM ET Please let me know which works best for you, and we will send a dial-in number. - Many thanks, (b) (6) Confidential Commercial Information - Exempt from Disclosure under FOIA ? 552(b)(4) This submission contains trade secret and confidential commercial or financial information. This information is exempt from public disclosure under the Freedom of Information Act, 5 U.S.C. ? 552(b) (4), and may not be disclosed without the prior written authorization of Apple Inc. Such disclosure is prohibited by the U.S. Criminal Code, 18 U.S.C. ? 1905. If the Department of Veterans Affairs receives an FOIA request for this information, the Department must comply with 38 C.F.R. ? 1.558(c) and (d), by providing Apple Inc. with timely advance notice at: 1 Infinite Loop, Cupertino, CA 95014, Attention: General Counsel, and a meaningful opportunity to object before making the disclosure. The Department should either specifically identify the business information requested or provide a copy of any specific records that have been requested. VA-18-0298 and 18-0299-B-000207 On May 22, 2017, at 2:59 PM, Bruce Moskowitz <(b) (6) mac.com> wrote: Thank you I am available anytime Sent from my iPhone On May 22, 2017, at 5:10 PM, Selnick, Darin wrote: - Hi (b) (6) Bruce and Marc would be happy to provide further explanation of the agenda for the upcoming VA/Centers/Apple partnership call. - Bruce can be reached at cell 561-346-(b) (6) I am happy to assist anyway I can. Best Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - VA-18-0298 and 18-0299-B-000208 From: To: Cc: Bcc: Subject: Date: Attachments: - (b) (6) apple.com <(b) (6) apple.com> on behalf of (b) (6) <(b) (6) apple.com> Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin [EXTERNAL] Re: VA/Centers/Apple call Tue May 23 2017 13:02:09 CDT Please use the following dial-in number. - (4), Phone number: 1-866-639-(b) (b) (5) Passcode: (b) (4), (b) (5) Mr. Sherman and Darin, I hope you can join us. It would be most helpful to have everyone on one call. Speak with you soon! - Many thanks, (b) (6) On May 23, 2017, at 10:54 AM, Bruce Moskowitz <(b) (6) mac.com> wrote: Thank you can we do 345 today? If so would you like me to call you if not call my cell Sent from my iPad Bruce Moskowitz M.D. On May 23, 2017, at 1:45 PM, (b) (6) - <(b) (6) apple.com> wrote: Dr. Moskowitz and Mr. Sherman, It's a pleasure to meet you. (b) (6) next steps. and I look forward to connecting on a brief call to discuss Here are some times that work for us this week: Today - 3:30 - 4:30 PM ET Thursday - 9:30-11 AM ET, 12:15-1 PM ET, 4:30-5:30 PM ET Please let me know which works best for you, and we will send a dial-in number. - Many thanks, (b) (6) Confidential Commercial Information - Exempt from Disclosure under FOIA ? 552(b)(4) VA-18-0298 and 18-0299-B-000209 This submission contains trade secret and confidential commercial or financial information. This information is exempt from public disclosure under the Freedom of Information Act, 5 U.S.C. ? 552(b) (4), and may not be disclosed without the prior written authorization of Apple Inc. Such disclosure is prohibited by the U.S. Criminal Code, 18 U.S.C. ? 1905. If the Department of Veterans Affairs receives an FOIA request for this information, the Department must comply with 38 C.F.R. ? 1.558(c) and (d), by providing Apple Inc. with timely advance notice at: 1 Infinite Loop, Cupertino, CA 95014, Attention: General Counsel, and a meaningful opportunity to object before making the disclosure. The Department should either specifically identify the business information requested or provide a copy of any specific records that have been requested. On May 22, 2017, at 2:59 PM, Bruce Moskowitz <(b) (6) mac.com> wrote: Thank you I am available anytime Sent from my iPhone On May 22, 2017, at 5:10 PM, Selnick, Darin wrote: - Hi (b) (6) Bruce and Marc would be happy to provide further explanation of the agenda for the upcoming VA/Centers/Apple partnership call. - Bruce can be reached at cell 561-346-(b) (6) I am happy to assist anyway I can. Best Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - VA-18-0298 and 18-0299-B-000210 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin ; Bruce Moskowitz <(b) (6) mac.com> Marc Sherman <(b) (6) gmail.com> - RE: [EXTERNAL] Re: VA/Centers/Apple call Tue May 23 2017 13:08:06 CDT (b) (6) I will be at the airport, should be able to make the call. Darin Sent with Good (www.good.com) - -----Original Message----From: (b) (6) [(b) (6) apple.com] Sent: Tuesday, May 23, 2017 02:02 PM Eastern Standard Time To: Bruce Moskowitz Cc: Selnick, Darin; Marc Sherman Subject: [EXTERNAL] Re: VA/Centers/Apple call Please use the following dial-in number. (4), Phone number: 1-866-639-(b) (b) (5) (b) (4), (b) (5) Passcode: Mr. Sherman and Darin, I hope you can join us. It would be most helpful to have everyone on one call. Speak with you soon! - Many thanks, (b) (6) On May 23, 2017, at 10:54 AM, Bruce Moskowitz <(b) (6) mac.com> wrote: Thank you can we do 345 today? If so would you like me to call you if not call my cell Sent from my iPad Bruce Moskowitz M.D. On May 23, 2017, at 1:45 PM, (b) (6) - <(b) (6) apple.com> wrote: Dr. Moskowitz and Mr. Sherman, VA-18-0298 and 18-0299-B-000211 It's a pleasure to meet you. (b) (6) next steps. and I look forward to connecting on a brief call to discuss Here are some times that work for us this week: Today - 3:30 - 4:30 PM ET Thursday - 9:30-11 AM ET, 12:15-1 PM ET, 4:30-5:30 PM ET Please let me know which works best for you, and we will send a dial-in number. - Many thanks, (b) (6) Confidential Commercial Information - Exempt from Disclosure under FOIA ? 552(b)(4) This submission contains trade secret and confidential commercial or financial information. This information is exempt from public disclosure under the Freedom of Information Act, 5 U.S.C. ? 552(b) (4), and may not be disclosed without the prior written authorization of Apple Inc. Such disclosure is prohibited by the U.S. Criminal Code, 18 U.S.C. ? 1905. If the Department of Veterans Affairs receives an FOIA request for this information, the Department must comply with 38 C.F.R. ? 1.558(c) and (d), by providing Apple Inc. with timely advance notice at: 1 Infinite Loop, Cupertino, CA 95014, Attention: General Counsel, and a meaningful opportunity to object before making the disclosure. The Department should either specifically identify the business information requested or provide a copy of any specific records that have been requested. On May 22, 2017, at 2:59 PM, Bruce Moskowitz <(b) (6) mac.com> wrote: Thank you I am available anytime Sent from my iPhone On May 22, 2017, at 5:10 PM, Selnick, Darin wrote: - Hi (b) (6) Bruce and Marc would be happy to provide further explanation of the agenda for the upcoming VA/Centers/Apple partnership call. - Bruce can be reached at cell 561-346-(b) (6) I am happy to assist anyway I can. Best Darin Darin Selnick Senior Advisor to the Secretary VA-18-0298 and 18-0299-B-000212 Cell 202-390- and 18-0299-B-000213 From: To: Selnick, Darin - FW: Apple Point of Contact Thu May 25 2017 09:02:00 CDT Hi Bruce I was informed today that you had a conversation with Dr. Shulkin and that it is ok for VA OIT to start working with the Apple tech on area number 1, in order to make as much progress in advance of the June 14 meeting. Is that correct? Also, are there other areas VA can start working with Apple on to make progress before the June 14 call. I would also like to give you a call to discuss some next steps. I like you are the implementer for VA, so I need better clarity and to be in the loop so can coordinate all the different VA staff for Dr Shulkin.. Thanks Darin Sent with Good (www.good.com) -----Original Message----From: (b) (6) Sent: Tuesday, May 23, 2017 12:08 PM Eastern Standard Time To: Selnick, Darin Cc: Mulligan, Ricci Subject: Apple Point of Contact Mr. Selnick Quick recap on our conversation. From an IT perspective we are utilizing the native iOS mobile app, Emergency Medical Center Tracker, that Dr. Moskowitz developed. It provides an excellent starting point to accomplish task #1: The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. VA-18-0298 and 18-0299-B-000214 We have our resources in place, and are ready to engage with the Apple team. The areas we would want to focus on are: 1) Usability of the current/future application. A design engineer would be very helpful to provide insight into current best practices and help wireframe the next version. 2) Speed is going to be critical. Looking at the initial app, some of the code needs to be refactored and even rebuilt. 3) How to host and scale the application. This app will need to be scaled very quickly once completed. Handling load balancing and scaling the use of external APIs will require a detailed plan. Be glad to answer any questions you or the Apple team have, and look forward to working them. (b) (6) -- (b) (6) - Cell: (208) 841-(b) (6) VA-18-0298 and 18-0299-B-000215 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin wrote: Hi Bruce I was informed today that you had a conversation with Dr. Shulkin and that it is ok for VA OIT to start working with the Apple tech on area number 1, in order to make as much progress in advance of the June 14 meeting. Is that correct? Also, are there other areas VA can start working with Apple on to make progress before the June 14 call. I would also like to give you a call to discuss some next steps. I like you are the implementer for VA, so I need better clarity and to be in the loop so can coordinate all the different VA staff for Dr Shulkin.. Thanks Darin Sent with Good (www.good.com) -----Original Message----From: (b) (6) Sent: Tuesday, May 23, 2017 12:08 PM Eastern Standard Time To: Selnick, Darin Cc: Mulligan, Ricci Subject: Apple Point of Contact Mr. Selnick Quick recap on our conversation. VA-18-0298 and 18-0299-B-000216 From an IT perspective we are utilizing the native iOS mobile app, Emergency Medical Center Tracker, that Dr. Moskowitz developed. It provides an excellent starting point to accomplish task #1: The Veterans will need an app that provides for the appropriate medical facility and or physician that is geotagged to their location. It should list the closest certified cardiac center, stroke center, trauma center and pediatric center. It should also list qualified urgent care centers. We have our resources in place, and are ready to engage with the Apple team. The areas we would want to focus on are: 1) Usability of the current/future application. A design engineer would be very helpful to provide insight into current best practices and help wireframe the next version. 2) Speed is going to be critical. Looking at the initial app, some of the code needs to be refactored and even rebuilt. 3) How to host and scale the application. This app will need to be scaled very quickly once completed. Handling load balancing and scaling the use of external APIs will require a detailed plan. Be glad to answer any questions you or the Apple team have, and look forward to working them. (b) (6) -- (b) (6) - Cell: (208) 841-(b) (6) VA-18-0298 and 18-0299-B-000217 From: Bruce Moskowitz <(b) (6) mac.com> (b) (6) To: <(b) (6) brefnet.org>; Selnick, Darin ; (b) (6) (b) (6) < brefnet.org> - To: Cc: Bcc: Subject: Date: Attachments: RE: [EXTERNAL] EMCL APPLE VA Thu May 25 2017 11:27:09 CDT Thanks Darin Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) mac.com] Sent: Thursday, May 25, 2017 11:11 AM Eastern Standard Time To: (b) (6) Selnick, Darin Subject: [EXTERNAL] EMCL APPLE VA (b) (6) will work with the VA and Apple on agenda item one which is building on the EMCL platform. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000219 From: To: Cc: Bcc: Subject: Date: Attachments: (b) (6) <(b) (6) vamobile.us> Selnick, Darin [EXTERNAL] Contact Information for VHA 5Cs Team Thu May 25 2017 13:11:11 CDT Mr. (b) (6) vcf (b) (6) MD.vcf Sirs, - Dr. (b) (6) and I wanted to provide you with a better level of contact information for us. Please see the attached digital business cards which have our extended information. The cards should open easily and store on any platform you use, including and especially mobile. -Very Respectively, (b) (6) Director, VA Mobile Health Provider Program VHA Technology Director / GS-15 VA Central Office Dept. of Veterans Affairs Ph: 703.594(b) (6) AppleID: (b) (6) me.com Time is Short, and the Water Rises VA-18-0298 and 18-0299-B-000220 Owner: Filename: Last Modified: (b) (6) <(b) (6) vamobile.us> (b) (6) Mr. vcf Thu May 25 13:11:11 CDT 2017 VA-18-0298 and 18-0299-B-000221 Mr. (b) (6) vcf for Printed Item: 57 ( Attachment 1 of 2) Mr. (b) (6) Director VA Mobile Provider Program Dept. of Veterans Affairs Veterans Health Administration - 810 Vermont Avenue NW Suite(b) (6) Washington, DC 20420 United States 703.594(b) (6) 703.505(b) (6) (b) (6) ( Work Preferred Voice ) ( Voice Cell ) vamobile.us ( Work Preferred Internet ) va.gov ( Work Internet ) (b) (6) - https://www.linkedin.com/(b) (6) Version 3.0 iuk PRODID -//Apple Inc.//Mac OS X 10.12.5//EN Name Family: (b) (6) First: (b) (6) Middle: G. Prefix: Mr. Suffix: Formatted Name Mr. (b) (6) NICKNAME (6) ? (b) X-PHONETIC-LAST-NAME (b) (6) Organization Dept. of Veterans Affairs Veterans Health Administration Title Director VA Mobile Provider Program Electronic Mail Address ( Work Preferred Internet ) VA-18-0298 and 18-0299-B-000222 Mr. (b) (6) vcf for Printed Item: 57 ( Attachment 1 of 2) --(b) (6) vamobile.us Electronic Mail Address (b) (6) va.gov ( Work Internet ) Telephone Number 703.594(b) (6) ( Work Preferred Voice ) Telephone Number 703.505(b) (6) ( Voice Cell ) Address ( Work Preferred ) P.O. Address: Extended Address: Street: 810 Vermont Avenue NW Suite (b) (6) Locality: Washington Region: DC Postal Code: 20420 Country: United States - Address P.O. Address: Extended Address: Street: Locality: Washington D.C. 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Address: VA-18-0298 and 18-0299-B-000226 (b) (6) MD.vcf for Printed Item: 57 ( Attachment 2 of 2) Extended Address: Street: Locality: Region: Postal Code: Country: - - 490 L'Enfant Plaza East, Suite (b) (6) Washington DC 20024 X-SOCIALPROFILE ( type=gamecenter;x-user=(b) (6) (b) (6) :http://link.gc.apple.com/players/G:(b) (6) ) IMPP ( X-SERVICE-TYPE=GoogleTalk;type=pref ) xmpp:(b) (6) gmail.com X-ABLabel _$!!$_ Photograph /9j/4AAQSkZJRgABAQAAkACQAAD/4QB0RXhpZgAATU0AKgAAAAgABAEaAAUAAAABAAAAPgEb AAUAAAABAAAARgEoAAMAAAABAAIAAIdpAAQAAAABAAAATgAAAAAAAACQAAAAAQAAAJAAAAA BAAKgAgAEAAAAAQAACHKgAwAEAAAAAQAACHIAAAAA/+0AOFBob3Rvc2hvcCAzLjAAOEJJTQQEA AAAAAAAOEJJTQQlAAAAAAAQ1B2M2Y8AsgTpgAmY7PhCfv/iDPhJQ0NfUFJPRklMRQABAQAADOhh cHBsAhAAAG1udHJSR0IgWFlaIAfhAAEACQAJABsADmFjc3BBUFBMAAAAAEFQUEwAAAAAAAAAAA AAAAAAAAAAAAD21gABAAAAANMtYXBwbAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAEWRlc2MAAAFQAAAAYmRzY20AAAG0AAABzmNwcnQAAAOEAAA AI3d0cHQAAAOoAAAAFHJYWVoAAAO8AAAAFGdYWVoAAAPQAAAAFGJYWVoAAAPkAAAAFHJUUk MAAAP4AAAIDGFhcmcAAAwEAAAAIHZjZ3QAAAwkAAAAMG5kaW4AAAxUAAAAPmNoYWQAAAyUA AAALG1tb2QAAAzAAAAAKGJUUkMAAAP4AAAIDGdUUkMAAAP4AAAIDGFhYmcAAAwEAAAAIGFhZ2 cAAAwEAAAAIGRlc2MAAAAAAAAACERpc3BsYXkAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AABtbHVjAAAAAAAAACIAAAAMaHJIUgAAACYAAAGoa29LUgAAACYAAAGobmJOTwAAACYAAAGoa WQAAAAAACYAAAGoaHVIVQAAACYAAAGoY3NDWgAAACYAAAGoZGFESwAAACYAAAGodWtVQQ AAACYAAAGoYXIAAAAAACYAAAGoaXRJVAAAACYAAAGocm9STwAAACYAAAGobmxOTAAAACYAA AGoaGVJTAAAACYAAAGoZXNFUwAAACYAAAGoZmlGSQAAACYAAAGoemhUVwAAACYAAAGodml WTgAAACYAAAGoc2tTSwAAACYAAAGoemhDTgAAACYAAAGocnVSVQAAACYAAAGoZnJGUgAAAC YAAAGobXMAAAAAACYAAAGoY2FFUwAAACYAAAGodGhUSAAAACYAAAGoZXNYTAAAACYAAAGo ZGVERQAAACYAAAGoZW5VUwAAACYAAAGocHRCUgAAACYAAAGocGxQTAAAACYAAAGoZWxHU gAAACYAAAGoc3ZTRQAAACYAAAGodHJUUgAAACYAAAGoamFKUAAAACYAAAGocHRQVAAAACY AAAGoAFQAaAB1AG4AZABlAHIAYgBvAGwAdAAgAEQAaQBzAHAAbABhAHkAAHRleHQAAAAAQ29w eXJpZ2h0IEFwcGxlIEluYy4sIDIwMTcAAFhZWiAAAAAAAADzFgABAAAAARbKWFlaIAAAAAAAAHHAAA A5igAAAWdYWVogAAAAAAAAYSMAALnmAAAT9lhZWiAAAAAAAAAj8gAADJAAAL3QY3VydgAAAAAA AAQAAAAABQAKAA8AFAAZAB4AIwAoAC0AMgA2ADsAQABFAEoATwBUAFkAXgBjAGgAbQByAHcAf ACBAIYAiwCQAJUAmgCfAKMAqACtALIAtwC8AMEAxgDLANAA1QDbAOAA5QDrAPAA9gD7AQEBBwE NARMBGQEfASUBKwEyATgBPgFFAUwBUgFZAWABZwFuAXUBfAGDAYsBkgGaAaEBqQGxAbkBwQ HJAdEB2QHhAekB8gH6AgMCDAIUAh0CJgIvAjgCQQJLAlQCXQJnAnECegKEAo4CmAKiAqwCtgLBAss C1QLgAusC9QMAAwsDFgMhAy0DOANDA08DWgNmA3IDfgOKA5YDogOuA7oDxwPTA+AD7AP5BAYE EwQgBC0EOwRIBFUEYwRxBH4EjASaBKgEtgTEBNME4QTwBP4FDQUcBSsFOgVJBVgFZwV3BYYFlg WmBbUFxQXVBeUF9gYGBhYGJwY3BkgGWQZqBnsGjAadBq8GwAbRBuMG9QcHBxkHKwc9B08HYQ d0B4YHmQesB78H0gflB/gICwgfCDIIRghaCG4IggiWCKoIvgjSCOcI+wkQCSUJOglPCWQJeQmPCaQJu gnPCeUJ+woRCicKPQpUCmoKgQqYCq4KxQrcCvMLCwsiCzkLUQtpC4ALmAuwC8gL4Qv5DBIMKgxDD FwMdQyODKcMwAzZDPMNDQ0mDUANWg10DY4NqQ3DDd4N+A4TDi4OSQ5kDn8Omw62DtIO7g8JD yUPQQ9eD3oPlg+zD88P7BAJECYQQxBhEH4QmxC5ENcQ9RETETERTxFtEYwRqhHJEegSBxImEkUS ZBKEEqMSwxLjEwMTIxNDE2MTgxOkE8UT5RQGFCcUSRRqFIsUrRTOFPAVEhU0FVYVeBWbFb0V4B YDFiYWSRZsFo8WshbWFvoXHRdBF2UXiReuF9IX9xgbGEAYZRiKGK8Y1Rj6GSAZRRlrGZEZtxndGgQ aKhpRGncanhrFGuwbFBs7G2MbihuyG9ocAhwqHFIcexyjHMwc9R0eHUcdcB2ZHcMd7B4WHkAeah6UH r4e6R8THz4faR+UH78f6iAVIEEgbCCYIMQg8CEcIUghdSGhIc4h+yInIlUigiKvIt0jCiM4I2YjlCPCI/AkHyRN VA-18-0298 and 18-0299-B-000227 (b) (6) MD.vcf for Printed Item: 57 ( Attachment 2 of 2) CATEGORIES card UID a62bf4b3-666f-4b72-b444-51b96b7cb90f X-ABUID A62BF4B3-666F-4B72-B444-51B96B7CB90F:ABPerson VA-18-0298 and 18-0299-B-000228 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin ; Bruce W Moskowitz MD <(b) (6) - mac.com> RE: [EXTERNAL] Contact Information for VHA 5Cs Team Thu May 25 2017 14:19:50 CDT Thanks Bruce these two are the VHA staff that will be working on the 4 areas. Best Darin Sent with Good (www.good.com) -----Original Message----From: (b) (6) [(b) (6) vamobile.us] Sent: Thursday, May 25, 2017 02:14 PM Eastern Standard Time To: Selnick, Darin; Bruce W Moskowitz MD Subject: [EXTERNAL] Contact Information for VHA 5Cs Team Sirs, - Dr. (b) (6) and I wanted to provide you with a better level of contact information for us. Please see the attached digital business cards which have our extended information. The cards should open easily and store on any platform you use, including and especially mobile. -Very Respectively, (b) (6) Director, VA Mobile Health Provider Program VHA Technology Director / GS-15 VA Central Office Dept. of Veterans Affairs Ph: 703.594(b) (6) AppleID: (b) (6) me.com Time is Short, and the Water Rises VA-18-0298 and 18-0299-B-000229 and 18-0299-B-000230 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin - Re: [EXTERNAL] Contact Information for VHA 5Cs Team Thu May 25 2017 14:20:58 CDT Thank you I am available to answer any questions Sent from my iPad Bruce Moskowitz M.D. On May 25, 2017, at 3:19 PM, Selnick, Darin wrote: Thanks Bruce these two are the VHA staff that will be working on the 4 areas. Best Darin Sent with Good (www.good.com) -----Original Message----From: (b) (6) [(b) (6) vamobile.us] Sent: Thursday, May 25, 2017 02:14 PM Eastern Standard Time To: Selnick, Darin; Bruce W Moskowitz MD Subject: [EXTERNAL] Contact Information for VHA 5Cs Team Sirs, - Dr. (b) (6) and I wanted to provide you with a better level of contact information for us. Please see the attached digital business cards which have our extended information. The cards should open easily and store on any platform you use, including and especially mobile. -Very Respectively, (b) (6) Director, VA Mobile Health Provider Program VHA Technology Director / GS-15 VA Central Office VA-18-0298 and 18-0299-B-000231 Dept. of Veterans Affairs Ph: 703.594(b) (6) AppleID: (b) (6) me.com Time is Short, and the Water Rises VA-18-0298 and 18-0299-B-000232 From: Selnick, Darin ; (b) (6) (b) (6) < brefnet.org> (b) (6) <(b) (6) apple.com> - To: Cc: Bcc: Subject: Date: Attachments: RE: [EXTERNAL] EMCL APPLE VA Thu May 25 2017 14:24:23 CDT - Hi (b) (6) (b) (6) is our Apple contact who will connect with you on next steps from their end on going forward with agenda item 1. Best Darin Selnick Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) mac.com] Sent: Thursday, May 25, 2017 11:11 AM Eastern Standard Time To: (b) (6) Selnick, Darin Subject: [EXTERNAL] EMCL APPLE VA (b) (6) will work with the VA and Apple on agenda item one which is building on the EMCL platform. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000233 (b) (6) To: Cc: apple.com <(b) (6) apple.com> on behalf of (b) (6) <(b) (6) apple.com> (b) (6) (b) (6) < brefnet.org> Selnick, Darin Bcc: Subject: Date: Attachments: Re: [EXTERNAL] EMCL APPLE VA Thu May 25 2017 17:51:41 CDT From: (b) (6) It's very nice to meet you. We look forward to touching base after NDAs are signed with all organizations involved. In the interim, we plan to listen in on a conference call tomorrow that Dr. Moskowitz has invited us to with the medical centers and VA. We will be sure to add your name to the list of signatories. Thanks for your patience and I hope to be in touch again soon! Best regards, (b) (6) Confidential Commercial Information - Exempt from Disclosure under FOIA ? 552(b)(4) This submission contains trade secret and confidential commercial or financial information. This information is exempt from public disclosure under the Freedom of Information Act, 5 U.S.C. ? 552(b) (4), and may not be disclosed without the prior written authorization of Apple Inc. Such disclosure is prohibited by the U.S. Criminal Code, 18 U.S.C. ? 1905. If the Department of Veterans Affairs receives an FOIA request for this information, the Department must comply with 38 C.F.R. ? 1.558(c) and (d), by providing Apple Inc. with timely advance notice at: 1 Infinite Loop, Cupertino, CA 95014, Attention: General Counsel, and a meaningful opportunity to object before making the disclosure. The Department should either specifically identify the business information requested or provide a copy of any specific records that have been requested. On May 25, 2017, at 12:25 PM, (b) (6) <(b) (6) - brefnet.org> wrote: Thank you Darin, I look forward to speaking with (b) (6) Sincerely, (b) (6) Executive Director Biomedical Research& Education Foundation www.brefnet.org (c)561-512-(b) (6) 1010 N. Hancock St c/o WeWork Philadelphia, PA 19123 - VA-18-0298 and 18-0299-B-000234 On May 25, 2017, at 3:24 PM, Selnick, Darin wrote: - Hi (b) (6) (b) (6) is our Apple contact who will connect with you on next steps from their end on going forward with agenda item 1. Best Darin Selnick Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) mac.com] Sent: Thursday, May 25, 2017 11:11 AM Eastern Standard Time To: (b) (6) Selnick, Darin Subject: [EXTERNAL] EMCL APPLE VA (b) (6) will work with the VA and Apple on agenda item one which is building on the EMCL platform. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000235 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin Selnick, Darin VA-18-0298 and 18-0299-B-000238 ATT00001.txt for Printed Item: 65 ( Attachment 1 of 2) Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000239 Owner: Filename: Last Modified: Bruce Moskowitz <(b) (6) mac.com> Beyond Medication Reconciliation-The Correct Medication List.pdf Fri May 26 09:23:50 CDT 2017 VA-18-0298 and 18-0299-B-000240 Beyond Medication Reconciliation-The Correct Medication List.pdf for Printed Item: 65 ( Attachment 2 of 2) Opinion Beyond MedicationReconciliation The Correct MedicationList fewer times per day and aligning dosing intervals to reduce the frequency that medications should be taken. Similarly,the burden of adverseeffects can be minimizedby choosingthe lowest effective dose.This is a particularly difficult task because it may involve talking with various cliniciansand the patient, as well as understandingthe patient's insuranceplan, which may not cover all drugs. Minimize Out-of-Pocket Expenses.Unnecessarily expensivemedicationsdo not belongon the list;a medication the patient cannot afford will not help. Physiits effect. Shira H. Fischer,MD, ciansmay be hamperedby a lackof information about as PhD defined sometimes is ion Medicationreconciliat RANDCorporation, ketcosts.Electronicmedicalrecordscouldbe out-of-poc disor admission at lists medication the comparisonof Boston,Massachusetts. improvedto help play this role. charge, and is sometimes defined more broadly to Inform Outside Entities. The correct medication However,these patient. the from n informatio include MichaeJK. all entities interacting concepts set the bar too low: What is needed is not list will not be effective unless Paasche-Orlow,MD, list. Other clinicians the have also patient the MPH merely a reconciled list. but the correct medication with Sectionof General changesor problems n prescriptio about know to need of list. Achievingthis list would involve multiple levels InternalMedicine, extends to pharconcern This d. perpetuate be may reconciliation. Departmentof prompt programs refill automatic because macies Boston Medicine, prescribedmedicapreviously taking keep UniversitySchoolof to patients tion Reconcilia Levels of Medication Medicine,Boston, Commission requires ClinicianAgreement. All of the clinicianswho provide tions. Even though The Joint Massachusetts. , it likely occurs pharmacy the with ation care for the patient need to agreewhich medications communic only rarely. The SCRIPTstandard for e-prescribing, Version 10.6 (available correct a ining since2014) would accomplishmuch of mainta and g Creatin task. However, because many this not medication list for every patient pharmacies and EMRshave not fully be a trivial task, but it represents enabled all SCRIPTfunctionalities, this communicationis not a reality for most a fulfillment of the responsibility clinicians.2 Adam J. Rose,MD, MSc RANDCorporation, Boston.Massachusetts; andSectionof General InternalMedicine, Departmentof Medicine.Boston UniversitySchoolof Medicine,Boston, Massachusetts. Medication reconciliation is a major focus of quality measurement activities, and according to The Joint Commission,primary care clinicians are expected to 1 reconcile a patient's medications at every visit. In principle,medicationreconciliationis quite important; in practice, however, it has failed to have a demonstrableeffect on patient outcomes.This may partly be becausethe lackof agreementabout what constitutes medication reconciliation makesit difficult to decide when it has occurred and therefore difficult to study .! will of physicians. Corresponding Author: Adam J. Rose,MD,MSc, RANDCorporation, 20 ParkPlaza,Ste920, Boston,MA 02116 (arose@rand.org). jama.com should be on the list. It is often necessaryto compare multiple lists,none of which maybe completelycorrect or up-to-date. Dueto gapsin electronicmedicalrecord (EMR)interoperability,this can be a challenging,laborious,and error-pronetasl<. Patient Agreement. Incorporating the patient's perspective is fundamental. Keeping medications on the list that patients cannot obtain or do not want to take is misleading.If the patient purposefullystops a medication, the clinician must decide whether the medicationis stillwarranted(andpersuadethe patient) . or removeit from the list. Deprescribe.Someof the medicationson the patient's variousmedicationlists mayno longerbe appropriateor may neverhavebeenideal.Carryingthesesuboptimal choicesforward does not serve the patient's interests.Prescribingshouldbe pairedwith deprescribing: Inappropriateandunnecessarymedicationsshould be removedfrom the list. DecreasePatient Burden. The burden of adherencecan be minimized by choosingmedicationsgiven Reasonsfor Medication Reconciliation It will likely be time-consumingto develop and maintain the correct medication list. In medicine,and especially in primary care, there is no shortage of worthwhile activities.Incurrent clinicalsettingsin which most practitionersalreadyhavetoo muchto do,3why should the correct medication list receive priority? There are severalreasons. 1. Substantialpotential to improve patient outcomes. Establishingthe correct medicationlist hasdemon4 stratedeffect on outcomes.Onestudy,ProjectRED steps the (an int~rvention that included most of suggested above), included 749 patients and demonstrateda decreaseof approximately30% in patients returning to the hospital within 30 days, from 0.45 to 0.31 hospitalizationor emergencydepartmentvisits per month. Otherstudieshavelinked similar approacheswith improved medication adherence.s l=he effort invested in achieving the correct medication list could potentially improve outcomesmore than other competingpriorities. JAMA May23/30,2017 Vo!ume317,Number20 I :\ I ' 2057 VA-18-0298 and 18-0299-B-000241 ----==~--'--------------,------- I~" [' -.~ Beyond Medication Reconciliation-The Correct Medication List.pdf for Printed Item: 65 ( Attachment 2 of 2) Opinion Viewpoint 2. Havingthe correct medicationlist willprevent problemsthat wouldhavetaken even more effortto solve.Creatinga correct listwilltake time, but havingthe listcouldhelpavert crisesand readmissions.For example, duplicate or interacting medicationscouldbe discoveredand rectifiedbeforethey leadto an adverse event. Also,havinga correct listcouldsimplifythe workflowfor manysrakehold~rs. 3. Strategiesare availableto facilitatedevelopingand maintaining the correct medicationlist. The piimary clinicianshould ultimatelybe responsibleforthese strategies,althoughsomeofthis workcanbe delegated.Technologycanalsohelp.Fullimplementationofstandards,as previouslymentioned,willmakecommunicationwithpharmaciesmorereliable-andinformationwillflow inboth directions.Indication-based prescribingcouldpreventerra:rs,whereasavailability ofcost informationinthe EMRcoulddecrease cost. A system to allowpatients or ~aregiversto offer , amendmentsbetweenvisitswill improveaccuracy. 4. Establishinga correct medicationlistwilloften involveremoving medications.The rate of polypharmacy(definedas taking '2.::5 medications)for USindividualsolderthan 65 years is close to 40%.6 The correctmedicationlistwillhelpto address polypharmacy by ensuring that medications are appropriately stopped,reducingthepotentialfor medicationerror,adverseeffects, interactions.and excessivecosts. 5. The correct medicationlist. instead of a more limitedconception of medicationreconciliation,is what most patients would likelywant.- scribedherein.7 The resultsof that pilotcouldsupport the idea of payingforthe activityof maintaininga correctmedicationlist. 2. Howcanthe task of creatingand maintainingthe correctmedicationlistbe measured?Primarycare cliniciansand hospitalists currentlymust attest that medicationreconciliationhas been completed,butthisdoesnot measureaccuracy.Currently, novalidated measuresare availableto assess the qualityof medication reconciliation.Moremeaningfulmeasuresare needed, and studiescan be builtupon these measuresto assessthe valueof me~icationreconciliationacrossa gradientof howcomprehensivelyit was performed. 3. Whoshotld be responsiblefor thistask?Whiledelegatingsome of the responsibility is possible, systems made up of care teams, engaged patients, and helpfultechnology need to be developedto achieveand maintainthe correct medicationlist with a minimumof human effort and maximum.effectiveness. Developingsuch systems is where the ultimateresponsibility shouldlie. 4. Whenshouldthisbe doneandforwhom?Althoughcurrentpractice is based on assumptionsabout which patients need medicationreconciliationand when.additionalresearchisneededto identifypatientswhowouldbenefitmostfromthis activity.For example,in the CMSpilot,Part D plansare encouragedto find creativewaysto identifypatients at the highestriskof adverse events andfocus effortson them.7 Conclusions Creatingand maintaininga correctmedicationlistfor everypatient willnot be a trivialtask, but it representsa fulfillmentof the responQuestions InvolvingMedication Reconciliation However,creatingandmaintainingacorrectmedicationlistalsocre- sibilityof physicians.Properlydevelopingand maintaininga correct medicationlistfor allpatientswillrequireappropriatedelegation, ates some questions: 1. Who will pay for this?Some programsalready pay for an en- implementationof relevantinformationtechnology,creatingsyshancedversionof medicationreconciliation.Oneexampleisthe tems to support the workto maintaina list, and developingpayCentersfor Medicare&Medicaid Services(CMS)EnhancedMedi- ment mechanismsand performancemeasures. It is time to look cationTherapyManagementpilot,that pays MedrcarePart D beyond basicmedicationreconciliation.Allpatients should have plans to conduct or arrange for activitiessimilarto those de- confidencethat their medicationlististhe correctlist. ARTICLEINFORMATION PublishedOnline:April20, 2017. doi:10.1001/jama.2017.4628 Conflict of Interest Disclosures:All authorshave completedandsubmittedthe lCMJEFormfor Disclosureof PotentialConflictsof Interest andno disclosures were reported. 2058 6. KantorED,RehmCD,HaasJS,ChanAT, 2. FischerS,RoseA. Responsible e-prescribing needse-discontinuation.JAMA. 2017;317(5):469-470:' o GiovannucciEL Tren~sin prescriptiondrug use amongadultsin the UnitedStatesfrom 1999-2012. 3. YarnallKS,Pollakl - RE: [EXTERNAL] Apple call Fri May 26 2017 09:27:57 CDT Yes, will get that to you today Darin Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) mac.com] Sent: Friday, May 26, 2017 10:20 AM Eastern Standard Time To: Selnick, Darin Subject: [EXTERNAL] Apple call I need the email of everyone who will be on the call June 14 for today if possible. Enjoy the holiday. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000243 Darin Selnick (b) (6) @gmail.com> Selnick, Darin Re: FW: [EXTERNAL] Apple call Fri May 26 2017 10:56:36 CDT Hi Bruce Here is the email list for all the VA staff for the June 14 call. How much time Dr. Shulkin will be able to stay on the call will depend on the hearings that day. Dr. Shulkin - vacodjs1@va.gov Darin Selnick - darin.selnick@va.gov (b) (6) - (b) (6) va.gov Rob Thomas - rob.thomas2@va.gov Jennifer Lee - jennifer.s.lee@va.gov Ricci Mulligan - ricci.mulligan@va.gov (b) (6) - (b) (6) (b) (6) ?(b) (b) (6) (6) va.gov - (b) (6) - (b) (6) va.gov va.gov Best regards Darin On Fri, May 26, 2017 at 7:34 AM, Selnick, Darin wrote: Sent with Good (www.good.com) -----Original Message----From: Bruce Moskowitz [(b) (6) mac.com] Sent: Friday, May 26, 2017 10:20 AM Eastern Standard Time To: Selnick, Darin VA-18-0298 and 18-0299-B-000244 Subject: [EXTERNAL] Apple call I need the email of everyone who will be on the call June 14 for today if possible. Enjoy the holiday. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000245 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Thomas, Rob C. II Selnick, Darin ; Thomas, Rob C. II ; Thomas, Rob C. II Selnick, Darin --- - -- Re: [EXTERNAL] June 14 call Wed May 31 2017 20:05:06 CDT Thank you 5 to 7 minutes. Sent from my iPhone > On May 31, 2017, at 7:00 PM, Selnick, Darin wrote: > > Hi Bruce > > Speaking for VA on item number one will be the following: > > Lead: Rob Thomas and (b) (6) OIT > Support: (b) (6) - Clinical and Ricci Mulligan OIT > > Best > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) gmail.com] > Sent: Wednesday, May 31, 2017 12:08 PM > To: Selnick, Darin; Thomas, Rob C. II > Subject: [EXTERNAL] June 14 call > > I I need to review who is speaking on item one for the VA prior to the call. Thank you > > Sent from my iPad - VA-18-0298 and 18-0299-B-000252 Bruce Moskowitz MD. and From: To: (b) (6) <(b) (6) frenchangel59.com> <(b) (6) frenchangel59.com>; (b) (6) ((b) (6) apple.com) <(b) (6) apple.com>; Bruce Moskowitz <(b) (6) mac.com>; (b) (6) gmail.com (b) (6) < gmail.com>; (b @frenchangel59.com ) <(b @frenchangel59.com>; vacodjs1@va.com ; (6 ) ) Alaigh, Poonam, M.D. ; (b) (6) mayo.edu (b) (6) < mayo.edu>; (b) (6) mayo.edu <(b) (6) mayo.edu>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) jhu.edu <(b) (6) jhu.edu>; (b) (6) kp.org <(b) (6) kp.org>; (b) (b) @responsivehealth.org < @responsivehealth.org>; (6) (6) (6) (b) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) (MSSM) ((b) (6) mssm.edu) <(b) (6) mssm.edu>; (b) (6) brefnet.org <(b) (6) brefnet.org>; (b) (6) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) BWH.HARVARD.EDU <(b) (6) bwh.harvard.edu>; (b) (6) (b) (6) (b) (6) ( mayo.edu) mayo.edu>; (b) (6) ; (b) (6) (b) (6) - - _ _..,. - Cc: Bcc: Subject: [EXTERNAL] Conference Call with (b) (6) June 14th / 11:00 AM - 12:30 PM EST Date: Tue Jun 06 2017 15:50:08 CDT Attachments: - and his Team (APPLE) - Wednesday, StartTime: Wed Jun 14 10:00:00 Central Daylight Time 2017 EndTime: Wed Jun 14 11:30:00 Central Daylight Time 2017 Location: Conference Call - Doctor Bruce Moskowitz is The Host Recurring: No ShowReminder: No Accepted: Yes AcceptedTime: Tue Jun 06 16:03:00 Central Daylight Time 2017 Wednesday, June 14th 11:00 AM - 12:30 PM EST (8:00 AM - 9:30 AM PST) VA-18-0298 and 18-0299-B-000254 -- Dial-in Information: (4), US: 1-866-244-(b) (b) (5) (4), International: 719-457-(b) (b) (5) (4), (b) Passcode: (b) (5) Participants: Dr. Bruce Moskowitz Marc Sherman - CPA, Esq Ike Perlmutter APPLE (b) (6) (b) (6) (b) (6) (b) (6) - Apple, Chief Executive Officer - Apple, Chief Operating Officer - Apple, Director of Global Government - Apple, Vice President for Public Policy and Government Affairs Office of Veterans Affairs Doctor David Shulkin - Secretary of Veterans Affairs Dr. Poonam Alaigh - Acting Under Secretary for Health Darin Selnick - Senior Advisor to the Secretary Rob C. Thomas II - Acting Assistant Secretary & Chief Information Officer Department of Veterans Affairs (b) (6) (b) (6) - Senior Advisor, Acting Under Secretary for Health, Department of Veterans Affairs, Veterans Health Administration -- Medical Institutions: (b) (6) - Chair |Mayo Clinic Department of Public Affairs - Chief Information Officer, Mayo Clinic (b) (6) M.D. - Associate Dean, Center for Connected Care Professor of Medicine, Mayo Clinic College of Medicine (b) (6) (b) (6) Dr. (b) (6) - Interim Chief Information Officer, Cleveland Clinic - Associate Chief Information Officer, Cleveland Clinic (b) (6) - Senior Vice President and CIO, Johns Hopkins Health System, Johns Hopkins Medicine, Vice Provost and CIO, Johns Hopkins University (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Dr. (b) (6) Health - Senior Vice President, Care Delivery Technology Services, Kaiser Permanente - Cofounder, CEO - Responsive Health MD - Cofounder Responsive Health; Mount Sinai Health System - Payer Advisor, Responsive Health - Development Head - Responsive Health - SME for Public Sector - Responsive Health - Biomedical Research & Education Foundation, Executive Director M.D. - Vice President, Connected Health | Partners HealthCare - Chief Information Officer and Vice President, Information Systems, Brigham VA-18-0298 and 18-0299-B-000255 Thank you, (b) (6) (646) 201-(b) (6) (Cell) frenchangel59.com (b) (6) VA-18-0298 and 18-0299-B-000256 (b) (6) From: To: <(b) (6) frenchangel59.com> (b) (6) ((b) (6) apple.com) <(b) (6) apple.com>; Bruce Moskowitz <(b) (6) mac.com>; (b) (6) gmail.com <(b) (6) gmail.com>; (b @frenchangel59.com ) <(b @frenchangel59.com>; vacodjs1@va.com ; (6 ) ) Alaigh, Poonam, M.D. ; mayo.edu (b) (6) (b) (6) < mayo.edu>; mayo.edu <(b) (6) mayo.edu>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) jhu.edu <(b) (6) jhu.edu>; (b) (6) kp.org <(b) (6) kp.org>; (b) (b) @responsivehealth.org < @responsivehealth.org>; (6) (6) (6) (b) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) (b) (6) (b) (6) (MSSM) ( mssm.edu) < mssm.edu>; (b) (6) brefnet.org <(b) (6) brefnet.org>; (b) (6) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) BWH.HARVARD.EDU <(b) (6) bwh.harvard.edu>; (b) (6) (b) (6) (b) (6) ( mayo.edu) mayo.edu>; (b) (6) ; (b) (6) - _ _..,. - Cc: Bcc: Subject: [EXTERNAL] Conference Call with (b) (6) June 14th / 11:00 AM - 12:30 PM EST Date: Tue Jun 06 2017 15:50:08 CDT Attachments: - - and his Team (APPLE) - Wednesday, Wednesday, June 14th 11:00 AM - 12:30 PM EST (8:00 AM - 9:30 AM PST) -- Dial-in Information: (4), US: 1-866-244-(b) (b) (5) (4), International: 719-457-(b) (b) (5) (4), (b) Passcode: (b) (5) Participants: Dr. Bruce Moskowitz VA-18-0298 and 18-0299-B-000257 Marc Sherman - CPA, Esq Ike Perlmutter APPLE (b) (6) (b) (6) (b) (6) (b) (6) - Apple, Chief Executive Officer - Apple, Chief Operating Officer - Apple, Director of Global Government - Apple, Vice President for Public Policy and Government Affairs Office of Veterans Affairs Doctor David Shulkin - Secretary of Veterans Affairs Dr. Poonam Alaigh - Acting Under Secretary for Health Darin Selnick - Senior Advisor to the Secretary Rob C. Thomas II - Acting Assistant Secretary & Chief Information Officer Department of Veterans Affairs (b) (6) (b) (6) - Senior Advisor, Acting Under Secretary for Health, Department of Veterans Affairs, Veterans Health Administration Medical Institutions: (b) (6) - Chair |Mayo Clinic Department of Public Affairs - Chief Information Officer, Mayo Clinic (b) (6) M.D. - Associate Dean, Center for Connected Care Professor of Medicine, Mayo Clinic College of Medicine (b) (6) (b) (6) - Interim Chief Information Officer, Cleveland Clinic - Associate Chief Information Officer, Cleveland Clinic Dr. (b) (6) (b) (6) - Senior Vice President and CIO, Johns Hopkins Health System, Johns Hopkins Medicine, Vice Provost and CIO, Johns Hopkins University (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) - Senior Vice President, Care Delivery Technology Services, Kaiser Permanente - Cofounder, CEO - Responsive Health MD - Cofounder Responsive Health; Mount Sinai Health System - Payer Advisor, Responsive Health - Development Head - Responsive Health - SME for Public Sector - Responsive Health (b) (6) (b) (6) Dr. (b) (6) Health - Biomedical Research & Education Foundation, Executive Director M.D. - Vice President, Connected Health | Partners HealthCare - Chief Information Officer and Vice President, Information Systems, Brigham Thank you, (b) (6) (646) 201-(b) (6) (Cell) (b) (6) frenchangel59.com VA-18-0298 and 18-0299-B-000258 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin - RE: [EXTERNAL] June 14 call Fri Jun 09 2017 15:03:38 CDT Hi Bruce Do you have some time on Monday for a call to discuss the June 14th agenda, and do you have an updated agenda with the topics and who is presenting on them. I know the last week that there has been a lot of work and preparation for the call, and I want to make sure I have the right people on the call and ready. I also want to discuss with you where VA is with its work on the 4 topics. For the meeting itself the VA team would like to be clear on the following" - Is there an update full agenda - Purpose - What do we want to accomplish/outcomes of the meeting - Role going forward of Responsive Health - Clarity on the direction of topic 1 - Participation and role of top principles in the meeting, Ike, (b) (6) Dr. Shulkin Thanks so much. - Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - -----Original Message----From: bruce moskowitz [mailto:(b) (6) Sent: Wednesday, May 31, 2017 9:05 PM To: Selnick, Darin (b) (6) Cc: Thomas, Rob C. II; (b) (6) - Subject: Re: [EXTERNAL] June 14 call gmail.com] --- Mulligan, Ricci; (b) (6) (b) (6) (b) (6) Thank you 5 to 7 minutes. Sent from my iPhone > On May 31, 2017, at 7:00 PM, Selnick, Darin wrote: VA-18-0298 and 18-0299-B-000259 > > Hi Bruce > > Speaking for VA on item number one will be the following: > > Lead: Rob Thomas and (b) (6) OIT (b) (6) > Support: - Clinical and Ricci Mulligan OIT > > Best > > Darin > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: Bruce Moskowitz [mailto:(b) (6) gmail.com] > Sent: Wednesday, May 31, 2017 12:08 PM > To: Selnick, Darin; Thomas, Rob C. II > Subject: [EXTERNAL] June 14 call > > I I need to review who is speaking on item one for the VA prior to the call. Thank you > > Sent from my iPad > Bruce Moskowitz M.D. - VA-18-0298 and 18-0299-B-000260 From: To: Cc: Bcc: Subject: Date: Attachments: bruce moskowitz <(b) (6) gmail.com> Selnick, Darin On Jun 9, 2017, at 1:03 PM, Selnick, Darin wrote: > > Hi Bruce > > Do you have some time on Monday for a call to discuss the June 14th agenda, and do you have an updated agenda with the topics and who is presenting on them. > > I know the last week that there has been a lot of work and preparation for the call, and I want to make sure I have the right people on the call and ready. > > I also want to discuss with you where VA is with its work on the 4 topics. > > For the meeting itself the VA team would like to be clear on the following" > - Is there an update full agenda > - Purpose > - What do we want to accomplish/outcomes of the meeting > - Role going forward of Responsive Health > - Clarity on the direction of topic 1 > - Participation and role of top principles in the meeting, Ike, (b) (6) Dr. Shulkin > > Thanks so much. > > Darin > > > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: bruce moskowitz [mailto:(b) (6) gmail.com] > Sent: Wednesday, May 31, 2017 9:05 PM > To: Selnick, Darin (b) (6) (b) (6) > Cc: Thomas, Rob C. II; (b) (6) Mulligan, Ricci; (b) (6) (b) (6) - - - --- VA-18-0298 and 18-0299-B-000261 > Subject: Re: [EXTERNAL] June 14 call > > > Thank you 5 to 7 minutes. > Sent from my iPhone > >> On May 31, 2017, at 7:00 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> Speaking for VA on item number one will be the following: >> >> Lead: Rob Thomas and (b) (6) OIT >> Support: (b) (6) - Clinical and Ricci Mulligan OIT >> >> Best >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) gmail.com] >> Sent: Wednesday, May 31, 2017 12:08 PM >> To: Selnick, Darin; Thomas, Rob C. II >> Subject: [EXTERNAL] June 14 call >> >> I I need to review who is speaking on item one for the VA prior to the call. Thank you >> >> Sent from my iPad >> Bruce Moskowitz M.D. - VA-18-0298 and 18-0299-B-000262 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin - RE: [EXTERNAL] June 14 call Fri Jun 09 2017 15:40:33 CDT Great, talk to you at 5pm on Monday. Stay safe and have a great weekend. Darin Darin Selnick Senior Advisor to the Secretary Cell 202-390-(b) (6) - -----Original Message----From: bruce moskowitz [mailto:(b) (6) Sent: Friday, June 09, 2017 4:37 PM To: Selnick, Darin Subject: Re: [EXTERNAL] June 14 call gmail.com] Yes currently climbing in New Mexico 15 stories up in air will be back Monday 5 works. Typing and hanging by one hand challenging! Sent from my iPhone > On Jun 9, 2017, at 1:03 PM, Selnick, Darin wrote: > > Hi Bruce > > Do you have some time on Monday for a call to discuss the June 14th agenda, and do you have an updated agenda with the topics and who is presenting on them. > > I know the last week that there has been a lot of work and preparation for the call, and I want to make sure I have the right people on the call and ready. > > I also want to discuss with you where VA is with its work on the 4 topics. > > For the meeting itself the VA team would like to be clear on the following" > - Is there an update full agenda > - Purpose > - What do we want to accomplish/outcomes of the meeting > - Role going forward of Responsive Health > - Clarity on the direction of topic 1 > - Participation and role of top principles in the meeting, Ike, (b) (6) Dr. Shulkin > > Thanks so much. > > Darin - VA-18-0298 and 18-0299-B-000263 > > > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: bruce moskowitz [mailto:(b) (6) > Sent: Wednesday, May 31, 2017 9:05 PM > To: Selnick, Darin (b) (6) > Cc: Thomas, Rob C. II; (b) (6) - - gmail.com] --- Mulligan, Ricci; (b) (6) (b) (6) (b) (6) > Subject: Re: [EXTERNAL] June 14 call > > > Thank you 5 to 7 minutes. > Sent from my iPhone > >> On May 31, 2017, at 7:00 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> Speaking for VA on item number one will be the following: >> >> Lead: Rob Thomas and (b) (6) OIT >> Support: (b) (6) - Clinical and Ricci Mulligan OIT >> >> Best >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) gmail.com] >> Sent: Wednesday, May 31, 2017 12:08 PM >> To: Selnick, Darin; Thomas, Rob C. II >> Subject: [EXTERNAL] June 14 call >> >> I I need to review who is speaking on item one for the VA prior to the call. Thank you >> >> Sent from my iPad >> Bruce Moskowitz M.D. - VA-18-0298 and 18-0299-B-000264 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin - RE: [EXTERNAL] June 14 call Mon Jun 12 2017 14:25:01 CDT Hi Bruce - I hear you are talking to (b) (6) Darin from Mayo at 5:15pm, do you want to call me afterwards. Sent with Good (www.good.com) -----Original Message----From: bruce moskowitz [(b) (6) gmail.com] Sent: Friday, June 09, 2017 04:37 PM Eastern Standard Time To: Selnick, Darin Subject: Re: [EXTERNAL] June 14 call Yes currently climbing in New Mexico 15 stories up in air will be back Monday 5 works. Typing and hanging by one hand challenging! Sent from my iPhone > On Jun 9, 2017, at 1:03 PM, Selnick, Darin wrote: > > Hi Bruce > > Do you have some time on Monday for a call to discuss the June 14th agenda, and do you have an updated agenda with the topics and who is presenting on them. > > I know the last week that there has been a lot of work and preparation for the call, and I want to make sure I have the right people on the call and ready. > > I also want to discuss with you where VA is with its work on the 4 topics. > > For the meeting itself the VA team would like to be clear on the following" > - Is there an update full agenda > - Purpose > - What do we want to accomplish/outcomes of the meeting > - Role going forward of Responsive Health > - Clarity on the direction of topic 1 VA-18-0298 and 18-0299-B-000265 - > - Participation and role of top principles in the meeting, Ike, (b) (6) Dr. Shulkin > > Thanks so much. > > Darin > > > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: bruce moskowitz [mailto:(b) (6) gmail.com] > Sent: Wednesday, May 31, 2017 9:05 PM > To: Selnick, Darin (b) (6) > Cc: Thomas, Rob C. II; (b) (6) Mulligan, Ricci; (b) (6) - --- - (b) (6) (b) (6) > Subject: Re: [EXTERNAL] June 14 call > > > Thank you 5 to 7 minutes. > Sent from my iPhone > >> On May 31, 2017, at 7:00 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> Speaking for VA on item number one will be the following: >> >> Lead: Rob Thomas and (b) (6) OIT >> Support: (b) (6) - Clinical and Ricci Mulligan OIT >> >> Best >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) gmail.com] >> Sent: Wednesday, May 31, 2017 12:08 PM >> To: Selnick, Darin; Thomas, Rob C. II >> Subject: [EXTERNAL] June 14 call >> >> I I need to review who is speaking on item one for the VA prior to the call. Thank you >> >> Sent from my iPad >> Bruce Moskowitz M.D. - VA-18-0298 and 18-0299-B-000266 and 18-0299-B-000267 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) gmail.com> Selnick, Darin wrote: Hi Bruce - I hear you are talking to (b) (6) Darin from Mayo at 5:15pm, do you want to call me afterwards. Sent with Good (www.good.com) -----Original Message----From: bruce moskowitz [(b) (6) gmail.com] Sent: Friday, June 09, 2017 04:37 PM Eastern Standard Time To: Selnick, Darin Subject: Re: [EXTERNAL] June 14 call Yes currently climbing in New Mexico 15 stories up in air will be back Monday 5 works. Typing and hanging by one hand challenging! Sent from my iPhone > On Jun 9, 2017, at 1:03 PM, Selnick, Darin wrote: > > Hi Bruce > > Do you have some time on Monday for a call to discuss the June 14th agenda, and do you have an updated agenda with the topics and who is presenting on them. > > I know the last week that there has been a lot of work and preparation for the call, and I want to make sure I have the right people on the call and ready. VA-18-0298 and 18-0299-B-000268 > > I also want to discuss with you where VA is with its work on the 4 topics. > > For the meeting itself the VA team would like to be clear on the following" > - Is there an update full agenda > - Purpose > - What do we want to accomplish/outcomes of the meeting > - Role going forward of Responsive Health > - Clarity on the direction of topic 1 > - Participation and role of top principles in the meeting, Ike, (b) (6) Dr. Shulkin > > Thanks so much. > > Darin > > > > Darin Selnick > Senior Advisor to the Secretary > Cell 202-390-(b) (6) > > > -----Original Message----> From: bruce moskowitz [mailto:(b) (6) gmail.com] > Sent: Wednesday, May 31, 2017 9:05 PM > To: Selnick, Darin (b) (6) > Cc: Thomas, Rob C. II; (b) (6) Mulligan, Ricci; (b) (6) - - --- - (b) (6) (b) (6) > Subject: Re: [EXTERNAL] June 14 call > > > Thank you 5 to 7 minutes. > Sent from my iPhone > >> On May 31, 2017, at 7:00 PM, Selnick, Darin wrote: >> >> Hi Bruce >> >> Speaking for VA on item number one will be the following: >> >> Lead: Rob Thomas and (b) (6) OIT >> Support: (b) (6) - Clinical and Ricci Mulligan OIT >> >> Best >> >> Darin >> >> Darin Selnick >> Senior Advisor to the Secretary >> Cell 202-390-(b) (6) >> >> >> -----Original Message---->> From: Bruce Moskowitz [mailto:(b) (6) gmail.com] >> Sent: Wednesday, May 31, 2017 12:08 PM >> To: Selnick, Darin; Thomas, Rob C. II - VA-18-0298 and 18-0299-B-000269 >> Subject: [EXTERNAL] June 14 call >> >> I I need to review who is speaking on item one for the VA prior to the call. Thank you >> >> Sent from my iPad >> Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000270 From: To: Cc: Bcc: Subject: Date: Attachments: Mulligan, Ricci ; (b) (6) mayo.edy <(b) (6) mayo.edy>; Selnick, Darin ; Selnick, Darin (b) (6) <(b) (6) apple.com>; Bruce Moskowitz <(b) (6) mac.com>; (b) (6) gmail.com (b) (6) < gmail.com>; (b @frenchangel59.com ) <(b @frenchangel59.com>; vacodjs1@va.com ; (6 ) ) Alaigh, Poonam, M.D. ; mayo.edu (b) (6) (b) (6) < mayo.edu>; mayo.edu <(b) (6) mayo.edu>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) jhu.edu <(b) (6) jhu.edu>; (b) (6) kp.org <(b) (6) kp.org>; (b) (b) @responsivehealth.org < @responsivehealth.org>; (6) (6) (6) (b) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) (b) (6) (b) (6) (MSSM) < mssm.edu>; brefnet.org <(b) (6) brefnet.org>; (b) (6) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) BWH.HARVARD.EDU (b) (6) < bwh.harvard.edu>; (b) (6) (b) (6) mayo.edu>; (b) (6) ; (b) (6) ; cloverhealth.com <(b) (6) cloverhealth.com>; (b) (6) cognizant.com (b) (6) (b) (6) < cognizant.com>; cognizant.com <(b) (6) cognizant.com> I - - - - Cc: Bcc: Subject: [EXTERNAL] Agenda: Conference Call | VA, Apple & Medical/Digital Experts Wednesday, June 14th / 11:00 AM - 12:30 PM EST (8:00 AM - 9:30 AM PST) Date: Tue Jun 13 2017 11:33:28 CDT Attachments: confcallagenda.pdf Wednesday, June 14th 11:00 AM - 12:30 PM EST (8:00 AM - 9:30 AM PST) Dial-in Information: - (4), US: 1-866-244-(b) (b) (5) VA-18-0298 and 18-0299-B-000285 - (4), International: 719-457-(b) (b) (5) - (4), (b) Passcode: (b) (5) *6 - Mute or un-mute your line Thank you, (b) (6) -- 212-576-(b) (6) (Office) (646) 201-(b) (6) (Cell) (b) (6) frenchangel59.com VA-18-0298 and 18-0299-B-000286 Owner: Filename: Last Modified: (b) (6) --- <(b) (6) frenchangel59.com> confcallagenda.pdf Tue Jun 13 11:33:28 CDT 2017 VA-18-0298 and 18-0299-B-000287 confcallagenda.pdf for Printed Item: 86 ( Attachment 1 of 1) Conference Call | VA, Apple & Medical/Digital Experts Date: Wednesday | June 14, 2017 Time: 11 a.m. - 12:30 p.m. ET/10 - 11:30 a.m. CT/8 - 9:30 a.m. PT Dial-in Information: (4), United States: 1.866.244.(b) (b) (5) - (4), International: 719.457(b) (b) (5) - 1111 Passcode: (b) (4), (b) (5) Participants: Bruce Moskowitz, M.D. Marc Sherman Ike Perlmutter Apple: (b) (6) (b) (6) (b) (6) (b) (6) - Apple, Chief Executive Officer - Apple, Chief Operating Officer - Apple, Director of Global Government - Apple, Vice President for Public Policy and Government Affairs Office of Veterans Affairs: David Shulkin, M.D. - Secretary of Veterans Affairs Poonam Alaigh, M.D. - Acting Under-Secretary for Health Darin Selnick - Senior Advisor to the Secretary Rob C. Thomas II - Acting Assistant Secretary & Chief Information Officer Department of Veterans Affairs (b) (6) (b) (6) - Senior Advisor, Acting Under-Secretary for Health, Department of Veterans Affairs, Veterans Health Administration -- Medical Institutions: - Chief Information Officer, Mayo Clinic (b) (6) M.D. - Associate Dean/Center for Connected Care, Mayo Clinic (b) (6) - Interim Chief Information Officer, Cleveland Clinic (b) (6) M.D. - Associate Chief Information Officer, Cleveland Clinic (b) (6) - Senior Vice President and CIO, Johns Hopkins Health System, Johns Hopkins Medicine, Vice Provost and CIO, Johns Hopkins University (b) (6) - Senior Vice President, Care Delivery Technology Services, Kaiser Permanente (b) (6) - Cofounder, CEO - Responsive Health (b) (6) M.D. - Co-founder, Responsive Health/ Mount Sinai Health System (b) (6) - Payer Advisor, Responsive Health (b) (6) - Development Head, Responsive Health (b) (6) - SME for Public Sector, Responsive Health (b) (6) - Biomedical Research & Education Foundation, Executive Director (b) (6) M.D. - Vice President, Connected Health | Partners HealthCare (b) (6) M.D. - Chief Information Officer and Vice President, Information Systems, Brigham Health (b) (6) - Moderator: - Chair, Department of Public Affairs/Mayo Clinic (b) (6) VA-18-0298 and 18-0299-B-000288 confcallagenda.pdf for Printed Item: 86 ( Attachment 1 of 1) Agenda: - 1) Introductions - (b) (6) Moderator 2) Review/Discussion of Purpose of Call - All Draft Meeting Objectives: o Consensus/endorsement of goals o Define roadmap and next steps o Determine core working team moving forward/ARCIV 3) Project Objectives/Status | Veteran's Administration Perspective - David Shulkin, M.D. 4) Perspective of the Medical Experts - What Works/What Doesn't - Medical Experts o Status of portable medical record for the private sector o What will it take to get to "state of the art?" o Preventive health/early detection of disease o How does the medical record pick up that which may threaten health o What are medical centers working on that has been well received by patients? 5) Discussion of Digital/Veteran Platform Project Road Map - (b) (6) Digital Veteran Platform Experience.d The attachment that reflects shared perspective of medical providers/Apple team. 6) Review/Discussion of Potential Project Requirements - All o Clinical needs re: obtaining information from the patient's EMR o Quick reference screen ? Patient problem list ? Medications ? Allergies ? Laboratory results ? Diagnostic tests by specialty ? Clinical notes by specialty o Dynamic vs. static EMR o Early disease detection o Chart medication adherence o Laboratory results depicted by in graph form to permit lifestyle modification conversations o Alerts for follow-up appointments/tests o Integration of clinical notes, lab and diagnostic text into integrated platform 7) Next steps Discussion: o Defining the core working team - ARCIV o Timeline VA-18-0298 and 18-0299-B-000289 confcallagenda.pdf for Printed Item: 86 ( Attachment 1 of 1) Digital Veteran Platform: Veteran-Mediated Data Exchange Background Improving the Veterans' experience and enhancing strategic partnerships are two of the key focus areas for the 2015 myVA Transformational Plan. Recognizing that technology will be the foundation on which this transformation will occur, the VA has proposed a "Digital Veteran Platform." The objective of this platform is to "build an ecosystem enabling external integration and innovation enabling transparency with Veterans and their care providers while expanding use of data with real-time analytics to support automated recommendations for care." As a complement to this platform, the VA and the White House have proposed a collaboration with innovative health systems and Apple to work on four initiatives: 1. Care Finder: a mechanism for Veterans to discover an appropriate medical facility and/or physician based on available services and location. 2. Veteran Health Data Exchange (VHDE): the ability for Veterans to download and view health records from both the Veteran sector and private sector on a portable device. 3. Improve Medication Tracking: a technology solution for Veterans to view medications and be able to track medication compliance, preventing over-utilization of controlled substances, and preventing medication errors. 4. Transitions of Care: a system that facilitates Veteran compliance with discharge recommendations (e.g., prescription pick-up, medication compliance, follow-up appointments, home health services) and communicates status to the care team. This digital platform is being proposed at a time when the national health expenditure is rapidly increasing, representing 17.8% of GDP in 2015, or $3.2 trillion ($9,990 per person), a 5.8% rise compared to the previous year.i Despite these costs, the US remains well behind its peers in how efficiently that expenditure results in improved health and longevity. ii There is growing recognition that the fundamental changes required to reduce costs and improve outcomes in our healthcare system must begin with empowering the patient to take a greater role in her/his care. Initiatives such as Open Notes - which the VA helped to pioneer have shown that giving a patient full and transparent access to her/his health records improves safety as well as trust in the clinical relationship.iii Furthermore, evidence is mounting that empowering patients to care for themselves results in decreased costs and improved outcomes. iv However, patients today lack the ability to get an integrated view of their health data across a myriad of electronic health record (EHR) systems in the marketplace. Fortunately, private sector initiatives such as the Argonaut Projectv have proven that EHR vendors can align with the interests of patients and health systems to agree on a path forward involving standard application programming interfaces (APIs) for health. Additionally, bipartisan legislation such as the 21st-Century Cures Act has required health IT products to expose health data via APIs. These advances, when taken together, pave the way for a true 21st-Century Health IT System designed with the patient at the center.vi The National eHealth Exchange has also supported VA-18-0298 and 18-0299-B-000290 confcallagenda.pdf for Printed Item: 86 ( Attachment 1 of 1) health information exchange for clinicians, but this information is generally not directly available for patient viewing. It is within this rich milieu of health IT advancement that the VA and the White House have proposed this collaboration to identify solutions to problems for which the feasibility of a solution is only just becoming a reality. The VA has long been a pioneer in health IT innovation, which has been a necessity given their large and geographically diverse patient population. This is yet another opportunity for the VA to set an example for the rest of the country to follow, and it couldn't come at a more critical time for our nation. Proposal In order to achieve the greatest benefit for our Veterans in the shortest amount of time, we propose that this set of initiatives should begin by leveraging the work of the standards community to enable Veteran health data exchange (initiative #2 above). Only after this is in place will we be able to explore the feasibility of improved medication tracking and seamless transitions of care. The 'Care Finder' functionality (initiative #1 above) represents an extension of the current VA tool found at vets.gov, however, a more patient-centric approach would likely improve Veteran engagement. The lack of a national health system, universal patient identifier, and common provider directory presents several challenges with respect to ensuring this resource is accurate and up to date. This concept and implementation will continue to be explored. Five health systems have agreed to participate in support of these initiatives: o o o o o Cleveland Clinic Johns Hopkins Medicine Kaiser Permanente Mayo Clinic Partners HealthCare The 5 selected health systems will implement APIs based on the Fast Healthcare Interoperability Resources (FHIR) standard, as outlined in the Argonaut Data Query Implementation Guide 1.0.0:vii All major EHR vendors, including Epic and Cerner, have implemented or are working on the implementation of this standard within their software. This is of critical importance given the recent announcement by U.S. Secretary of Veterans Affairs Dr. David J. Shulkin that the VA will adopt the Cerner EHR to replace their current VistA health records system.viii Once this is in place, Apple will enable the Veteran to access the following items from her/his health record: problems, medications, allergies, laboratory test results, and procedures. The health records of multiple institutions may be aggregated and harmonized into one 'virtual' master copy, available for viewing. This data will continue to reside within each organization, but be accessible to Veterans via APIs to present the information when requested. VA-18-0298 and 18-0299-B-000291 confcallagenda.pdf for Printed Item: 86 ( Attachment 1 of 1) Given the reality that many Veterans receive a portion of their care at non-VA health systems (a fact accelerated by the 2014 Choice Act ix), this newfound data portability - with the patient at the center - will ensure that VA providers always have the most up-to-date information about a patient so that they can provide the most effective care. This work will begin as a limited pilot among patients who receive care at both the VA and one of the 5 health systems listed above. It will then be implemented across the VA and to any interested health system in the U.S. who has an EHR platform compatible with this open standard. Guiding Principles Healthcare is complex, and the challenges will be difficult to address. In order to succeed, all participants must be aligned according to a set of guiding principles. We propose to adhere to the following: 1. 2. 3. 4. We will act in the best interests of the Veteran. We will support the ability of the Veteran's care team to provide the best care. We will identify and implement standards-based solutions, where possible. We will deploy solutions that can be leveraged and adopted by the healthcare industry more broadly. Next Steps Implementing the Veteran health data exchange functionality will require coordination across the health systems, the VA, and Apple. We propose that each entity select appropriate technical and business representatives to serve on an exploratory workgroup in order to define milestones, timelines, and priorities, and to have this workgroup in place by August 31, 2017. Additional members may be included as needed. This group should also identify any barriers, impediments or concerns that need to be addressed in order to further the work. The workgroup will be led by a designated representative from the VA. While this scope of this initiative will initially be constrained in order to provide something of value to Veterans in a relatively short period of time, we recognize that there are many problems in health care worth solving, and see this as a stepping stone to work more closely with the VA to identify and find sustainable solutions to their most pressing needs. It is hard to overstate the potential impact of this initiative; the nationwide implementation of a standards-based approach to patient-mediated data access and exchange across the VA and partner institutions will serve as a model for the future of healthcare, not only in the US, but around the world. It will set a standard by which all other health systems will be judged, and patients, once they realize the freedom and power it affords, will not settle for anything less. i https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-andreports/nationalhealthexpenddata/nationalhealthaccountshistorical.html ii https://www.bloomberg.com/news/articles/2016-09-29/u-s-health-care-system-ranks-as-one-of-the-least-efficient iii http://www.nejm.org/doi/full/10.1056/NEJMp1310132 iv https://hbr.org/2017/06/the-value-of-teaching-patients-to-administer-their-own-care VA-18-0298 and 18-0299-B-000292 confcallagenda.pdf for Printed Item: 86 ( Attachment 1 of 1) v http://argonautwiki.hl7.org/index.php?title=Main_Page http://www.nejm.org/doi/full/10.1056/NEJMp1700235 vii http://www.fhir.org/guides/argonaut/r2/ viii https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2914 ix https://www.va.gov/opa/choiceact/documents/choice-act-summary.pdf vi VA-18-0298 and 18-0299-B-000293 From: To: (b) (6) <(b) (6) frenchangel59.com> (b) (6) <(b) (6) apple.com>; Bruce Moskowitz <(b) (6) mac.com>; (b) (6) gmail.com (b) (6) < gmail.com>; (b @frenchangel59.com ) <(b @frenchangel59.com>; vacodjs1@va.com ; (6 ) ) Alaigh, Poonam, M.D. ; mayo.edu (b) (6) (b) (6) < mayo.edu>; mayo.edu <(b) (6) mayo.edu>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) jhu.edu <(b) (6) jhu.edu>; (b) (6) kp.org <(b) (6) kp.org>; (b) (b) @responsivehealth.org < @responsivehealth.org>; (6) (6) (6) (b) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) (b) (6) (b) (6) (MSSM) < mssm.edu>; brefnet.org <(b) (6) brefnet.org>; (b) (6) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) BWH.HARVARD.EDU (b) (6) < bwh.harvard.edu>; (b) (6) (b) (6) mayo.edu>; (b) (6) ; (b) (6) ; cloverhealth.com <(b) (6) cloverhealth.com>; (b) (6) cognizant.com (b) (6) (b) (6) < cognizant.com>; cognizant.com <(b) (6) cognizant.com> I - - - - Cc: Bcc: Subject: [EXTERNAL] UPDATED ATTACHMENT: Agenda: Conference Call | VA, Apple & Medical/Digital Experts - Wednesday, June 14th / 11:00 AM - 12:30 PM EST (8:00 AM - 9:30 AM PST) Date: Tue Jun 13 2017 11:46:39 CDT Attachments: confcallagenda.pdf This content should not be distributed outside of the participants of this call nor should it be published publicly. Date: Wednesday | June 14, 2017 VA-18-0298 and 18-0299-B-000294 Time: 11 a.m. - 12:30 p.m. ET/10 - 11:30 a.m. CT/8 - 9:30 a.m. PT Dial-in Information: (4), United States: 1.866.244.(b) (b) (5) - - (4), International: 719.457.(b) (b) (5) (4), (b) Passcode: (b) (5) *6 - Mute or un-mute your line Participants: Bruce Moskowitz, M.D. Marc Sherman Ike Perlmutter Apple: (b) (6) (b) (6) (b) (6) (b) (6) - Apple, Chief Executive Officer - Apple, Chief Operating Officer - Apple, Director of Global Government - Apple, Vice President for Public Policy and Government Affairs Office of Veterans Affairs: David Shulkin, M.D. - Secretary of Veterans Affairs Poonam Alaigh, M.D. - Acting Under-Secretary for Health Darin Selnick - Senior Advisor to the Secretary Rob C. Thomas II - Acting Assistant Secretary & Chief Information Officer -- Department of Veterans Affairs (b) (6) - Senior Advisor, Acting Under-Secretary for Health, Department of Veterans Affairs, Veterans Health Administration (b) (6) Medical Institutions: (b) (6) (b) (6) (b) (6) - Chief Information Officer, Mayo Clinic M.D. - Associate Dean/Center for Connected Care, Mayo Clinic - Interim Chief Information Officer, Cleveland Clinic VA-18-0298 and 18-0299-B-000295 (b) (6) M.D. - Associate Chief Information Officer, Cleveland Clinic (b) (6) - Senior Vice President and CIO, Johns Hopkins Health System, Johns Hopkins Medicine, Vice Provost and CIO, Johns Hopkins University -(b) (6) - Senior Vice President, Care Delivery Technology Services, Kaiser Permanente (b) (6) - Cofounder, CEO - Responsive Health (b) (6) M.D. - Co-founder, Responsive Health/ Mount Sinai Health System (b) (6) - Payer Advisor, Responsive Health (b) (6) - Development Head, Responsive Health (b) (6) - SME for Public Sector, Responsive Health (b) (6) - Biomedical Research & Education Foundation, Executive Director (b) (6) M.D. - Vice President, Connected Health | Partners HealthCare (b) (6) M.D. - Chief Information Officer and Vice President, Information Systems, Brigham Health Moderator: (b) (6) - Chair, Department of Public Affairs/Mayo Clinic Agenda: - 1) Introductions - (b) (6) 2) Review/Discussion of Purpose of Call - All Moderator Draft Meeting Objectives: ****** Consensus/endorsement of goals ****** Define roadmap and next steps ****** Determine core working team moving forward/ARCIV 3) Project Objectives/Status | Veteran's Administration Perspective - David Shulkin, M.D. 4) Perspective of the Medical Experts - What Works/What Doesn't - Medical Experts VA-18-0298 and 18-0299-B-000296 ****** Status of portable medical record for the private sector ****** What will it take to get to "state of the art?" o Preventive health/early detection of disease o How does the medical record pick up that which may threaten health ****** What are medical centers working on that has been well received by patients? 5) Discussion of Digital/Veteran Platform Project Road Map - (b) (6) 6) Review/Discussion of Potential Project Requirements - All ********* Clinical needs re: obtaining information from the patient's EMR o Quick reference screen ** Patient problem list ** Medications ** Allergies ** Laboratory results ** Diagnostic tests by specialty ** Clinical notes by specialty ********* Dynamic vs. static EMR ********* Early disease detection ********* Chart medication adherence ********* Laboratory results depicted by in graph form to permit lifestyle modification conversations ********* Alerts for follow-up appointments/tests ********* Integration of clinical notes, lab and diagnostic text into integrated platform 7) Next steps Discussion: ********* Defining the core working team - ARCIV ********* Timeline VA-18-0298 and 18-0299-B-000297 Thank you, (b) (6) -- 212-576-(b) (6) (Office) (646) 201-(b) (6) (Cell) (b) (6) frenchangel59.com VA-18-0298 and 18-0299-B-000298 Owner: Filename: Last Modified: (b) (6) --- <(b) (6) frenchangel59.com> confcallagenda.pdf Tue Jun 13 11:46:39 CDT 2017 VA-18-0298 and 18-0299-B-000299 confcallagenda.pdf for Printed Item: 88 ( Attachment 1 of 1) Conference Call | VA, Apple & Medical/Digital Experts Date: Wednesday | June 14, 2017 Time: 11 a.m. - 12:30 p.m. ET/10 - 11:30 a.m. CT/8 - 9:30 a.m. PT Dial-in Information: (4), (b) United States: 1.866.24(b) (5) International: 719.45(b) (4), (b) (5) Passcode: (b) (4), (b) (5) Participants: Bruce Moskowitz, M.D. Marc Sherman Ike Perlmutter Apple: (b) (6) (b) (6) (b) (6) (b) (6) - Apple, Chief Executive Officer - Apple, Chief Operating Officer - Apple, Director of Global Government - Apple, Vice President for Public Policy and Government Affairs Office of Veterans Affairs: David Shulkin, M.D. - Secretary of Veterans Affairs Poonam Alaigh, M.D. - Acting Under-Secretary for Health Darin Selnick - Senior Advisor to the Secretary Rob C. Thomas II - Acting Assistant Secretary & Chief Information Officer Department of Veterans Affairs (b) (6) (b) (6) - Senior Advisor, Acting Under-Secretary for Health, Department of Veterans Affairs, Veterans Health Administration Medical Institutions: - Chief Information Officer, Mayo Clinic (b) (6) M.D. - Associate Dean/Center for Connected Care, Mayo Clinic (b) (6) - Interim Chief Information Officer, Cleveland Clinic (b) (6) M.D. - Associate Chief Information Officer, Cleveland Clinic (b) (6) - Senior Vice President and CIO, Johns Hopkins Health System, Johns Hopkins Medicine, Vice Provost and CIO, Johns Hopkins University (b) (6) - Senior Vice President, Care Delivery Technology Services, Kaiser Permanente (b) (6) - Cofounder, CEO - Responsive Health (b) (6) M.D. - Co-founder, Responsive Health/ Mount Sinai Health System (b) (6) - Payer Advisor, Responsive Health (b) (6) - Development Head, Responsive Health (b) (6) - SME for Public Sector, Responsive Health (b) (6) - Biomedical Research & Education Foundation, Executive Director (b) (6) M.D. - Vice President, Connected Health | Partners HealthCare (b) (6) M.D. - Chief Information Officer and Vice President, Information Systems, Brigham Health (b) (6) Moderator: - Chair, Department of Public Affairs/Mayo Clinic (b) (6) VA-18-0298 and 18-0299-B-000300 confcallagenda.pdf for Printed Item: 88 ( Attachment 1 of 1) Agenda: 1) Introductions - (b) (6) Moderator 2) Review/Discussion of Purpose of Call - All Draft Meeting Objectives: ? Consensus/endorsement of goals ? Define roadmap and next steps ? Determine core working team moving forward/ARCIV 3) Project Objectives/Status | Veteran's Administration Perspective - David Shulkin, M.D. 4) Perspective of the Medical Experts - What Works/What Doesn't - Medical Experts ? Status of portable medical record for the private sector ? What will it take to get to "state of the art?" o Preventive health/early detection of disease o How does the medical record pick up that which may threaten health ? What are medical centers working on that has been well received by patients? 5) Discussion of Digital/Veteran Platform Project Road Map - (b) (6) Digital Veteran Platform Experience.docx The attachment that reflects shared perspective of medical providers/Apple team. 6) Review/Discussion of Potential Project Requirements - All ? Clinical needs re: obtaining information from the patient's EMR o Quick reference screen ? Patient problem list ? Medications ? Allergies ? Laboratory results ? Diagnostic tests by specialty ? Clinical notes by specialty ? Dynamic vs. static EMR ? Early disease detection ? Chart medication adherence ? Laboratory results depicted by in graph form to permit lifestyle modification conversations ? Alerts for follow-up appointments/tests ? Integration of clinical notes, lab and diagnostic text into integrated platform 7) Next steps Discussion: ? Defining the core working team - ARCIV ? Timeline VA-18-0298 and 18-0299-B-000301 confcallagenda.pdf for Printed Item: 88 ( Attachment 1 of 1) This content should not be distributed outside of the participants of this call nor should it be published publicly. Digital Veteran Platform: Veteran-Mediated Data Exchange Background Improving the Veterans' experience and enhancing strategic partnerships are two of the key focus areas for the 2015 myVA Transformational Plan. Recognizing that technology will be the foundation on which this transformation will occur, the VA has proposed a "Digital Veteran Platform." The objective of this platform is to "build an ecosystem enabling external integration and innovation enabling transparency with Veterans and their care providers while expanding use of data with real-time analytics to support automated recommendations for care." As a complement to this platform, the VA and the White House have proposed a collaboration with innovative health systems and Apple to work on four initiatives: 1. Care Finder: a mechanism for Veterans to discover an appropriate medical facility and/or physician based on available services and location. 2. Veteran Health Data Exchange (VHDE): the ability for Veterans to download and view health records from both the Veteran sector and private sector on a portable device. 3. Improve Medication Tracking: a technology solution for Veterans to view medications and be able to track medication compliance, preventing over-utilization of controlled substances, and preventing medication errors. 4. Transitions of Care: a system that facilitates Veteran compliance with discharge recommendations (e.g., prescription pick-up, medication compliance, follow-up appointments, home health services) and communicates status to the care team. This digital platform is being proposed at a time when the national health expenditure is rapidly increasing, representing 17.8% of GDP in 2015, or $3.2 trillion ($9,990 per person), a 5.8% rise compared to the previous year.i Despite these costs, the US remains well behind its peers in how efficiently that expenditure results in improved health and longevity.ii There is growing recognition that the fundamental changes required to reduce costs and improve outcomes in our healthcare system must begin with empowering the patient to take a greater role in her/his care. Initiatives such as Open Notes - which the VA helped to pioneer have shown that giving a patient full and transparent access to her/his health records improves safety as well as trust in the clinical relationship.iii Furthermore, evidence is mounting that empowering patients to care for themselves results in decreased costs and improved outcomes.iv However, patients today lack the ability to get an integrated view of their health data across a myriad of electronic health record (EHR) systems in the marketplace. Fortunately, private sector initiatives such as the Argonaut Projectv have proven that EHR vendors can align with the interests of patients and health systems to agree on a path forward involving standard application programming interfaces (APIs) for health. Additionally, bipartisan legislation such as the 21st-Century Cures Act has required health IT products to expose health data via APIs. These advances, when taken together, pave the way for a true 21st-Century Health IT System designed with the patient at the center.vi The National eHealth Exchange has also supported VA-18-0298 and 18-0299-B-000302 confcallagenda.pdf for Printed Item: 88 ( Attachment 1 of 1) health information exchange for clinicians, but this information is generally not directly available for patient viewing. It is within this rich milieu of health IT advancement that the VA and the White House have proposed this collaboration to identify solutions to problems for which the feasibility of a solution is only just becoming a reality. The VA has long been a pioneer in health IT innovation, which has been a necessity given their large and geographically diverse patient population. This is yet another opportunity for the VA to set an example for the rest of the country to follow, and it couldn't come at a more critical time for our nation. Proposal In order to achieve the greatest benefit for our Veterans in the shortest amount of time, we propose that this set of initiatives should begin by leveraging the work of the standards community to enable Veteran health data exchange (initiative #2 above). Only after this is in place will we be able to explore the feasibility of improved medication tracking and seamless transitions of care. The 'Care Finder' functionality (initiative #1 above) represents an extension of the current VA tool found at vets.gov, however, a more patient-centric approach would likely improve Veteran engagement. The lack of a national health system, universal patient identifier, and common provider directory presents several challenges with respect to ensuring this resource is accurate and up to date. This concept and implementation will continue to be explored. Five health systems have agreed to participate in support of these initiatives: o o o o o Cleveland Clinic Johns Hopkins Medicine Kaiser Permanente Mayo Clinic Partners HealthCare The 5 selected health systems will implement APIs based on the Fast Healthcare Interoperability Resources (FHIR) standard, as outlined in the Argonaut Data Query Implementation Guide 1.0.0:vii All major EHR vendors, including Epic and Cerner, have implemented or are working on the implementation of this standard within their software. This is of critical importance given the recent announcement by U.S. Secretary of Veterans Affairs Dr. David J. Shulkin that the VA will adopt the Cerner EHR to replace their current VistA health records system.viii Once this is in place, Apple will enable the Veteran to access the following items from her/his health record: problems, medications, allergies, laboratory test results, immunizations, vital signs, and procedures. The health records of multiple institutions may be aggregated and harmonized into one 'virtual' master copy, available for viewing. This data will continue to reside within each organization, but be accessible to Veterans via APIs to present the information when requested. VA-18-0298 and 18-0299-B-000303 confcallagenda.pdf for Printed Item: 88 ( Attachment 1 of 1) Given the reality that many Veterans receive a portion of their care at non-VA health systems (a fact accelerated by the 2014 Choice Actix), this newfound data portability - with the patient at the center - will ensure that VA providers always have the most up-to-date information about a patient so that they can provide the most effective care. This work will begin as a limited pilot among patients who receive care at both the VA and one of the 5 health systems listed above. It will then be implemented across the VA and to any interested health system in the U.S. who has an EHR platform compatible with this open standard. Guiding Principles Healthcare is complex, and the challenges will be difficult to address. In order to succeed, all participants must be aligned according to a set of guiding principles. We propose to adhere to the following: 1. 2. 3. 4. We will act in the best interests of the Veteran. We will support the ability of the Veteran's care team to provide the best care. We will identify and implement standards-based solutions, where possible. We will deploy solutions that can be leveraged and adopted by the healthcare industry more broadly. Next Steps Implementing the Veteran health data exchange functionality will require coordination across the health systems, the VA, and Apple. We propose that each entity select appropriate technical and business representatives to serve on an exploratory workgroup in order to define milestones, timelines, and priorities, and to have this workgroup in place by August 31, 2017. Additional members may be included as needed. This group should also identify any barriers, impediments or concerns that need to be addressed in order to further the work. The workgroup will be led by a designated representative from the VA. While the scope of this initiative will initially be constrained in order to provide something of value to Veterans in a relatively short period of time, we recognize that there are many problems in health care worth solving, and see this as a stepping stone to work more closely with the VA to identify and find sustainable solutions to their most pressing needs. It is hard to overstate the potential impact of this initiative; the nationwide implementation of a standards-based approach to patient-mediated data access and exchange across the VA and partner institutions will serve as a model for the future of healthcare, not only in the US, but around the world. It will set a standard by which all other health systems will be judged, and patients, once they realize the freedom and power it affords, will not settle for anything less. i https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-andreports/nationalhealthexpenddata/nationalhealthaccountshistorical.html ii https://www.bloomberg.com/news/articles/2016-09-29/u-s-health-care-system-ranks-as-one-of-the-least-efficient iii http://www.nejm.org/doi/full/10.1056/NEJMp1310132 iv https://hbr.org/2017/06/the-value-of-teaching-patients-to-administer-their-own-care VA-18-0298 and 18-0299-B-000304 confcallagenda.pdf for Printed Item: 88 ( Attachment 1 of 1) v http://argonautwiki.hl7.org/index.php?title=Main_Page http://www.nejm.org/doi/full/10.1056/NEJMp1700235 vii http://www.fhir.org/guides/argonaut/r2/ viii https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2914 ix https://www.va.gov/opa/choiceact/documents/choice-act-summary.pdf vi This content should not be distributed outside of the participants of this call nor should it be published publicly. VA-18-0298 and 18-0299-B-000305 (b) (6) From: ; (b) (6) <(b) (6) apple.com>; Bruce Moskowitz (b) (6) < mac.com>; (b) (6) gmail.com <(b) (6) gmail.com>; (b @frenchangel59.com ) <(b @frenchangel59.com>; vacodjs1@va.com ; (6 ) ) Alaigh, Poonam, M.D. ; mayo.edu (b) (6) (b) (6) < mayo.edu>; mayo.edu <(b) (6) mayo.edu>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) ccf.org <(b) (6) ccf.org>; (b) (6) jhu.edu <(b) (6) jhu.edu>; (b) (6) kp.org <(b) (6) kp.org>; (b) (b) @responsivehealth.org < @responsivehealth.org>; (6) (6) (b) (6) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) (b) (6) (b) (6) (MSSM) < mssm.edu>; brefnet.org <(b) (6) brefnet.org>; (b) (6) PARTNERS.ORG <(b) (6) partners.org>; (b) (6) BWH.HARVARD.EDU (b) (6) < bwh.harvard.edu>; (b) (6) (b) (6) mayo.edu>; (b) (6) ; (b) (6) ; cloverhealth.com <(b) (6) cloverhealth.com>; (b) (6) cognizant.com <(b) (6) cognizant.com>; (b) (6) cognizant.com (b) (6) < cognizant.com> To: - Cc: Bcc: Subject: Date: Attachments: - Veterans Affairs, Apple, Academic Health System Collaboration Wed Jun 14 2017 13:45:43 CDT Good Afternoon, Thank you for your participation on the mid-day call to discuss the collaboration between the Veterans Affairs, Apple and the five academic medical centers. As we discussed, we will begin by identifying those individuals from each of the aforementioned organizations to serve on a governance committee as well as those individuals who will be part of the work group for this initiative. Please forward your recommendations and their contact information to me by Thursday June 22 ((b) (6) va.gov ). Thank you for your participation and enthusiasm! (b) (6) (b) (6) VA-18-0298 and 18-0299-B-000306 Senior Advisor, acting Under Secretary for Health Department of Veterans Affairs Veterans Health Administration 810 Vermont Avenue, NW - Rm. (b) (6) Washington, DC 20420 - iPhone: 202-407-(b) (6) (b) (6) va.gov VA-18-0298 and 18-0299-B-000307 From: Selnick, Darin (b) (6) Date: June 26, 2017 at 3:13:36 PM EDT To: (b) (6) <(b) (6) jhu.edu>, (b) (6) <(b) (6) ccf.org>, "(b) (6) <(b) (6) kp.org>, "(b) (6) <(b) (6) mayo.edu>, (b) (6) kp. (b) (6) (b) (6) (b) (6) (b) (6) org, < jhmi.edu>, " < mayo.edu>, "(b) (6) <(b) (6) mayo.edu>, (b) (6) ccf.org, (b) (6) ccf.org, (b) (6) partners.org, (b) (6) (b) (6) (b) (6) (b) (6) PARTNERS.ORG, " M.D." < ccf.org>, (b) (6) <(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) @va.gov>, < apple.com>, < apple.com>, (b) (6) (b) (6) (b) (6) (b) (6) < apple.com>, < apple.com>, IP (b) (6) (b) (6), (b) (5) <(b @frenchangel59.com>, gmail.com, va.gov, Poonam Alaigh ) (6) <(b) hotmail.com>, (b) (6) aol.com, (b) (6) jhhc.com (6 ) Subject: VA-Apple EMR Project As we discussed on the conference call we have set up three committees to commence work (the academic centers may add to the working group). I want to take the opportunity to thank everyone for their commitment to this important project. We will have available to the group, the ability to tap the end user in different medical specialties with an emphasis on primary care and preventative medicine along with surgical sub specialists. If their is an omission or change in assignment please contact me. The executive committee: VA Representatives: Dr. David Shulkin Dr. Poonam Alaigh Apple representatives: (b) (6) 5 Academic Centers Johns Hopkins (b) (6) Partners (b) (6) Cleveland (b) (6) Mayo Clinic to assign Kaiser Permanente (b) (6) Mr. Marc Sherman Mr. IKe Perlmutter Dr. Bruce Moskowitz Mid level project Managers: - VA: Rob Thomas, (b) (6)(b) (6) Apple: (b) (6) (b) (6) Academic Medical Centers (b) (6) Johns Hopkins (b) (6) (b) (6) Partners: M.D., (b) (6) (b) (6) (b) (6) Cleveland Clinic: (b) (6) Mayo Clinic: M.D., (b) (6) (b) (6) Kaiser Permanente, (b) (6) BREF Foundation (b) (6) M.D. M.D. VA-18-0298 and 18-0299-B-000309 Working Group (b) (6) VA: (b) (6) John Short, (b) (6) (6) (b) (6) Apple: (working Group Manager) (b) (6) (b) (6) Academic Centers: (b) (6) (b) (6) (b) (6) and from KP (b) (6) Dr. CC - from Partners Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000310 From: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin wrote: Hi Bruce Your email from earlier today was forwarded to me. There seems to be some misunderstanding as to my role as I was not on the email nor am I listed in it. As you know, I have had the VA responsibility to provide the overall responsibility to manage and provide oversight for the VA/Apple/Center partnership. -- - I still do have that responsibility. Please add me to the Mid Level Project Manager list, as I coordinate with Rob and (b) (6) update Dr. Shulkin,I communicate on a regular basis with (b) (6) from Apple, and update (b) (6) at the WH. - I would also appreciate you cc me in your communications on this project with VA staff, Rob and (b) (6) Thanks so much VA-18-0298 and 18-0299-B-000311 Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) : From: Bruce Moskowitz <(b) (6) mac.com> Date: June 26, 2017 at 3:13:36 PM EDT To: (b) (6) <(b) (6) jhu.edu>, (b) (6) <(b) (6) ccf.org>, "(b) (6) (b) (6) (b) (6) (b) (6) < kp.org>, " < mayo.edu>, (b) (6) kp. (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) org, < jhmi.edu>, " < mayo.edu>, " <(b) (6) mayo.edu>, (b) (6) ccf.org, (b) (6) ccf.org, (b) (6) partners.org, (b) (6) (b) (6) PARTNERS.ORG, "(b) (6) M.D." <(b) (6) ccf.org>, (b) (6) , < apple.com>, < apple.com>, (b) (6) <(b) (6) apple.com>, (b) (6) <(b) (6) apple.com>, IP (b (b) (6) (b) (6), (b) (5) <) @frenchangel59.com>, gmail.com, va.gov, Poonam Alaigh (b) (6) (b) (6) (b) (6) <(6 hotmail.com>, aol.com, jhhc.com ) Subject: VA-Apple EMR Project As we discussed on the conference call we have set up three committees to commence work (the academic centers may add to the working group). I want to take the opportunity to thank everyone for their commitment to this important project. We will have available to the group, the ability to tap the end user in different medical specialties with an emphasis on primary care and preventative medicine along with surgical sub specialists. If their is an omission or change in assignment please contact me. The executive committee: VA Representatives: Dr. David Shulkin Dr. Poonam Alaigh Apple representatives: (b) (6) 5 Academic Centers Johns Hopkins (b) (6) Partners (b) (6) Cleveland (b) (6) Mayo Clinic to assign Kaiser Permanente (b) (6) Mr. Marc Sherman Mr. IKe Perlmutter Dr. Bruce Moskowitz Mid level project Managers: - VA: Rob Thomas, (b) (6)(b) (6) VA-18-0298 and 18-0299-B-000312 Apple: (b) (6) (b) (6) Academic Medical Centers (b) (6) Johns Hopkins (b) (6) (b) (6) Partners: M.D., (b) (6) (b) (6) (b) (6) Cleveland Clinic: Mayo Clinic: (b) (6) M.D., (b) (6) (b) (6) Kaiser Permanente, (b) (6) BREF Foundation (b) (6) M.D. M.D. Working Group (b) (6) VA: (b) (6) John Short, (b) (6) (6) Apple: (b) (6) (working Group Manager) (b) (6) (b) (6) Academic Centers: (b) (6) (b) (6) (b) (6) and from KP Dr. (b) (6) CC - from Partners Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000313 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) wrote: Hi Bruce Your email from earlier today was forwarded to me. There seems to be some misunderstanding as to my role as I was not on the email nor am I listed in it. VA-18-0298 and 18-0299-B-000314 As you know, I have had the VA responsibility to provide the overall responsibility to manage and provide oversight for the VA/Apple/Center partnership. -- - I still do have that responsibility. Please add me to the Mid Level Project Manager list, as I coordinate with Rob and (b) (6) update Dr. Shulkin,I communicate on a regular basis with (b) (6) from Apple, and update (b) (6) at the WH. - I would also appreciate you cc me in your communications on this project with VA staff, Rob and (b) (6) Thanks so much Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) : From: Bruce Moskowitz <(b) (6) mac.com> Date: June 26, 2017 at 3:13:36 PM EDT To: (b) (6) <(b) (6) jhu.edu>, (b) (6) <(b) (6) ccf.org>, "(b) (6) (b) (6) (b) (6) (b) (6) < kp.org>, " < mayo.edu>, (b) (6) kp. (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) org, < jhmi.edu>, " < mayo.edu>, " <(b) (6) mayo.edu>, (b) (6) ccf.org, (b) (6) ccf.org, (b) (6) partners.org, (b) (6) (b) (6) PARTNERS.ORG, "(b) (6) M.D." <(b) (6) ccf.org>, (b) (6) , < apple.com>, < apple.com>, (b) (6) <(b) (6) apple.com>, (b) (6) <(b) (6) apple.com>, IP (b (b) (6) (b) (6), (b) (5) <) @frenchangel59.com>, gmail.com, va.gov, Poonam Alaigh (b) (6) (b) (6) (b) (6) <(6 hotmail.com>, aol.com, jhhc.com ) Subject: VA-Apple EMR Project As we discussed on the conference call we have set up three committees to commence work (the academic centers may add to the working group). I want to take the opportunity to thank everyone for their commitment to this important project. We will have available to the group, the ability to tap the end user in different medical specialties with an emphasis on primary care and preventative medicine along with surgical sub specialists. If their is an omission or change in assignment please contact me. The executive committee: VA Representatives: Dr. David Shulkin VA-18-0298 and 18-0299-B-000315 Dr. Poonam Alaigh Apple representatives: (b) (6) 5 Academic Centers Johns Hopkins (b) (6) Partners (b) (6) Cleveland (b) (6) Mayo Clinic to assign Kaiser Permanente (b) (6) Mr. Marc Sherman Mr. IKe Perlmutter Dr. Bruce Moskowitz Mid level project Managers: - VA: Rob Thomas, (b) (6)(b) (6) Apple: (b) (6) (b) (6) Academic Medical Centers (b) (6) Johns Hopkins (b) (6) (b) (6) Partners: M.D., (b) (6) (b) (6) Cleveland Clinic: (b) (6) (b) (6) Mayo Clinic: M.D., (b) (6) (b) (6) Kaiser Permanente, (b) (6) BREF Foundation (b) (6) M.D. M.D. Working Group (b) (6) VA: (b) (6) John Short, (b) (6) (6) (b) (6) Apple: (working Group Manager) (b) (6) (b) (6) Academic Centers: (b) (6) (b) (6) (b) (6) and from KP Dr. (b) (6) CC - from Partners Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000316 From: To: Cc: Bcc: Subject: Date: Attachments: Selnick, Darin (b) (6) wrote: Hi Bruce Your email from earlier today was forwarded to me. There seems to be some misunderstanding as to my role as I was not on the email nor am I listed in it. As you know, I have had the VA responsibility to provide the overall responsibility to manage and provide oversight for the VA/Apple/Center partnership. -- - I still do have that responsibility. Please add me to the Mid Level Project Manager list, as I coordinate with Rob and (b) (6) update Dr. Shulkin,I communicate on a regular basis with (b) (6) from Apple, and update (b) (6) at the WH. - I would also appreciate you cc me in your communications on this project with VA staff, Rob and (b) (6) Thanks so much Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) : From: Bruce Moskowitz <(b) (6) mac.com> Date: June 26, 2017 at 3:13:36 PM EDT To: (b) (6) <(b) (6) jhu.edu>, (b) (6) <(b) (6) ccf.org>, "(b) (6) (b) (6) (b) (6) (b) (6) < kp.org>, " < mayo.edu>, (b) (6) kp. (b) (6) (b) (6) (b) (6) (b) (6) org, < jhmi.edu>, " < mayo.edu>, "(b) (6) <(b) (6) mayo.edu>, (b) (6) ccf.org, (b) (6) ccf.org, (b) (6) partners.org, (b) (6) (b) (6) (b) (6) (b) (6) PARTNERS.ORG, " M.D." < ccf.org>, (b) (6) , < apple.com>, < apple. VA-18-0298 and 18-0299-B-000318 com>, (b) (6) <(b) (6) <(b @frenchangel59.com>, (b) (6) )(b) (6) <(6 hotmail.com>, (b) (6) ) Subject: VA-Apple EMR Project apple.com>, (b) (6) gmail.com, (b) (6), (b) (5) aol.com, (b) (6) jhhc.com - <(b) (6) apple.com>, IP va.gov, Poonam Alaigh As we discussed on the conference call we have set up three committees to commence work (the academic centers may add to the working group). I want to take the opportunity to thank everyone for their commitment to this important project. We will have available to the group, the ability to tap the end user in different medical specialties with an emphasis on primary care and preventative medicine along with surgical sub specialists. If their is an omission or change in assignment please contact me. The executive committee: VA Representatives: Dr. David Shulkin Dr. Poonam Alaigh Apple representatives: (b) (6) 5 Academic Centers Johns Hopkins (b) (6) Partners (b) (6) Cleveland (b) (6) Mayo Clinic to assign Kaiser Permanente (b) (6) Mr. Marc Sherman Mr. IKe Perlmutter Dr. Bruce Moskowitz Mid level project Managers: - VA: Rob Thomas, (b) (6)(b) (6) Apple: (b) (6) (b) (6) Academic Medical Centers (b) (6) Johns Hopkins (b) (6) (b) (6) Partners: M.D., (b) (6) (b) (6) (b) (6) Cleveland Clinic: (b) (6) Mayo Clinic: M.D., (b) (6) (b) (6) Kaiser Permanente, (b) (6) BREF Foundation (b) (6) M.D. M.D. Working Group (b) (6) VA: (b) (6) John Short, (b) (6) (6) (b) (6) Apple: (working Group Manager) (b) (6) (b) (6) Academic Centers: (b) (6) (b) (6) (b) (6) and from KP Dr. (b) (6) CC - from Partners Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000319 and Page 421 of 428 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) mac.com> Selnick, Darin wrote: Hi Bruce One more addition. For the VA working group please add Ricci Mulligan as the VA working group lead. Thanks Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) From: Bruce Moskowitz [mailto:(b) (6) Sent: Monday, June 26, 2017 7:23 PM To: Selnick, Darin mac.com] VA-18-0298 and 18-0299-B-000321 Cc: (b) (6) Thomas, Rob C. II Subject: Re: [EXTERNAL] Fwd: VA-Apple EMR Project Thank you for the update please refer to the last sentence in my email each organization will add corrections to the list Sent from my iPad Bruce Moskowitz M.D. On Jun 26, 2017, at 6:14 PM, Selnick, Darin wrote: Hi Bruce Your email from earlier today was forwarded to me. There seems to be some misunderstanding as to my role as I was not on the email nor am I listed in it. As you know, I have had the VA responsibility to provide the overall responsibility to manage and provide oversight for the VA/Apple/Center partnership. -- - I still do have that responsibility. Please add me to the Mid Level Project Manager list, as I coordinate with Rob and (b) (6) update Dr. Shulkin,I communicate on a regular basis with (b) (6) from Apple, and (b) (6) update at the WH. - I would also appreciate you cc me in your communications on this project with VA staff, Rob and (b) (6) Thanks so much Darin Darin Selnick Senior Advisor to the Secretary - Cell 202-390-(b) (6) : VA-18-0298 and 18-0299-B-000322 Page 423 of 428 From: Bruce Moskowitz <(b) (6) mac.com> Date: June 26, 2017 at 3:13:36 PM EDT To: (b) (6) <(b) (6) jhu.edu>, (b) (6) <(b) (6) ccf.org>, "(b) (6) (b) (6) (b) (6) (b) (6) < kp.org>, " < mayo.edu>, (b) (6) kp. (b) (6) (b) (6) (b) (6) (b) (6) org, < jhmi.edu>, " < mayo.edu>, "(b) (6) <(b) (6) mayo.edu>, (b) (6) ccf.org, (b) (6) ccf.org, (b) (6) partners.org, (b) (6) (b) (6) PARTNERS.ORG, "(b) (6) M.D." <(b) (6) ccf.org>, (b) (6) , < apple.com>, < apple.com>, (b) (6) <(b) (6) apple.com>, (b) (6) <(b) (6) apple.com>, IP (b (b) (6) (b) (6), (b) (5) <) @frenchangel59.com>, gmail.com, va.gov, Poonam Alaigh (6) (b) (6) (b) (6) <(b) hotmail.com>, aol.com, jhhc.com (6 ) Subject: VA-Apple EMR Project As we discussed on the conference call we have set up three committees to commence work (the academic centers may add to the working group). I want to take the opportunity to thank everyone for their commitment to this important project. We will have available to the group, the ability to tap the end user in different medical specialties with an emphasis on primary care and preventative medicine along with surgical sub specialists. If their is an omission or change in assignment please contact me. The executive committee: VA Representatives: Dr. David Shulkin Dr. Poonam Alaigh Apple representatives: (b) (6) 5 Academic Centers Johns Hopkins (b) (6) Partners (b) (6) Cleveland (b) (6) Mayo Clinic to assign Kaiser Permanente (b) (6) Mr. Marc Sherman Mr. IKe Perlmutter Dr. Bruce Moskowitz Mid level project Managers: - VA: Rob Thomas, (b) (6)(b) (6) Apple: (b) (6) (b) (6) Academic Medical Centers (b) (6) Johns Hopkins (b) (6) (b) (6) Partners: M.D., (b) (6) (b) (6) (b) (6) Cleveland Clinic: Mayo Clinic: (b) (6) M.D., (b) (6) (b) (6) Kaiser Permanente, (b) (6) BREF Foundation Working Group VA: (b) (6) - (b) (6) (6) (b) (6) M.D. M.D. John Short, (b) (6) VA-18-0298 and 18-0299-B-000323 - Apple: (b) (6) (working Group Manager) (b) (6) (b) (6) Academic Centers: (b) (6) (b) (6) (b) (6) and from KP Dr. (b) (6) CC from Partners Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000324 From: Cc: Bruce Moskowitz <(b) (6) mac.com> DJS ; Bowman, ) Thomas ; Marc Sherman <(b) (6) gmail.com> Bcc: Subject: Date: Attachments: Re: [EXTERNAL] Shulkin Interview on FoxNews - Friday, October 20, 2017 Sun Oct 22 2017 08:29:18 CDT To: I Well done! Sent from my iPad Bruce Moskowitz M.D. > On Oct 22, 2017, at 8:50 AM, DJS wrote: > > Thank you Ike- the President saw it as well and called me- he had you exact sentiments and asked about how you and (b) (6) are and said to pass on his regards (that was on my list to do today) > > David > > > > Sent with Good (www.good.com) > > ________________________________ > From: IP > Sent: Sunday, October 22, 2017 3:11:05 AM > To: DJS > Cc: Bowman, Thomas; (b) (6) gmail.com; Marc Sherman; '(b) (6) mac.com' > Subject: [EXTERNAL] Shulkin Interview on FoxNews - Friday, October 20, 2017 > > David, > > I caught your interview Friday on Fox news and want to congratulate you. You were superb. Your responses that focused on the VA and the principal issue of veterans' care was right on point. That interview really did a great service to what you (and we) are doing to improve the quality of care for our veterans for the long term. > > Ike > > http://www.foxnews.com/transcript/2017/10/20/va-secretary-brave-soldiers-dont-deserve-to-bepoliticized.html > - - VA-18-0298 and 18-0299-B-000325 Page 426 of 428 From: - Bowman, Thomas Captain (b) (6) USN Tue Jan 09 2018 09:28:53 CST - Bruce: I have called the number in your email for (b) (6) but no answer on the phone. Please confirm that the below number is his number: - (b) (6) 240.373 Thanks. Tom VA-18-0298 and 18-0299-B-000326 From: Bruce Moskowitz <(b) (6) mac.com> Bowman, Thomas wrote: Bruce: I have called the number in your email for Peter but no answer on the phone. Please confirm that the below number is his number: - 240.373.(b) (6) . Thanks. Tom VA-18-0298 and 18-0299-B-000327 Ha, Richard From: Sent: To: Subject: (b) (6) Friday, May 18, 2018 12:20 PM COS-PMO; Powers, Pamela; Ullyot, John; Tucker, Brooks; Hutton, James; (b) (6) FW: [EXTERNAL] time sensitive fact-check FYI below. We are referring all questions about the nomination to the White House, but I will keep everyone posted on the inquiries we are getting. Thanks, (b) (6) Department of Veterans Affairs 202-461-(b) (6) (b) (6) @va.gov @(b) (6) From:( [mailto(b) (6) @axios.com] b Sent: Friday, May 18, 2018 12:16 PM ) To: (b)((6) @va.gov> Cc: (b) 6)(6) @axios.com> Subject: [EXTERNAL] time sensitive fact-check Hi (b) (6) We've been told two things that we'll be publishing in our story at 2pm: - ? ? - - That Robert Wilkie spoke to (b) (6) before President Trump made his decision. ((b) (6) recommended him highly to Trump after the conversation.) That Wilkie and Peter O'Rourke recently flew down to West Palm Beach to meet with Ike Perlmutter (one of the most important blessings to get in Trumpworld for VA). Per a source familiar with their interaction: "Ike loved him [Wilkie]. Ike was very very high on him." Are we missing anything? If there are any facts here you want to challenge or additional context to add, please let me know by 1:55pm. Otherwise we plan to publish at 2pmET. 202.390.(b) (6) Best, (b) (6) - To help protect y our priv acy , Microsoft Office prev ented automatic download of this picture from the Internet. A on White@1x.png (b) (6) NATIONAL POLITICAL REPORTER (b) (6) @axios.com | 202.390.(b) (6) 1 VA-18-0298 and 18-0299-B-000328 Ha, Richard From: Sent: To: Cc: Subject: Sandoval, Camilo J. Tuesday, March 06, 2018 7:13 PM O'Rourke, Peter M. Hayes-Byrd, Jacquelyn FW: [EXTERNAL] Fwd: EMR FYI... From: Sandoval, Camilo J. Sent: Tuesday, March 06, 2018 7:12 PM To: Blackburn, Scott R. Subject: RE: [EXTERNAL] Fwd: EMR Is Bruce's email one of the questions you think we've already answered in the past? Can I offer a suggestion? Could we possibly create a tracker on all the incoming questions/answers? I believe this might clarify the question and help get a quicker reply and keep everyone on the same page. Example below based on what Bruce requested today. Thoughts? Question/Topic Follow-Up Questions Response/Comments 1. Cloud ? Are we getting the cloud ? Document reference ? correctly ? Strategy? ? POC? 2. CIO ? Candidate Pool? ? ? Key Qualifications? ? Separation of roles? 3. Physician Input ? Patient Centric? ? ? Physician Usability Scope? ? 4. ? ? 5. Apple Project ? ? Who is POC? ? Project update? ? Mental Health Strategy and Portable EMR Solution that works with DOD & VA & Community? 6. ? ? 7. ? ? From: Blackburn, Scott R. Sent: Tuesday, March 06, 2018 5:05 PM 1 VA-18-0298 and 18-0299-B-000329 To: Sandoval, Camilo J. Subject: FW: [EXTERNAL] Fwd: EMR Sent with Good (www.good.com) From: David Shulkin Sent: Tuesday, March 06, 2018 7:09:43 AM To: Blackburn, Scott R. Subject: [EXTERNAL] Fwd: EMR Can we begin to address and then ill respond back? Sent from my iPhone Begin forwarded message: (b) (6) From: Bruce Moskowitz @mac.com> Date: March 5, 2018 at 6:49:58 AM EST (b) (6) (b) (6) To: @gmail.com, @reagan.com (b) (6) (b) (b) (6) Cc: @gmail.com, IP <(6) @frenchangel59.com>, Subject: EMR @gmail.com I would like to underscore the importance of getting the "Cloud"correctly and the other four issues with the new CIO's. Also the composition of the physician input has to change immediately so that the EMR is patient centric and usable from the physician perspective. Second this is going to take years to implement and especially in mental health we need a portable EMR solution that works with the DOD, the VA and the private sector. No one at the VA got back to me on what the Apple project can and can not do in terms of solving this problem. Sent from my iPad Bruce Moskowitz M.D. 2 VA-18-0298 and 18-0299-B-000330 Ha, Richard From: Sent: To: Cc: Subject: Hayes-Byrd, Jacquelyn Tuesday, March 13, 2018 4:40 PM Kuy, SreyRam (HOU) (b) (6) FW: Medical Device Registry Call - Wed 3/14/2018 at 7:30 am Good afternoon, Thank you I can be there. I am including (b) (6) Jacquie Jacquelyn Hayes-Byrd, Deputy Chief of Staff US Department of Veterans Affairs Jacquelyn.Hayes-Byrd@va.gov Cell: 202-817-5873 - on this email to ensure that the time/date is on my schedule. From: Kuy, SreyRam (HOU) Sent: Tuesday, March 13, 2018 4:36 PM To: Hayes-Byrd, Jacquelyn; (b) (6) Cc: O'Rourke, Peter M. Subject: Medical Device Registry Call - Wed 3/14/2018 at 7:30 am Hi Jacquie! Great seeing you again today (briefly)! I spoke with Peter today about an effort around developing a Medical Device Registry, in collaboration with Bruce Moskowitz and his colleagues. We have a weekly call with the workgroup on Wednesdays at 7:30 am, and Peter suggested we hold tomorrow's call at 7:30 am in his office, and if you have time, perhaps you could join? I'll forward the invite to you. Let me know if you have any questions at all! Thank you! -Srey (713-503-4274) SreyRam Kuy, MD Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 1 VA-18-0298 and 18-0299-B-000331 Mobile: 713-503-4274 Office: 202-461-4875 and Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, March 13, 2018 6:08 PM (b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) ; Hayes-Byrd, Jacquelyn; - (b) (6) Subject: Attachments: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) Medical Device Registry Summit - 1 pager.pdf; Summit Planning Meeting - Minutes.docx 1111 - Dear Colleagues, For our planning meeting on Medical Device Registry tomorrow morning, attached is a 1 pager (double sided), which can be used for discussion with outside stakeholders. Also, I've attached meeting minutes from both prior conference calls. The minutes are displayed chronologically, with the most recent at the end. I've also invited a few other colleagues to join the call, depending on their availability. And many apologies to our west coast colleagues for the very early time Conference call line: 800-767-(b) (5) Code (b) (5) Wednesday March 14, 2018 at 7:30 am Eastern Thank you so much for all your enthusiasm and support for this effort! Warmly, SreyRam 1111 - SreyRam Kuy, MD Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000333 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: ? ? ? ? ? Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: ? SreyRam Kuy, MD SreyRam.Kuy@va.gov ? @va.gov (b) (6) Diffu sionof _, EXCELLENCE ::: ::, ~ 8.oransFlrst Diffusing Bes t P,actices Ac,oss VHA U.S.Department of Veterans Affairs VAi VA-18-0298 and 18-0299-B-000334 Medical Device Registry Summit Month, Day, 2018 Draft Agenda Meeting Objective: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts 1. Welcome and introductions of participants and organization 2. Moderated Roundtable Discussion with Key Agency Leadership ? ? ? ? ? Panel Moderator - facilitates with questions Secretary of the VA FDA Commissioner (TBD) CMS leadership (TBD) HHS Leadership (TBD) 3. Topic Focused Presentations ? Why Registries Matter - Data about how it helps lower costs, improve outcomes - Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management - Speaker ? Other Key Topics 4. Closing Remarks, Thanks to Participants, Outline Key Next Steps ? Speaker TBD Diffu sionof ~ 8. _, EXCELLENCE ::: ::, oransFlrst Diffusing Bes t P,actices Ac,oss VHA VAl{i) U.S.Department of Veterans Affairs VA-18-0298 and 18-0299-B-000335 SreyRam Kuy, MD (b) (6) Draft, Pre-Decisional, Only for Internal VA use Medical Device Registry Summit February 21, 2018 Meeting Minutes Meeting Objective: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts 1. Welcome and introductions of participants and organization Last Name Moskowitz Organization Role Bruce Bruce Danica McIntosh Moskowitz Marinac-Dabic Veterans Affairs NCPS SreyRam Thomas Kuy Concannon Veterans Affairs Special Advisor to the Secretary First Name Aaron (b) (6) (b) (6) 2. Discuss current state of VA/UDI Current state of VA o Product recall office in the VA takes 0-10 days to initiate a recall, with an estimated 99% recall rate o Bruce is conducting a stop-gap analysis focusing on implants, both biologic and non-biologic (mostly biological tissue in the VA population) o Suggestion from Danica: expand stop-gap analysis to close calls UDI o CFR requires UDI manufacturers o Getting information on the implanted devices, see if you can make that fast and easily go into patient medical records Track what gets implanted o o However, UDI has some push back from manufacturers, including: o Too expensive, small manufacturers who cannot afford it o Might not work for all devices because of packaging o Should be acquired by anyone purchasing a device o GUDID database ? Need to bring in all these data sources and get an API to bring into your system 3. Discuss purpose and goals for the "Medical Device Registry" Diffusion of ; ,,' EXCELLENCE ::::;' Diffusing BestPracticesAcross VHAo VAl(i) U.S.Department ofVeterans Affairs VA-18-0298 and 18-0299-B-000336 SreyRam Kuy, MD (b) (6) Draft, Pre-Decisional, Only for Internal VA use Registry's Importance for Patients o Patients do not know the manufacturer of devices or type of device o This becomes an issue if they do not know why their device needs to get a revision o Need to capture this importation and develop a national registry to easily do recall o Need tracking system and registry 4. Discuss purpose and goals for the "Medical Device Registry" Summit Narrow the Focus to Make It Specifically about the Problem o What people are interested in: o Cost benefit analysis o 400% price reduction for manufacturers o Implant registry improves cost and quality with a good system o Not just in case of error; the registry can act as an early detection system o Really hopes for longer standing registries where you get outcome reports from them, pull something from the market if quality or safety is lower (i.e. if the device is not doing its job) o The registry will be a valuable resource and tool o Patient groups would love to use information to fund the study for feedback with people with devices o Many research opportunities (b) (6) can give input to incorporate outcomes o o Can locate a device in an organization (RSLD) such as an IV pump, and can find a device in an organization o Can help in the long term improve their product, become safer, and of better quality than the competitor 5. Determine Format of the "Medical Device Registry" Summit Part 1 o Discuss the rational for the Medical Device Registry, including use cases, purpose, etc. o Hear from each stakeholder, perspective, what is in it for them, barriers, SWAT analysis (better, faster, cheaper) Part 2 o How to structure data capture; discuss stop gap analysis from NCPS and, potentially, the Mercy Hospital Study 6. Determine Panel of Speakers/Attendants Summit invitees should include: o Medtronic o Johnson and Johnson o Recommend smaller companies, like Titan o Invite a portfolio of patient groups (Danica going to send to us) (b) (6) group, nice demonstration of organic collection of data to large roundtable o o Need to invite an additional voice, preferable a front-line provider o Need to invite provider groups - 7. Ideas for Medical Device Registry Diffusion of ; ,,' EXCELLENCE ::::;' Diffusing BestPracticesAcross VHAo VAl(i) U.S.Department ofVeterans Affairs VA-18-0298 and 18-0299-B-000337 SreyRam Kuy, MD (b) (6) Draft, Pre-Decisional, Only for Internal VA use Idea: Have a Patient Safety Device Score People need to report o Train and educate people, do a root cause analysis, consider reporting structures o Learn from users' experiences and use their issues (learning from the field, field is seeing this) o Open database through NIH, can match with registries for global device 8. Next Steps Forward o -- 1. Create agenda template: Danica o Draft agenda: SreyRam/(b) (6) 2. Initiate contact with key stakeholders: Danica/Aaron/(b) (6) 3. Reach out for speakers and attendance (e.g. patient advocacy groups, manufacturers, provider groups, Cerner, major medical journals, etc.): Danica/Aaron/(b) (6) 4. Look for summit venues: Aaron ((b) (6) can help as well) 5. Create one-pager of summit or project, and modify for external audience: SreyRam 6. Pick a date, based on FDA's calendar: (b) (6) oo February 28, 2018 Meeting Minutes First Name Aaron Role Organization Biomedical Research and Education Foundation Global Healthy Living Foundation NCPS Veterans Affairs Veterans Affairs Global Healthy Living Foundation Special Advisor to the Veterans Affairs Last Name Moskowitz (b) (6) Bruce McIntosh (b) (6) SreyRam Kuy Secretary 1. Discuss symposium speakers - For the symposium, it may be beneficial to have an unbiased third party speaker, such as an academic or consultant - A speaker who can talk about what already exists in terms of medical registries - Have a speaker on the UDI 2. Discuss outreach - Participants on this call, such as (b) (6) and Aaron, are going to reach out to patient advocacy groups, provider groups, medical device groups, etc. - (b) (6) will have informal calls to reach out to people; he wants a common message or paragraph we want to send out to experts o ? Diffusion of ; ,,' EXCELLENCE ::::;' Diffusing BestPracticesAcross VHAo \ IA I '?' 9' U.S.Department VI"\ ofVeterans Affairs VA-18-0298 and 18-0299-B-000338 SreyRam Kuy, MD (b) (6) Draft, Pre-Decisional, Only for Internal VA use - SreyRam will reach out to Secretary Shulkin to reach out to counterparts 3. Discuss location - DJS recommended we use the VA auditorium 4. Discuss dates - Calendars- tell everyone to email potential conflicts - However, Bruce noted that as long as we get CMS and VA leadership, others will send someone of important, won't want to be left out with major players of the audience 5. Action Items - One pager (vague without any promises for external use) with "common message" that can be used in informal phone calls: SreyRam - Send one pager to experts/industry leaders to invite them into the conversation: Aaron, (b) (6) and Danica - Diffusion of ; ,,' EXCELLENCE ::::;' Diffusing BestPracticesAcross VHAo VAl(i) U.S.Department ofVeterans Affairs VA-18-0298 and 18-0299-B-000339 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, March 20, 2018 4:06 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) Hayes-Byrd, Jacquelyn; 1111 (b) (6) Subject: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5) Attachments: -Medical Device Registry Summit - 1 pager.pdf; Medical Device Registry Summit - 1 pager.docx 1111 Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam 1111 - Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000340 and Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? ? ? ? ? 3. Panel Moderator - facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" - Data about how it helps lower costs, improve outcomes o Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD o Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" o Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo o (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" o Frederic Resnic, MD ? Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000342 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o @va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000343 VI'\ o Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? ? ? ? ? 3. Panel Moderator - facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" - Data about how it helps lower costs, improve outcomes ? Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management ? Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD ? Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" ? Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo ? (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" ? Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" ? Frederic Resnic, MD ? Talks by other stakeholders (Amazon, Medtronic) TBD -- 4. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" ? Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffu sionof _, EXCELLENCE ::: ::, ~ 8.oransFlrst Diffusing Bes t P,actices Ac,oss VHA U.S.Department of Veterans Affairs VAi VA-18-0298 and 18-0299-B-000344 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: ? ? ? ? ? Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: ? SreyRam Kuy, MD SreyRam.Kuy@va.gov ? @va.gov (b) (6) Diffu sionof _, EXCELLENCE ::: ::, ~ 8.oransFlrst Diffusing Bes t P,actices Ac,oss VHA U.S.Department of Veterans Affairs VAi VA-18-0298 and 18-0299-B-000345 Ha, Richard From: Sent: To: Subject: Hayes-Byrd, Jacquelyn Wednesday, March 21, 2018 9:44 AM (b) (6) ; Kuy, SreyRam (HOU); (b) (6) GHLF; Bruce Moskowitz; Aaron Moskowitz; (b) (6) Thomas Concannon; McIntosh, Bruce (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) RE: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - Thank you! Sent with Good (www.good.com) From: (b) (6) Sent: Tuesday, March 20, 2018 1:33:48 PM To: Kuy, SreyRam (HOU); (b) (6) GHLF; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) '; (b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: RE: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - Hello everyone: Apologies for the delay in sending the one-pager with comments/suggestions back from last week's discussion. Please see attached for minor suggestions and look forward to talking tomorrow morning! (b) (6) , PhD, MPH | (b) (6) Patient-Centered Research Global Healthy Living Foundation 515 N. Midland Ave - Upper Nyack, NY 10960 Cell: +1 (646) 427 (b) (6) | Office: +1 (845) 348 (b) (6) | Fax: +1 (845) 348 (b) (6) (b) (6) @ghlf.org GHLF.org | CreakyJoints.org | ArthritisPower.org Facebook.com/CreakyJoints | Twitter.com/CreakyJoints | Twitter.com/GHLForg Improving the lives of people with chronic disease through better access to care, education, support, advocacy and patient-centered research. ---- - - 1 VA-18-0298 and 18-0299-B-000346 From: Kuy, SreyRam (HOU) Sent: Wednesday, March 14, 2018 10:34 AM To: (b) (6) @ghlf.org>; (b) (6) GHLF (b) (6) @ghlf.org>; Bruce Moskowitz (b) (6) (b) (6) < @mac.com>; Aaron Moskowitz < @me.com>; Thomas Concannon (b) (6) @rand.org>; McIntosh, Bruce (NCPS) <(b) (6) @va.gov>; (b) (6) @atlasresearch.us>; (b) (6) (Atlas Research) (b) (6) @va.gov>; 'Marinac-Dabic, Danica' <(b) (6) fda.hhs.gov>; '(b) (6) dc-crd.com>; (b) (6) @dc-crd.com>; (b) (6) (b) (6) @va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) va.gov> Subject: RE: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) Thank you everyone for your great input and effort on this project! (b) (6) great question. Here is the double-sided one pager, as an editable word version (attached). I made it as "track- changes" enabled, so changes can be seen. I think it's reasonable to share revisions and changes with the whole group. Again, thanks for all your hard work and looking forward to a successful summit in June! Warmly, SreyRam SreyRam Kuy, MD Special Advisor to the Secretary Veterans Health Administration 1111 - - Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 -- -- From: (b) (6) [mailto:(b) (6) @ghlf.org] Sent: Wednesday, March 14, 2018 9:47 AM To: Kuy, SreyRam (HOU); (b) (6) GHLF; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - Hi Srey Ram: Thanks again for these conference calls with the group - exciting to see how wonderfully this is developing! Shall we make comments/edits to the one-pager you sent us in word version or are we waiting on another version from you? And are we sending back the document with comments to everyone in the group or just you- I ask for version control purposes. --S 2 VA-18-0298 and 18-0299-B-000347 (b) (6) , PhD, MPH | (b) (6) Global Healthy Living Foundation ---- Patient-Centered Research - - 515 N. Midland Ave - Upper Nyack, NY 10960 Cell: +1 (646) 427 (b) (6) | Office: +1 (845) 348 (b) (6) | Fax: +1 (845) 348 (b) (6) (b) (6) @ghlf.org GHLF.org | CreakyJoints.org | ArthritisPower.org Facebook.com/CreakyJoints | Twitter.com/CreakyJoints | Twitter.com/GHLForg Improving the lives of people with chronic disease through better access to care, education, support, advocacy and patient-centered research. From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 13, 2018 18:08 To: (b) (6) GHLF <(b) (6) @ghlf.org>; Bruce Moskowitz <(b) (6) @mac.com>; Aaron Moskowitz (b) (6) < @me.com>; Thomas Concannon <(b) (6) @rand.org>; McIntosh, Bruce (NCPS) (b) (6) @va.gov>; (b) (6) @atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) @va.gov>; 'Marinac-Dabic, Danica' <(b) (6) fda.hhs.gov>; (b) (6) (b) (6) @ghlf.org>; '(b) (6) dc-crd.com>; '(b) (6) @dc-crd.com>; (b) (6) (b) (6) @va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) va.gov>; (b) (6) @va.gov> Subject: Medical Device Registry Summit - Planning Meeting, Wednesday March 14, 2018 at 7:30 am Eastern, Conference call line: 800-767-(b) (5) Code (b) (5) Dear Colleagues, For our planning meeting on Medical Device Registry tomorrow morning, attached is a 1 pager (double sided), which can be used for discussion with outside stakeholders. Also, I've attached meeting minutes from both prior conference calls. The minutes are displayed chronologically, with the most recent at the end. I've also invited a few other colleagues to join the call, depending on their availability. And many apologies to our west coast colleagues for the very early time Conference call line: 800-767-(b) (5) Code (b) (5) Wednesday March 14, 2018 at 7:30 am Eastern Thank you so much for all your enthusiasm and support for this effort! Warmly, SreyRam - -- 1111 - 1111 - 3 VA-18-0298 and 18-0299-B-000348 SreyRam Kuy, MD Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 4 VA-18-0298 and 18-0299-B-000349 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? ? ? ? ? 3. Commented [S1]: If this is going to be a document we are circulating I was wondering if it may work better for this page to be page 2, and what is currently page 2, to be page 1- to provide more context and framing. Panel Moderator - facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" -Matter" - Data about how it helps lower costs, improve outcomes o Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD o Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" o Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo o (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" o Frederic Resnic, MD ? Talks by other stakeholders (Amazon, Medtronic) TBD 4. Commented [S2]: Since this is an introductory session (I'm assuming), wondering if the "Why registries matter" topic could also include "Perspectives on registries (thereby including a multi-stakeholder perspective) and spanning things like a) surveillance, b) post-market observation, c) Best practices sessions or models of current registries, d) Hurdles and obstacles e) Some kind of data on integrating clinical and PROs? The idea being that each topic could relate to a different stakeholder. Just a thought. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA VA U.S.Department ofVeteran Affairs VA-18-0298 and 18-0299-B-000350 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Commented [S3]: Would be useful to add "Aims" as well to this- this will allow us to highlight the "multi-stakeholder" focus of the conference. It would also nicely lead into participating partners. Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov (b) (6) o @va.gov VA U.S.Department ofVeteran Affairs VA-18-0298 and 18-0299-B-000351 Ha, Richard From: Sent: To: Cc: Subject: Kuy, SreyRam (HOU) Tuesday, March 27, 2018 6:11 PM Hayes-Byrd, Jacquelyn (b) (6) RE: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) (b) (5) - Code 1111 Jacquie, Thank you!!! -Srey From: Hayes-Byrd, Jacquelyn Sent: Tuesday, March 27, 2018 5:30 PM To: Kuy, SreyRam (HOU) Cc: (b) (6) Subject: RE: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - Hello! I have reserved the 2nd floor conference room in this bldg. for the Summit. Let me know if I am off base. Thanks, Jacquie From: Kuy, SreyRam (HOU) Sent: Tuesday, March 27, 2018 5:05 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/28/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Thank you so much for all your efforts! Warmly, SreyRam 1111 - 1111 - 1 VA-18-0298 and 18-0299-B-000352 SreyRam Kuy, MD, MHS, FACS Special Advisor to the Secretary Senior Advisor to the PDUSH Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 2 VA-18-0298 and 18-0299-B-000353 Ha, Richard From: Sent: To: Subject: Hayes-Byrd, Jacquelyn Thursday, March 29, 2018 6:20 AM (b) (6) RE: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) (b) (5) - Code 1111 Thank you From: (b) (6) Sent: Wednesday, March 28, 2018 6:46 AM To: Hayes-Byrd, Jacquelyn Subject: RE: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - Ok, this event is confirmed. I can reach out to Dr. SreyRam to identify the type of logistical support she will need (Power Point, Microphone, Banner, etc) Monday, June 04, 2018 7:00 AM - 5:00 PM Medical Supply Conference (Web Confirmed) VACO RM 230/330 (b) (6) retary 810 Vermont Ave, NW Washingt DC 20420 (b) (6) (b) (6) VA Core Values: @va.gov egrity, Commitment, Advocacy, Respect, and Excellence--I CARE From: Hayes-Byrd, Jacquelyn Sent: Tuesday, March 27, 2018 5:29 PM To: (b) (6) Subject: FW: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - This Subject is the 2nd floor reservation title for June 4, 2018 From: Kuy, SreyRam (HOU) Sent: Tuesday, March 27, 2018 5:05 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Medical Device Registry Summit - Planning Meeting: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: 1 1111 - VA-18-0298 and 18-0299-B-000354 Medical Device Registry Summit - Planning Call Wednesday 3/28/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Thank you so much for all your efforts! Warmly, SreyRam 1111 - SreyRam Kuy, MD, MHS, FACS Special Advisor to the Secretary Senior Advisor to the PDUSH Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 2 VA-18-0298 and 18-0299-B-000355 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, April 03, 2018 4:57 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn; 1111 (b) (6) Subject: Attachments: Medical Device Registry Summit - Planning Meeting Wednesday April 4 at 7:30 am: Conference call line 800-767-(b) (5) Code (b) (5) 3-28-2018 device registry meeting.docx 1111 - Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/28/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Attached are the minutes from last week's call. Again, thank you so much for all your efforts! Warmly, SreyRam 1111 - SreyRam Kuy, MD, MHS, FACS Senior Advisor to the PDUSH Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000356 1 Medical Device Registry Symposium March 28, 2018 Meeting Minutes Meeting Objective: Bring together VA, FDA, and other federal agencies and key stakeholders for a national symposium about medical device registry efforts 1. Participants and organization First Name Aaron Last Name Moskowitz Bruce Bruce Danica McIntosh Moskowitz Marinac-Dabic (b) (6) (b) (6) SreyRam Thomas Kuy Concannon Organization BREF GHLF Veterans Affairs Food and Drug Administration DC-CRD DC-CRD Veterans Affairs GHLF Veterans Affairs RAND 2. Discuss updates Symposium Logistics o Auditorium Secured o SreyRam talking to DJS today to finalize date; DJS going to reach out to other leadership, such as HHS secretary and FDA commissioner (update: spoke with Chief of Staff, date finalized) Danica Speaker o Danica is going to reach out to Dr. (b) (6) and potentially add as speaker for return on investment for registries o Danica going to send one of his past presentations o Include a forum at the end; many "acronyms" we can invite to the forum , led pinnacle registry, and is part of the o Recommends that we consider (b) (6) American association for orthopedic surgeon coordinating a registry o Lots of recent developments, need to invite speakers who can move the needle DOD o Bruce having trouble finding someone significantly involved in implant registry at DOD Bruce Moskowitz o Wants to invite major manufacturers, big players, to be there in attendance o Bruce is going to invite the head of American Association of Surgeons to attend and relay info to their list serve Would there be controversy if J&J is asked to speak and metronics is not? Trying to avoid hot o water o Move the needle vs. politics discussion 1111 Diffusion of ; ,,' EXCELLENCE ::::;' Diffusing BestPracticesAcross VHAo VAl(i) U.S.Department ofVeterans Affairs VA-18-0298 and 18-0299-B-000357 2 Shilpa o Our focus topics should reflect the speakers if such a way that our speakers will complement of all the topics 3. Action Item 4. Follow up with DOD- Bruce 5. Follow up with additional contacts she wants to include in this discussion- Danica 6. Reach out to orthopedics- (b) (6) 7. Finalize dates- SreyRam - Diffusion of ; ,,' EXCELLENCE ::::;' Diffusing BestPracticesAcross VHAo VAl(i) U.S.Department ofVeterans Affairs VA-18-0298 and 18-0299-B-000358 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, April 10, 2018 4:30 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn; 1111 (b) (6) Subject: Attachments: Medical Device Registry Summit - Planning Meeting Wednesday April 11, 2018 at 7:30 am; Conference call line: 800-767-(b) (5) Code (b) (5) Medical Device Registry Summit - 1 pager.docx 1111 - Dear colleagues, Looking forward to catching up tomorrow for our weekly Wednesday morning call. Here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 4/11/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) I don't think I've been emailed any revisions to the agenda yet (many apologies if you did send and I missed!). So I'm attaching the agenda - welcome all your revisions! I added the Pew Trust as a tentative participant. Feel free to revise the editable word doc (it's track changes enabled) and share with us all. Not too late to send in changes! I owe Dr. Moskowitz a budget - Bruce and I are editing it. Thank you so much for all your efforts! Much appreciated! Warmly, SreyRam 1111 - SreyRam Kuy, MD, MHS, FACS Senior Advisor to the PDUSH Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000359 and Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD ? CMS leadership (TBD) ? HHS Leadership (TBD) 3. Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" - Data about how it helps lower costs, improve outcomes o Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD o Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" o Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo o (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" - Frederic Resnic, MD ? "Title TBD" - Art Sedrakyan, MD ? "Title TBD" - Pew Charitable Trust (tentative) ? Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000361 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o @va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000362 VI'\ o Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Thursday, April 05, 2018 4:59 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn; 1111 (b) (6) Subject: Attachments: Medical Device Registry Summit - Planning Committee - Draft Agenda Medical Device Registry Summit - 1 pager.docx Hi Everyone! Great conversation yesterday morning. Attached is the draft agenda, "Track changes enabled". Please do revise and add to it, and circulate your additions to the whole group. All your efforts are greatly appreciated! -SreyRam SreyRam Kuy, MD, MHS, FACS Senior Advisor to the PDUSH Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000363 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD ? CMS leadership (TBD) ? HHS Leadership (TBD) 3. Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" - Data about how it helps lower costs, improve outcomes o Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD o Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" o Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo o (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" - Frederic Resnic, MD ? "Title TBD" - Art Sedrakyan, MD ? Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000364 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o @va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000365 VI'\ o Ha, Richard From: Sent: To: McIntosh, Bruce (NCPS) Tuesday, April 10, 2018 10:30 PM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) ; Hayes-Byrd, Jacquelyn;(b) (6) Subject: Attachments: RE: Medical Device Registry Summit - Planning Committee - Draft Agenda Medical Device Registry Summit - 1 pager_BMedits.docx I edited two names for spelling and added two VA physicians as potential speakers: Dr. Nicholas Giori has an innovative approach to medical device registry outcome monitoring of orthopedic joint replacements, and Dr. Stephen Waldo who leads VA CART-CL (heart catheterizations- stents) where they have advanced to RTLS implant tracking and EHR integration for stent and cardiac device implants in the EP labs. Thanks, Bruce From: Kuy, SreyRam (HOU) Sent: Thursday, April 05, 2018 4:59 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) ; Hayes-Byrd, Jacquelyn; (b) (6) Subject: Medical Device Registry Summit - Planning Committee - Draft Agenda Hi Everyone! Great conversation yesterday morning. Attached is the draft agenda, "Track changes enabled". Please do revise and add to it, and circulate your additions to the whole group. All your efforts are greatly appreciated! -SreyRam SreyRam Kuy, MD, MHS, FACS Senior Advisor to the PDUSH Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000366 and Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD ? CMS leadership (TBD) ? HHS Leadership (TBD) 3. Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" - Data about how it helps lower costs, improve outcomes o Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD o Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" o Merritt H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo o (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" - Frederic Resnic, MD ? "Title TBD" - Art Sedrakyan, MD ? "Title TBD" - Stephen Waldo, MD ? "Title TBD" - Nicholas Giori, MD ? Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000368 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o @va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000369 VI'\ o Ha, Richard From: Sent: To: (Atlas Research) Tuesday, April 17, 2018 5:35 PM Marinac-Dabic, Danica; Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; (b) (6) Thomas Concannon; McIntosh, Bruce (NCPS); '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) ' Hayes-Byrd, Jacquelyn; Medical Device Registry Summit - Action Items Medical Device Registry Summit - Agenda - Dr. SreyRam Kuy.docx (b) (6) Subject: Attachments: Hi team, In preparation for our weekly call tomorrow, here are a few reminders from last week's action items. 1. Fill in the 3rd page of the agenda (agenda attached) with list of attendees/groups invited to the symposium-- Everyone 2. Contact speakers for the title, topic, and content of their presentation (needed to ensure appropriate topics and no redundancy)--Everyone 3. Send us contact information for the speakers so we can coordinate a call with them all prior to the event-- Everyone 4. Create a draft to operationalize the "formal and structured interaction between attendees"--(b) (6) a. Add this to the agenda draft--(b) (6) 5. Create a draft to operationalize the "smaller discussion groups between or after the topic focused presentations"--Danica a. Add this to the agenda draft--(b) (6) 6. Edit agenda with track changes--Everyone Thanks again everyone for all your hard work! Looking forward to our call tomorrow. Let us know if you have any questions. All the best, SreyRam and (b) (6) o - - 1 VA-18-0298 and 18-0299-B-000370 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD ? CMS leadership (TBD) ? HHS Leadership (TBD) 3. Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" - Data about how it helps lower costs, improve outcomes o Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD o Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" o Merritt H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo o (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" - Frederic Resnic, MD ? "Title TBD" - Art Sedrakyan, MD ? "Title TBD" - Stephen Waldo, MD ? "Title TBD" - Nicholas Giori, MD ? "Title TBD" - Pew Charitable Trust (tentative) ? Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffusion of ,,' EXCELLENCE ::::: ' Diffus ing BestPracticesAc,ossVHA ' VAl(i) U.S. Depar tm e nt ofVele rc1nsAffair,; VA-18-0298 and 18-0299-B-000371 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o va.gov (b) (6) Diffusion of ,,' EXCELLENCE ::::: ' Diffus ing BestPracticesAc,ossVHA ' VAl(i) U.S. Depar tm e nt ofVele rc1nsAffair,; VA-18-0298 and 18-0299-B-000372 List of Symposium Attendees/Groups: Name Affiliation Title ,. ./ ... / / ... ... ..... ..' Diffusion of ,,' EXCELLENCE ::::: ' Diffus ing BestPracticesAc,ossVHA ' - VAl(i) U.S. Depar tm e nt ofVele rc1nsAffair,; VA-18-0298 and 18-0299-B-000373 Ha, Richard From: Sent: To: - Concannon, Thomas <(b) (6) rand.org> Tuesday, April 17, 2018 5:51 PM (b) (6) (Atlas Research); Marinac-Dabic, Danica; Kuy, SreyRam (HOU); '(b) (6) Bruce Moskowitz; Aaron Moskowitz; McIntosh, Bruce (NCPS); (b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) GHLF'; (b) (6) Subject: [EXTERNAL] Re: Medical Device Registry Summit - Action Items For item 4 in the agenda, following is a draft plan for involving attendees actively in the summit. This plan follows from the meeting aims (stated in my own words): ? Aim1 is to unveil, learn about and discuss the VA national device registry plan ? Aim 2 is to leverage the VA experience in the development and spread of other device registries To accomplish both of these aims, we'll need a systematic approach for identifying key stakeholder communities and finding a way to meaningfully involve them in the meeting.. Identifying the stakeholder communities who can advance meeting aims. If we want to keep the list of stakeholder communities contained for now, we could focus on the bolded groups that have already been mentioned during our planning calls. If this is the right list of stakeholder communities, the next step is to extend invitations to flesh each community out 1. The actors - the developers of device registries in other settings. These include AAOS, ECRI, DCRI, and others 2. Other stakeholders - those whose decision-making depends on registries, including: ? Policymakers who use registry data in regulatory decisions ? Payers who use registry data in coverage determinations ? ? ? ? ? Patient communities (GHLF, PPRNs, others) who use registries with patient-centered data to report and track health data and use it to plan care Industry associations or representatives (Advamed, J&J, DePuy, others) who will increasingly use registries with RWD in device development Clinicians who use registry-based evidence in clinical decision making Researchers who use registries to produce new evidence (and others) Involving actors and stakeholders meaningfully. We need a quick plan that will not cost a lot of time and resources to organize. The most effective approach will be to structure stakeholder listening sessions that are aligned with the meeting agenda. 1. Danica is redrafting the agenda to group speaker sessions in some way. Presumably, this will give some shape to the two aims. I proposed to organize stakeholder listening sessions around aim 2 and related topics: how we leverage the VA experience in the development of device registries nationally. 2. The listening sessions should form a major part of any report and action plan that comes out of the summit. This is what will make the summit reflective of multi-stakeholder views and not just of the organizing committee. 3. We should allow for pre-meeting feedback from stakeholder representatives on the draft of the agenda, listening sessions, and proposed reporting and action plan. (b) (6) o 1 VA-18-0298 and 18-0299-B-000374 (b) (6) (b) (6) From: " (Atlas Research)" < va.gov> Date: Tuesday, April 17, 2018 at 5:36 PM (b) (6) To: Danica Marinac-Dabic < fda.hhs.gov>, "Kuy, SreyRam (HOU)" (b) (6) (b) (6) , GHLF < ghlf.org>, Bruce Moskowitz (b) (6) (b) (6) < mac.com>, Aaron Moskowitz < me.com>, "Concannon, Thomas" (b) (6) (b) (6) (b) (6) < rand.org>, Bruce McIntosh < va.gov>, (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < atlasresearch.us>, ' < ghlf.org>, ' < dc-crd.com>, (b) (6) (b) (6) (b) (6) (b) (6) ' < dc-crd.com>, " < va.gov>, "Hayes(b) (6) (b) (6) Byrd, Jacquelyn" , " < va.gov>, (b) (6) (b) (6) " < va.gov> Subject: Medical Device Registry Summit - Action Items Hi team, In preparation for our weekly call tomorrow, here are a few reminders from last week's action items. 1. Fill in the 3rd page of the agenda (agenda attached) with list of attendees/groups invited to the symposium-- Everyone 2. Contact speakers for the title, topic, and content of their presentation (needed to ensure appropriate topics and no redundancy)--Everyone 3. Send us contact information for the speakers so we can coordinate a call with them all prior to the event-- Everyone 4. Create a draft to operationalize the "formal and structured interaction between attendees"--(b) (6) a. Add this to the agenda draft--(b) (6) 5. Create a draft to operationalize the "smaller discussion groups between or after the topic focused presentations"--Danica a. Add this to the agenda draft--(b) (6) 6. Edit agenda with track changes--Everyone Thanks again everyone for all your hard work! Looking forward to our call tomorrow. Let us know if you have any questions. All the best, SreyRam and (b) (6) - - - __________________________________________________________________________ This email message is for the sole use of the intended recipient(s) and may contain information that is sensitive, proprietary, and/or privileged. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message. 2 VA-18-0298 and 18-0299-B-000375 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, April 17, 2018 5:58 PM (b) (6) (Atlas Research); Marinac-Dabic, Danica; '(b) (6) GHLF'; Bruce Moskowitz; Aaron (b) (6) Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Attachments: FW: Medical Device Registry Summit - 1 pager (005)DMD.docx Medical Device Registry Summit - 1 pager (005)DMD.docx (b) (6) thanks for sharing! great job with keeping us on track! Danica, thanks for sending suggestions! Sharing with everyone Danica's great suggestions, attached. Looking forward to hearing everyone's great input tomorrow! -SreyRam (b) (6) From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Tuesday, April 17, 2018 5:03 PM To: Kuy, SreyRam (HOU) Subject: [EXTERNAL] Medical Device Registry Summit - 1 pager (005)DMD.docx Dear SreyRam, For your consideration I've attached my suggested revisions to the June 4th Medical Device Registry Summit Program. I look forward to tomorrow's discussion. Best, Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - 1111 U.S.FOOD& DRU (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; 1 VA-18-0298 and 18-0299-B-000376 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 Welcome and Introductions of Participants and Organizations- SreyRam Kuy Session 1: Keynote Address: Leveraging the Medical Device Ecosystem Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Roundtable Discussion with Key Agency Leadership Moderator: SreyRam Kuy, MD, PhD ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD ? CMS leadership (TBD) ? NIH Leadership (TBD) - Mike Lauer, MD ? CDC ? AHRQ ? HHS Session 2. VA Landscape Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? Current VA Medical Device Registries in Place - Maximo o (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000377 VI'\ o - Session 3. Value of Registries for Partners/Stakeholders Moderator: (b) (6) Titan Spine ? Enabling Patient Participation in Device Registries", Harlan Krumholtz, MD, Yale ? Professional societies perspective - ACC/AAOS ? Hospital/system perspective - Kaiser ? Industry perspective - AdvaMed/MDMA ? Payer perspective- Blue Cross/CMS Panel Discussion: Session 4. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health ? UDI implementation - Terrie Reed, FDA ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic ? Straegically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell ? Methodology innovations - (b) (6) PhD - Medtronic ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH ? ONC- led efforts -TBD Panel Discussion: Session 5. Partnership Efforts/Sustainability Considerations Moderator: Bruce Moscowitz , MD, BREF ? Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH ? PCORTF harmonization efforts - (b) (6) PhD, OS/ASPE ? Leveraging existing national informatics/standards efforts - (b) (6) Panel Discussion: - Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000378 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000379 VI'\ o Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, April 24, 2018 4:07 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; 1111 (b) (6) Subject: (b) (6) (b) (6) Medical Device Registry Summit - Planning Meeting 4/25/2018; Conference call line: 800-767-(b) (5) Code (b) (5) - 1111 Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 4/25/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Danica, Bruce, (b) (6) and I are having a call this afternoon to try to finalize the speaker schedule, and as soon as that's done, will forward on to you all. Thank you so much for all your efforts! Warmly, SreyRam o 1111 - Senior Advisor Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 SreyRam Kuy, MD, MHS, FACS Senior Advisor to the PDUSH Veterans Health Administration Associate Chief of Staff Quality, Safety & Value 1 VA-18-0298 and 18-0299-B-000380 Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 2 VA-18-0298 and 18-0299-B-000381 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Wednesday, April 25, 2018 8:39 AM '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron Moskowitz'; 'Thomas Concannon'; McIntosh, Bruce (b) (6) (b) (6) (NCPS); ' (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; 1111 (b) (6) Subject: Attachments: (b) (6) (b) (6) (b) (6) Medical Device Registry Summit Medical Implant Registry Summit Program 4-25-2018.docx; Medical Implant Registry Summit - List of Invitees.docx Dear Colleagues, Wonderful discussion this morning! Thank you for everyone's input & support, whether by phone or email or otherwise. I appreciate all your efforts! Next steps and deliverables: Danica - could you add the final closing panel (VA/FDA/Others) to the agenda (b) (6) (b) (6) Bruce McIntosh/Danica (and anyone else) - could you add a patient perspective/speaker to the agenda Everyone - could you please send a list of attendees to invite (see attached prelim, draft list) Could I ask you to send to me this by end of tomorrow, Thursday 4/25/2018? Would like to get things the list of attendees vetted by our leadership, the agenda sent to communications, and the final list of speakers to invite for a planning conference call. Thank you so very much!!! -SreyRam - SreyRam Kuy, MD, MHS, FACS From: Kuy, SreyRam (HOU) Sent: Tuesday, April 24, 2018 4:07 PM To: '(b) (6) GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz <(b) (6) mac.com>; Aaron Moskowitz (b) (6) < me.com>; Thomas Concannon <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; 'Marinac-Dabic, Danica' <(b) (6) fda.hhs.gov>; '(b) (6) <(b) (6) ghlf.org>; '(b) (6) <(b) (6) dc-crd.com>; '(b) (6) <(b) (6) dc-crd.com>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) (b) (6) < va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: Medical Device Registry Summit - Planning Meeting 4/25/2018; Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 4/25/2018 7:30 am - 8:00 am Eastern - 1111 - 1111 1 VA-18-0298 and 18-0299-B-000382 Conference call line: 800-767-(b) (5) Code (b) (5) Danica, Bruce, (b) (6) and I are having a call this afternoon to try to finalize the speaker schedule, and as soon as that's done, will forward on to you all. Thank you so much for all your efforts! Warmly, SreyRam o 1111 - Senior Advisor Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 SreyRam Kuy, MD, MHS, FACS Senior Advisor to the PDUSH Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 2 VA-18-0298 and 18-0299-B-000383 Medical Implant Registry Summit DRAFT list of invitees Date: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use Invitees Societies AAMI AORN ECRI American Academy of Orthopaedic Surgeons Orthopedic Network News Society for Vascular Surgery The American Association for Vascular Surgery American College of Surgeons The American Society of General Surgeons American Dental Association VA Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar Office of Dentistry: Dr. (b) (6) (b) (6) of Reproductive Health in Women's Health: Dr. (b) (6) (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) Ophthalmology: Dr. (b) (6) and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) Prosthetic and Sensory Aids Service: Ms. (b) (6) and Mr. (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. (b) (6) - (b) (6) NCPS: Ms. (b) (6) and Ms. (b) (6) Salt Lake City VAMC: Mr. (b) (6) - Mr. (b) (6) Mr. Medical Device Companies Abbot Laboratories Academy Medical LLC AMO Sales and Services Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000384 VI'\ o AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA Nuvasive Smith & Nephew St. Jude Medical Zimmer Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000385 VI'\ o Medical Implant Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 - 4:00 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD 8:45 - 10:00 Session 1: Value for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs TBA - VA patient Leveraging the Medical Device Ecosystem Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Value Roundtable Discussion Moderator: SreyRam Kuy, MD, PhD ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS leadership (TBD) ? Professional societies perspective - AMA - Kathy Blake ? Hospital/system perspective - Kaiser ? Industry perspective - AdvaMed/MDMA 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000386 VI'\ o Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? Current VA Medical Device Registries - Maximo o TBD Office of Healthcare Technology Management, Veterans Health Affairs ? "Title TBD" - Nicholas Giori, MD ? "Title TBD" - Stephen Waldo, MD (or Paul Varosy, MD) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Lunch: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - TBD ? UDI implementation efforts - Terrie Reed, FDA ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic Panel Discussion: 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz, MD, BREF Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000387 VI'\ o Objective: Begin development of the framework for VA registry development Panel: Jack Cronenwett, MD, Art Sedrakyan, MD; PhD, Mike Lauer, MD, PhD, (b) (6) ? Who should be at the table: What can we learn from VQI? - Jack Cronenwett, MD, Dartmouth, M2S ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH ? Quality Management opportunities and compliance with standards- (b) (6) ? Privacy/Ethics issues - TBD Panel Discussion: 3:15 -4:00 Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o VHA Leadership Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000388 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000389 VI'\ o Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, May 01, 2018 6:06 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; 1111 (b) (6) Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) Medical Device Registry Summit - Planning Call, 5/2/2018 Wednesday 7:30 am Eastern, 800-767-(b) (5) Code (b) (5) Medical Implant Registry Summit - List of Invitees.docx; VA Medical Implant Registry Summit Invitation and 1 Pager.docx; VA Medical Implant Registry Summit Program.docx 1111 - Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday mornings 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Again, many apologies to our west coast colleagues for the very early time. Attached is the program, a sample invitation letter with one pager, and a preliminary invitee list. Please feel free to add to the invitee list, edit the program and the invite letter, and share with us all. Thank you so very much for ALL your hard work and efforts around this summit! Warmly, SreyRam SreyRam Kuy, MD, MHS, FACS 1111 - Special Advisor Office of the Secretary Department of Veterans Affairs Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000390 and Medical Implant Registry Summit DRAFT list of invitees Date: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use Invitees Societies AAMI AORN ECRI American Academy of Orthopaedic Surgeons Orthopedic Network News Society for Vascular Surgery The American Association for Vascular Surgery American College of Surgeons The American Society of General Surgeons American Dental Association AMA - Kathy Blake Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Leadership DOD Leadership HHS Leadership - Health Systems (b) (6) Kaiser VA COS Mr. Peter O'Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000392 VI'\ o (b) (6) (b) (6) of Reproductive Health in Women's Health: Dr. (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merrit H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt (b) (6) - FDA Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Terrie Reed, FDA Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH Vahan Simonyan, PhD (FDA) Greg Pappas, MD, PhD FDA/CDRH Medical Device Companies Abbot Laboratories Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000393 VI'\ o Nuvasive Smith & Nephew St. Jude Medical Zimmer AdvaMed/MDMA Others: John Rumsfeld, MD (ACC) Art Sedrakyan, MD, PhD, Cornell/MDEpiNet Harlan Krumholz, MD, Yale Fred Resnic, MD, Lahey Clinic Jack Cronenwett, MD, Dartmouth, M2S (b) (6) Rob Portman Mike Lauer, MD (NIH) Elise Berliner (AHRQ) (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000394 VI'\ o DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 May 1, 2018 From: SreyRam Kuy, MD To: ---Subj: Medical Implant Registry Summit Dear Colleagues The Department of Veterans Affairs is convening leaders to host a national healthcare summit on "Medical Implants Registry". VA is partnering with sister agencies to ensure patient safety and implement the largest health system medical implant tracking program in the country. We would like to respectfully invite you to participate in this national "Medical Implants Registry Summit". The summit will be held on June 4, 2018 at in the VA auditorium. Medical Implant Registry Summit Date: Monday, June 4, 2018 Location: VA Auditorium, room 230 Leadership Panel: 8:30 am -4:30 pm Attached is a one pager briefing on medical implant registry systems, and a draft of the "Medical Implant Registry Summit" program. Warmly, SreyRam Kuy, MD Special Advisor Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Confidential - Working DRAFT, Informational Only, Pre-Decisional - VA Internal Use Only VA-18-0298 and 18-0299-B-000395 A VA Medical Implant Registry: Why it Matters The Vision ? A nationwide Implant Registry that enables VA to monitor the safety of implants in our veterans, track quality metrics and ensure the best possible care for VA patients Current surveillance of medical implants is piecemeal ? Adverse Event Reports: mandatory for manufacturers & hospitals, but incomplete clinical data ? Insurance Claims data - lack clinical details ? Clinical Registries - operated by various groups & societies but not linked to VA's Electronic Medical Records Does VA need an Implant Registry? ? Yes! o o o Needed to monitor patient safety Needed for recall of faulty medical implants Needed to measure quality & compare outcomes of implants Why is an Implant Registry important to the VA? ? A medical implant registry will: o Allow us to notify patients about safety recalls o Allows us to identify the exact device when patient shows up in ER with complications o Allows us to track clinical follow-up What makes an Implant Registry effective for the VA? ? An effective medical implant registry will: o Link with the VA's Electronic Medical Record to facilitate rapid identification o Easily accessible for VA clinicians, and from any VA medical center the veteran presents at o UDI barcode input automated (manual entry raises risk of error & patient safety) o Tracks both medical devices and biological implants (pending legislation will require VA to track biological implants) o Monitors veterans from the pre-registry era (comprises the majority of implants needing surveillance) o Implementable in the short-term via VA's CPRS and VistA, and able to interface with Cerner in the long term Collaboration ? As VA develops the nations' largest implant registry, we welcome opportunities to collaborate with our sister agencies & the medical community in novel partnerships that advance this vision. Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Confidential - Working DRAFT, Informational Only, Pre-Decisional - VA Internal Use Only VA-18-0298 and 18-0299-B-000396 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Implant Registry Summit Date: June 4, 2018 Location: VA Auditorium 8:30 - 4:30 pm 8:30 Welcome and Introductions of Participants and Organizations SreyRam Kuy, MD 8:45 - 10:00 Session 1: Value for Stakeholders Objective: To describe value of medical implant registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA - Patient perspectives Leveraging the Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) invited/available Value Roundtable Discussion Moderator: SreyRam Kuy, MD ? Department of Veterans Affairs Leadership ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS Leadership - TBD ? DOD Leadership - TBD ? HHS Leadership - TBD ? Professional societies perspective - AMA - Kathy Blake ? Hospital/system perspective - (b) (6) Kaiser ? Industry perspective - AdvaMed/MDMA - Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000397 VI'\ o 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merrit H. Raitt, MD Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? Current VA Medical Device Registries - Maximo o Presenter TBD, VA Office of Healthcare Technology Management ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL o Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch Break: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - TBD (10 min) ? UDI implementation efforts - Terrie Reed, FDA (10 min) - invited/available ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) - invited/available ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH (10 min) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000398 VI'\ o ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) - invited/available ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: TBD Objective: Begin development of the framework for VA registry development ? Who should be at the table: What can we learn from VQI? - Jack Cronenwett, MD, Dartmouth, M2S (10 min) ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) ? Quality Management opportunities and compliance with standards- (b) (6) (10 min) ? Privacy/Ethics issues -Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 -4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD - Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan - Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD - NESTcc Patient (TBD) Closing Remarks o VA Leadership Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000399 VI'\ o Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000400 VI'\ o From: To: Kuy, SreyRam (HOU) "(b) (6) GHLF"; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas Research); "Marinac-Dabic, Danica"; "(b) (6) "(b) (6) (b) (6) (b) (6) (b) (6) "(b) (6) Hayes-Byrd, Jacquelyn; (b) (6) - (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) (b) (6) Medical Device Registry Summit - Planning Meeting VA Medical Implant Registry Summit Program 5-8-2018.docx Medical Implant Registry Summit - List of Invitees 5-8-2018.docx Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: -- Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda and a slate of speakers. Several fantastic subject matter experts on board to participate! Attached is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam Special Advisor Office of the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 VA-18-0298 and 18-0299-B-000401 Medical Implant Registry Summit DRAFT list of invitees Date of Summit: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use *These are planned invitees - they have not yet confirmed attendance, and may send a representative in their place. Invitees* Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Administrator Seema Verma (tentative) or representative HHS Secretary Alex Azar (tentative) or representative DoD Secretary James Mattis or representatiave (tentative) VA employees COS Mr. Peter O'Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Secretary Wilkie (tentative) or Deputy Secretary Bowman (tentative) Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. (b) (6) (b) (6) of Reproductive Health in Women's Health: Dr. (b) (6) (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. - Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ Mr. I tel\ (b) (6) US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000402 VI'\ o (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt FDA Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Terrie Reed, FDA Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH Vahan Simonyan, PhD (FDA) Greg Pappas, MD, PhD FDA/CDRH Others: John Rumsfeld, MD (ACC) Art Sedrakyan, MD, PhD, Cornell/MDEpiNet Harlan Krumholz, MD, Yale Fred Resnic, MD, Lahey Clinic Jack Cronenwett, MD, Dartmouth, M2S (b) (6) Rob Portman Mike Lauer, MD (NIH) AHRQ representative (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon PEW Trust EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel - Donald Rucker, MD Kristy Mitchel - Avalere Christine Stake - Ann & Robert H. Lurie Children's Hospital of Chicago (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000403 VI'\ o Societies/Nonprofits Association for the Advancement of Medical Instrumentation (AAMI) leadership (b) (6) (b) (6) PhD (b) (6) FHIMSS (b) (6) PhD Association of peri-Operative Registered Nurses (AORN) (b) (6) MSHA, RN, CNOR, CSSM (b) (6) MHA, RN-BC, CNOR, CSSM (b) (6) MSN, RN, CNOR (b) (6) MSN, MBA, RN, ACNS-BC, CNS-CP, CNOR Emergency Care Research Institute (ECRI) (b) (6) MD, PhD (b) (6) MS American Academy of Orthopaedic Surgeons (AAOS) (b) (6) MD (b) (6) MD (b) (6) III MD American College of Cardiology (b) (6) MD, FACC (b) (6) MD, FACC (b) (6) Jr., MD, MBA, FACC (b) (6) MD, FACC American Association of Neurological Surgeons (b) (6) MD, PhD, FAANS, FACS (b) (6) MD, FAANS (b) (6) MD, MPH, FAANS, FACS (b) (6) MD, FAANS American Neurological Association (b) (6) PhD, MS (b) (6) MD Society for Vascular Surgery (b) (6) III, MD (b) (6) MD (b) (6) MD - American College of Surgeons (b) (6) - Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000404 VI'\ o (b) (6) (b) (6) (b) (6) American Dental Association (b) (6) DDS (b) (6) DDS AMA (b) (6) (b) (6) -Kathy Blake MD, MHA MD AcademyHealth (b) (6) -Dr. - - Association for Healthcare Resources and Materials Management (AHRMM) (b) (6) (b) (6) (b) (6) Senior Supply Chain ( aha.org) Cognitive Health - Julia Skapik, MD, PhD Pew Charitable Trust (b) (6) MD Henry J. Kaiser Family Foundation (b) (6) Medical Device Companies (Tentative - pending OGC and ethics approval, would send invite to their government affairs contact) Abbot Laboratories Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000405 VI'\ o Nuvasive Smith & Nephew St. Jude Medical Zimmer AdvaMed/MDMA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000406 VI'\ o DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit VA Auditorium Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. - 4:30 p.m. 8:30 a.m. Welcome and Introductions of Participants and Organizations SreyRam Kuy, MD 8:45 a.m. - 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective (10 min) Christine Stake Leveraging the Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Value Roundtable Discussion Moderator: SreyRam Kuy, MD ? VA Secretary or Deputy Secretary ? FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS Administrator Seema Verma (tentative) ? HHS Secretary Alex Azar (tentative) or representative ? DoD Secretary James Mattis or representative (tentative) ? Professional societies perspective - AMA - Cathy Blake 10 a.m. - 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000407 VI'\ o Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? Current VA Medical Device Registries - Maximo o Presenter TBD VA Office of Healthcare Technology Management ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL o Stephen Waldo, MD (or Paul Varosy, MD) Director, VA Clinical Assessment, Reporting and Tracking Program (CART) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) Panel Discussion: Speakers + MD (VA, Vanderbilt) and John Rumsfeld, MD (ACC) + EHR Vendor + DOD Representative 11:30 a.m. - 12:30 p.m. Lunch Break 12:30 p.m. - 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - Don Rucker (10 min) ? UDI implementation efforts - Terrie Reed, FDA (10 min) - invited/available ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) - invited/available ? Harmonization Efforts with National/International Registries Danica MarinacDabic, MD, PhD, MMSC, FISPE - FDA/CDRH (10 min) ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) - invited/available ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000408 VI'\ o Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2 p.m. - 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: TBD Objective: Begin development of the framework for VA registry development ? Who should be at the table: What can we learn from VQI? - Jack Cronenwett, MD, Dartmouth, M2S (10 min) ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) (b) (6) ? Quality Management opportunities and compliance with standards- (10 min) ? Privacy/Ethics issues -Rob Portman, JD (10 min) - - Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ), Julia Skapik, Cognitive Health (invited and available), Kristy Mitchel (Avalere) 3:15 p.m. - 4:30 p.m. Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD - Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan - Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD - NESTcc Patient (TBD) Closing Remarks o VA Leadership Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Diffusionof _,- ::::;' ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHAo \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000409 VI'\ o Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) Tuesday, May 08, 2018 3:49 PM Kuy, SreyRam (HOU); '(b) (6) McIntosh, Bruce (NCPS); (b) (6) '(b) (6) '(b) (6) fda.hhs.gov> GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (Atlas Research); '(b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Attachments: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program05082018.docx The latest round of revisions. 1. 2. 3. 4. 5. (b) (6) from Kaiser - has a last minute conflict and I removed her - but she definitely wants to help with the effort in the next phase. Added Julia Skapik, MD,PhD to the Panel ( former ONC, currently with Cognitive Health ) Added Kristy Mitchel to the Panel - formerly ACC now Avalere Still waiting to hear from (b) (6) Still waiting to hear from AHRQ Several people requested the agenda. Are we finalizing tomorrow? Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - 1111 The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. OOD DU ADMI . IS-Tll:ATON (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; -----Original Appointment----- From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 20, 2018 4:06 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); Marinac-Dabic, Danica; '(b) (6) '(b) (6) '(b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Medical Device Registry Summit - Planning Meeting When: Wednesday, May 09, 2018 7:30 AM-8:00 AM (UTC-05:00) Eastern Time (US & Canada). Where: Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - 1 VA-18-0298 and 18-0299-B-000410 Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam 1111 - Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 << File: Medical Device Registry Summit - 1 pager.docx >> << File: Medical Device Registry Summit - 1 pager.pdf >> 2 VA-18-0298 and 18-0299-B-000411 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 - 4:30 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 - 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA - VA patient Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS leadership (TBD) ? Professional societies perspective - AMA - Cathy Blake (invited and available) ? Hospital/system perspective - (b) (6) Kaiser ? Industry perspective - AdvaMed/MDMA (invited) ? ONC - Don Rucker - 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000412 VI'\ o Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program ? Current VA Medical Device Registries - Maximo o Presenter TBD VA Office of Healthcare Technology Management ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL o Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) MD (VA, Vanderbilt) Lunch: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? UDI implementation efforts - Terrie Reed, FDA (10 min) - invited/available ? Harmonization Efforts with National/International Registries and Consortia- Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH (10 min) - invited/available ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) - invited/available ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000413 VI'\ o 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development ? Who should be at the table : What can we learn from VQI?- Jack Cronenwett, MD, Dartmouth, M2S (10 min) - invited/available ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) - invited/available ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) - invited/available ? Quality Management opportunities and compliance with standards- (b) (6) (10 min) - invited/available ? Privacy/Ethics issues -Rob Portman (10 min) JD Panel Discussion: Speakers + Julia Skapik, Cognitive Health (invited and available), Kristy Mitchel (Avalere) - invited and available 3:15 -4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD Panel: Bruce McIntosh - VA - invited/available Art Sedrakyan - Weill Cornell Medical College- invited /available Danica Marinac-Dabic, MD, PhD - FDA - invited/available Rachael Fleurence, PhD - NESTcc - invited available Bruce Moscowitz, MD - BREF - invited/available Patient representative Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000414 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000415 VI'\ o Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000416 VI'\ o Ha, Richard From: Sent: To: - - GHLF <(b) (6) ghlf.org> Tuesday, May 08, 2018 12:50 PM Marinac-Dabic, Danica; Kuy, SreyRam (HOU); Bruce Moskowitz; Aaron Moskowitz; Thomas (b) (6) Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); (b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) 1111 1111 (b) (6) Subject: Attachments: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program05022018-bn.docx Hi all, I added the name of our patient speaker, Christine Stake, to the attached program. We are working with Chris on her comments so we can share them in the coming week. Since she's probably not known to everyone, here's her bio: Chris has been a patient, caregiver and researcher for hip replacement. She is passionate about making sure that clinical decision making is a shared process between patients and health professionals and is particularly interested in health decision making at all ages due to her experience as a young person requiring joint replacement. She's especially concerned about medical device safety and tracking, given that younger people may need revision surgery due to the early age of initial joint replacement. It's important to her that the factors most important to patients, such as quality of life, are prioritized in both clinical care and research. Chris is currently employed at Ann & Robert H. Lurie Children's Hospital of Chicago as the Research Operations Manager for Neuroscientific Aspects of Pain. She also serves as a Patient Governor for the ArthritisPower patient research registry and app (www.ArthritisPower.org). (b) (6) (b) (6) PhD | Patient-Centered Research - Global Healthy Living Foundation 515 N. Midland Ave - Upper Nyack, NY 10960 Cell: +1 (917) 455 (b) (6) | Office: +1 (845) 348 (b) (6) | Fax: +1 (845) 348 (b) (6) (b) (6) ghlf.org GHLF.org | CreakyJoints.org | ArthritisPower.org Facebook.com/CreakyJoints | Twitter.com/CreakyJoints | Twitter.com/GHLForg - 1111 1111 1111 Improving the lives of people with chronic disease through better access to care, education, support, advocacy and patient-centered research. From: Marinac-Dabic, Danica [mailto:(b) (6) Sent: Monday, May 7, 2018 7:56 AM fda.hhs.gov] 1 VA-18-0298 and 18-0299-B-000417 To: 'Kuy, SreyRam (HOU)' ; (b) (6) GHLF <(b) (6) ghlf.org>; Bruce Moskowitz (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (b) (6) (b) (6) (b) (6) (Atlas Research) < va.gov>; < ghlf.org>; '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < dc-crd.com>; ' < dc-crd.com>; < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: RE: Medical Device Registry Summit - Planning Meeting Sending updated Program with the names of confirmed speakers THIS MORNING. AHRQ is sending another speaker - as Eiise Berliner has a conflict. Stay tuned. Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - 1111 The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. O0D&D U ADMI . IS-TltAT ON (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; -----Original Appointment----- From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 20, 2018 4:06 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); Marinac-Dabic, Danica; '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) ' Hayes-Byrd, Jacquelyn; Subject: Medical Device Registry Summit - Planning Meeting When: Wednesday, May 09, 2018 7:30 AM-8:00 AM (UTC-05:00) Eastern Time (US & Canada). Where: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. 1111 - 1111 - 2 VA-18-0298 and 18-0299-B-000418 Thank you so much for all your efforts! Warmly, SreyRam Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 << File: Medical Device Registry Summit - 1 pager.docx >> << File: Medical Device Registry Summit - 1 pager.pdf >> 3 VA-18-0298 and 18-0299-B-000419 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 - 4:30 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 - 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) Christine Stake, PhD, MA, Hip Replacement Patient Global Healthy Living Foundation, ArthritisPower Patient Powered Research Network Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS leadership (TBD) ? Professional societies perspective - AMA - Cathy Blake (invited and available) ? Hospital/system perspective - (b) (6) Kaiser ? Industry perspective - AdvaMed/MDMA (invited) ? ONC - Don Rucker - 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000420 VI'\ o Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program ? Current VA Medical Device Registries - Maximo o Presenter TBD VA Office of Healthcare Technology Management ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL o Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - TBD (10 min) - ? UDI implementation efforts - Terrie Reed, FDA (10 min) - invited/available ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) - invited/available ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH (10 min) - invited/available ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) - invited/available Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000421 VI'\ o ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development ? Who should be at the table : What can we learn from VQI?- Jack Cronenwett, MD, Dartmouth, M2S (10 min) - invited/available ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) - invited/available ? Quality Management opportunities and compliance with standards- (b) (6) (10 min) - invited/available ? Privacy/Ethics issues -Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 -4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD - Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan - Weill Cornell Medical College- invited /available Danica Marinac-Dabic, MD, PhD - FDA - invited/available Rachael Fleurence, PhD - NESTcc Bruce Moscowitz, MD - BREF Patient Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000422 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000423 VI'\ o o (b) (6) va.gov Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000424 VI'\ o Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Wednesday, May 02, 2018 10:59 AM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) McIntosh, Bruce (NCPS); (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program05022018.docx - Cathy Blake - confirmed; Jack Cronenwett - confirmed; Elsie Berliner - sending another person from AHRQ; still waiting for AdvaMed speaker and confirmation for (b) (6) and ONC - speaker . I updated the agenda with the confirmed speakers ( I called them invited/available). Sending further updates as I receive them. Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - 1111 The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. (b) (6) OOD DU ADMI l'-IIS-Tll:ATON fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; -----Original Appointment----- From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 20, 2018 4:06 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas Research); Marinac-Dabic, Danica; '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) ' Hayes-Byrd, Jacquelyn; Cc: (b) (6) Subject: Medical Device Registry Summit - Planning Meeting When: Wednesday, May 02, 2018 11:30 AM-12:00 PM . Where: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call 1111 - 1 VA-18-0298 and 18-0299-B-000425 Wednesday mornings 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Again, many apologies to our west coast colleagues for the very early time. Thank you so very much for ALL your hard work and efforts around this summit! Warmly, SreyRam SreyRam Kuy, MD, MHS, FACS 1111 - Special Advisor Office of the Secretary Department of Veterans Affairs Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 << File: VA Medical Implant Registry Summit Program.docx >> << File: VA Medical Implant Registry Summit - Invitation and 1 Pager.docx >> << File: Medical Implant Registry Summit - List of Invitees.docx >> 2 VA-18-0298 and 18-0299-B-000426 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 - 4:30 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 - 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA - VA patient Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS leadership (TBD) ? Professional societies perspective - AMA - Cathy Blake (invited and available) ? Hospital/system perspective - (b) (6) Kaiser ? Industry perspective - AdvaMed/MDMA (invited) ? ONC - Don Rucker - 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000427 VI'\ o Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program ? Current VA Medical Device Registries - Maximo o Presenter TBD VA Office of Healthcare Technology Management ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL o Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - TBD (10 min) - ? UDI implementation efforts - Terrie Reed, FDA (10 min) - invited/available ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) - invited/available ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH (10 min) - invited/available ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) - invited/available Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000428 VI'\ o ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development ? Who should be at the table : What can we learn from VQI?- Jack Cronenwett, MD, Dartmouth, M2S (10 min) - invited/available ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) - invited/available ? Quality Management opportunities and compliance with standards- (b) (6) (10 min) - invited/available ? Privacy/Ethics issues -Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 -4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD - Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan - Weill Cornell Medical College- invited /available Danica Marinac-Dabic, MD, PhD - FDA - invited/available Rachael Fleurence, PhD - NESTcc Bruce Moscowitz, MD - BREF Patient Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000429 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000430 VI'\ o o (b) (6) va.gov Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000431 VI'\ o Ha, Richard Subject: Location: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 5/2/2018 7:30 AM Wed 5/2/2018 8:00 AM Tentative 1111 - Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; 1111 (b) (6) (b) (6) (b) (6) Optional Attendees: (b) (6) 1 VA-18-0298 and 18-0299-B-000432 Ha, Richard Subject: Location: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 5/2/2018 7:30 AM Wed 5/2/2018 8:00 AM Tentative 1111 - Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; 1111 (b) (6) (b) (6) (b) (6) Optional Attendees: (b) (6) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday mornings 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Again, many apologies to our west coast colleagues for the very early time. Thank you so very much for ALL your hard work and efforts around this summit! Warmly, SreyRam SreyRam Kuy, MD, MHS, FACS 1111 - Special Advisor Office of the Secretary Department of Veterans Affairs Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 1 VA-18-0298 and 18-0299-B-000433 Mobile: 713-503-4274 Office: 202-461-4875 ' (1i r 1 1( <<,,, 11 l( m1 1 1, , 11111 \ r 1( 1 . 11]1I' ' l l ll ff'I I ff'I I .. 2 VA-18-0298 and 18-0299-B-000434 Medical Implant Registry Summit DRAFT list of invitees Date: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use Invitees Societies AAMI AORN ECRI American Academy of Orthopaedic Surgeons Orthopedic Network News Society for Vascular Surgery The American Association for Vascular Surgery American College of Surgeons The American Society of General Surgeons American Dental Association AMA - Kathy Blake Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Leadership DOD Leadership HHS Leadership - Health Systems (b) (6) Kaiser VA COS Mr. Peter O'Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000435 VI'\ o (b) (6) (b) (6) of Reproductive Health in Women's Health: Dr. (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merrit H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt (b) (6) - FDA Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Terrie Reed, FDA Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH Vahan Simonyan, PhD (FDA) Greg Pappas, MD, PhD FDA/CDRH Medical Device Companies Abbot Laboratories Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000436 VI'\ o Nuvasive Smith & Nephew St. Jude Medical Zimmer AdvaMed/MDMA Others: John Rumsfeld, MD (ACC) Art Sedrakyan, MD, PhD, Cornell/MDEpiNet Harlan Krumholz, MD, Yale Fred Resnic, MD, Lahey Clinic Jack Cronenwett, MD, Dartmouth, M2S (b) (6) Rob Portman Mike Lauer, MD (NIH) Elise Berliner (AHRQ) (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000437 VI'\ o DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 May 1, 2018 From: SreyRam Kuy, MD To: ---Subj: Medical Implant Registry Summit Dear Colleagues The Department of Veterans Affairs is convening leaders to host a national healthcare summit on "Medical Implants Registry". VA is partnering with sister agencies to ensure patient safety and implement the largest health system medical implant tracking program in the country. We would like to respectfully invite you to participate in this national "Medical Implants Registry Summit". The summit will be held on June 4, 2018 at in the VA auditorium. Medical Implant Registry Summit Date: Monday, June 4, 2018 Location: VA Auditorium, room 230 Leadership Panel: 8:30 am -4:30 pm Attached is a one pager briefing on medical implant registry systems, and a draft of the "Medical Implant Registry Summit" program. Warmly, SreyRam Kuy, MD Special Advisor Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Confidential - Working DRAFT, Informational Only, Pre-Decisional - VA Internal Use Only VA-18-0298 and 18-0299-B-000438 A VA Medical Implant Registry: Why it Matters The Vision ? A nationwide Implant Registry that enables VA to monitor the safety of implants in our veterans, track quality metrics and ensure the best possible care for VA patients Current surveillance of medical implants is piecemeal ? Adverse Event Reports: mandatory for manufacturers & hospitals, but incomplete clinical data ? Insurance Claims data - lack clinical details ? Clinical Registries - operated by various groups & societies but not linked to VA's Electronic Medical Records Does VA need an Implant Registry? ? Yes! o o o Needed to monitor patient safety Needed for recall of faulty medical implants Needed to measure quality & compare outcomes of implants Why is an Implant Registry important to the VA? ? A medical implant registry will: o Allow us to notify patients about safety recalls o Allows us to identify the exact device when patient shows up in ER with complications o Allows us to track clinical follow-up What makes an Implant Registry effective for the VA? ? An effective medical implant registry will: o Link with the VA's Electronic Medical Record to facilitate rapid identification o Easily accessible for VA clinicians, and from any VA medical center the veteran presents at o UDI barcode input automated (manual entry raises risk of error & patient safety) o Tracks both medical devices and biological implants (pending legislation will require VA to track biological implants) o Monitors veterans from the pre-registry era (comprises the majority of implants needing surveillance) o Implementable in the short-term via VA's CPRS and VistA, and able to interface with Cerner in the long term Collaboration ? As VA develops the nations' largest implant registry, we welcome opportunities to collaborate with our sister agencies & the medical community in novel partnerships that advance this vision. Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Confidential - Working DRAFT, Informational Only, Pre-Decisional - VA Internal Use Only VA-18-0298 and 18-0299-B-000439 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Implant Registry Summit Date: June 4, 2018 Location: VA Auditorium 8:30 - 4:30 pm 8:30 Welcome and Introductions of Participants and Organizations SreyRam Kuy, MD 8:45 - 10:00 Session 1: Value for Stakeholders Objective: To describe value of medical implant registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA - Patient perspectives Leveraging the Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) invited/available Value Roundtable Discussion Moderator: SreyRam Kuy, MD ? Department of Veterans Affairs Leadership ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS Leadership - TBD ? DOD Leadership - TBD ? HHS Leadership - TBD ? Professional societies perspective - AMA - Kathy Blake ? Hospital/system perspective - (b) (6) Kaiser ? Industry perspective - AdvaMed/MDMA - Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000440 VI'\ o 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merrit H. Raitt, MD Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? Current VA Medical Device Registries - Maximo o Presenter TBD, VA Office of Healthcare Technology Management ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL o Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch Break: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - TBD (10 min) ? UDI implementation efforts - Terrie Reed, FDA (10 min) - invited/available ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) - invited/available ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH (10 min) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000441 VI'\ o ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) - invited/available ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: TBD Objective: Begin development of the framework for VA registry development ? Who should be at the table: What can we learn from VQI? - Jack Cronenwett, MD, Dartmouth, M2S (10 min) ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) ? Quality Management opportunities and compliance with standards- (b) (6) (10 min) ? Privacy/Ethics issues -Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 -4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD - Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan - Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD - NESTcc Patient (TBD) Closing Remarks o VA Leadership Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000442 VI'\ o Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000443 VI'\ o Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Friday, April 27, 2018 11:37 AM McIntosh, Bruce (NCPS); Kuy, SreyRam (HOU); '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron (b) (6) (b) (6) Moskowitz'; 'Thomas Concannon'; ' (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; 1111 (b) (6) Subject: Attachments: (b) (6) [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program04262018_BM editDMDeditREV.docx Made the correction - time is now consistent on the first page and in the last session - ending at 4:30. Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) 1111 U.S.FOODle DRUG (b) (6) - fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; From: Marinac-Dabic, Danica Sent: Thursday, April 26, 2018 11:29 PM To: 'McIntosh, Bruce (NCPS)' <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; '(b) (6) (b) (6) (b) (6) GHLF' < ghlf.org>; Bruce Moskowitz < mac.com>; Aaron Moskowitz <(b) (6) me.com>; Thomas Concannon <(b) (6) rand.org>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; '(b) (6) <(b) (6) dc-crd.com>; '(b) (6) <(b) (6) dc-crd.com>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: RE: Medical Device Registry Summit - Planning Meeting - Bruce and the Team, Do you think we need to invite someone from DOD? Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) 1111 U.S.FOODle DRUG (b) (6) - fda.hhs.gov; 1 VA-18-0298 and 18-0299-B-000444 Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov] Sent: Thursday, April 26, 2018 9:28 PM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6) (b) (6) GHLF' < ghlf.org>; Bruce Moskowitz <(b) (6) mac.com>; Aaron Moskowitz <(b) (6) me.com>; Thomas Concannon <(b) (6) rand.org>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (b) (6) (b) (6) (b) (6) (Atlas Research) < va.gov>; ' < ghlf.org>; '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < dc-crd.com>; ' < dc-crd.com>; < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: RE: Medical Device Registry Summit - Planning Meeting o Nice work Danica! Attached are edits to Agenda for VA section. I am waiting to receive who will cover for (b) (5) presentation (still TBD). Don't hold up locking this in though if we have to leave as TBD. Regarding a VA patient to present, I think we may be making this too complicated. To find a VA patient who is comfortable presenting with a story to tell effectively and with proper HIPAA release and clearance will likely be complicated, especially without funding for travel. Perhaps we should use one of the previous non-VA patients presented earlier with a known story , or remove this. Thanks, Bruce - From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Thursday, April 26, 2018 9:14 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); '(b) (6) '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Colleagues, The updated document is attached. Please note that I added additional names of potential speakers, panelists and moderators for your consideration. In addition I marked the names of those speakers who have been already tentatively invited/available (pending the VA Senior leadership approval). Please review and revise as needed. Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link poin ts to the correct file and location. (b) (6) fda.hhs.gov; 2 VA-18-0298 and 18-0299-B-000445 Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; -----Original Appointment----- From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 20, 2018 4:06 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas Research); Marinac-Dabic, Danica; '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) ' Hayes-Byrd, Jacquelyn; Subject: Medical Device Registry Summit - Planning Meeting When: Wednesday, April 25, 2018 7:30 AM-8:00 AM (UTC-05:00) Eastern Time (US & Canada). Where: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam 1111 - 1111 - Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 3 VA-18-0298 and 18-0299-B-000446 << File: Medical Device Registry Summit - 1 pager.docx >> << File: Medical Device Registry Summit - 1 pager.pdf >> 4 VA-18-0298 and 18-0299-B-000447 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 - 4:30 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 - 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA - VA patient Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS leadership (TBD) ? Professional societies perspective - AMA - Kathy Blake ? Hospital/system perspective - (b) (6) Kaiser ? Industry perspective - AdvaMed/MDMA - 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: TBD Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000448 VI'\ o ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program ? Current VA Medical Device Registries - Maximo o Presenter TBD VA Office of Healthcare Technology Management ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL o Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - TBD (10 min) ? UDI implementation efforts - Terrie Reed, FDA (10 min) - invited/available ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) - invited/available ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH (10 min) ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) - invited/available ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000449 VI'\ o Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development ? Who should be at the table : What can we learn from VQI?- Jack Cronenwett, MD, Dartmouth, M2S (10 min) ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) ? Quality Management opportunities and compliance with standards- (b) (6) (10 min) ? Privacy/Ethics issues -Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 -4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD - Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan - Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD - NESTcc Bruce Moscowitz, MD - BREF Patient Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000450 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000451 VI'\ o (b) (6) va.gov Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000452 VI'\ o Ha, Richard From: Sent: To: Cc: Subject: Attachments: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Friday, April 27, 2018 10:30 AM 'Bruce Moskowitz' McIntosh, Bruce (NCPS); Kuy, SreyRam (HOU); (b) (6) GHLF; Aaron Moskowitz; Thomas (b) (6) (b) (6) Concannon; (b) (6) (Atlas Research); (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program04262018_BM editDMDedit.docx - Just added a placeholder on the VA session Panel for DOD panelist Another option would be to have DOD speaker. I was given (by a colleague )as a suggestion the name of Col. John Smith who works with FDA on another collaborative project; not sure if you know him and if he is the right person. Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) 1111 U.S.FOOD& DRUG - (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; From: Bruce Moskowitz [mailto:(b) (6) mac.com] Sent: Friday, April 27, 2018 5:27 AM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Cc: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; (b) (6) GHLF <(b) (6) ghlf.org>; Aaron Moskowitz <(b) (6) me.com>; Thomas Concannon <(b) (6) rand.org>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < ghlf.org>; < dc-crd.com>; < dc-crd.com>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: Re: Medical Device Registry Summit - Planning Meeting 1111 1111 Yes very important Sent from my iPad Bruce Moskowitz M.D. (b) (6) On Apr 26, 2018, at 11:29 PM, Marinac-Dabic, Danica < fda.hhs.gov> wrote: Bruce and the Team, 1 VA-18-0298 and 18-0299-B-000453 Do you think we need to invite someone from DOD? Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; 1111 - --- From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov] Sent: Thursday, April 26, 2018 9:28 PM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) (b) (6) (b) (6) ; ' GHLF' < ghlf.org>; Bruce Moskowitz <(b) (6) mac.com>; Aaron Moskowitz <(b) (6) me.com>; Thomas Concannon <(b) (6) rand.org>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; ' < ghlf.org>; ' <(b) (6) dc- (b) (6) (b) (6) (b) (6) crd.com>; ' < dc-crd.com>; (b) (6) < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: RE: Medical Device Registry Summit - Planning Meeting 1111- Nice work Danica! Attached are edits to Agenda for VA section. I am waiting to receive who will cover for (b) (5) presentation (still TBD). Don't hold up locking this in though if we have to leave as TBD. Regarding a VA patient to present, I think we may be making this too complicated. To find a VA patient who is comfortable presenting with a story to tell effectively and with proper HIPAA release and clearance will likely be complicated, especially without funding for travel. Perhaps we should use one of the previous non-VA patients presented earlier with a known story , or remove this. Thanks, Bruce - From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Thursday, April 26, 2018 9:14 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) McIntosh, Bruce (NCPS); (b) (6) (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Colleagues, The updated document is attached. Please note that I added additional names of potential speakers, panelists and moderators for your consideration. In addition I marked the names of those speakers who have been already tentatively invited/available (pending the VA Senior leadership approval). Please review and revise as needed. Danica 2 VA-18-0298 and 18-0299-B-000454 Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link poin ts to the correct file and location. (b) (6) 1111 - fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; -----Original Appointment----- From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 20, 2018 4:06 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas Research); Marinac-Dabic, Danica; (b) (6) (b) (6) (b) (6) ' ' ' (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Medical Device Registry Summit - Planning Meeting When: Wednesday, April 25, 2018 7:30 AM-8:00 AM (UTC-05:00) Eastern Time (US & Canada). Where: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam 1111 - 1111 - Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 3 VA-18-0298 and 18-0299-B-000455 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 << File: Medical Device Registry Summit - 1 pager.docx >> << File: Medical Device Registry Summit - 1 pager.pdf >> 4 VA-18-0298 and 18-0299-B-000456 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 - 4:00 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 - 10:00 Session 1: Value of Registries for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritize opportunities Patient Needs (15 min) TBA - VA patient Leveraging Medical Device Ecosystem (15 min) Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NESTcc) - invited/available Value Roundtable Discussion (45min) Moderator: SreyRam Kuy, MD, PhD ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS leadership (TBD) ? Professional societies perspective - AMA - Kathy Blake ? Hospital/system perspective - (b) (6) Kaiser ? Industry perspective - AdvaMed/MDMA - 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: TBD Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000457 VI'\ o ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD Director, VA National Cardiac Device Surveillance Program ? Current VA Medical Device Registries - Maximo o Presenter TBD VA Office of Healthcare Technology Management ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of RTLS into CART-CL o Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, National Center for Patient Safety Panel Discussion: Speakers + (b) (6) (ACC) + EHR Vendor + DOD Representative MD (VA, Vanderbilt) and John Rumsfeld, MD Lunch: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health (invited/available) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - TBD (10 min) ? UDI implementation efforts - Terrie Reed, FDA (10 min) - invited/available ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell/MDEpiNet (10 min) - invited/available ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH (10 min) ? Patient -enabled evidence generation - Harlan Krumholz, MD, Yale (10 min) - invited/available ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic (10 min) - invited/available Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000458 VI'\ o Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) (invited/available), 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Objective: Begin development of the framework for VA registry development ? Who should be at the table : What can we learn from VQI?- Jack Cronenwett, MD, Dartmouth, M2S (10 min) ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH (10 min) ? Quality Management opportunities and compliance with standards- (b) (6) (10 min) ? Privacy/Ethics issues -Rob Portman (10 min) JD Panel Discussion: Speakers + Mike Lauer, MD (NIH), Elise Berliner (AHRQ) 3:15 -4:30 Panel: Pulling it All Together/Next Steps Objective: To summarize key recommendations and prioritize the next steps toward building VA Medical Device Registry Moderator: Harlan Krumholz, MD - Panel: Bruce McIntosh - VA (b) (6) Kaiser Permanente - NJRR Art Sedrakyan - Weill Cornell Medical College Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD - NESTcc Bruce Moscowitz, MD - BREF Patient Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000459 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000460 VI'\ o (b) (6) va.gov Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000461 VI'\ o Ha, Richard From: Sent: To: Cc: Subject: - - GHLF <(b) (6) ghlf.org> Friday, April 27, 2018 10:20 AM Marinac-Dabic, Danica; 'Bruce Moskowitz' McIntosh, Bruce (NCPS); Kuy, SreyRam (HOU); Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) (b) (6) (b) (6) (Atlas Research); (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting (b) (6) Regarding Bruce McIntosh's comment below, we have a non-VA patient who could fill this role. She was part of our PCORI-funded arthroplasty engagement project (BeTTER SAID) where patients identified device selection/tracking as a critical concern. I'll check with her about her interest and availability. Then I'll get back to everyone with more info about the patient so we can collectively make a decision. (b) (6) (b) (6) PhD | Patient-Centered Research - Global Healthy Living Foundation 515 N. Midland Ave - Upper Nyack, NY 10960 Cell: +1 (917) 455 (b) (6) | Office: +1 (845) 348 (b) (6) | Fax: +1 (845) 348 (b) (6) (b) (6) ghlf.org GHLF.org | CreakyJoints.org | ArthritisPower.org Facebook.com/CreakyJoints | Twitter.com/CreakyJoints | Twitter.com/GHLForg - 1111 1111 1111 Improving the lives of people with chronic disease through better access to care, education, support, advocacy and patient-centered research. From: Marinac-Dabic, Danica [mailto:(b) (6) @fda.hhs.gov] Sent: Friday, April 27, 2018 8:09 AM To: 'Bruce Moskowitz' <(b) (6) mac.com> Cc: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; (b) (6) GHLF (b) (6) (b) (6) < ghlf.org>; Aaron Moskowitz < me.com>; Thomas Concannon <(b) (6) rand.org>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; (b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) dc-crd.com>; (b) (6) <(b) (6) dc-crd.com>; (b) (6) (b) (6) < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: RE: Medical Device Registry Summit - Planning Meeting 1111 TY. Danica Marinac-Dabic, MD, PhD, MMSc, FISPE 1 VA-18-0298 and 18-0299-B-000462 Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) 1111 U.S.FOOD& DRUG - (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; From: Bruce Moskowitz [mailto:(b) (6) mac.com] Sent: Friday, April 27, 2018 7:50 AM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Cc: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; (b) (6) GHLF (b) (6) (b) (6) (b) (6) < ghlf.org>; Aaron Moskowitz < me.com>; Thomas Concannon < rand.org>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; (b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) dc-crd.com>; (b) (6) <(b) (6) dc-crd.com>; (b) (6) (b) (6) < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) (b) (6) (b) (6) < va.gov>; <(b) (6) va.gov> Subject: Re: Medical Device Registry Summit - Planning Meeting - ----- 1111 1111 Will ask Sent from my iPad Bruce Moskowitz M.D. (b) (6) On Apr 27, 2018, at 7:45 AM, Marinac-Dabic, Danica < fda.hhs.gov> wrote: Any suggestions? Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; - 1111 From: Bruce Moskowitz [mailto:(b) (6) mac.com] Sent: Friday, April 27, 2018 5:27 AM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Cc: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Kuy, SreyRam (HOU) ; (b) (6) GHLF <(b) (6) ghlf.org>; Aaron Moskowitz <(b) (6) me.com>; Thomas Concannon <(b) (6) rand.org>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; (b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) dc-crd.com>; (b) (6) <(b) (6) dc-crd.com>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) 2 VA-18-0298 and 18-0299-B-000463 < va.gov>; < va.gov> ISubject: Re: Medical Device Registry Summit - Planning Meeting (b) (6) (b) (6) (b) (6) (b) (6) Yes very important Sent from my iPad Bruce Moskowitz M.D. (b) (6) On Apr 26, 2018, at 11:29 PM, Marinac-Dabic, Danica < wrote: fda.hhs.gov> Bruce and the Team, Do you think we need to invite someone from DOD? Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; 1111 - ------ From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov] Sent: Thursday, April 26, 2018 9:28 PM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6) GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz <(b) (6) mac.com>; Aaron Moskowitz <(b) (6) me.com>; (b) (6) (b) (6) (b) (6) Thomas Concannon < rand.org>; < atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; '(b) (6) <(b) (6) dc-crd.com>; '(b) (6) <(b) (6) dc-crd.com>; (b) (6) <(b) (6) va.gov>; Hayes- Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: RE: Medical Device Registry Summit - Planning Meeting Nice work Danica! Attached are edits to Agenda for VA section. I am waiting to receive who will cover for (b) (5) presentation (still TBD). Don't hold up locking this in though if we have to leave as TBD. Regarding a VA patient to present, I think we may be making this too complicated. To find a VA patient who is comfortable presenting with a story to tell effectively and with proper HIPAA release and clearance will likely be complicated, especially without funding for travel. Perhaps we should use one of the previous non-VA patients presented earlier with a known story , or remove this. Thanks, Bruce - 3 VA-18-0298 and 18-0299-B-000464 From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Thursday, April 26, 2018 9:14 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; (b) (6) Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (Atlas (b) (6) (b) (6) (b) (6) (b) (6) Research); ' ' ' (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting - - Colleagues, The updated document is attached. Please note that I added additional names of potential speakers, panelists and moderators for your consideration. In addition I marked the names of those speakers who have been already tentatively invited/available (pending the VA Senior leadership approval). Please review and revise as needed. Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link poin ts to the correct file and location. (b) (6) - 1111 fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; -----Original Appointment----- From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 20, 2018 4:06 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas (b) (6) (b) (6) Research); Marinac-Dabic, Danica; ' ' '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; Subject: Medical Device Registry Summit - Planning Meeting When: Wednesday, April 25, 2018 7:30 AM-8:00 AM (UTC-05:00) Eastern Time (US & Canada). Where: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) - 1111 - 1111 - 4 VA-18-0298 and 18-0299-B-000465 We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 << File: Medical Device Registry Summit - 1 pager.docx >> << File: Medical Device Registry Summit - 1 pager.pdf >> 5 VA-18-0298 and 18-0299-B-000466 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Wednesday, April 25, 2018 6:05 AM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) McIntosh, Bruce (NCPS); (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Attachments: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Medical Device Registry Summit Program04242018.docx Further revisions added to the version Bruce had sent las night. Talk to you at 7:30. Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; -----Original Appointment----- From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 20, 2018 4:06 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); Marinac-Dabic, Danica; '(b) (6) '(b) (6) '(b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Medical Device Registry Summit - Planning Meeting When: Wednesday, April 25, 2018 7:30 AM-8:00 AM (UTC-05:00) Eastern Time (US & Canada). Where: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board 1111 - 1111 - 1 VA-18-0298 and 18-0299-B-000467 to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 << File: Medical Device Registry Summit - 1 pager.docx >> << File: Medical Device Registry Summit - 1 pager.pdf >> 2 VA-18-0298 and 18-0299-B-000468 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 Location: VA Auditorium, #230 8:30 - 4:00 8:30 Welcome and Introductions of Participants and OrganizationsSreyRam Kuy, MD, PhD 8:45 - 10:00 Session 1: Value for Stakeholders Objective: To describe value of registries to major stakeholders; identify the gaps; prioritiez opportunities Patient Needs TBA - VA patient Leveraging the Medical Device Ecosystem Rachael Fleurence PhD, Executive Director, National Evaluation System for health Technologies (NEST) Value Roundtable Discussion Moderator: SreyRam Kuy, MD, PhD ? Department of Veterans Affairs, SreyRam Kuy, MD (possible comments by Chief of Staff Peter O'Rourke TBD) ? Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health ? CMS leadership (TBD) ? Professional societies perspective - AMA - Kathy Blake ? Hospital/system perspective - Kaiser ? Industry perspective - AdvaMed/MDMA 10:00 - 11:30 Session 2. VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000469 VI'\ o Moderator: TBD ? Current Cardiac Device Monitoring in the VA o Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? Current VA Medical Device Registries - Maximo o TBD Office of Healthcare Technology Management, Veterans Health Affairs ? "Title TBD" - Nicholas Giori, MD ? "Title TBD" - Stephen Waldo, MD (or Paul Varosy, MD) ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Lunch: 11:30 - 12:30 12:30 - 2:00 Session 3. Infrastructure/Methodology Opportunities for Standing Up the VA Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, Harvard Medical School/Harvard School of Public Health Objective: To identify key national and international efforts in the device space that can be leveraged for the development of VA registry; present short- and long-term opportunities ? ONC Efforts - TBD ? UDI implementation efforts - Terrie Reed, FDA ? Strategically Coordinated Registry Networks (CRNs) - Linking Registries with other data sources - Art Sedrakyan, MD, PhD, Cornell ? Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH ? Patient -enabled evidence generation - Harlan Krumholtz, MD, Yale ? Active Surveillance via DELTA in National Registries - Fred Resnic, MD, Lahey Clinic Panel Discussion: 2:00 - 3:15 Session 4. From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Bruce Moscowitz , MD, BREF Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000470 VI'\ o Objective: Begin development of the framework for VA registry development Panel: Jack Cronenwett, MD, Art Sedrakyan, MD; PhD, Mike Lauer, MD, PhD, (b) (6) ? Who should be at the table : What can we learn from VQI?- Jack Cronenwett, MD, Dartmouth, M2S ? How to build in the sustainability: Return of Investment (ROI) Multi-stakeholder Analysis - Greg Pappas, MD, PhD FDA/CDRH ? Quality Management opportunities and compliance with standards- (b) (6) ? Privacy/Ethics issues - TBD Panel Discussion: 3:15 -4:00 Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or USH or PDUSH for VHA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000471 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000472 VI'\ o Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Wednesday, April 11, 2018 7:41 AM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) McIntosh, Bruce (NCPS); (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: [EXTERNAL] RE: Medical Device Registry Summit - Planning Meeting Dialing in a few minutes. Sorry - had a phone issue. Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. . - 1111 OOD DRU ADMI . ISTltAT ON (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; -----Original Appointment----- From: Kuy, SreyRam (HOU) [mailto:SreyRam.Kuy@va.gov] Sent: Tuesday, March 20, 2018 4:06 PM To: Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); Marinac-Dabic, Danica; '(b) (6) '(b) (6) '(b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Medical Device Registry Summit - Planning Meeting When: Wednesday, April 11, 2018 7:30 AM-8:00 AM (UTC-05:00) Eastern Time (US & Canada). Where: Conference call line: 800-767-(b) (5) Code (b) (5) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. 1111 - 1111 - 1 VA-18-0298 and 18-0299-B-000473 Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 << File: Medical Device Registry Summit - 1 pager.docx >> << File: Medical Device Registry Summit - 1 pager.pdf >> 2 VA-18-0298 and 18-0299-B-000474 Ha, Richard Subject: Location: FW: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 3/21/2018 7:30 AM Wed 3/21/2018 8:00 AM Tentative 1111 - Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Organizer: Kuy, SreyRam (HOU) Can this be added to my schedule? Sent with Good (www.good.com) From: Kuy, SreyRam (HOU) Sent: Tuesday, March 20, 2018 1:05:15 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) '(b) (6) '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; Subject: Medical Device Registry Summit - Planning Meeting When: Occurs every Wednesday from 7:30 AM to 8:00 AM effective 3/21/2018 until 6/11/2018. (UTC-05:00) Eastern Time (US & Canada) Where: Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam 1111 - 1 VA-18-0298 and 18-0299-B-000475 Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 2 VA-18-0298 and 18-0299-B-000476 Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? ? ? ? ? 3. Panel Moderator - facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" - Data about how it helps lower costs, improve outcomes o Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD o Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" o Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo o (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" o Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" o Frederic Resnic, MD ? Talks by other stakeholders (Amazon, Medtronic) TBD 4. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" o Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000477 VI'\ o National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: o o o o o Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: o SreyRam Kuy, MD SreyRam.Kuy@va.gov o va.gov (b) (6) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000478 VI'\ o Medical Device Registry Summit Draft Agenda Date: June 4, 2018 (TBD) Location: VA Auditorium, #230 1. Welcome and Introductions of Participants and Organizations 2. Moderated Roundtable Discussion with Key Agency Leadership ? ? ? ? ? 3. Panel Moderator - facilitates with questions (SreyRam Kuy, MD) Secretary David J. Shulkin, MD, Secretary of the VA Commissioner Scott Gottlieb, MD, FDA Commissioner CMS leadership (TBD) HHS Leadership (TBD) Topic Focused Presentations (15 minutes each) ? "Why Registries Matter" - Data about how it helps lower costs, improve outcomes ? Subject Matter Expert TBD ? NEST - the next frontier in device surveillance and outcomes management ? Danica Marinac-Dabic, MD, PhD, MMSC, FISPE Director, Center for Devices and Radiological, FDA ? "Enabling Patient Participation in Device Registries" - Title TBD ? Harlan M Krumholz, MD Director, Center for Outcomes Research and Evaluation, Yale University ? "Current Cardiac Device Monitoring in the VA" ? Merrit H. Raitt, MD (TBD) Director, National Cardiac Device Surveillance Program, Veterans Health Affairs ? "Current VA Medical Device Registries in Place" - Maximo ? (b) (6) (b) (6) Office of Healthcare Technology Management, Veterans Health Affairs ? "Building Future-State Model for VHA Implant Tracking" ? Bruce McIntosh, PharmD VA National Manager, Product Recall Office, National Center for Patient Safety ? "Title TBD" ? Frederic Resnic, MD ? Talks by other stakeholders (Amazon, Medtronic) TBD -- 4. Closing Remarks and Outline Key Next Steps ? "Pulling it All Together: Next Steps Working with Our Partners" ? Carolyn Clancy, MD or Chris Vojta, MD, USH or PDUSH for VHA Diffu sionof _, EXCELLENCE ::: ::, ~ 8.oransFlrst Diffusing Bes t P,actices Ac,oss VHA U.S.Department of Veterans Affairs VAi VA-18-0298 and 18-0299-B-000479 National Medical Device Registry Summit Subject: Medical Device Registry Summit Purpose: Bring together VA, FDA, and other federal agencies and key stakeholders for a national summit about medical device registry efforts Current Participating Partners: ? ? ? ? ? Department of Veterans Affairs US Food and Drug Administration Biomedical Research and Education Foundation Global Healthy Living Foundation RAND Corporation Contacts: ? SreyRam Kuy, MD SreyRam.Kuy@va.gov ? va.gov (b) (6) Diffu sionof _, EXCELLENCE ::: ::, ~ 8.oransFlrst Diffusing Bes t P,actices Ac,oss VHA U.S.Department of Veterans Affairs VAi VA-18-0298 and 18-0299-B-000480 Ha, Richard Subject: Location: Medical Device Registry Summit - Planning Meeting Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Wed 3/21/2018 7:30 AM Wed 3/21/2018 8:00 AM Tentative 1111 - Weekly Recurrence: Recurrence Pattern:every Wednesday from 7:30 AM to 8:00 AM Meeting Status: Not yet responded Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) (b) (6) ' ' Hayes-Byrd, Jacquelyn; 1111 (b) (6) (b) (6) Dear colleagues, In preparation for our weekly Wednesday morning call, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesday 3/21/2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) We've made great headway with fleshing out the Medical Device Registry Summit details, and attached is a much more detailed agenda, with locations, possible time and a slate of speakers. Several fantastic subject matter experts on board to participate! This is a draft - welcome all your input, ideas, revisions! Feel to revise the editable word doc and share with us all. Again, many apologies to our west coast colleagues for the very early time. Thank you so much for all your efforts! Warmly, SreyRam 1111 - Special Advisor to the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1069 Washington, DC 20420 1 VA-18-0298 and 18-0299-B-000481 Mobile: 713-503-4274 Office: 202-461-4875 ' (1i r 1( \ r 1( 1 1 1 <<.,, 1 l it 'I ' r; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn Cc: (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) < va.gov> Subject: RE: Summit Monday June 4, 2018 Will discuss this with SecVA ASAP. Perhaps he'd be better suited to give brief welcoming remarks? - From: Kuy, SreyRam (HOU) Sent: Thursday, May 10, 2018 3:23 PM (b) (6) To: (b) (6) Hayes-Byrd, Jacquelyn (b) (6) (b) (6) (b) (6) Cc: Subject: Summit Monday June 4, 2018 -- - Hi (b) (6) and (b) (6) I wanted to check if this was on the Secretary's schedule. Under COS Peter O'Rourke's leadership, VA is hosting a healthcare summit about Medical Device Registries. There'll be panel on Monday June 4, at 8:45 - 10 am, that will include leadership from the various agencies, and the plan was to have SecVA on the panel too. I think the DepCoS Jacquie Hayes-Byrd had mentioned her staff would facilitate getting it on the SecVA's calendar, but wanted to double check if you needed anything else. Attached is the summit program. And please let us know who else we should keep in the loop. Thank you! SreyRam Kuy, MD, MHS, FACS 1 VA-18-0298 and 18-0299-B-000515 Special Advisor Office of the Secretary Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #1022 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 2 VA-18-0298 and 18-0299-B-000516 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 To: Acting Secretary Wilkie From: SreyRam Kuy, MD Subj: Medical Device Registry Summit Does VA Need a Medical Device Registry? ? Yes! o Allows us to notify patients about safety recalls o Allows us to identify the exact device when patient shows up in ER with complications o Allows us to track & compare outcomes of implants Why Registries Matter to VHA: ? Legislation: H.R. 28: Rep Roe, unanimous vote Jan 2017 (408-0) S. 23: Senator Cassidy, SVAC hearing 5/2017 "Biological Implant Tracking and Veteran Safety Act" ? Focused on biological implants only ? Adopt UDI for biologicals & a tracking system that enables recall notification ? 6 months for VA to implement ? VHA doesn't have a standardized system. Multiple databases capturing only about 60% of patients with implants. Past VA Efforts ? Several VA funded initiatives over past 10 years, $5.5 million spent on trying to build our own product ? VITAS (Veterans Implant Tracking and Alert System) and ITR (Implant Tracking Registry) ? Now efforts focused on COTS based solution The Summit ? VA convenes leaders on medical device tracking; ? Partners with sister agencies FDA and CMS to ensure patient safety; ? Highlights efforts of VA to implement largest health system device tracking program and FDA NEST Stakeholders Federal ? Rep Roe & Senator Cassidy ? FDA o Unique Device Identifiers (UDI) in 2007 to enable tracking VA-18-0298 and 18-0299-B-000517 o Registry efforts contracted out ? $3 million to "Medical Device Innovation Consortium" in 2016 ? Establish post market surveillance system NEST (National Evaluation System for Health Technology) 1 ? CMS & HHS - 2017 MEDPAC recommendation to require device identifiers on claims forms 2,3 ? VA ? DoD Private Interests ? American Association of Tissue Banks o Focus on biological implants o Accredits organizations for a fee (125 tissue banks) ? Bruce Moskowitz, MD o Founder of nonprofit "Biomedical Research and Education Foundation" (BREF) o Son (Aaron) serves as executive director of BREF 1 2 3 https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm http://medpac.gov/docs/default-source/reports/jun17_ch7.pdf?sfvrsn=0 https://blogs.fda.gov/fdavoice/index.php/tag/national-evaluation-system-for-medical-devices-nest/ VA-18-0298 and 18-0299-B-000518 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Friday, May 25, 2018 12:47 PM Kuy, SreyRam (HOU); '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (b) (6) McIntosh, Bruce (NCPS); (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) [EXTERNAL] MOST RECENT AGENDA + BIOS - VA MEDICAL DEVICE REGISTRY SUMMIT VA Medical Device Summit Final.docx; 2018 VA Registry Summit Bios Final.docx Hello Colleagues, Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format - we hope you'd like it)) and the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file). Please send the outstanding bios to (b) (6) (copied) today if possible or early next week. Have a great weekend! Danica - Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - 1111 u (b) (6) fda.hhs.gov; 1 VA-18-0298 and 18-0299-B-000519 Medical Device Registry Summit June 4, 2018 Brief Biographical Sketches for Moderators and Presenters Kathleen Blake, MD, MPH (b) (6) Kathleen Blake is Vice President, Healthcare Quality, at the American Medical Association where she works to ensure that physicians have the information and tools they need to successfully participate in new payment (b) (6) programs. (b) (6) Jack L. Cronenwett, M.D. (b) (6) Jack L. Cronenwett is Professor of Surgery and The Dartmouth Institute for Health Policy and Clinical Practice at Dartmouth-Hitchcock Medical Center, and Chief Medical Officer for Medstreaming/M2S, which provide (b) (6) Rachael L. Fleurence, PhD (b) (6) Dr. Rachael L. Fleurence is the Executive Director for the NEST Coordinating Center and (b) (6) 1 VA-18-0298 and 18-0299-B-000520 (b) (6) Harlan Krumholz M.D (b) (6) Harlan Krumholz is a cardiologist, health care scientist, and health care improvement expert at Yale University where he is the Harold H. Hines, Jr. Professor of Medicine and the Director Emeritus of the National Clinician Scholars Program, formerly the Robert Wood Johnson Foundation Clinical Scholars Program, a postdoctoral training program that he co-directed from 1996-2017. He is the Director of the Center for Outcomes Research and Evaluation (CORE) at Yale-New Haven Hospital. He has led (b) (6) Danica Marinac-Dabic, MD, PhD, MMSc, FISPE (b) (6) Danica Marinac-Dabic is the Director of the Division of Epidemiology at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). She has over (b) (6) (b) (6) 2 VA-18-0298 and 18-0299-B-000521 (b) (6) Gregory Pappas, MD, PhD Gregory Pappas is the Associate Director for National Devices Surveillance at the FDA's Center for Devices (b) (6) and Radiological Health (CDRH). He previously served as the (b) (6) Terrie Reed, MSc (b) (6) Terrie Reed works as a Senior Advisor for UDI Adoption at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Formerly, Terrie worked as a (b) (6) (b) (6) Art Sedrakyan, MD, PhD (b) (6) Art Sedrakyan is a Professor at Weill Cornell Medical College and leads the FDA Medical Device Epidemiology (MDEpiNet) Coordinating, Science and Infrastructure Center. At Cornell, he directs the (b) (6) (b) (6) 3 VA-18-0298 and 18-0299-B-000522 Vahan Simonyan, Ph.D. (b) (6) Vahan Simonyan has solid scientific background in varied academic disciplines: MS in Physical Organic Chemistry, PhD in Quantum Physics and Mathematics, post-doctoral training in Nanotechnology and Quantum Statistical Thermodynamics. After 2001 he switched his expertise to (b) (6) Julia Skapik, M.D., M.P.H. (b) (6) Julia Skapik a board-certified Internist and Clinical Informaticist and Chief Health Information Officer at Cognitive Medical Systems. Currently, she is focused on (b) (6) 4 VA-18-0298 and 18-0299-B-000523 Medical Device Registry Summit June 4, 2018 Brief Biographical Sketches for Moderators and Presenters Kathleen Blake, MD, MPH Kathleen Blake is Vice President, Healthcare Quality, at the American Medical Association where she works (b) (6) to ensure that physicians have the information and tools they need to successfully participate in new payment (b) (6) programs. (b) (6) Jack L. Cronenwett, M.D. (b) (6) Jack L. Cronenwett is Professor of Surgery and The Dartmouth Institute for Health Policy and Clinical Practice at Dartmouth-Hitchcock Medical Center, and Chief Medical Officer for Medstreaming/M2S, which provide (b) (6) Rachael L. Fleurence, PhD (b) (6) Dr. Rachael L. Fleurence is the Executive Director for the NEST Coordinating Center and (b) (6) 1 VA-18-0298 and 18-0299-B-000524 (b) (6) t Harlan Krumholz M.D (b) (6) Harlan Krumholz is a cardiologist, health care scientist, and health care improvement expert at Yale University where he is the Harold H. Hines, Jr. Professor of Medicine and the Director Emeritus of the National Clinician Scholars Program, formerly the Robert Wood Johnson Foundation Clinical Scholars Program, a postdoctoral training program that he co-directed from 1996-2017. He is the Director of the Center for Outcomes Research and Evaluation (CORE) at Yale-New Haven Hospital. He has led (b) (6) Danica Marinac-Dabic, MD, PhD, MMSc, FISPE (b) (6) Danica Marinac-Dabic is the Director of the Division of Epidemiology at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). She has over (b) (6) (b) (6) 2 VA-18-0298 and 18-0299-B-000525 garnered experience in obstetrics, gynecology, and epidemiology in the academic and hospital settings as well as teaching experience in academic environment. Gregory Pappas, MD, PhD Gregory Pappas is the Associate Director for National Devices Surveillance at the FDA's Center for Devices (b) (6) and Radiological Health (CDRH). He previously served as the (b) (6) Terrie Reed, MSc (b) (6) Terrie Reed works as a Senior Advisor for UDI Adoption at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Formerly, Terrie worked as a(b) (6) Art Sedrakyan, MD, PhD (b) (6) Art Sedrakyan is a Professor at Weill Cornell Medical College and leads the FDA Medical Device Epidemiology (MDEpiNet) Coordinating, Science and Infrastructure Center. At Cornell, he directs (b) (6) (b) (6) 3 VA-18-0298 and 18-0299-B-000526 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Friday, May 25, 2018 12:56 PM Kuy, SreyRam (HOU); '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron Moskowitz'; 'Thomas (b) (6) Concannon'; McIntosh, Bruce (NCPS); '(b) (6) (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) - (b) (6) (b) (6) (b) (6) (b) (6) [EXTERNAL] MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit PROGRAM VA Medical Device Registry Summit FINAL DRAFT .docx Sorry - did not attach the AGENDA/PROGRAM - attaching it now. Made formatting changes and added the times for each presentation/panel discussion. Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) 1111 The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. O0D - DRU IS-TltAY ON (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; _____________________________________________ From: Marinac-Dabic, Danica Sent: Friday, May 25, 2018 12:47 PM To: 'Kuy, SreyRam (HOU)' ; '(b) (6) GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: MOST RECENT AGENDA + BIOS - VA MEDICAL DEVICE REGISTRY SUMMIT Hello Colleagues, Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format - we hope you'd like it)) and the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file). Please send the outstanding bios to (b) (6) (copied) today if possible or early next week. << File: VA Medical Device Summit Final.docx >> << File: 2018 VA Registry Summit Bios Final.docx >> Have a great weekend! - 1 VA-18-0298 and 18-0299-B-000527 Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) << OLE Object: Picture (Device Independent Bitmap) >> (b) (6) fda.hhs.gov; 1111 - 2 VA-18-0298 and 18-0299-B-000528 DEPARTMENT OF VETERANS AFFAIRS Medical Device Registry Summit June 4, 2018 GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 Presenter/Affiliations Registration 8:30-8:45 Welcome and Introduction of Participants and Organizations 8:45-10:00 Session 1: Value for Stakeholders SreyRam Kuy, MD - VA Objective: To describe value of medical device registries to major stakeholders, identify the gaps and prioritize the opportunities Moderator: SreyRam Kuy, MD - VA 8:45-9:00 Patient Perspective 9:00-9:15 Leveraging the National Medical Device Ecosystem 9:15-10:00 Christine Stake, Patient Governor-The Arthritis Power Patient Research Registry Rachael Fleurence, PhD NESTcc Value Roundtable Discussion: o Veterans Affairs (VA) Chief of Staff Peter O'Rourke o Food and Drug Administration (FDA) o Scott Gottlieb, MD, FDA Commissioner o Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health o Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) o Secretary of Health and Human Services Alex M. Azar (tentative) o Secretary of Defense James N. Mattis (tentative) o American Medical Association, Kathleen Blake, MD o National Coordinator for Health Information Technology - Donald Rucker, MD 10:00-11:30 Session 2: VA Landscape Diffusion of ,, EXCELLENCE ::: :;~ Oiffu1 in9 Prac l,cesAuossVHA Bo,1 IC\ 9' \IA I U.S.Department ofVeteransAffai rs VA-18-0298 VI'\ and 18-0299-B-000529 Objective: To share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA 10:00-10:10 Current Cardiac Device Monitoring in the VA Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA) 10:10-10:20 Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System 10:20-10:30 Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories Paul Varosy, MD Director, CART Program 10:30-10:50 Building Future-State Model for VHA Implant Tracking Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety 10:50-11:30 Panel Discussants: Speakers & Julia Skapik, MD, PhD Cognitive Medical Systems 11:30-12:30 Lunch 12:30-2PM Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry - Short and Long-Term Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities Moderator: Sharon-Lise Normand, PhD - Harvard Medical School/Harvard School of Public Health 12:30-12:40 Strategically Coordinated Registry Networks - Linking Registries with other data sources Art Sedrakyan, MD, PhD WCMC MDEpiNet 12:40-12:50 Unique Device Identifier implementation efforts Terrie Reed, FDA Harmonization Efforts with National/International Registries Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA 12:50-1:00 Diffusion of ,, EXCELLENCE ::: :;~ Oiffu1 in9 Prac l,cesAuossVHA Bo,1 Q 9' \IA I U.S.Department ofVeteransAffai rs VA-18-0298 VI'\ and 18-0299-B-000530 1:00-1:10 Patient -enabled evidence generation Harlan Krumholz, MD - Yale University 1:10-1:20 Active Surveillance via DELTA in National Registries (b) (6) MD - Lahey Clinic 1:20-2:00 Panel Discussants: Speakers & Vahan Simonyan, PhD - FDA 2:00-3:15 Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Objective: How to begin development of the framework for a VA Medical Device Registry Moderator: Thomas Concannon, PhD - RAND 2:00-2:10 Device Evaluation in a Quality Improvement Registry: Lessons learned from VQI. 2:10-2:20 How to Build in the Sustainability: Return of Investment Multi-stakeholder Analysis Greg Pappas, MD, PhD - FDA 2:20-2:30 Privacy/Ethics Issues Robert M Portman, JD Powers, Pyles, Sutter and Verville PC 2:30-3:15 Panel Discussants: Speakers & Kristi Mitchell - Avalere Health 3:15-4:30 Jack Cronenwett, MD Dartmouth Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a VA Medical Device Registry Moderator: Harlan Krumholz, MD - Yale University Panel Discussants: Bruce McIntosh, PhD - VA Art Sedrakyan, MD, PhD - WCMC Danica Marinac-Dabic, MD, PhD - FDA Rachael Fleurence, PhD - NEST 5:00 Closing Remarks VA Leadership - Dr. Carolyn Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Diffusion of ,, EXCELLENCE ::: :;~ Oiffu1 in9 Prac l,cesAuossVHA Bo,1 IC\ 9' \IA I U.S.Department ofVeteransAffai rs VA-18-0298 VI'\ and 18-0299-B-000531 Ha, Richard From: Sent: To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov> Saturday, May 26, 2018 12:16 AM McIntosh, Bruce (NCPS); Kuy, SreyRam (HOU); '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron (b) (6) (b) (6) Moskowitz'; 'Thomas Concannon'; ' (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) Cc: Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) [EXTERNAL] LIST OF ATENDEES - VA Medical Device Registry Summit Medical Implant Registry Summit - List of Invitees 5-25-2018 .docx Dear Colleagues, I have updated the list of attendees with couple of additional FDA, NIH staff/leadership and other experts from other organizations (please see attached). Please note that I used the version dated 5-8 and made updates and save it as 5- 25. Please advise if we need to merge some other versions to this one. Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) 1111 U.S.FOOD & DRUG ADMIN ISTIATION (b) (6) - fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov] Sent: Friday, May 25, 2018 2:53 PM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6) (b) (6) GHLF' < ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz' (b) (6) (b) (6) (b) (6) < me.com>; 'Thomas Concannon' < rand.org>; ' <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> (b) (6) (b) (6) Cc: < fda.hhs.gov> Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Thanks Danica, I like the new format. I also changed myself from PhD to PharmD for the last panel discussion and removed (b) (6) from Dr. (b) (6) title. Regarding timing for the first session, I want each of the VA speakers to have at least 15 minutes, that leaves 30 minutes for the panel discussion (I changed times for presentations for panel and this session). Also, I think SreyRam mentioned Dr. (b) (6) would be added to the last panel. SreyRam is in clinic today and will review this later. o - - -- 1 VA-18-0298 and 18-0299-B-000532 Thanks and enjoy the holiday everyone. Bruce From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Friday, May 25, 2018 1:28 PM To: Kuy, SreyRam (HOU) ; '(b) (6) GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' (b) (6) (b) (6) < mac.com>; 'Aaron Moskowitz' < me.com>; 'Thomas Concannon' <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; '(b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) (b) (6) < ghlf.org>; < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; < va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Removed FDA Commissioner's name ( in the attached) version as just confirmed by Dr. Shuren's office that he will represent the FDA/CDRH. Still working on Don Rucker's confirmation. -- Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; _____________________________________________ From: Marinac-Dabic, Danica Sent: Friday, May 25, 2018 12:56 PM To: 'Kuy, SreyRam (HOU)' ; '(b) (6) GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) me.com>; 'Thomas Concannon' <(b) (6) rand.org>; 'McIntosh, Bruce (NCPS)' <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < atlasresearch.us>; ' (Atlas Research)' < va.gov>; ' <(b) (6) ghlf.org>; '(b) (6) <(b) (6) va.gov>; 'Hayes-Byrd, Jacquelyn' ; '(b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; ' < va.gov>; ' <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Sorry - did not attach the AGENDA/PROGRAM - attaching it now. Made formatting changes and added the times for each presentation/panel discussion. << File: PROGRAM VA Medical Device Registry Summit FINAL DRAFT .docx >> Danica Marinac-Dabic, MD, PhD, MMSc, FISPE 2 VA-18-0298 and 18-0299-B-000533 Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. 1111 - (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; _____________________________________________ From: Marinac-Dabic, Danica Sent: Friday, May 25, 2018 12:47 PM To: 'Kuy, SreyRam (HOU)' ; '(b) (6) GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: MOST RECENT AGENDA + BIOS - VA MEDICAL DEVICE REGISTRY SUMMIT Hello Colleagues, Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format - we hope you'd like it)) and the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file). Please send the outstanding bios to (b) (6) (copied) today if possible or early next week. << File: VA Medical Device Summit Final.docx >> << File: 2018 VA Registry Summit Bios Final.docx >> Have a great weekend! Danica - Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) << OLE Object: Picture (Device Independent Bitmap) >> (b) (6) fda.hhs.gov; 1111 - 3 VA-18-0298 and 18-0299-B-000534 Medical Implant Registry Summit DRAFT list of invitees Date of Summit: June 4, 2018 This is a pre-decisional, working draft intended only for internal VA use *These are planned invitees - they have not yet confirmed attendance, and may send a representative in their place. Invitees* Agencies Department of Veterans Affairs Leadership Food and Drug Administration Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health FDA Commissioner Scott Gottlieb, MD/Jeff Shuren, Director, Center for Devices and Radiological Health CMS Administrator Seema Verma (tentative) or representative HHS Secretary Alex Azar (tentative) or representative DoD Secretary James Mattis or representatiave (tentative) VA employees COS Mr. Peter O'Rourke Deputy COS Ms. Jacquelyn Hayes-Byrd Secretary Wilkie (tentative) or Deputy Secretary Bowman (tentative) Acting USH/Executive in Charge PDUSH Acting ADUSH QSV: Dr. Saurabha Bhatnagar Acting DUSH OE: Dr. Gerard Cox ADUSH Operations Management: Dr. Steve Young ADUSH Administrative Operations: Dr. Tammy Czarnecki Deputy Chief Patient Care Services: Dr. Lucille Beck National Surgery Office: Dr. William Gunnar (b) (6) Office of Dentistry: Dr. (b) (6) (b) (6) of Reproductive Health in Women's Health: Dr. (b) (6) (b) (6) of Gastroenterology: Dr. (b) (6) (b) (6) Cardiology: Dr. (b) (6) (b) (6) (b) (6) Ophthalmology: Dr. and Dr. (b) (6) National Program Office for Sterile Processing: Ms. (b) (6) (b) (6) Prosthetic and Sensory Aids Service: Ms. and Mr. (b) (6) (b) (6) Procurement and Logistics Service: Mr. Mr. (b) (6) Mr. (b) (6) (b) (6) NCPS: Ms. and Ms. - Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ Mr. I tel\ (b) (6) US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000535 VI'\ o (b) (6) Salt Lake City VAMC: Mr. VA Office of Healthcare Technology Management Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System Stephen Waldo, MD (or Paul Varosy, MD), Director, VA Clinical Assessment, Reporting and Tracking Program (CART) Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety (b) (6) MD, VA, Vanderbilt FDA Terrie Reed, FDA/CDRH Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA/CDRH Vahan Simonyan, PhD - FDA/CBER Greg Pappas, MD, PhD FDA/CDRH (b) (6) MD, MPH, FDA/CDRH (b) (6) PhD - FDA/CDRH on detail to HHS National Evaluation System for health Technologies Coordinating Center /MDIC Rachael Fleurence, PhD, Executive Director Medical Device Epidemiology Network (MDEpiNet) Art Sedrakyan, MD, PhD, Weill Cornell Medical College, MDEpiNet Coordinating Science and Infrastructure Center Sharon-Lise Normand, PhD, Harvard medical School/Harvard School of Public Health/MDEpiNet Methodology Center Fred Resnic, MD, Leahy Clinic Leahy Clinic Jack Cronenwett, MD, Dartmouth Julia Skapik , MD, PhD - Cognitive Health (b) (6) - NIH/NLM Kristy Mitchell - Avalere (b) (6) - John Rumsfeld, MD (ACC) Harlan Krumholz, MD, Yale (b) (6) Rob Portman Michael Lauer, MD (NIH) Elise Berliner - AHRQ (sending replacement) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000536 VI'\ o (b) (6) PhD (b) (6) (b) (6) (b) (6) (b) (6) Thomas Concannon PEW Trust EHR Vendor DOD Representative for Session 2 panel ONC Representative for Session 3 panel - Donald Rucker, MD Kristy Mitchel - Avalere Christine Stake - Ann & Robert H. Lurie Children's Hospital of Chicago (b) (6) Societies/Nonprofits Association for the Advancement of Medical Instrumentation (AAMI) leadership (b) (6) (b) (6) PhD (b) (6) FHIMSS (b) (6) PhD Association of peri-Operative Registered Nurses (AORN) (b) (6) MSHA, RN, CNOR, CSSM (b) (6) MHA, RN-BC, CNOR, CSSM (b) (6) MSN, RN, CNOR (b) (6) MSN, MBA, RN, ACNS-BC, CNS-CP, CNOR Emergency Care Research Institute (ECRI) (b) (6) MD, PhD (b) (6) MS American Academy of Orthopaedic Surgeons (AAOS) (b) (6) MD (b) (6) MD (b) (6) III MD American College of Cardiology (b) (6) MD, FACC (b) (6) MD, FACC (b) (6) Jr., MD, MBA, FACC (b) (6) MD, FACC American Association of Neurological Surgeons (b) (6) MD, PhD, FAANS, FACS (b) (6) MD, FAANS (b) (6) MD, MPH, FAANS, FACS Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000537 VI'\ o - (b) (6) MD, FAANS American Neurological Association (b) (6) PhD, MS (b) (6) MD Society for Vascular Surgery (b) (6) III, MD (b) (6) MD (b) (6) MD American College of Surgeons (b) (6) (b) (6) (b) (6) (b) (6) American Dental Association (b) (6) DDS (b) (6) DDS AMA (b) (6) (b) (6) -Kathy Blake MD, MHA MD AcademyHealth (b) (6) -Dr. - - Association for Healthcare Resources and Materials Management (AHRMM) (b) (6) (b) (6) (b) (6) Senior Supply Chain ( aha.org) Cognitive Health - Julia Skapik, MD, PhD Pew Charitable Trust (b) (6) MD Henry J. Kaiser Family Foundation (b) (6) Medical Device Companies (Tentative - pending OGC and ethics approval, would send invite to their government affairs contact) Abbot Laboratories Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000538 VI'\ o Academy Medical LLC AMO Sales and Services AvKare Biotronk Boston Scientific Buffalo Supply Depuy Synthes Joint Reconstruction Depuy Synthes Spine Depuy Synthes Trauma Encore Endologix Howmedica Medtronic USA Nuvasive Smith & Nephew St. Jude Medical Zimmer AdvaMed/MDMA Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000539 VI'\ o Ha, Richard From: Sent: To: Hayes-Byrd, Jacquelyn Tuesday, May 29, 2018 6:53 PM Kuy, SreyRam (HOU); '(b) (6) McIntosh, Bruce (NCPS); (b) (6) (b) (6) '(b) (6) (b) (6) Cc: Subject: (b) (6) (b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; (b) (6) (b) (6) (b) (6) (b) (6) (b) (5) RE: Medical Device Registry Summit - Weekly Planning Meeting - Wednesdays 7:30 am; Conference call line: 800-767-(b) (5) Code (b) (5) 1111 - Thank you for all of your hard work in making this event happen. Jacquie Sent with Good (www.good.com) From: Kuy, SreyRam (HOU) Sent: Tuesday, May 29, 2018 1:54:17 PM To: '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (NCPS); (b) (6) (b) (6) (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) Hayes(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Byrd, Jacquelyn; Cc: (b) (5) Subject: Medical Device Registry Summit - Weekly Planning Meeting - Wednesdays 7:30 am; Conference call line: 800 767-(b) (5) Code (b) (5) 1111 - Dear colleagues, Nearing the finish line! Thank you ALL for your phenomenal efforts pulling together this national summit on Medical Device Registries! We've got a fantastic line-up of amazing speakers! Thanks for making this possible. For our weekly Wednesday morning calls, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesdays 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) I've attached the latest version of the agenda, the speaker ready packet, and the RSVP list (as of 5/29/2018 at 2 pm). Could you look over, and if the speakers you've been in contact with aren't on the list, please have them RSVP as soon as possible to the office of protocol at rsvpprotocol@va.gov. This is the list that will go to security, allowing them to enter the building. Thank you! Thank you so much for all your incredible efforts! So proud of your work and this wonderful summit. Warmly, 1111 - 1 VA-18-0298 and 18-0299-B-000540 SreyRam SreyRam Kuy, MD, MHS, FACS Special Advisor Office of the Secretary Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #858 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 2 VA-18-0298 and 18-0299-B-000541 Ha, Richard From: Sent: To: Kuy, SreyRam (HOU) Tuesday, May 22, 2018 4:53 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: Attachments: (b) (6) (b) (6) (b) (6) (b) (6) (b) (5) Medical Device Registry Summit - Weekly Planning Meeting - Wednesdays 7:30 am; Conference call line: 800-767-(b) (5) Code (b) (5) News Release - Medical Device Registry Summit - Dr. SreyRam Kuy.docx; Medical Device Registry Summit Program June 4, 2018.docx 1111 - Dear colleagues, For our weekly Wednesday morning calls, here's the call-in information: Medical Device Registry Summit - Planning Call Wednesdays 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Thank you so much for all your efforts! Warmly, SreyRam 1111 - SreyRam Kuy, MD, MHS, FACS Special Advisor Office of the Secretary Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW, #858 Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000542 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. - 4:30 p.m. 8:30 a.m. Welcome and Introduction of Participants and Organizations SreyRam Kuy, MD 8:45 a.m. - 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective Christine Stake, Patient Governor, the ArthritisPower Patient Research Registry Leveraging the Medical Device Ecosystem Rachael Fleurence Ph.D., National Evaluation System for Health Technologies Value Roundtable Discussion Moderator: SreyRam Kuy, MD o Veterans Affairs (VA) Chief of Staff Peter O'Rourke o Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD o Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health o Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) o Secretary of Health and Human Services Alex M. Azar (tentative) o Secretary of Defense James N. Mattis (tentative) o American Medical Association, Kathleen Blake, MD Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000543 VI'\ o 10 a.m. - 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA) ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories o Stephen Waldo, MD or Paul Varosy, MD Director, CART Program ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + John Rumsfeld, MD, American College of Cardiology 11:30 a.m. - 12:30 p.m. Lunch Break 12:30 p.m. - 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, PhD (Harvard Medical School/Harvard School of Public Health) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities ? Efforts of the Office of the National Coordinator (ONC) for Health Information Technology o Don Rucker, MD (ONC) ? Unique Device Identifier implementation efforts o Terrie Reed (FDA) ? Strategically Coordinated Registry Networks - Linking Registries with other data sources o Art Sedrakyan, MD, PhD (Cornell/MDEpiNet) ? Harmonization Efforts with National/International Registries o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE (FDA/Center for Devices and Radiological Health (CDRH)) ? Patient -enabled evidence generation Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000544 VI'\ o o Harlan Krumholz, MD (Yale University) ? Active Surveillance via DELTA in National Registries o Fred Resnic, MD (Lahey Clinic) Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) 2 p.m. - 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Thomas Concannon, PhD (RAND) Objective: How to begin development of the framework for a Medical Device Registry ? Who should be at the table: What can we learn from Vascular Quality Initiative? o Jack Cronenwett, MD (Dartmouth) ? How to build in the sustainability: Return of Investment Multi-stakeholder Analysis o Greg Pappas, MD, PhD (FDA/CDRH) ? Privacy/Ethics issues o Robert M Portman, JD (Powers, Pyles, Sutter and Verville PC) Panel Discussion: Speakers + Mike Lauer, MD (National Institute of Health), Elise Berliner, PhD (Agency for Healthcare Research and Quality), Julia Skapik, MD (Cognitive Medical Systems), Kristi Mitchell (Avalere Health) 3:15 p.m. - 4:30 p.m. Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a Medical Device Registry Moderator: Harlan Krumholz, MD (Yale University) Panel: Bruce McIntosh, PharmD (VA) Art Sedrakyan, MD (Weill Cornell Medical College) Danica Marinac-Dabic, MD, PhD (FDA) Rachael Fleurence, PhD (National Evaluation System for Health Technology Coordinating Center) Closing Remarks VA Leadership - Dr. Carolyn Clancy Questions? Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ IQ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000545 VI'\ o VA U.S.Department of Veterans Affairs News Release Office of Public Affairs Media Relations Washington , DC 20420 (202 ) 461 -7600 www.va.gov May 2018 VA Medical Device Registry Summit Every day, doctors and nurses at VA medical centers across the country are innovating: creating ground breaking cures, developing novel procedures and performing lifesaving treatments. They do this because serving our nation's heroes with excellence is their commitment. Today, we're shining the spotlight on one example of this VA excellence. VA is convening thought leaders on medical device tracking, and partnering with sister agencies, FDA, CMS, HHS and DoD to ensure patient safety. Medical Device Registries are critically important because they allow us to notify patients about safety recalls, identify the exact device when patient shows up in ER with complications, and track & compare outcomes of implants. Partnering with these medical experts and sister agencies, VA is working to implement the largest health system device tracking program in the nation. On June 4, 2018, VA will be hosting a summit of thought leaders and sister agencies. The public is invited to participate. Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW, Washington, DC 20420 June 4, 2018, 8:30 a.m. - 4:30 p.m. Interested parties may RSVP to attend in person, with space limited to the first 150 who RSVP. RSVP at rsvpprotocol@va.gov. The summit will also be broadcast live in two parts. The public can also register to watch online here: Link for the Medical Device Registry Summit Morning Session 1: https://www.webcaster4.com/Webcast/Page/89/25950 Link for the Medical Device Registry Summit Afternoon Session 2: https://www.webcaster4.com/Webcast/Page/89/25951 VA-18-0298 and 18-0299-B-000546 Ha, Richard From: Sent: To: Subject: (b) (6) Thursday, May 31, 2018 9:35 AM Hayes-Byrd, Jacquelyn RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Of course. Will do right now. From: Hayes-Byrd, Jacquelyn Sent: Wednesday, May 30, 2018 9:24 PM To: (b) (6) Subject: FW: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Jack Can you provide Pete's? (b) (6) Sent with Good (www.good.com) - From: (b) (6) Sent: Wednesday, May 30, 2018 1:04:16 PM To: McIntosh, Bruce (NCPS); Marinac-Dabic, Danica; Kuy, SreyRam (HOU); '(b) (6) GHLF'; 'Bruce Moskowitz'; 'Aaron (b) (6) (b) (6) Moskowitz'; 'Thomas Concannon'; '(b) (6) (Atlas Research); '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Please see the latest bios. Still missing: SreyRam Kuy, MD - VA Peter O'Rourke Bruce McIntosh, PharmD (b) (6) MD Robert M Portman Kristi Mitchell Carolyn Clancy Seema Verma (tentative) James N. Mattis (tentative) Thank you, __________________________________________________________________________________________ MSc (b) (6) (b) (6) Office of Surveillance and Biometrics| CDRH| FDA 1 VA-18-0298 and 18-0299-B-000547 - White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R(b) (6) Silver Spring MD 20993 | Tel: 301-796 (b) (6) E-mail: fda.hhs.gov (b) (6) U.S. ODo DRUG ADNJ IITIATION Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/r/cdrhcustomerservice?sm=UcbfugmQLNUc0a7AE7WJWNqbmQCW8dh6L8vrch4XjDy8OdSZxGJUGQ8w CRWTw4AHOlHjM03RqVT0wMLQrUilPQ%3d%3d From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov] Sent: Tuesday, May 29, 2018 8:09 PM To: (b) (6) <(b) (6) fda.hhs.gov>; Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, (b) (6) (b) (6) SreyRam (HOU) ; ' GHLF' < ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) me.com>; 'Thomas Concannon' <(b) (6) rand.org>; '(b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; ' < ghlf.org>; <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; < va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit I attached the Bios and pictures for: Merritt H. Raitt, MD, Nicholas Giori, MD, PhD Paul Varosy, MD Bruce McIntosh, PharmD Thanks, Bruce -------- From: (b) (6) [mailto:(b) (6) fda.hhs.gov] Sent: Tuesday, May 29, 2018 12:14 PM To: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; (b) (6) (b) (6) Kuy, SreyRam (HOU) ; ' GHLF' < ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) me.com>; 'Thomas Concannon' <(b) (6) rand.org>; '(b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; ' < ghlf.org>; <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; < va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Dear all, 2 VA-18-0298 and 18-0299-B-000548 Please see attached the latest agenda and bios. Also, below is the list of the bios I am missing, if possible forward me by COB tomorrow, May 30. SreyRam Kuy, MD - VA Peter O'Rourke Bruce McIntosh, PharmD (b) (6) MD Robert M Portman Kristi Mitchell Carolyn Clancy Seema Verma (tentative) James N. Mattis (tentative) Best Regards, __________________________________________________________________________________________ (b) (6) MSc (b) (6) - Office of Surveillance and Biometrics| CDRH| FDA (b) (6) White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R (b) (6) Silver Spring MD 20993 | Tel: 301-796 (b) (6) E-mail: fda.hhs.gov - U.S.FOOD& DRUCI ADN 11115 J IA II ON Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/r/cdrhcustomerservice?sm=UcbfugmQLNUc0a7AE7WJWNqbmQCW8dh6L8vrch4XjDy8OdSZxGJUGQ8w CRWTw4AHOlHjM03RqVT0wMLQrUilPQ%3d%3d ------- From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov] Sent: Friday, May 25, 2018 2:53 PM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6) (b) (6) GHLF' < ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz' (b) (6) (b) (6) (b) (6) < me.com>; 'Thomas Concannon' < rand.org>; ' <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> (b) (6) (b) (6) Cc: < fda.hhs.gov> Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Thanks Danica, 3 o VA-18-0298 and 18-0299-B-000549 - - I like the new format. I also changed myself from PhD to PharmD for the last panel discussion and removed (b) (6) from Dr. (b) (6) title. Regarding timing for the first session, I want each of the VA speakers to have at least 15 minutes, that leaves 30 minutes for the panel discussion (I changed times for presentations for panel and this session). Also, I think SreyRam mentioned Dr. (b) (6) would be added to the last panel. SreyRam is in clinic today and will review this later. Thanks and enjoy the holiday everyone. Bruce - From: Marinac-Dabic, Danica [mailto:(b) (6) fda.hhs.gov] Sent: Friday, May 25, 2018 1:28 PM To: Kuy, SreyRam (HOU) ; '(b) (6) GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' (b) (6) (b) (6) < mac.com>; 'Aaron Moskowitz' < me.com>; 'Thomas Concannon' <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; '(b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) (b) (6) < ghlf.org>; < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Removed FDA Commissioner's name ( in the attached) version as just confirmed by Dr. Shuren's office that he will represent the FDA/CDRH. Still working on Don Rucker's confirmation. Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) -- - The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; _____________________________________________ From: Marinac-Dabic, Danica Sent: Friday, May 25, 2018 12:56 PM To: 'Kuy, SreyRam (HOU)' ; '(b) (6) GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' (b) (6) (b) (6) < mac.com>; 'Aaron Moskowitz' < me.com>; 'Thomas Concannon' <(b) (6) rand.org>; 'McIntosh, Bruce (NCPS)' <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < atlasresearch.us>; ' (Atlas Research)' < va.gov>; ' <(b) (6) ghlf.org>; '(b) (6) <(b) (6) va.gov>; 'Hayes-Byrd, Jacquelyn' ; '(b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov> (b) (6) (b) (6) Cc: < fda.hhs.gov> Subject: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit 4 VA-18-0298 and 18-0299-B-000550 Sorry - did not attach the AGENDA/PROGRAM - attaching it now. Made formatting changes and added the times for each presentation/panel discussion. << File: PROGRAM VA Medical Device Registry Summit FINAL DRAFT .docx >> Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. 1111 - fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; (b) (6) _____________________________________________ From: Marinac-Dabic, Danica Sent: Friday, May 25, 2018 12:47 PM To: 'Kuy, SreyRam (HOU)' ; '(b) (6) GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: MOST RECENT AGENDA + BIOS - VA MEDICAL DEVICE REGISTRY SUMMIT Hello Colleagues, Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format - we hope you'd like it)) and the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file). Please send the outstanding bios to (b) (6) (copied) today if possible or early next week. << File: VA Medical Device Summit Final.docx >> << File: 2018 VA Registry Summit Bios Final.docx >> Have a great weekend! Danica Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) << OLE Object: Picture (Device Independent Bitmap) >> (b) (6) fda.hhs.gov; - 1111 - 5 VA-18-0298 and 18-0299-B-000551 Ha, Richard From: Sent: To: McIntosh, Bruce (NCPS) Tuesday, May 29, 2018 12:30 PM (b) (6) Marinac-Dabic, Danica; Kuy, SreyRam (HOU); '(b) (6) (b) (6) 'Aaron Moskowitz'; 'Thomas Concannon'; '(b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) Subject: (b) (6) (b) (6) (b) (6) (b) (6) GHLF'; 'Bruce Moskowitz'; (Atlas Research); '(b) (6) (b) (6) (b) (6) RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Thanks Marta. I have the bios and pictures for four VA speakers highlighted below and will add these to the document Danica started Friday and send over to you today. Bruce From: (b) (6) [mailto:(b) (6) fda.hhs.gov] Sent: Tuesday, May 29, 2018 12:14 PM To: McIntosh, Bruce (NCPS) <(b) (6) va.gov>; Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; (b) (6) Kuy, SreyRam (HOU) ; ' GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) me.com>; 'Thomas Concannon' (b) (6) (b) (6) (b) (6) (b) (6) < rand.org>; ' < atlasresearch.us>; (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; (b) (6) (b) (6) (b) (6) < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) va.gov>; <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) <(b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov> Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Dear all, Please see attached the latest agenda and bios. Also, below is the list of the bios I am missing, if possible forward me by COB tomorrow, May 30. SreyRam Kuy, MD - VA Peter O'Rourke Donald Rucker, MD Merritt H. Raitt, MD, Nicholas Giori, MD, PhD Paul Varosy, MD Bruce McIntosh, PharmD (b) (6) MD Robert M Portman Kristi Mitchell Carolyn Clancy Seema Verma (tentative) James N. Mattis (tentative) 1 VA-18-0298 and 18-0299-B-000552 Best Regards, __________________________________________________________________________________________ MSc (b) (6) (b) (6) - Office of Surveillance and Biometrics| CDRH| FDA (b) (6) White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R(b) (6) Silver Spring MD 20993 | Tel: 301-796(b) (6) E-mail: fda.hhs.gov - U.S.FOOD& DRUI ADNJ IITIATION Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/r/cdrhcustomerservice?sm=UcbfugmQLNUc0a7AE7WJWNqbmQCW8dh6L8vrch4XjDy8OdSZxGJUGQ8w CRWTw4AHOlHjM03RqVT0wMLQrUilPQ%3d%3d --- - From: McIntosh, Bruce (NCPS) [mailto:(b) (6) va.gov] Sent: Friday, May 25, 2018 2:53 PM To: Marinac-Dabic, Danica <(b) (6) fda.hhs.gov>; Kuy, SreyRam (HOU) ; '(b) (6) GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' <(b) (6) mac.com>; 'Aaron Moskowitz' (b) (6) < me.com>; 'Thomas Concannon' <(b) (6) rand.org>; '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < atlasresearch.us>; (Atlas Research) < va.gov>; ' <(b) (6) ghlf.org>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: RE: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Thanks Danica, I like the new format. I also changed myself from PhD to PharmD for the last panel discussion and removed (b) (6) (b) (6) from Dr. title. Regarding timing for the first session, I want each of the VA speakers to have at least 15 minutes, that leaves 30 minutes for the panel discussion (I changed times for presentations for panel and this session). Also, I think SreyRam mentioned Dr. (b) (6) would be added to the last panel. SreyRam is in clinic today and will review this later. Thanks and enjoy the holiday everyone. Bruce - o - - From: Marinac-Dabic, Danica [mailto:(b) (6) Sent: Friday, May 25, 2018 1:28 PM To: Kuy, SreyRam (HOU) ; '(b) (6) <(b) (6) mac.com>; 'Aaron Moskowitz' <(b) (6) (b) (6) < rand.org>; McIntosh, Bruce (NCPS) <(b) (6) fda.hhs.gov] GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' me.com>; 'Thomas Concannon' va.gov>; '(b) (6) 2 VA-18-0298 and 18-0299-B-000553 <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) (b) (6) < ghlf.org>; < va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; < va.gov>; < va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: [EXTERNAL] RE: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Removed FDA Commissioner's name ( in the attached) version as just confirmed by Dr. Shuren's office that he will represent the FDA/CDRH. Still working on Don Rucker's confirmation. -- Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) - The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; _____________________________________________ From: Marinac-Dabic, Danica Sent: Friday, May 25, 2018 12:56 PM To: 'Kuy, SreyRam (HOU)' ; '(b) (6) GHLF' <(b) (6) ghlf.org>; 'Bruce Moskowitz' (b) (6) (b) (6) < mac.com>; 'Aaron Moskowitz' < me.com>; 'Thomas Concannon' <(b) (6) rand.org>; 'McIntosh, Bruce (NCPS)' <(b) (6) va.gov>; '(b) (6) <(b) (6) atlasresearch.us>; '(b) (6) (Atlas Research)' <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) (b) (6) < ghlf.org>; ' < va.gov>; 'Hayes-Byrd, Jacquelyn' ; '(b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov>; '(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) < va.gov>; ' < va.gov>; ' <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov>; '(b) (6) <(b) (6) va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: MOST RECENT AGENDA/PROGRAM for VA Medical Device Registry Summit Sorry - did not attach the AGENDA/PROGRAM - attaching it now. Made formatting changes and added the times for each presentation/panel discussion. << File: PROGRAM VA Medical Device Registry Summit FINAL DRAFT .docx >> Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) The link ed image cannot be d isplay ed. The file may hav e been mov ed, ren amed, or deleted. Verify that the link poin ts to the correct file and location. 1111 - (b) (6) fda.hhs.gov; Excellent Customer Service is important to us. Please take a moment to provide feedback regarding the customer service you have received. https://www.research.net/s/cdrhcustomerservice?O=600&D=640&B=641&E=&S=E; 3 VA-18-0298 and 18-0299-B-000554 _____________________________________________ From: Marinac-Dabic, Danica Sent: Friday, May 25, 2018 12:47 PM To: 'Kuy, SreyRam (HOU)' ; '(b) (6) GHLF' <(b) (6) ghlf.org>; Bruce Moskowitz (b) (6) (b) (6) < mac.com>; Aaron Moskowitz < me.com>; Thomas Concannon <(b) (6) rand.org>; McIntosh, Bruce (NCPS) <(b) (6) va.gov>; (b) (6) <(b) (6) atlasresearch.us>; (b) (6) (Atlas Research) <(b) (6) va.gov>; '(b) (6) <(b) (6) ghlf.org>; (b) (6) <(b) (6) va.gov>; Hayes-Byrd, Jacquelyn ; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov>; (b) (6) <(b) (6) va.gov> Cc: (b) (6) <(b) (6) fda.hhs.gov> Subject: MOST RECENT AGENDA + BIOS - VA MEDICAL DEVICE REGISTRY SUMMIT Hello Colleagues, Attached please find the CLOSE TO FINAL DRAFT of the AGENDA ( in a slightly changed format - we hope you'd like it)) and the WORKING DRAFT OF THE SPEAKERS BIOS ( the ones we had on file). Please send the outstanding bios to (b) (6) (copied) today if possible or early next week. << File: VA Medical Device Summit Final.docx >> << File: 2018 VA Registry Summit Bios Final.docx >> Have a great weekend! Danica - Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology Center for Devices and Radiological/OSB White Oak Campus, 10903 New Hampshire Avenue, Bldg 66/R- (b) (6) Silver Spring MD 20993; (301)796-(b) (6) << OLE Object: Picture (Device Independent Bitmap) >> (b) (6) fda.hhs.gov; 1111 - 4 VA-18-0298 and 18-0299-B-000555 Ha, Richard Subject: Location: Medical Device Registry Summit - Weekly Planning Meeting - Final One! 7:30 am Conference call line: 800-767-(b) (5) Code (b) (5) Start: End: Show Time As: Fri 6/1/2018 7:30 AM Fri 6/1/2018 8:00 AM Tentative Recurrence: (none) Meeting Status: Not yet responded 1111 - Kuy, SreyRam (HOU) Organizer: Required Attendees:'(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (NCPS); (b) (6) (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (5) Dear colleagues, This is our FINAL 7:30 am planning call! Chance to tie up loose ends and finalize. Here's the call-in information: Medical Device Registry Summit - Planning Call Friday June 1, 2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Thank you SO MUCH for all your PHENOMENAL efforts! Warmly, SreyRam SreyRam Kuy, MD, MHS, FACS 1111 - Special Advisor Office of the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000556 and Ha, Richard From: Sent: To: Subject: Attachments: Kuy, SreyRam (HOU) Thursday, May 31, 2018 5:54 PM '(b) (6) GHLF'; Bruce Moskowitz; Aaron Moskowitz; Thomas Concannon; McIntosh, Bruce (b) (6) (b) (6) (NCPS); (Atlas Research); 'Marinac-Dabic, Danica'; '(b) (6) (b) (6) (b) (6) Hayes-Byrd, Jacquelyn; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (5) Mock, Teresa J.; Medical Device Registry Summit - Weekly Planning Meeting - Final One! 7:30 am; Conference call line: 800-767-(b) (5) Code (b) (5) RSVP GUEST LIST Regitry Summit as of 5.31.18.xlsx; Medical Device Registry Summit Program June 4 2018 - Preliminary.docx; News Release - Medical Device Registry Summit - Dr. SreyRam Kuy 5-2018.docx 1111 - Dear colleagues, This is our FINAL 7:30 am planning call! Chance to tie up loose ends and finalize. I attached up updated agenda (some changes in order in the beginning to accommodate Secretary/Agency Leadership schedules. Also attached is the latest RSVP list as of 5/31/2018 at 2:50 pm. Powerpoints: We're received 9 PowerPoints so far, from: Fleurence, Giori, Majithia, McIntosh, Pappas, Raitt, Reed, Stake and Varosy. Here's the call-in information: Medical Device Registry Summit - Planning Call Friday June 1, 2018 7:30 am - 8:00 am Eastern Conference call line: 800-767-(b) (5) Code (b) (5) Thank you SO MUCH for all your PHENOMENAL efforts! Warmly, SreyRam SreyRam Kuy, MD, MHS, FACS 1111 - Special Advisor Office of the Secretary Veterans Health Administration Associate Chief of Staff Quality, Safety & Value Michael E. DeBakey VA Medical Center 810 Vermont Avenue, NW Washington, DC 20420 Mobile: 713-503-4274 Office: 202-461-4875 1 VA-18-0298 and 18-0299-B-000558 and DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. - 4:30 p.m. 8:30 a.m. Welcome SreyRam Kuy, MD 8:35 a.m. Keynote Address Acting Secretary of Veterans Affairs Peter O'Rourke 8:45 a.m. - 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Value Roundtable Discussion Moderator: SreyRam Kuy, MD o Veterans Affairs (VA) Acting Secretary Peter O'Rourke o Food and Drug Administration (FDA) Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health o Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) o American Medical Association, Kathleen Blake, MD Patient Perspective Christine Stake, Patient Governor, the ArthritisPower Patient Research Registry Leveraging the Medical Device Ecosystem Rachael Fleurence Ph.D., National Evaluation System for Health Technologies, FDA 10 a.m. - 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000560 VI'\ o Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA) ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories o Paul Varosy, MD CART Program ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + Kristi Mitchell (Avalere Health) 11:30 a.m. - 12:30 p.m. Lunch Break 12:30 p.m. - 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, PhD (Harvard Medical School/Harvard School of Public Health) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities ? Unique Device Identifier implementation efforts o Terrie Reed (FDA) ? Strategically Coordinated Registry Networks - Linking Registries with other data sources o Art Sedrakyan, MD, PhD (Cornell/MDEpiNet) ? Harmonization Efforts with National/International Registries o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE (FDA/Center for Devices and Radiological Health (CDRH)) ? Patient -enabled evidence generation o Harlan Krumholz, MD (Yale University) ? Active Surveillance via DELTA in National Registries (b) (6) o MD (Lahey Clinic) Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000561 VI'\ o 2 p.m. - 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Thomas Concannon, PhD (RAND) Objective: How to begin development of the framework for a Medical Device Registry ? Who should be at the table: What can we learn from Vascular Quality Initiative? o Jack Cronenwett, MD (Dartmouth) ? How to build in the sustainability: Return of Investment Multi-stakeholder Analysis o Greg Pappas, MD, PhD (FDA/CDRH) ? Topic TBD (b) (6) (b) (6) o MD, PhD, FCCM (United Healthcare) Panel Discussion: Speakers + Julia Skapik, MD (Cognitive Medical Systems) 3:15 p.m. - 4:30 p.m. Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a Medical Device Registry Moderator: Harlan Krumholz, MD (Yale University) Panel: Bruce McIntosh, PharmD (VA) Art Sedrakyan, MD (Weill Cornell Medical College) Danica Marinac-Dabic, MD, PhD (FDA) Rachael Fleurence, PhD (National Evaluation System for Health Technology Coordinating Center, FDA) Closing Remarks VA Leadership - Dr. Carolyn Clancy Questions? Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000562 VI'\ o May 2018 VA Medical Device Registry Summit Every day, doctors and nurses at VA medical centers across the country are innovating: creating ground breaking cures, developing novel procedures and performing lifesaving treatments. They do this because serving our nation's heroes with excellence is their commitment. Today, we're shining the spotlight on one example of this VA excellence. VA is convening academic leaders on medical device tracking, and partnering with sister agencies, FDA, CMS and DoD to ensure patient safety. Medical Device Registries are critically important because they allow us to notify patients about safety recalls, identify the exact device when patient shows up in ER with complications, and track & compare outcomes of implants. Partnering with these medical experts and sister agencies, VA is working to implement the largest health system device tracking program in the nation. On June 4, 2018, VA will be hosting a summit of thought leaders and sister agencies. The public is invited to participate. Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW, Washington, DC 20420 June 4, 2018, 8:30 a.m. - 4:30 p.m. Interested parties may RSVP to attend in person, with space limited to the first 150 who RSVP. RSVP at rsvpprotocol@va.gov by Friday June 1, 2018. The summit will also be broadcast live in two parts. The public can also register to watch online here: Link for the Medical Device Registry Summit Morning Session 1: https://www.webcaster4.com/Webcast/Page/89/25950 Link for the Medical Device Registry Summit Afternoon Session 2: https://www.webcaster4.com/Webcast/Page/89/25951 VA-18-0298 and 18-0299-B-000563 RSVP R R R R R R R R R R R R R Count Category Last Name SECVA Staff Bock SECVA Staff (b) (6) SECVA Staff SECVA Staff SECVA Staff VA Leadership Clancy VA Leadership Shelby VA Leadership Spickler Personal Guest (b) (6) VA Leadership Murphy SECVA Staff (b) (6) Family Family First Name Tonia Full Name Tonia Bock Carolyn Peter David C. Carolyn Clancy Peter Shelby David C. Spickler Thomas J. Thomas J. Murphy Honorific Ms. Mr. Ms. Ms. Ms. Dr. The Honorable Mr. Mr. Mr. Ms. Mr. Mr. Title Spouse Executive Secretary (b) (6) , Office of the Secretary (b) (6) to the Secretary (b) Center for Women Veterans (b) Office of Employment Discrimination Complaint Adjudication (6) Executive in Charge, Veterans Health Administration (6) Assistant Secretary for Human Resources and Administration Acting Chairman, Board of Veterans' Appeals Acting Under Secretary for Benefits Organizati Address 1 Address 2 City State Phone Scheduler Email Fax Salutation Washingt 202-461- Departme Room 1027810 DepartmenRoo (b) A810 Vermo Washingto (202) 461-(b) Departme Roo (6) 810 Washingt Ms. (6) Departme Roo 810 Washingt 202-461- (b) (6) Ms. Departme Suite 1575 I Washingt 202-461- Ms. (b) (6) Departme Room 800 810 Washingt 202-461- uests (colle Dr. Clancy Departme Room 200 810 Washingt 202-461- Mr. 425 I StreetWashingt 202-632- Mr. Departme Room Departme Room 520 1800 G Departme VACO 1717 H (b) (6) Office of Survivors Assistance Mrs. (b) Mrs. (6) Washingt 202-461- Washingt 202-461- (b) (6) Mr. Ms. Notes Preceden Swearing (b) (6) (b) (6) (b) (6) VA-18-0298 and 18-0299-B-000564 (b) (6) (b) (6) @gmail.com @verizon.net (b) (b) (6) . @gmail.com (6) (b) (6) @gmail.com (b) (6) @gmail.com (b) (6) @hotmail.com (b) (6) @gmail.com (b) @southrun.org (6) (b) (6) @msn.com (b) (6) @comdt.uscg.mil (b) (6) @alionscience.com (b) (6) @mitre.org (b) (6) @gmail.com (b) (6) @gmail.com (b) @celero-strat.com (6) (b) (6) @us.ibm.com (b) (6) @cisco.com (b) (6) @verizon.net (b) (6) @yahoo.com (b) (6) @gamil.com (b) (6) @yahoo.com (b) (6) n@cox.net (b) (6) @msn.com ( @gocluff.com b (b) (6) @gmail.com ) ((b) (6) @us.army.mil 6 (b) (6) ) @earthlink.net (b) (6) @yahoo.com (b) (6) @gmail.com (b) (6) @gmail.com (b) (6) @gmail.com (b) (6) @mac.com (b) @verizon.net (6) (b) (6) @verizon.net (b) (6) @crowell.com (b) (6) (b) (6) @gamil.com @yahoo.com (b) (6) @msn.com (b) (6) @us.ibm.com ( @gocluff.com b (b) (6) @mitre.org ) ( (6) (b) @yahoo.com 6 (b) ) @celero-strat.com (6) (b) (6) @verizon.net (b) (6) (b) (6) , South Run Baptist Church VA-18-0298 and 18-0299-B-000565 --?? ----?? -?? --?? -------II ---RSVP Yes Count 1 Organization Last Name First Name 11111111 yes yes yes 1 1 1 yes Yes Yes yes Yes 1 1 1 1 1 VA National Center for Patient Safety DHA MEDLOG American Medical Association Phone 14-253 (b) (6) Email (b) (6) Blake, MD, MPH Kathleen Kathleen Blake, MD, MPH @va.gov va.gov (b) (6) l@mail.mil (b) @swcp.com (6) 01-619 Vice President, Healthcare Quality (b) (6) yes yes 1 1 yes yes yes 1 1 1 Yes yes yes yes yes 1 1 1 1 1 yes yes 1 1 U.S Food & Drug Administration VACO (b) (6) Thomas Thomas Concannon Senior Policy Researcher Jack L. Jack L. Cronenwett, M.D. Professor of Surgery 11111111 11111111 (b) (6) Rachael Rachael Fleurence Nickolas Nicholas Giori 919-665 202-461 617-794 312-422 (b) (6) @optelgroup.com (b) (6) @va.gov (b) (6) rand.org (b) (6) @aha.org (b) (6) @dartmouth.edu 865-280 202-461 (b) (6) @va.gov> (b) (6) @epic.com 202-372 410-637 708-606 (b) (6) va.gov (b) (6) @va.gov (b) (6) @masimo.com (b) (6) @mdic.org (b .(b) @cta.com )(b) (6) va.gov (b) (6) (6) @healthdatalink.org (b) .(b) @bookzurman.com (6) (6) Executive Director 301 346 Chief of Orthopedic Surgery. M.D, Ph.D. (b) (6) 317-455 301-535 (b) (6) 11111111 1 1 1 1 Title (b) (6) Optel Group VACO, Secretary's Center for Strategic The RAND Corporation Concannon American Hospital Association (b) (6) Dartmouth-Hitchcock Medical Center Cronenwett, M.D . (b) (6) Office of Quality, Safety and Value (QSV) Sofware Developer - Epic Rehabilitation & Prosthetics Services, VA Central Office VHA Maximo National Evaluation System for health Technology (NEST) Coordinating Center Fleurence Computer Technology Associates, Inc. (b) (6) VA Palo Alto HCS Giori Health Data Link Inc. (b) (6) BookZurman yes yes Yes yes Full Name (b) (6) Quality Safety and Value VHA Integra VHA Yale School of Medicine (b) (6) Gunnar William National Director of Surgery Harold H. Hines 919-395 (b) (6) 443-253 202-632 Professor of Medicine and Epidemiology and Public 203-764 1 1 1 1 1 FDA VA Medical Center, Iowa GHX Bradan Inc. DHA MEDLOG yes yes Yes Yes yes yes Yes Yes yes 1 1 1 1 1 1 1 1 1 VHA Johns Hopkins University FDA Office of Acquisition and Logistics Mayo Clinic Summit MedTech Intelligence ECRI Institute Lahey Hospital and Medical Center fda.hhs.gov William.Gunnar@va.gov (b) (6) (b) (6) Hines Jr. ( Dr. Krumholz) Harold H. (b) (6) (b) (6) Yes Yes yes yes yes (b) (6) 301-796 202-461-7148 William Gunnar 301-796 319-339 404.977. 562-338 301-619 n 708- 449 240-228 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) 708-786 507-284 202.407. 610-667 (b) (6) 11111111 yes yes yes 1 1 1 U.S Food & Drug Administration Marinac-Dabic, MD, PhD, MMSc, FISPE Danica (b) (6) Masimo VACO VA National Center for Patient Safety (NCPS) Office of Quality, Safety and Value yes yes yes Yes Yes Yes yes yes Yes 1 1 1 1 1 1 1 1 1 McIntosh American Hospital Association (b) (6) VHA Global Healthy Living Foundation Cerner Corporation Integra LifeSciences GHX Health Data Link, Inc. VHA Procurement & Logistics Office Bruce A. Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Bruce A. McIntosh, Director, Division of Epidemiology (b) (6) 301-796 08-606 02-382 National Manager, Product Recall Office (b) (6) (b) (6) 312-422 202 461 917-455 (b) 484-682 (6) 267-455 312- 884 602-653 (b) .(b) (6) @va.gov (6) (6) (b) (6) @integralife.com (b) ? (b) .(b) (6) @va.gov ? (b) (6) (b) (6) @yale.edu ? (6) . I (b) (6) (b) (6) @fda.hhs.gov (b) (6) (b) @va.gov ? (b) (6) (6)@ghx.com ? (b) (6) @bradan.io ? (b) (b) (6) @mail.mil ? (6) I (b) (6) @va.gov (b) (6) @jhuapl.edu ? (b) (6) ? (b) (6) ? (b) (6) ? (b) I (6) @fda.hhs.gov @va.gov @mayo.edu @summitllc.us ? (b) medtechintelligence.com ? (b) (6) (6) @ecri.org ? gmail.com ? I (b) (6) fda.hhs.gov (b) (6) @masimo.com ? (b) (6) @va.gov ? I -?? --? -? -?? -----II -- 1111 Speaker 1111 1111 Speaker 1111 Speaker Speaker 1111 (b) (6) va.gov Speaker (b) (6) @aha.org ? (b) (6) @va.gov ? (b) (6) ghlf.org ? (b) (6) @Cerner.com ? (b) (6) @integralife.com ? ? (b) (6) ? (b) (6) ? @healthdata.link va.gov VA-18-0298 and 18-0299-B-000566 yes Yes 1 1 yes Yes YES 1 1 1 yes yes 1 1 yes yes yes Yes yes yes 1 1 1 1 1 1 yes Yes 1 1 yes yes yes yes 1 1 1 1 yes yes 1 1 United Healthcare (b) (6) Dr. VA Portland Health Care System Raitt MD FDA Center for Devices and Radiological Health (CDRH) Reed VACO (b) (6) ECRI Institute Office of Cybersecurity & Aerospace VACO, Secretary's Center for Strategic Harvard Medical School U.S Food & Drug Administration FDA Cognitive Medical Systems RAND Corporation Sharon-Lise, PHD Shuren, Dr. Simonyan, Dr. SkapiK, MD, MPH VACO George E. Wahlen Department of (b) (6) Dr. (b) (6) Merritt H. Merritt H Raitt MD Terrie L. (b) (6) 714-252 (b) (6) (b) (6) (b) (6) 971-757 (b) (6) 301-796 2-461 -825 (b) (6) fda.hhs.gov (b) (6) @va.gov (b) @ecri.org (6) (b) (6) @maryland.gov (b) (6) @va.gov Terrie L. Reed Senior Advisor Office of Surveillance and Biometrics (b) (6) -767 -461 Normand Jeffrey Vaham Julia Sharon-Lise T.Normand Professor, Dept. of Health Care Policy, Harvard Medical School Professor, Dept. of Biostatistics, Harvard T.H. Chan School of Public Health 617-432 Dr. Jeffrey Shuren Dr. Vaham Simonyan Julia Skapik, MD, MPH Director of the Center for Devices and Radiological Health (CDRH) at FDA. Lead Scientist Chief Health Information Officer (b) (6) Christine E. Stake (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Zenooz, Dr. Ashwini Dr. Ashwini Zenooz @hcp.med.harvard.edu 845-323 303-905 (b) @ghlf.org (6) (b) (6) va.gov 703-598 202-461 (b) (6) va.gov (b) (6) @wwt.com (b) (6) @va.gov (b) (6) @vva.org (b) (6) (b) (6) Speaker @va.gov (b) (6) fda.hhs.gov (b) (6) fda.hhs.gov (b) @cognitivemedicine.com (6) (b) @rand.org (6) (b) (6) @gmail.com 301-796 301-796 703-413 Christine E. uhc.com Director VA National Cardiac Device Surveillance Program Chief of Cardiology, (b) (6) Stake SECVA Staff Global Healthy Living Foundation VHA Supply Chain Office VA Eastern Colorado Health Care System World Wide Technology Inc. VHA Vietnam Veterans of America (b) (6) Chief Medical Officer (CMO), VA Electronic Health Record Modernization (EHRM) 202-382-4997 801-726 (b) (6) (b) (6) (b) (6) Panel Speaker @va.gov @va.gov VA-18-0298 and 18-0299-B-000567 Ha, Richard From: Sent: To: Cc: Mitchell, Brian P. Friday, June 01, 2018 9:48 AM COS-PMO Hayes-Byrd, Jacquelyn; (b) (6) Subject: Attachments: - Tallman, Gary; Wagner, John (Wolf); Ullyot, John; (b) (6) ; , Ph.D Monday's remarks at the Medical Device Registry Summit 2018 06 04-2 Medical Device Registry Summit.docx; Medical Device Registry Summit Program June 4 2018 - Preliminary.docx (b) (6) (b) (6) Sir, Attached and below are brief opening remarks (5 mins.) for the Medical Device Registry Summit, Monday morning, at 8:30, in Room 230. The audience will consist of about 75 medical experts from federal agencies and the healthcare community. About one third will be from VA. The purpose of the summit is to advance collaborative efforts to create a national management and tracking system to unify, expand, and improve existing medical devise registries. The main objectives of your remarks are: (a) to stress the importance of the collaboration and VA's commitment to its success, and (b) to thank our public and private partners for their participation in the summit and the effort. Internal and external media will be present. Dr. SreyRam Kuy will introduce you. You will speak from the podium and depart immediately afterwards. The summit's program is also attached. Jackie will have hardcopies for you. V/r (b) (6) --- o (b) (6) - - o Department of Veterans Affairs o Office 202-461-(b) (6) o Cell 202-203-(b) (6) DRAFT 2: Medical Device Registry Summit Monday, June 4, 2018 Good morning. Thank you, Doctor [SreyRam Kuy, MD], for that introduction and for taking charge of this summit. 1 VA-18-0298 and 18-0299-B-000568 I'd also like to thank our key partners in this effort: ? Dr. Danica Marinac-Dabic [dan-NEE-sa Ma-RIN-ac DA-bic] of FDA, ? Dr. Thomas Concannon at RAND, ? Dr. and Dr. from the Global Healthy Living Foundation. (b) (6) (b) (6) (b) (6) [ ? Also VA's Dr. Bruce McIntosh, and Acting COS Jacquelyn Hayes-Byrd and her team, who have all worked very hard to make this summit a success. (b) (6) 2 (b) (6) VA-18-0298 and 18-0299-B-000569 Finally, I'd like to thank two people who are not here but who have been driving forces in the development of medical device registries -- Dr. Bruce Moskowitz and Mr. Aaron Moskowitz of the Biomedical Research & Education Foundation. A few days ago, we announced a major decision: ? to move forward with a multi-billion-dollar contract to modernize VA's electronic health records, ? by adopting the same EHR platform used by DoD, ? with a few additional functions to accommodate the special needs of Veterans. Today we're here to talk about one way to make the most out of the new EHR system. 3 VA-18-0298 and 18-0299-B-000570 In the past few years, VA has worked with DoD to develop a Joint Patient Safety Reporting program to learn from reported healthcare system vulnerabilities, including the inability to identify specific patient implants. o Now we're looking to expand that collaboration to include the Food & Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), as well as our Community Care partners. o So we have organized this summit to bring together industry and academic leaders and sister-agency experts to map out a strategy for launching the largest medical device-implant tracking program in the Nation. Medical devices are a $170 billion business, accounting for 6 percent of U.S. health spending in 2013. o Implantable device sales are estimated to have been $43 billion in 2011 and are expected to reach $74 billion this year. But for all that money, it's hard to know what works best for patients -- and what puts them at greater risk. o Current tracking systems don't provide enough clinical detail, or they aren't linked to VA's EHR system. o Adverse Event Reports are mandatory for hospitals and manufacturers, but they don't provide enough information for us to tell which patients are affected. The solution is a nationwide medical implant registry that enables us to identify and manage patients with implanted medical devices and biological implants, no matter where they receive their care. 4 VA-18-0298 and 18-0299-B-000571 Such a system would enable us to -- ? measure quality & compare outcomes, ? monitor patient safety, ? recall faulty devices, ? notify patients about safety recalls, ? know the exact device in question when patient shows up in ER with complications, ? and track clinical follow-up. The system must be implementable in the short term via VA's CPRS and VistA, and able to interface in the long term with VA's new EHR system. With a well-managed medical device tracking system, and a fully integrated EHR system linking VA and DoD and our Community Care providers: o We will know, from day one, what implants a Veteran has received on active duty, so nothing is lost when a Veteran enters our care. o We will know how those implants have performed for each Veteran. o We will also know how the same implants have performed for all other Veterans and active-duty servicemembers. o We will be able to identify and address the concerns of individual Veterans about their implants. o We will also be able to see whether other patients have experienced the same issues, to better assess the risk. 5 VA-18-0298 and 18-0299-B-000572 o And we will be able to share that information with other providers and with device manufacturers, which will mean both better design and better use of implants. The result will be safer, more efficient, more patient-centered care -- not just for Veterans, but for all implant recipients. Congress has mandated that we track medical implants, and this administration is committed to fielding the very best, inclusive, patient-centered implant tracking system. We can't do that without the collaboration of our sister agencies and nongovernmental partners. o So we greatly appreciate your participation in this summit. Thank you for being here. I look forward to hearing about your discussions later. ### 6 VA-18-0298 and 18-0299-B-000573 DRAFT 2: Medical Device Registry Summit Monday, June 4, 2018 Good morning. Thank you, Doctor [SreyRam Kuy, MD], for that introduction and for taking charge of this summit. I'd also like to thank our key partners in this effort: o Dr. Danica Marinac-Dabic [dan-NEE-sa Ma-RIN-ac DA-bic] of FDA, o Dr. Thomas Concannon at RAND, o Dr. (b) (6) (b) (6) and Dr. [ from the Global Healthy Living Foundation. (b) (6) o Also VA's Dr. Bruce McIntosh, (b) (6) (b) (6) and Acting COS Jacquelyn Hayes-Byrd and her team, who have all worked very hard to make this summit a success. VA-18-0298 and 18-0299-B-000574 1 Finally, I'd like to thank two people who are not here but who have been driving forces in the development of medical device registries -- Dr. Bruce Moskowitz and Mr. Aaron Moskowitz of the Biomedical Research & Education Foundation. A few days ago, we announced a major decision: - to move forward with a multi-billiondollar contract to modernize VA's electronic health records, - by adopting the same EHR platform used by DoD, - with a few additional functions to accommodate the special needs of Veterans. Today we're here to talk about one way to make the most out of the new EHR system. VA-18-0298 and 18-0299-B-000575 2 In the past few years, VA has worked with DoD to develop a Joint Patient Safety Reporting program to learn from reported healthcare system vulnerabilities, including the inability to identify specific patient implants. o Now we're looking to expand that collaboration to include the Food & Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), as well as our Community Care partners. o So we have organized this summit to bring together industry and academic leaders and sister-agency experts to map out a strategy for launching the largest medical device-implant tracking program in the Nation. Medical devices are a $170 billion business, accounting for 6 percent of U.S. health spending in 2013. VA-18-0298 and 18-0299-B-000576 3 o Implantable device sales are estimated to have been $43 billion in 2011 and are expected to reach $74 billion this year. But for all that money, it's hard to know what works best for patients -- and what puts them at greater risk. o Current tracking systems don't provide enough clinical detail, or they aren't linked to VA's EHR system. o Adverse Event Reports are mandatory for hospitals and manufacturers, but they don't provide enough information for us to tell which patients are affected. The solution is a nationwide medical implant registry that enables us to identify and manage patients with implanted medical devices and biological implants, no matter where they receive their care. VA-18-0298 and 18-0299-B-000577 4 Such a system would enable us to -- o measure quality & compare outcomes, o monitor patient safety, o recall faulty devices, o notify patients about safety recalls, o know the exact device in question when patient shows up in ER with complications, o and track clinical follow-up. The system must be implementable in the short term via VA's CPRS and VistA, and able to interface in the long term with VA's new EHR system. With a well-managed medical device tracking system, and a fully integrated EHR system linking VA and DoD and our Community Care providers: o We will know, from day one, what implants a Veteran has received on VA-18-0298 and 18-0299-B-000578 5 active duty, so nothing is lost when a Veteran enters our care. o We will know how those implants have performed for each Veteran. o We will also know how the same implants have performed for all other Veterans and active-duty servicemembers. o We will be able to identify and address the concerns of individual Veterans about their implants. o We will also be able to see whether other patients have experienced the same issues, to better assess the risk. o And we will be able to share that information with other providers and with device manufacturers, which will mean both better design and better use of implants. VA-18-0298 and 18-0299-B-000579 6 The result will be safer, more efficient, more patient-centered care -- not just for Veterans, but for all implant recipients. Congress has mandated that we track medical implants, and this administration is committed to fielding the very best, inclusive, patient-centered implant tracking system. We can't do that without the collaboration of our sister agencies and nongovernmental partners. o So we greatly appreciate your participation in this summit. Thank you for being here. I look forward to hearing about your discussions later. ### VA-18-0298 and 18-0299-B-000580 7 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. - 4:30 p.m. 8:30 a.m. Welcome and Introduction of Participants and Organizations* Acting Secretary of VA Peter O'Rourke 8:45 a.m. - 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective Christine Stake, Patient Governor, the ArthritisPower Patient Research Registry Leveraging the Medical Device Ecosystem Rachael Fleurence Ph.D., National Evaluation System for Health Technologies Value Roundtable Discussion Moderator: SreyRam Kuy, MD o Veterans Affairs (VA) Acting Secretary Peter O'Rourke o Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD o Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health o Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) o American Medical Association, Kathleen Blake, MD Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000581 VI'\ o 10 a.m. - 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA) ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories (b) (6) o MD CART Program ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + Kristi Mitchell (Avalere Health) 11:30 a.m. - 12:30 p.m. Lunch Break 12:30 p.m. - 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, PhD (Harvard Medical School/Harvard School of Public Health) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities ? Unique Device Identifier implementation efforts o Terrie Reed (FDA) ? Strategically Coordinated Registry Networks - Linking Registries with other data sources o Art Sedrakyan, MD, PhD (Cornell/MDEpiNet) ? Harmonization Efforts with National/International Registries o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE (FDA/Center for Devices and Radiological Health (CDRH)) ? Patient -enabled evidence generation o Harlan Krumholz, MD (Yale University) ? Active Surveillance via DELTA in National Registries (b) (6) o MD (Lahey Clinic) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000582 VI'\ o Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) 2 p.m. - 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Thomas Concannon, PhD (RAND) Objective: How to begin development of the framework for a Medical Device Registry ? Who should be at the table: What can we learn from Vascular Quality Initiative? o Jack Cronenwett, MD (Dartmouth) ? How to build in the sustainability: Return of Investment Multi-stakeholder Analysis o Greg Pappas, MD, PhD (FDA/CDRH) ? Privacy/Ethics issues o Robert M Portman, JD (Powers, Pyles, Sutter and Verville PC) ? Topic TBD (b) (6) (b) (6) o MD, PhD, FCCM (United Healthcare) Panel Discussion: Speakers + Julia Skapik, MD (Cognitive Medical Systems) 3:15 p.m. - 4:30 p.m. Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a Medical Device Registry Moderator: Harlan Krumholz, MD (Yale University) Panel: Bruce McIntosh, PharmD (VA) Art Sedrakyan, MD (Weill Cornell Medical College) Danica Marinac-Dabic, MD, PhD (FDA) Rachael Fleurence, PhD (National Evaluation System for Health Technology Coordinating Center) Closing Remarks VA Leadership - Dr. Carolyn Clancy Questions? Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000583 VI'\ o Ha, Richard From: Sent: To: Subject: Attachments: Morris, Genevieve (OS/ONC/IO) Wednesday, June 20, 2018 8:29 AM O'Rourke, Peter M. [EXTERNAL] Fwd: Update_Important Request External Reviewers.xlsx See attached for the NDA list. Let me know if you have any questions. From: "Truex, Matthew" Subject: RE: Update_Important Request Date: 19 June 2018 08:49 To: "Windom, John H." , "Foster, Michele (SES)" , "(b) (6) @va.gov>, "(b) (6) @va.gov>, (b) (6) @va.gov> Cc: "Sandoval, Camilo J." , "Morris, Genevieve (OS/ONC/IO)" , "Zenooz, Ashwini" , "Short, John (VACO)" , "(b) (6) (b) (6) (COLONEL)" < @va.gov> - John - Updated to include organization/affiliation. Thanks, Matt Matthew Truex Contracting Officer Department of Veterans Affairs Office of Procurement, Acquisition and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724 Office: 732-440-9650 Mobile: 732-320-1968 e-mail: matthew.truex@va.gov "For Internal VA Use Only - Working Draft, Pre-Decisional, Deliberative Document: This e-mail and any attachments are intended only for the use of the addressee(s) named herein and may contain privileged and/or confidential information. If you are not the intended recipient of this e-mail, you are hereby notified that any dissemination, distribution or copying of this e-mail, and any attachments thereto, is strictly prohibited. If you have received this e-mail in error, please notify me via return e-mail or telephone (732) 440-9650, and permanently delete the original and any copy of any e-mail and any printout thereof." 1 VA-18-0298 and 18-0299-B-000584 From: Windom, John H. Sent: Monday, June 18, 2018 5:00 PM To: Truex, Matthew; Foster, Michele (SES); (b) (6) Cc: Sandoval, Camilo J.; Morris, Genevieve (OS/ONC/IO) (Genevieve.Morris@hhs.gov); Zenooz, Ashwini; Short, John (VACO); (b) (6) (COLONEL) Subject: RE: Update_Important Request Matt, Please add their organization for clarity. Vr John John H. Windom, Senior Executive Service (SES) Program Executive for Electronic Health Record Modernization (PEO EHRM) 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 John.Windom@va.gov Office: (202) 461-5820 Mobile: (202) 794-4911 Executive Assistant: Ms. (b) (6) - Appointments and Scheduling (b) (6) (b) (6) @va.gov Office: 202-382 - -- From: (b) (6) Sent: Monday, June 18, 2018 4:07 PM To: Windom, John H.; Foster, Michele (SES); (b) (6) Cc: Sandoval, Camilo J.; Morris, Genevieve (OS/ONC/IO) (Genevieve.Morris@hhs.gov); Zenooz, Ashwini; Short, John (VACO); (b) (6) (COLONEL) Subject: RE: Update_Important Request John, As requested, provided is a listing of non-VA employees (at that time) who were involved in the various external reviews during the EHRM acquisition phase. Listing was generated based on the numerous MITRE led reviews and White House review(s). Thanks, Matt Matthew Truex Contracting Officer Department of Veterans Affairs Office of Procurement, Acquisition and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724 Office: 732-440-9650 Mobile: 732-320-1968 e-mail: matthew.truex@va.gov 2 VA-18-0298 and 18-0299-B-000585 "For Internal VA Use Only - Working Draft, Pre-Decisional, Deliberative Document: This e-mail and any attachments are intended only for the use of the addressee(s) named herein and may contain privileged and/or confidential information. If you are not the intended recipient of this e-mail, you are hereby notified that any dissemination, distribution or copying of this e-mail, and any attachments thereto, is strictly prohibited. If you have received this e-mail in error, please notify me via return e-mail or telephone (732) 440-9650, and permanently delete the original and any copy of any e-mail and any printout thereof." From: Windom, John H. Sent: Saturday, June 16, 2018 1:43 AM To: Truex, Matthew; Foster, Michele (SES); (b) (6) Cc: Sandoval, Camilo J.; Morris, Genevieve (OS/ONC/IO) (Genevieve.Morris@hhs.gov); Zenooz, Ashwini; Short, John (VACO); (b) (6) (COLONEL) Subject: Update_Important Request Michele and TAC Team: This request comes directly from the Acting Secretary in support of hearing preps. Please provide a list of names of the non-VA employees (supporting various external reviews) that have signed NDAs to review our EHRM acquisition/program documents in advance of contract award (May 17, 2018). Thank you, John John H. Windom, Senior Executive Service (SES) Program Executive for Electronic Health Record Modernization (PEO EHRM) 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 John.Windom@va.gov Office: (202) 461-5820 Mobile: (202) 794-4911 Executive Assistant: Ms. (b) (6) - Appointments and Scheduling (b) (6) @va.gov Office: 202-382-(b) (6) -- 3 VA-18-0298 and 18-0299-B-000586 (b) (6) (b) (6) Morris Moskowitz Genevieve Bruce Perlmutter Ike (b) (6) (b) (6) Organization/Affiliation US Army/DHA CareJourney Indiana Health Information Exchange Mitre Mitre The Mayo Clinic Mitre Mayo Clinic Geisinger Kaiser Permanente Ascention Health Kaiser Permanente Mitre Lahey Health Leavitt Parners, LLC DHA/DHMS Intermountain Healthcare US Navy/SPAWAR Massachusetts General Hospital Mitre Collective Medical Technologies, Inc. University of California, Los Angeles/American College of Surgeons Harvard Medical School/Boston's Children Hospital Sutter Health Massachusetts General Hospital/Partners Healthcare System Office of the National Coordinatorfor Health Information Technology (ONC) Internist/External Expert Participant Universal Health Services American College of Surgeons University of Washington Medical Center CEO Marvel Entertainment Intermountain Healthcare Johns Hopkins University VA-18-0298 and 18-0299-B-000587 (b) (6) Sherman (b) (6) Marc Mitre Mitre Johns Hopkins University The Mayo Clinic Mitre Mitre Mitre Alvarez & Marsal University of Pittsburgh Medical Center The Healthcare Information and Management Systems Society US Air Force University of Washington Mitre Mitre Mitre HealthSouth VA-18-0298 and 18-0299-B-000588 Ha, Richard From: Sent: To: Subject: Attachments: (b) (6) Friday, June 01, 2018 2:08 PM COS-PMO; O'Rourke, Peter M. FW: Monday's remarks at the Medical Device Registry Summit 2018 06 04-2 Medical Device Registry Summit.docx; Medical Device Registry Summit Program June 4 2018 - Preliminary.docx Per your request - here are the electrons for Monday's opening remarks. Thank you. From: (b) (6) Sent: Friday, June 01, 2018 9:48 AM To: COS-PMO Cc: Hayes-Byrd, Jacquelyn; (b) (6) ; Tallman, Gary; Wagner, John (Wolf); Ullyot, John; (b) (6) Ph.D Subject: Monday's remarks at the Medical Device Registry Summit Sir, Attached and below are brief opening remarks (5 mins.) for the Medical Device Registry Summit, Monday morning, at 8:30, in Room 230. The audience will consist of about 75 medical experts from federal agencies and the healthcare community. About one third will be from VA. The purpose of the summit is to advance collaborative efforts to create a national management and tracking system to unify, expand, and improve existing medical devise registries. The main objectives of your remarks are: (a) to stress the importance of the collaboration and VA's commitment to its success, and (b) to thank our public and private partners for their participation in the summit and the effort. Internal and external media will be present. Dr. SreyRam Kuy will introduce you. You will speak from the podium and depart immediately afterwards. (b) (6) The summit's program is also attached. will have hardcopies for you. V/r (b) (6) - -- (b) (6) o (b) (6) - - o Department of Veterans Affairs o Office 202-461-(b) (6) o Cell 202-203-(b) (6) 1 VA-18-0298 and 18-0299-B-000589 DRAFT 2: Medical Device Registry Summit Monday, June 4, 2018 Good morning. Thank you, Doctor [SreyRam Kuy, MD], for that introduction and for taking charge of this summit. I'd also like to thank our key partners in this effort: ? Dr. Danica Marinac-Dabic [dan-NEE-sa Ma-RIN-ac DA-bic] of FDA, ? Dr. Thomas Concannon at RAND, ? Dr. and Dr. from the Global Healthy Living Foundation. (b) (6) (b) (6) (b) (6) [ , and ? Also VA's Dr. Bruce McIntosh, Acting COS Jacquelyn Hayes-Byrd and her team, who have all worked very hard to make this summit a success. (b) (6) 2 VA-18-0298 and 18-0299-B-000590 Finally, I'd like to thank two people who are not here but who have been driving forces in the development of medical device registries -- Dr. Bruce Moskowitz and Mr. Aaron Moskowitz of the Biomedical Research & Education Foundation. A few days ago, we announced a major decision: ? to move forward with a multi-billion-dollar contract to modernize VA's electronic health records, ? by adopting the same EHR platform used by DoD, ? with a few additional functions to accommodate the special needs of Veterans. Today we're here to talk about one way to make the most out of the new EHR system. 3 VA-18-0298 and 18-0299-B-000591 In the past few years, VA has worked with DoD to develop a Joint Patient Safety Reporting program to learn from reported healthcare system vulnerabilities, including the inability to identify specific patient implants. o Now we're looking to expand that collaboration to include the Food & Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), as well as our Community Care partners. o So we have organized this summit to bring together industry and academic leaders and sister-agency experts to map out a strategy for launching the largest medical device-implant tracking program in the Nation. Medical devices are a $170 billion business, accounting for 6 percent of U.S. health spending in 2013. o Implantable device sales are estimated to have been $43 billion in 2011 and are expected to reach $74 billion this year. But for all that money, it's hard to know what works best for patients -- and what puts them at greater risk. o Current tracking systems don't provide enough clinical detail, or they aren't linked to VA's EHR system. o Adverse Event Reports are mandatory for hospitals and manufacturers, but they don't provide enough information for us to tell which patients are affected. The solution is a nationwide medical implant registry that enables us to identify and manage patients with implanted medical devices and biological implants, no matter where they receive their care. 4 VA-18-0298 and 18-0299-B-000592 Such a system would enable us to -- ? measure quality & compare outcomes, ? monitor patient safety, ? recall faulty devices, ? notify patients about safety recalls, ? know the exact device in question when patient shows up in ER with complications, ? and track clinical follow-up. The system must be implementable in the short term via VA's CPRS and VistA, and able to interface in the long term with VA's new EHR system. With a well-managed medical device tracking system, and a fully integrated EHR system linking VA and DoD and our Community Care providers: o We will know, from day one, what implants a Veteran has received on active duty, so nothing is lost when a Veteran enters our care. o We will know how those implants have performed for each Veteran. o We will also know how the same implants have performed for all other Veterans and active-duty servicemembers. o We will be able to identify and address the concerns of individual Veterans about their implants. o We will also be able to see whether other patients have experienced the same issues, to better assess the risk. 5 VA-18-0298 and 18-0299-B-000593 o And we will be able to share that information with other providers and with device manufacturers, which will mean both better design and better use of implants. The result will be safer, more efficient, more patient-centered care -- not just for Veterans, but for all implant recipients. Congress has mandated that we track medical implants, and this administration is committed to fielding the very best, inclusive, patient-centered implant tracking system. We can't do that without the collaboration of our sister agencies and nongovernmental partners. o So we greatly appreciate your participation in this summit. Thank you for being here. I look forward to hearing about your discussions later. ### 6 VA-18-0298 and 18-0299-B-000594 DRAFT 2: Medical Device Registry Summit Monday, June 4, 2018 Good morning. Thank you, Doctor [SreyRam Kuy, MD], for that introduction and for taking charge of this summit. I'd also like to thank our key partners in this effort: o Dr. Danica Marinac-Dabic [dan-NEE-sa Ma-RIN-ac DA-bic] of FDA, o Dr. Thomas Concannon at RAND, o Dr. (b) (6) and Dr. (b) (6) ] from the Global Healthy Living Foundation. o Also VA's Dr. Bruce McIntosh, (b) (6) , and Acting COS Jacquelyn Hayes-Byrd and her team, who have all worked very hard to make this summit a success. VA-18-0298 and 18-0299-B-000595 1 Finally, I'd like to thank two people who are not here but who have been driving forces in the development of medical device registries -- Dr. Bruce Moskowitz and Mr. Aaron Moskowitz of the Biomedical Research & Education Foundation. A few days ago, we announced a major decision: - to move forward with a multi-billiondollar contract to modernize VA's electronic health records, - by adopting the same EHR platform used by DoD, - with a few additional functions to accommodate the special needs of Veterans. Today we're here to talk about one way to make the most out of the new EHR system. VA-18-0298 and 18-0299-B-000596 2 In the past few years, VA has worked with DoD to develop a Joint Patient Safety Reporting program to learn from reported healthcare system vulnerabilities, including the inability to identify specific patient implants. o Now we're looking to expand that collaboration to include the Food & Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), as well as our Community Care partners. o So we have organized this summit to bring together industry and academic leaders and sister-agency experts to map out a strategy for launching the largest medical device-implant tracking program in the Nation. Medical devices are a $170 billion business, accounting for 6 percent of U.S. health spending in 2013. VA-18-0298 and 18-0299-B-000597 3 o Implantable device sales are estimated to have been $43 billion in 2011 and are expected to reach $74 billion this year. But for all that money, it's hard to know what works best for patients -- and what puts them at greater risk. o Current tracking systems don't provide enough clinical detail, or they aren't linked to VA's EHR system. o Adverse Event Reports are mandatory for hospitals and manufacturers, but they don't provide enough information for us to tell which patients are affected. The solution is a nationwide medical implant registry that enables us to identify and manage patients with implanted medical devices and biological implants, no matter where they receive their care. VA-18-0298 and 18-0299-B-000598 4 Such a system would enable us to -- o measure quality & compare outcomes, o monitor patient safety, o recall faulty devices, o notify patients about safety recalls, o know the exact device in question when patient shows up in ER with complications, o and track clinical follow-up. The system must be implementable in the short term via VA's CPRS and VistA, and able to interface in the long term with VA's new EHR system. With a well-managed medical device tracking system, and a fully integrated EHR system linking VA and DoD and our Community Care providers: o We will know, from day one, what implants a Veteran has received on VA-18-0298 and 18-0299-B-000599 5 active duty, so nothing is lost when a Veteran enters our care. o We will know how those implants have performed for each Veteran. o We will also know how the same implants have performed for all other Veterans and active-duty servicemembers. o We will be able to identify and address the concerns of individual Veterans about their implants. o We will also be able to see whether other patients have experienced the same issues, to better assess the risk. o And we will be able to share that information with other providers and with device manufacturers, which will mean both better design and better use of implants. VA-18-0298 and 18-0299-B-000600 6 The result will be safer, more efficient, more patient-centered care -- not just for Veterans, but for all implant recipients. Congress has mandated that we track medical implants, and this administration is committed to fielding the very best, inclusive, patient-centered implant tracking system. We can't do that without the collaboration of our sister agencies and nongovernmental partners. o So we greatly appreciate your participation in this summit. Thank you for being here. I look forward to hearing about your discussions later. ### VA-18-0298 and 18-0299-B-000601 7 DEPARTMENT OF VETERANS AFFAIRS 810 Vermont Avenue NW Washington, DC 20571 Medical Device Registry Summit GV (Sonny) Montgomery Veterans Auditorium, Room 230 810 Vermont Avenue, NW Washington, DC 20420 June 4, 2018 8:30 a.m. - 4:30 p.m. 8:30 a.m. Welcome and Introduction of Participants and Organizations* Acting Secretary of VA Peter O'Rourke 8:45 a.m. - 10 a.m. Session 1: Value for Stakeholders Objective: To describe value of medical device registries to major stakeholders; identify the gaps; prioritize opportunities Patient Perspective Christine Stake, Patient Governor, the ArthritisPower Patient Research Registry Leveraging the Medical Device Ecosystem Rachael Fleurence Ph.D., National Evaluation System for Health Technologies Value Roundtable Discussion Moderator: SreyRam Kuy, MD o Veterans Affairs (VA) Acting Secretary Peter O'Rourke o Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD o Jeff Shuren, MD, PhD, Director, Center for Devices and Radiological Health o Centers for Medicare and Medicaid Services Administrator Seema Verma (tentative) o American Medical Association, Kathleen Blake, MD Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000602 VI'\ o 10 a.m. - 11:30 a.m. Session 2: VA Landscape Objective: Share examples of successful device monitoring at VA, registry infrastructure at VA and present the vision for the future Moderator: Danica Marinac-Dabic, MD, PhD, MMSC, FISPE - FDA ? Current Cardiac Device Monitoring in the VA o Merritt H. Raitt, MD, Director, National Cardiac Device Surveillance Program, Veterans Health Affairs (VHA) ? Improving Device Surveillance by Analyzing Passively Collected Electronic Health Record Data o Nicholas Giori, MD, PhD, Chief of Orthopedic Surgery, VA Palo Alto Health Care System ? Medical Device Tracking in Cardiology: The integration of Real Time Locations System into The Clinical Assessment, Reporting, and Tracking System (CART) for Cardiac Catheterization Laboratories (b) (6) o , MD CART Program ? Building Future-State Model for VHA Implant Tracking o Bruce McIntosh, PharmD, VA National Manager, Product Recall Office, National Center for Patient Safety Panel Discussion: Speakers + Kristi Mitchell (Avalere Health) 11:30 a.m. - 12:30 p.m. Lunch Break 12:30 p.m. - 2 p.m. Session 3: Infrastructure/Methodology Opportunities for Standing Up a Medical Device Registry - Short and Long-Term Moderator: Sharon-Lise Normand, PhD (Harvard Medical School/Harvard School of Public Health) Objective: To identify key national and international efforts in the device space that can be leveraged for the development of a Medical Device Registry; present short- and long-term opportunities ? Unique Device Identifier implementation efforts o Terrie Reed (FDA) ? Strategically Coordinated Registry Networks - Linking Registries with other data sources o Art Sedrakyan, MD, PhD (Cornell/MDEpiNet) ? Harmonization Efforts with National/International Registries o Danica Marinac-Dabic, MD, PhD, MMSC, FISPE (FDA/Center for Devices and Radiological Health (CDRH)) ? Patient -enabled evidence generation o Harlan Krumholz, MD (Yale University) ? Active Surveillance via DELTA in National Registries (b) (6) o , MD (Lahey Clinic) Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000603 VI'\ o Panel Discussion: Speakers + Vahan Simonyan, PhD (FDA) 2 p.m. - 3:15 p.m. Session 4: From the Conceptual Framework to the Developmental Efforts and Sustainability Moderator: Thomas Concannon, PhD (RAND) Objective: How to begin development of the framework for a Medical Device Registry ? Who should be at the table: What can we learn from Vascular Quality Initiative? o Jack Cronenwett, MD (Dartmouth) ? How to build in the sustainability: Return of Investment Multi-stakeholder Analysis o Greg Pappas, MD, PhD (FDA/CDRH) ? Privacy/Ethics issues o Robert M Portman, JD (Powers, Pyles, Sutter and Verville PC) ? Topic TBD (b) (6) o , MD, PhD, FCCM (United Healthcare) Panel Discussion: Speakers + Julia Skapik, MD (Cognitive Medical Systems) 3:15 p.m. - 4:30 p.m. Panel: Pulling it All Together Objective: To summarize key points in the next steps toward building a Medical Device Registry Moderator: Harlan Krumholz, MD (Yale University) Panel: Bruce McIntosh, PharmD (VA) Art Sedrakyan, MD (Weill Cornell Medical College) Danica Marinac-Dabic, MD, PhD (FDA) Rachael Fleurence, PhD (National Evaluation System for Health Technology Coordinating Center) Closing Remarks VA Leadership - Dr. Carolyn Clancy Questions? Contact: SreyRam Kuy, MD Special Advisor, Office of the Secretary Department of Veterans Affairs SreyRam.Kuy@va.gov (713) 503-4274 Diffusionof _,- ::: :;; ~ 8........ ~ EXCELLENCE Diftm ingBeslPra< ticesAuossVHA \II\ I tel\ US.Department ofVeteransAffairs VA-18-0298 and 18-0299-B-000604 VI'\ o Ha, Richard From: Sent: To: Cc: Subject: O'Rourke, Peter M. Monday, June 18, 2018 11:34 PM (b) (6) (b) (6) RE: [EXTERNAL] Re: College of Surgeons contact information I'll work out a time tomorrow and let you know. Thank you. - From: (b) (6) Sent: Monday, June 18, 2018 8:06:05 PM To: O'Rourke, Peter M.; Bruce Moskowitz Cc: (b) (6) Subject: RE: [EXTERNAL] Re: College of Surgeons contact information Hi Pete.....good to meet you.....is there any time on Wednesday that works for you....i can work around your schedule.....Dave -----Original Message----- From: O'Rourke, Peter M. [mailto:Peter.ORourke@va.gov] Sent: Monday, June 18, 2018 5:46 PM To: Bruce Moskowitz <(b) (6) @mac.com> (b) (6) (b) (6) Cc: @facs.org>; @baptisthealth.net>; (b) (6) @facs.org>; (b) (6) @facs.org> Subject: RE: [EXTERNAL] Re: College of Surgeons contact information Thank you Bruce. Dr. (b) (6) good to meet you. I'd like to schedule some time for us to have a call. When would be a good time? Pete ________________________________ From: Bruce Moskowitz Sent: Monday, June 18, 2018 3:33:56 PM To: O'Rourke, Peter M. Cc: (b) (6) @facs.org; (b) (6) @facs.org Subject: [EXTERNAL] Re: College of Surgeons contact information Thank you I have provided an introduction to Dr. David Hoyt and his excellent group at the American College of Surgeons who offered their assistance for the VA inspections. Sent from my iPad Bruce Moskowitz M.D. > On Jun 18, 2018, at 5:59 PM, O'Rourke, Peter M. wrote: > > Dr. Moskowitz, > - - 1 VA-18-0298 and 18-0299-B-000605 > Can you provide me a point of contact at the College of Surgeons that I can talk to about independent inspections of VA facilities? I don't know anyone there so a point of contact would be very helpful. > > Thank you, > Peter > > Acting Secretary > Department of Veterans Affairs > 2 VA-18-0298 and 18-0299-B-000606 Ha, Richard From: Sent: To: Subject: Attachments: Sandoval, Camilo J. Friday, May 04, 2018 2:16 AM (b) (6) Hayes-Byrd, Jacquelyn; O'Rourke, Peter M. RE: Please Review Tonight [EXTERNAL] RE: VA EHR NDA; [EXTERNAL] NDA.pdf; [EXTERNAL] Re: VA EHR NDA And in case anyone ask, here are the signed NDA's of Ike, Bruce, and Marc. From: Sandoval, Camilo J. Sent: Friday, May 04, 2018 2:12 AM To: (b) (6) .; Hayes-Byrd, Jacquelyn; O'Rourke, Peter M. Subject: RE: Please Review Tonight Pete-- This request from members of congress is based on inaccurate reporting by Arthur Allen from Politico, which was fueled by (b) (5) A key question Arthur Allen and interested members of congress should investigate and write about is, why did (b) (5) And for the record, it was a team of top medical CIOs and practitioners--put together by Ike Perlmutter and Bruce Moskowitz-- who identified the flaws in the contract and made the recommendations, not MITRE. (b) (5) (b) (5) . From:(b Sent: )(Thursday, May 03, 2018 7:31 PM 6 To: Sandoval, Camilo J.; Hayes-Byrd, Jacquelyn; O'Rourke, Peter M. ) Subject: RE: Please Review Tonight Good info Cam, we may want to remind the interested parties of that. From: Sandoval, Camilo J. Sent: Thursday, May 03, 2018 4:13:22 PM To: Hayes-Byrd, Jacquelyn; O'Rourke, Peter M.; (b) (6) Subject: RE: Please Review Tonight 1 VA-18-0298 and 18-0299-B-000607 Thank you Jacquie. If we go back to Shulkin's EHRM hearing testimony, he mentions under oath that he and Scott Blackburn requested outside, non-governmental help from the top 5 Medical CIO's. These experts are who alerted him to the many interoperability issues previously unknown to Cerner or VA staff. From: Hayes-Byrd, Jacquelyn Sent: Thursday, May 03, 2018 5:42 PM To: O'Rourke, Peter M.; Sandoval, Camilo J.; (b) (6) Subject: Please Review Tonight - Please see these two documents tonight as the Dep Sec provided this to Colonel (b) (6) late this afternoon And (b) (6) will be giving it to the Secretary first in the a.m. don't want you to be blindsided and I would like for you to be prepared to discuss. Jacquie 1111 From: (b) (6) Sent: Thursday, May 03, 2018 5:32 PM To: Hayes-Byrd, Jacquelyn Subject: REQUESTED SCAN Special Assistant Office of the Secretary 810 Vermont Ave, NW Washington, DC 20420 202-461-(b) (6) (O) (b) (6) @va.gov (b) (6) VA Core Values: Integrity, Commitment, Advocacy, Respect, and Excellence--I CARE 2 VA-18-0298 and 18-0299-B-000608 Ha, Richard From: Sent: To: Cc: Subject: Attachments: IP <(b) (6) @frenchangel59.com> Tuesday, March 13, 2018 2:07 PM Marc Sherman; Blackburn, Scott R. (DISABLED ACCT) (b) (6) @gmail.com; Bruce Moskowitz; Truex, Matthew; Windom, John H.; DJS [EXTERNAL] RE: VA EHR NDA Perlmutter.EHR NDA v2 mbs.pdf I - Attached is my signed NDA. Thank you. - From: Marc Sherman [mailto:(b) (6) @gmail.com] Sent: Tuesday, March 13, 2018 1:40 PM To: Blackburn, Scott R. Cc: IP;(b) (6) @gmail.com; Bruce Moskowitz; Truex, Matthew; Windom, John H.; DJS Subject: Re: VA EHR NDA - Scott, Matt and John Thank you for the NDA draft that you sent along and the organized approach. I have attached the following to close the loop: 1. a marked up version of the NDA with a few necessary adjustments in red-line so you can see the changes that were made, 2. a blank copy of the amended NDA for Bruce and Ike to sign, and 3. a signed version by me of the amended NDA. Thanks and happy to help as requested. Marc On Tue, Mar 13, 2018 at 10:31 AM, Blackburn, Scott R. wrote: Ike, Bruce, Marc: Thank each of you for agreeing to lend an extra set of outside eyes on the EHR contract. We appreciate your support and want to make sure we get to the best place possible for Veterans, the country and taxpayers. As we are incredibly grateful to you for volunteering your time, we want to make this as easy as possible for you. Here are 3 next steps. 1) We will need you to sign the attached NDA. Please return to Matt Truex (cc'd). 2) Matt will then send you the latest package under separate cover. 1 VA-18-0298 and 18-0299-B-000609 3) Given government contracts are different than what you are used to reading, we would propose a quick phone call so that we can orient you to the contract and help focus you on the parts where your expertise will be most valuable. Matt Truex (who is the government contracting officer) and John Windom (who is our EHR (b) (6) leader) will lead this from our side. I will ask (cc'd) here to help set up a time. We can either do this all together, if calendars match up, or separately if need be. (b) (6) (b) (6) We have also connected with , and (b) (6) all have all received the NDA and we are working with them. I am hoping to connect with Dr. who today. Thanks again! Scott Scott Blackburn Acting CIO & Executive-in-Charge, Office of Information & Technology Department of Veterans Affairs 2 VA-18-0298 and 18-0299-B-000610 o NON-DISCLOSURE AGREEMENT (Dated March 13, 2018) 1. I acknowledge that I ha ve been selecied to participate in the planning for an electronic health record acquisition. In the course of participating in this acquisition , I may be or have been given access to or entrusted with Source Selection Information (as defined in Federal Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked as "proprietary" (e.g., restrictive legend per FAR 52.215- 1) that I cannot release to others nor can I 1 use for the financial benefit of others or myself I Source Selection Information is defined in FAR 2. 101 & 3. 104 and other sensitive Government data includes data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1). Data includes all data, information and software, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is deriv ed from, based on, incorporates , includes or refers to such Source Selection and/or proprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates , includes or refers to data shall be treated as Source Selection , or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. 2 . I understand that 41 U.S .C. ? 423 , commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101 -2107, and provisions FAR 3.104 govern the release of proprietary and source selection information . As it relates to the information that has been made available to me pursuant to this Non-Disclosure Agreement , I certify that I will not disclose any contractor bid, solicitation, proprietary, or Source Selection Information directly or indirectly to any person other than the President of the United States or a member of his administration to whom the President authorizes , another person subject to an equally restrictive Non-Disclosure Agreement related to the subject matter of this Agreement , the Secretary of the Department of Veterans Affairs or a person authorized by the head of agency or the contracting officer to receive such information. I understand that unauthorized disclosure of such information may subject me to substantial administrati ve, civil and criminal penalties , including fines , imprisonment, and loss of employment under the Procurement Integrity Act or other applicable laws and regulations . 3. I certify that I will not discuss evaluation of source selection matters with any unauthorized individuals (including Government personnel other than those set out in Paragraph 2 above), even after contract award, without specific prior approval from proper authority. 4. These provisions are consistent with, and do not supersede , conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information , (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagemen t, a gross waste of funds, an abuse of authority , or a substantial and specific danger to public health or safety , or (4) any other whistleblower protection . The definitions , requirements , obligations , rights , sanctions, and liabilities created by controlling Executi ve orders and statutory provisions are incorporated into this agreement and are controlling. These statutes and Executive orders include the following : VA-18-0298 and 18-0299-B-000611 NON-DISCLOSURE AGREEMENT Planning for an electronic health record acquisition , Dated Tuesday March 13, 2018 Page l2 [Executive Order No. 12958; [)[be Privacy Act (5 U.S.C: ? 552a); [)[be Trade Secrets Act (18 U.S.C. ? 1905); [J;ection 7211 of title 5, United States Code (governing disclosures to Congress); [J;ection 1034 of title 10, United States Code, as amended by the Military Whistl~blower Protection Act (governing disclosure to Congress by members of the military); , CBection 2302(b)(8) of title 5, United States Code, as amended by the Whistleblower Protection Action (governing disclosures of illegality, waste, fraud, abuse or public health or safety threats); []Ihe Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosures that could expose confidential Government agents); and Ofhe statutes which protect against disclosure that may compromise the national security, including sections 641, 793, 794, 798, and 952 of title 18, United States Code, and section 4(b) of the Subversive Activities Act of 1950 (50 U.S.C. ? 783(b)). Additionally, pursuant to 38 Code of Federal Regulations 1.201, all VA employees with knowledge or information about actual or possible violations of criminal law related to VA programs, operations, facilities, contracts, or information technology systems shall immediately report such knowledge or information to their supervisor, any management official, or directly to the Office of Ins ctor General. (b) (6) Name Printed: Isaac Perlmutter Organizational Conflict(s) of Interest (OCis): VA-18-0298 and 18-0299-B-000612 Ha, Richard From: Sent: To: Cc: Subject: Attachments: Bruce Moskowitz <(b) (6) @mac.com> Tuesday, March 13, 2018 2:59 PM Blackburn, Scott R. (DISABLED ACCT); Truex, Matthew; Windom, John H. DJS; IP; (b) (6) @gmail.com [EXTERNAL] NDA.pdf NDA.pdf - Sent from my iPad Bruce Moskowitz M.D. 1 VA-18-0298 and 18-0299-B-000613 NON-DISCLOSURE AGREEMENT (Dated March 13, 2018) 1. I acknowledge that I have been selected to participate in the planning/or an electronic health record acquisition. In the course of participating in this acquisition, I may be or have been given access to or entrusted with Source Selection Information (as defined in Federal Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1) that I cannot release to others nor can I use for the financial benefit of others or myself. Source Selection Information is defined in FAR2.101 & 3.104 and other sensitive Government data includes data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1 ). Data includes all data, information and software, regardless of the medium (e.g. electronic or paper) and/or format in which the d,ata exists, and includes data which is derived from, based on, incorporates, includes or refers to such Source Selection and/or proprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates, includes or refers to data shall be treated as Source Selection, or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. \ 2. I understand that 41 U.S.C. ? 423, commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101-2107, and provisions FAR 3.104 govern the release of proprietary and source ~election information . As it relates to the information that has been made available to me pursuant to this Non-Disclosure Agreement, I certify that I will not disclose any contractor'bid, solicitation, proprietary, or Source Selection Information directly or indirectly to any persor\. other than the President of the United States or a member of his administration to whom the President authorizes, another person subject to an equally restrictive Non-Disclosure Agreement related to the subject matter of this Agreement, the Secretary of the Department of Veterans Affairs or a person authorized by the head of agency or the contracting officer to receive such "information. I understand that unauthorized disclosure of such information may subject me to substantial administrative, civil and criminal penalties, including fines, imprisonment, and loss of employment under the Procurement Integrity Act or other applicable laws and regulations. 3. I certify that I will n6t discuss evaluation of source selection matters with any unauthorized individuals (including Qover~ment personnel other than those set out in Paragraph 2 above), even after contract award, without specific prior approval from proper authority. 4. These provisions are1consistent with, and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection. The definitions, requirements, obligations, rights, sanctions, and liabilities 'created by controlling Executive orders and statutory provisions are incorporated into this agreement and are controlling. These statutes and Executive orders include the following: VA-18-0298 and 18-0299-B-000614 NON-DISCLOSURE AGREEMENT Planningfor an electronichealth record acquisition Dated TuesdayMarch 13, 2018 Pagel2 !:Executive OrderNo. 12958; OI'he PrivacyAct (5 U.S.C. ? 552a); OI'he Trade SecretsAct (18 U.S.C. ? 1905); [:aection 7211 of title 5, United States Code (governingdisclosuresto Congress); [:aection 1034 of title 10, United StatesCode, as amendedby the Military Whlstleblower ProtectionAct (governingdisclosureto Congressby membersof the military); !:Section 2302(b)(8) of title 5, United States Code, as amendedby the w.histleblower ProtectionAction (governingdisclosuresof illegality,waste, :fraud,abus~ or public health or saretytbreats); . : I Ofhe IntelligenceIdentitiesProtectionAct of 1982(50 U.S.C. ? 421 et seq.) (governing disclosuresthat could expose confidentialGovernmentagents);and [Jfhe statuteswhich protect against disclosurethat may compromisethe national security, includingsections641, 793, 794, 798, and 952 of title 18, United States Code, and section 4(b) of the Subversive~tivities Act of 1950 (50 U.S.C. ? 783(b)). Additionally,pursuanttq38 Code of FederalRegulations1.201, all VA employeeswith . knowledgeor informationabout actual or possibleviolationsof criminal law relatedto VA programs,operations,facilities,contracts,or informationtechnologysystems shallimmediately report such knowledgeorinformationto their supervisor,any managementofficial,or directlyto the Office of InspectorGeneral. (b) (6) Name Printed: RUCE MQSKQW\TZ, M.D. 411N.FLAGER OR., #7100 EST PALM B_EACH, FL33401 6(~c.-e.H.os.~ow, -r2-,YLD OrganizationalConflict(s)oflnterest (OCis): .... VA-18-0298 and 18-0299-B-000615 Ha, Richard From: Sent: To: Cc: Subject: Attachments: - Marc Sherman <(b) (6) @gmail.com> Tuesday, March 13, 2018 1:40 PM Blackburn, Scott R. (DISABLED ACCT) IP; (b) (6) @gmail.com; Bruce Moskowitz; Truex, Matthew; Windom, John H.; DJS [EXTERNAL] Re: VA EHR NDA EHR NDA v2.pdf; EHR NDA v2 mbs.pdf; EHR NDA v2 RL.pdf - Scott, Matt and John Thank you for the NDA draft that you sent along and the organized approach. I have attached the following to close the loop: 1. a marked up version of the NDA with a few necessary adjustments in red-line so you can see the changes that were made, 2. a blank copy of the amended NDA for Bruce and Ike to sign, and 3. a signed version by me of the amended NDA. Thanks and happy to help as requested. Marc On Tue, Mar 13, 2018 at 10:31 AM, Blackburn, Scott R. wrote: Ike, Bruce, Marc: Thank each of you for agreeing to lend an extra set of outside eyes on the EHR contract. We appreciate your support and want to make sure we get to the best place possible for Veterans, the country and taxpayers. As we are incredibly grateful to you for volunteering your time, we want to make this as easy as possible for you. Here are 3 next steps. 1) We will need you to sign the attached NDA. Please return to Matt Truex (cc'd). 2) Matt will then send you the latest package under separate cover. 3) Given government contracts are different than what you are used to reading, we would propose a quick phone call so that we can orient you to the contract and help focus you on the parts where your expertise will be most valuable. Matt Truex (who is the government contracting officer) and John Windom (who is our EHR leader) will lead this from our side. I will ask Liz Callaghan (cc'd) here to help set up a time. We can either do this all together, if calendars match up, or separately if need be. We have also connected with Stephanie Reel, Stan Huff, Dr. Karson, Dr. Ko, Dr. Shretha, and Jon Manis who all have all received the NDA and we are working with them. I am hoping to connect with Dr. Cooper today. 1 VA-18-0298 and 18-0299-B-000616 Thanks again! Scott Scott Blackburn Acting CIO & Executive-in-Charge, Office of Information & Technology Department of Veterans Affairs 2 VA-18-0298 and 18-0299-B-000617 NON-DISCLOSURE AGREEMENT (Dated March 13, 2018) 1. I acknowledge that I have been selected to participate in the planning for an electronic health record acquisition. In the course of participating in this acquisition, I may be or have been given access to or entrusted with Source Selection Information (as defined in Federal Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked or considered as "proprietary" (e.g., restrictive legend per FAR 52.215-1) that I cannot release to others nor can I use for the financial benefit of others or myself. Source Selection Information is defined in FAR 2.101 & 3.104 and other sensitive Government data includes data marked or considered as "proprietary" (e.g., restrictive legend per FAR 52.215-1). Data includes all data, information and software, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is derived from, based on, incorporates, includes or refers to such Source Selection and/or proprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates, includes or refers to data shall be treated as Source Selection, or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. 2. I understand that 41 U.S.C. ? 423, commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101-2107, and provisions FAR 3.104 govern the release of proprietary and source selection information . As it relates to the information that has been made available to me pursuant to this Non-Disclosure Agreement, I certify that I will not disclose any contractor bid, solicitation, proprietary, or source Source selection Selection information Information directly or indirectly to any person other than the President of the United States or a member of his administration to whom the President authorizes, another person subject to an equally restrictive Non-Disclosure Agreement related to the subject matter of this Agreement, the Secretary of the Department of Veterans Affairs or a person authorized by the head of agency or the contracting officer to receive such information. I understand that unauthorized disclosure of such information may subject me to substantial administrative, civil and criminal penalties, including fines, imprisonment, and loss of employment under the Procurement Integrity Act or other applicable laws and regulations. 3. I certify that I will not discuss evaluation of source selection matters with any unauthorized individuals (including Government personnel other than those set out in Paragraph 2 above), even after contract award, without specific prior approval from proper authority. 4. These provisions are consistent with, and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection. The definitions, requirements, obligations, rights, sanctions, and liabilities created by controlling Executive orders and statutory provisions are incorporated into this agreement and are controlling. These statutes and Executive orders include the following: ?Executive Order No. 12958; ?The Privacy Act (5 U.S.C. ? 552a); ?The Trade Secrets Act (18 U.S.C. ? 1905); ?Section 7211 of title 5, United States Code (governing disclosures to Congress); ?Section 1034 of title 10, United States Code, as amended by the Military Whistleblower Protection Act (governing disclosure to Congress by members of the military); and 18-0299-B-000618 ?Section 2302(b)(8) of title 5, United States Code, as amended byVA-18-0298 the Whistleblower NON-DISCLOSURE AGREEMENT Planning for an electronic health record acquisition Dated Tuesday March 13, 2018 Page |2 Protection Action (governing disclosures of illegality, waste, fraud, abuse or public health or safety threats); ?The Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosures that could expose confidential Government agents); and ?The statutes which protect against disclosure that may compromise the national security, including sections 641, 793, 794, 798, and 952 of title 18, United States Code, and section 4(b) of the Subversive Activities Act of 1950 (50 U.S.C. ? 783(b)). Additionally, pursuant to 38 Code of Federal Regulations 1.201, all VA employees with knowledge or information about actual or possible violations of criminal law related to VA programs, operations, facilities, contracts, or information technology systems shall immediately report such knowledge or information to their supervisor, any management official, or directly to the Office of Inspector General. Signature: Name Printed: Title: Organization: Organizational Conflict(s) of Interest (OCIs): VA-18-0298 and 18-0299-B-000619 NON-DISCLOSURE AGREEMENT (Dated March 13, 2018) 1. I acknowledge that I have been selected to participate in the planning for an electronic health record acquisition. In the course of participating in this acquisition, I may be or have been given access to or entrusted with Source Selection Information (as defined in Federal Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1) that I cannot release to others nor can I use for the financial benefit of others or myself. Source Selection Information is defined in FAR 2.101 & 3.104 and other sensitive Government data includes data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1). Data includes all data, information and software, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is derived from, based on, incorporates, includes or refers to such Source Selection and/or proprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates, includes or refers to data shall be treated as Source Selection, or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. 2. I understand that 41 U.S.C. ? 423, commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101-2107, and provisions FAR 3.104 govern the release of proprietary and source selection information . As it relates to the information that has been made available to me pursuant to this Non-Disclosure Agreement, I certify that I will not disclose any contractor bid, solicitation, proprietary, or Source Selection Information directly or indirectly to any person other than the President of the United States or a member of his administration to whom the President authorizes, another person subject to an equally restrictive Non-Disclosure Agreement related to the subject matter of this Agreement, the Secretary of the Department of Veterans Affairs or a person authorized by the head of agency or the contracting officer to receive such information. I understand that unauthorized disclosure of such information may subject me to substantial administrative, civil and criminal penalties, including fines, imprisonment, and loss of employment under the Procurement Integrity Act or other applicable laws and regulations. 3. I certify that I will not discuss evaluation of source selection matters with any unauthorized individuals (including Government personnel other than those set out in Paragraph 2 above), even after contract award, without specific prior approval from proper authority. 4. These provisions are consistent with, and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection. The definitions, requirements, obligations, rights, sanctions, and liabilities created by controlling Executive orders and statutory provisions are incorporated into this agreement and are controlling. These statutes and Executive orders include the following: VA-18-0298 and 18-0299-B-000620 NON-DISCLOSURE AGREEMENT Planning for an electronic health record acquisition Dated Tuesday March 13, 2018 Page |2 ___________________________________________ ?Executive Order No. 12958; ?The Privacy Act (5 U.S.C. ? 552a); ?The Trade Secrets Act (18 U.S.C. ? 1905); ?Section 7211 of title 5, United States Code (governing disclosures to Congress); ?Section 1034 of title 10, United States Code, as amended by the Military Whistleblower Protection Act (governing disclosure to Congress by members of the military); ?Section 2302(b)(8) of title 5, United States Code, as amended by the Whistleblower Protection Action (governing disclosures of illegality, waste, fraud, abuse or public health or safety threats); ?The Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosures that could expose confidential Government agents); and ?The statutes which protect against disclosure that may compromise the national security, including sections 641, 793, 794, 798, and 952 of title 18, United States Code, and section 4(b) of the Subversive Activities Act of 1950 (50 U.S.C. ? 783(b)). Additionally, pursuant to 38 Code of Federal Regulations 1.201, all VA employees with knowledge or information about actual or possible violations of criminal law related to VA programs, operations, facilities, contracts, or information technology systems shall immediately report such knowledge or information to their supervisor, any management official, or directly to the Office of Inspector General. Signature: Name Printed: Organizational Conflict(s) of Interest (OCIs): VA-18-0298 and 18-0299-B-000621 NON-DISCLOSURE AGREEMENT (Dated March 13, 2018) 1. I acknowledge that I have been selected to participate in the planning for an electronic health record acquisition. In the course of participating in this acquisition, I may be or have been given access to or entrusted with Source Selection Information (as defined in Federal Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1) that I cannot release to others nor can I use for the financial benefit of others or myself. Source Selection Information is defined in FAR 2.101 & 3.104 and other sensitive Government data includes data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1). Data includes all data, information and software, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is derived from, based on, incorporates, includes or refers to such Source Selection and/or proprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates, includes or refers to data shall be treated as Source Selection, or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. 2. I understand that 41 U.S.C. ? 423, commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101-2107, and provisions FAR 3.104 govern the release of proprietary and source selection information . As it relates to the information that has been made available to me pursuant to this Non-Disclosure Agreement, I certify that I will not disclose any contractor bid, solicitation, proprietary, or Source Selection Information directly or indirectly to any person other than the President of the United States or a member of his administration to whom the President authorizes, another person subject to an equally restrictive Non-Disclosure Agreement related to the subject matter of this Agreement, the Secretary of the Department of Veterans Affairs or a person authorized by the head of agency or the contracting officer to receive such information. I understand that unauthorized disclosure of such information may subject me to substantial administrative, civil and criminal penalties, including fines, imprisonment, and loss of employment under the Procurement Integrity Act or other applicable laws and regulations. 3. I certify that I will not discuss evaluation of source selection matters with any unauthorized individuals (including Government personnel other than those set out in Paragraph 2 above), even after contract award, without specific prior approval from proper authority. 4. These provisions are consistent with, and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection. The definitions, requirements, obligations, rights, sanctions, and liabilities created by controlling Executive orders and statutory provisions are incorporated into this agreement and are controlling. These statutes and Executive orders include the following: VA-18-0298 and 18-0299-B-000622 NON-DISCLOSURE AGREEMENT Planning for an electronic health record acquisition Dated Tuesday March 13, 2018 Page |2 ___________________________________________ ?Executive Order No. 12958; ?The Privacy Act (5 U.S.C. ? 552a); ?The Trade Secrets Act (18 U.S.C. ? 1905); ?Section 7211 of title 5, United States Code (governing disclosures to Congress); ?Section 1034 of title 10, United States Code, as amended by the Military Whistleblower Protection Act (governing disclosure to Congress by members of the military); ?Section 2302(b)(8) of title 5, United States Code, as amended by the Whistleblower Protection Action (governing disclosures of illegality, waste, fraud, abuse or public health or safety threats); ?The Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosures that could expose confidential Government agents); and ?The statutes which protect against disclosure that may compromise the national security, including sections 641, 793, 794, 798, and 952 of title 18, United States Code, and section 4(b) of the Subversive Activities Act of 1950 (50 U.S.C. ? 783(b)). Additionally, pursuant to 38 Code of Federal Regulations 1.201, all VA employees with knowledge or information about actual or possible violations of criminal law related to VA programs, operations, facilities, contracts, or information technology systems shall immediately report such knowledge or information to their supervisor, any management official, or directly to the Office of Inspector General. Signature: (b) (6) Name Printed: Marc Sherman Organizational Conflict(s) of Interest (OCIs): VA-18-0298 and 18-0299-B-000623 Ha, Richard From: Sent: To: Subject: Attachments: - I noticed (b) (6) Mitre. Sandoval, Camilo J. Friday, June 22, 2018 8:00 AM O'Rourke, Peter M. RE: Update_Important Request External Reviewers.xlsx is not on this list, yet he had access to sensitive acquisition information even before being a sub for From: Truex, Matthew Sent: Tuesday, June 19, 2018 9:48 AM To: Windom, John H.; Foster, Michele (SES); (b) (6) Cc: Sandoval, Camilo J.; Morris, Genevieve (OS/ONC/IO) (Genevieve.Morris@hhs.gov); Zenooz, Ashwini; Short, John (VACO); (b) (6) . (COLONEL) Subject: RE: Update_Important Request John - Updated to include organization/affiliation. Thanks, Matt Matthew Truex Contracting Officer Department of Veterans Affairs Office of Procurement, Acquisition and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724 Office: 732-440-9650 Mobile: 732-320-1968 e-mail: matthew.truex@va.gov "For Internal VA Use Only - Working Draft, Pre-Decisional, Deliberative Document: This e-mail and any attachments are intended only for the use of the addressee(s) named herein and may contain privileged and/or confidential information. If you are not the intended recipient of this e-mail, you are hereby notified that any dissemination, distribution or copying of this e-mail, and any attachments thereto, is strictly prohibited. If you have received this e-mail in error, please notify me via return e-mail or telephone (732) 440-9650, and permanently delete the original and any copy of any e-mail and any printout thereof." From: Windom, John H. Sent: Monday, June 18, 2018 5:00 PM To: Truex, Matthew; Foster, Michele (SES); (b) (6) Cc: Sandoval, Camilo J.; Morris, Genevieve (OS/ONC/IO) (Genevieve.Morris@hhs.gov); Zenooz, Ashwini; Short, John (VACO); (b) (6) . (COLONEL) Subject: RE: Update_Important Request 1 VA-18-0298 and 18-0299-B-000624 Matt, Please add their organization for clarity. Vr John John H. Windom, Senior Executive Service (SES) Program Executive for Electronic Health Record Modernization (PEO EHRM) 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 John.Windom@va.gov Office: (202) 461-5820 Mobile: (202) 794-4911 Executive Assistant: Ms. (b) (6) - Appointments and Scheduling (b) (6) @va.gov Office: 202-382-(b) (6) -- -- From: Truex, Matthew Sent: Monday, June 18, 2018 4:07 PM To: Windom, John H.; Foster, Michele (SES); (b) (6) Cc: Sandoval, Camilo J.; Morris, Genevieve (OS/ONC/IO) (Genevieve.Morris@hhs.gov); Zenooz, Ashwini; Short, John (VACO); (b) (6) . (COLONEL) Subject: RE: Update_Important Request John, As requested, provided is a listing of non-VA employees (at that time) who were involved in the various external reviews during the EHRM acquisition phase. Listing was generated based on the numerous MITRE led reviews and White House review(s). Thanks, Matt Matthew Truex Contracting Officer Department of Veterans Affairs Office of Procurement, Acquisition and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724 Office: 732-440-9650 Mobile: 732-320-1968 e-mail: matthew.truex@va.gov "For Internal VA Use Only - Working Draft, Pre-Decisional, Deliberative Document: This e-mail and any attachments are intended only for the use of the addressee(s) named herein and may contain privileged and/or confidential information. If you are not the intended recipient of this e-mail, you are hereby notified that any dissemination, distribution or copying of 2 VA-18-0298 and 18-0299-B-000625 this e-mail, and any attachments thereto, is strictly prohibited. If you have received this e-mail in error, please notify me via return e-mail or telephone (732) 440-9650, and permanently delete the original and any copy of any e-mail and any printout thereof." From: Windom, John H. Sent: Saturday, June 16, 2018 1:43 AM To: Truex, Matthew; Foster, Michele (SES); (b) (6) Cc: Sandoval, Camilo J.; Morris, Genevieve (OS/ONC/IO) (Genevieve.Morris@hhs.gov); Zenooz, Ashwini; Short, John (VACO); (b) (6) . (COLONEL) Subject: Update_Important Request Michele and TAC Team: This request comes directly from the Acting Secretary in support of hearing preps. Please provide a list of names of the non-VA employees (supporting various external reviews) that have signed NDAs to review our EHRM acquisition/program documents in advance of contract award (May 17, 2018). Thank you, John John H. Windom, Senior Executive Service (SES) Program Executive for Electronic Health Record Modernization (PEO EHRM) 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 John.Windom@va.gov Office: (202) 461-5820 Mobile: (202) 794-4911 Executive Assistant: Ms. (b) (6) - Appointments and Scheduling (b) (6) @va.gov Office: 202-382-(b) (6) -- 3 VA-18-0298 and 18-0299-B-000626 LAST FIRST (b) (6) (b) (6) Morris Moskowitz Genevieve Bruce Perlmutter Ike (b) (6) (b) (6) Sherman (b) (6) Marc Organization/Affiliation US Army/DHA CareJourney Indiana Health Information Exchange Mitre Mitre The Mayo Clinic Mitre Mayo Clinic Geisinger Kaiser Permanente Ascention Health Kaiser Permanente Mitre Lahey Health Leavitt Parners, LLC DHA/DHMS Intermountain Healthcare US Navy/SPAWAR Massachusetts General Hospital Mitre Collective Medical Technologies, Inc. University of California, Los Angeles/American College of Surgeons Harvard Medical School/Boston's Children Hospital Sutter Health Massachusetts General Hospital/Partners Healthcare System Office of the National Coordinatorfor Health Information Technology (ONC) Internist/External Expert Participant Universal Health Services American College of Surgeons University of Washington Medical Center CEO Marvel Entertainment Intermountain Healthcare Johns Hopkins University Mitre Mitre Johns Hopkins University The Mayo Clinic Mitre Mitre Mitre Alvarez & Marsal University of Pittsburgh Medical Center The Healthcare Information and Management Systems Society US Air Force University of Washington Mitre Mitre Mitre HealthSouth VA-18-0298 and 18-0299-B-000627 From: To: Cc: Bcc: Subject: Date: Attachments: Bruce Moskowitz <(b) (6) @mac.com> O'Rourke, Peter M. [EXTERNAL] VA Undersecretary Mon Jul 16 2018 08:46:40 CDT - I suggested Dr. (b) (6) emails you directly to make sure his application is received. Thank you Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000628 Page 1 of 2 From: O'Rourke, Peter M. (b) (6) M.D. <(b) (6) @mayo.edu> To: Cc: Bcc: Subject: Date: Attachments: RE: [EXTERNAL] VA Undersecretary Mon Jul 16 2018 08:59:57 CDT Thank you. - Dr. (b) (6) I look forward to hearing from you. Pete Peter O'Rourke Acting Secretary Department of Veterans Affairs -----Original Message----From: Bruce Moskowitz [mailto:(b) (6) Sent: Monday, July 16, 2018 9:47 AM To: O'Rourke, Peter M. Cc: (b) (6) M.D. Subject: [EXTERNAL] VA Undersecretary - I suggested Dr. (b) (6) @mac.com] emails you directly to make sure his application is received. Thank you Sent from my iPad Bruce Moskowitz M.D. VA-18-0298 and 18-0299-B-000629 Page 2 of 2 VAi U.S.Department ofVeterans Affairs r, CEIVE ~ u .\ MAR 12 201 ; IY~~--== Daniel McGrath American Oversight 1030 sth Street , NW Suite B255 Washington , DC 20005 Re: Freedom of Information Act Tracking Number 18-07440-F Dear Mr. McGrath, This is an interim response to your Freedom of Information Act (FOIA) request to the Department of Veterans Affairs (VA) dated May 8, 2018 , in which you requested all records reflecting communications (including emails , email attachments , text messages , messages on messaging platforms (such as Slack , GChat or Google Hangouts, Lyne, Skype, or WhatsApp) , telephone call logs, calendar entries/invitations , meeting notices, meeting agendas , informational material , draft legislation, talking points, any handwritten or electronic notes taken during any oral communications , summaries of any oral communications, or other materials) between 1) the Office of the Secretary, the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer , or the Electronic Health Records Modernization (EHRM) Program Executive Office and 2) Isaac "Ike" Perlmutter , Bruce Moskowitz, or Jared Kushner". On May 8 , 2018 you amended your request to read as follows: All records reflecting communications (including emails , email attachments, text messages, messages on messaging platforms (such as Slack, GChat or Google Hangouts, Lyne, Skype , or WhatsApp) , telephone call logs, calendar entries/invitations , meeting notices, meeting agendas , informational material, draft legislation , talking points, any handwritten or electronic notes taken dur ing any oral communications, summaries of any oral communications , or other materials) between 1) political appointees and Senior Executive Service (SES) employees within the Office of the Secretary , the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer and, the Electronic Health Records Modernization (EHRM) Program Executive Office and 2) Isaac "Ike" Perlmutter , Bruce Moskowitz , or Jared Kushner. On May 17, 2018 , you agreed to aggregate two of your request as follows: All emails , text messages and messages on messaging platforms (such as Slack , GChat or Google Hangouts , Lyne, Skype, or WhatsApp) of political appointees3 and Senior Executive Service (SES) employees within 1) the Office of the Secretary , 2) the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer and, 3) the Electronic Health Records Modernization (EHRM) Program Executive Office that contain any of the following terms: ' ., = FOIA Request 18-07440-F McGrath Page 2 a. b. c. d. e. f. g. h. i. j. k. I. m. n. o. o Moskowitz; Perlmutter; Ike; "Trump's friend"; "Trump's Doctor"; "POTUS friend"; "POTUS's friend"; "POTUS' friend"; "POTUS doctor"; "POTUS's doctor"; "POTUS' doctor"; "President's friend"; "friend of POTUS"; "friend of President"; or "friend of the President". All records reflecting communications (including emails, email attachments, text messages, messages on messaging platforms (such as Slack, GChat or Google Hangouts, Lyne, Skype, or WhatsApp), telephone call logs, calendar entries/invitations, meeting notices, meeting agendas, informational material, draft legislation, talking points, any handwritten or electronic notes taken during any oral communications, summaries of any oral communications, or other materials) between 1) political appointees and Senior Executive Service (SES) employees within the Office of the Secretary, the Office of the Assistant Secretary for Information and Technology and the Chief Information Officer and, the Electronic Health Records Modernization (EHRM) Program Executive Office and 2) Isaac "Ike" Perlmutter, Bruce Moskowitz, or Jared Kushner. Please provide all responsive records from May 15, 2017, to the date of the search. The FOIA Service received your request on May 7, 2018, and assigned it FOIA tracking number 18-07440-F. Please refer to this number when communicating with the VA about this request. A thorough partial review of records has been conducted and this resulted in the attached responsive records being provided that includes two hundred and twenty (220) pages that specifically addresses your request for information. We are withholding information pursuant to FOIA exemption 5, [5 U.S.C. ? 552 {b)(5)], which protects from disclosure all inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency. FOIA Request 18-07440-F (McGrath) Page 3 FOIA exemption 6 permits an Agency to withhold from disclosure personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. The information withheld, such as names, are of a type that the privacy interest of the individual(s) to whom this information belongs outweighs any public interest in disclosure of this information. We are still reviewing documents and will continue to make releases on a rolling basis until all responsive documents have been reviewed and released. We appreciate your interest in the Department of Veterans Affairs. If you have any questions concerning this letter, you may contact Ms. Jacqueline Short of my staff at (202) 632-7426. Sincerely, f;- !Lr; w~ Ji:. Doloras Johnson Director, VACO FOIA Service Quality, Performance, and Risk (QPR) Office of Information and Technology (OIT) Enclosed From : To : Subject : Dat e: Bruce Moskowitz Blackburn ScottB [EXTERNAL]EMRcalls Wednesday, March 14, 2018 12:22:35 PM To save time can you tell me if the Cerner contract has a provis ion to have the EMR that is in Intensive care units interact with a central monitoring system? Currently all major institutions have a command and control center staff that monitors intensive care units located in different hospitals in their system. The future is expanding this to monitor emergency rooms, recovery rooms and telemetry beds. If it is not in place which should be a standard part of the contract we will have billions in further costs to the system. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298-C, VA-18-0299-C-000001 1 of 220 From : To : Bruce Moskowitz Cc: WindomJohnH : BlackburnScott8 .If;l(b )(6) k@gma il com Subject: Date: Thursday, March 15, 20 18 10 :52:11 AM [EXTERNAL] EMR documents I still have not received the EMR documents to review. You have my NDA. Please send ASAP. I am a reasonable speed reader so you can include all pages. Sent from my iPad Bruce Moskow itz M.D. VA-18-0298-C, VA-18-0299-C-000002 2 of 220 From : To : Cc: Subject: Date: Bruce Moskowitz Blf_?_fiburni~~~ !(b __ JI com [EXTERNAL] Follow up meet ing Friday, Novembe r 24., 20 17 7:08 :50 PM I am speaking for myself and it would seem to me that holding it at Cerner would restrain an open honest discussion of what is needed to insure that we have all the key pieces to have the the EMR that we all see as a necessity to provide the end users with all tools necessary to provide quality care. The five CIO 's are very knowledgeable regarding all capabilities of Cerner. I have been an end user of Cerner and know as do the CEO' s the process to quickly move the agenda forward. We are committed to your adoption of Cerner as the EMR however being rushed into a contract without due diligence on our part would be problematic. We can be available for a meeting in Washing ton ASAP fully realizing some will need to be on a conference call. I would recomme nd an agenda that reflects the way forward by both groups and would recommend you allow Stephanie Reel,Andrew Karson and Marc Sherman to assist in the agenda development. Sent from my iPad Bruce Moskowitz M.D. VA-18-0298-C, VA-18-0299-C-000003 3 of 220 From: To : Subject : Date: David Shulkin Blackburn ScottB [EXTERNAL] Fwd : Call with Secretary Shulkin Sunday, March 11, 2018 5:55:30 PM Can you join me at morning report in the am- 8 or 815 am to discuss next step s on thi s Note the emai ls below Sent from my iPhon e Begin forwarded message: From: Bruce Mo skowit z Date: March 11, 2018 at 12:57:53 PM EDT To: Ste hani e Re el ~h u.edu> , ,.... (b-)(-6)-....._ (b)(6) facs .org" b 6 fa.cs.or >, sutterhea lth.or , 1(b)(6)@ (b)(6) ma o.ed u, "Karson, Andrew Scott, M. D. " 1(b)(6) [g")mgbbarvard.edu> Cc: David Shulkin 1.:.: (b~ )(,=.,6 ):....__~ ~ .......=~.>, IP (R)@ frencban~s9:com>, l(b)(6) l@gmail.com (b)(6) ,l(b)(6) ~~p.com Subject: Call with Secre ary The Secretary w ill send out an emai l to set up a conference ca ll to discu ss the review of the EMR contra ct for the VA. This has tremendou s importan ce not ju st for the VA, but setting a standard for interop erability for the nation and also EMR innovation. I want to take the opportunity to thank everyone for their service to the Veteran s and advancing health care for the nation Sent from my iPhone VA-18-0298-C, VA-18-0299-C-000004 4 of 220 From : David Shulkin To : BlackburnScottB Subject : Date: [EXTERNAL] Fwd : Contact review Monday, March 12, 20 18 4: 19:03 PM Can we get them the nda as well? Sent from my iPhone Begin forwarded message: From: IP ~ @frenchangel59.com> Date: Mar~12 , 2018 at 2:50 :52 PM EDT To: David Shulkin 1(b)(6) @gmai).~ Cc: (b)(S) . " i (b)(6 ) mail.c m" 1(b)(6) b 6 mac .com> Subject : RE: Contact review (b)(6) _~...J!lailcom>, @gma il.com>, Bruce Mo skowitz David, How quick can you send the NDA to the people ? And why not send it to Bruce, Marc and myself so we can work around the clock to fini sh this? Thank you. l@mac.com] om> o-mail.com; mail.com Subject: Re: Cont act review The follo wing may be discussed on the review however if not, we need to be sure there is a platform for the plann ed device registry. Separately there needs to be the ability to insert a mental health tracker, nutriti onal tracker and wellness tracker. We do not want to find out there is add on charges for these essential elements of the EMR. It also needs to be worked out how mental health records, treatments and appointm ents do not fall through the cracks during this lengthy implementation . The head of Columbi a Psychiatry will Dr. Lieberman can assist with this aspect. Thank you. Sent from my iPad Bruce Moskowit z M.D. VA-18-0298-C, VA-18-0299-C-000005 5 of 220 From : David Shulkin To : BlackburnScottB Subject : Date: Tuesday, March 06, 2018 7: 10 :27 AM [EXTERNA L] Fwd: EMR Can we begin to address and then ill respond back? Sent from my iPhone Begin forward ed message: From: Bruce Mo skowit z ~(b)(G) Date: March 5. 2018 at 6:49:58 AM EST =~ To:l(b)(G) @gmail.com1(b) (6l Cc:l(b)(6) ~~ail.com, IP lb )(@french l(b)(6) @gmail.c _m l@mac.com> ~~ ~ >, Subject : EMR I would like to underscore the importanc e of getting the "Cloud"conec tly and the other four issues with the new CIO ' s. Also the compos ition of the phy sician input has to change immediately so that the EMR is patient centric and usable from the physician perspective . Second this is going to take years to implement and espec ially in mental health we need a portabl e EMR solution that works with the DOD , the VA and the private sector. No one at the VA got back to me on what the Apple proj ect can and can not do in terms of solving this probl em. Sent from my iPad Bruce Moskowitz M.D . VA-18-0298-C, VA-18-0299-C-000006 6 of 220 From : Bruce Moskowitz To : Cc: BlackburnScottB (b_)(_6_) ___ MarcSherman: WindomJohnH :l._ Subj ect : Date: [EXTERNAL] Re: Dr. Cooo per - Cloud expertise __, Mond ay, March 19, 20 18 6:00:02 PM Perfect Sent from my iPad Bruce Moskow itz M.D . On Mar 19 , 2018, at 2 :45 PM, Bl ackbum , Scott R. wrote: FYI. Dr. Cooper's time tomorrow night is limited (he wi ll be in between flights). Given he is a "sing le issue" guy; we are going to start the call at 7:30 and cover the Cloud issue from 7:30-8pm ET before everyone else jo ins at 8pm ET. I think we will have everyone except Stan Huff and Dr. Ko on the call l(b)(6js working a time on Wednesday to get them on a call. Scott From: Blackburn, Scott R. Sent: Monday, March 19, 2018 2:40 PM To :!rhHn\ ~ ~~~per LeslieT., M.D. Cc: Windom, John H.; IC ) l Short , John (VACO) Subject: RE: [EXTERNAL] VA EHR Call Update Thank you, Dr. Cooper. Dr. Moskow it z mentioned very specifica lly to me t hat we shou ld get your perspective on cloud so that we know we have that part correct. I am thinking we cover that issue from 7 :30-8pm ET before others join at 8pm. Thank you again for the suppor t. Scott I From :l(b)(6) Sent: Monday, March 19, 2018 1 :38 PM To: Cooper, Leslie T., M.D. Cc: Blackburn, Scott R.; Windom , John H.;._l (b_)(_6)___ Subject: RE: [EXTERNAL] VA EHR Call Update _. Dr. Cooper, thank you for your response. I have sent two out look invites, one star ti ng at 7:30PM ESTfor you to participate in as wel l as the 8PM ESTwith the group. Please let me know if you have any questions. Thanks, ~ From: Cooper, Leslie T., M.D. ~~ (b_)(_6 )____ ~ rv mayo.edu] VA-18-0298-C, VA-18-0299-C-000007 7 of 220 From : To: Blackburn ScottR. Bruce Moskowitz Subj ect: Date: Saturday, March 17, 20 18 8:4 1 :04 AM [EXTERNAL] Re: EHR Call Update as of 8PM Will assist if needed Sent from my iPad Bruc e Moskowitz M.D. On Mar 16, 20 18, at 9:44 PM , Blackb urn, Sco tt R. wrote : Bruce - I just wanted to give you a heads up. We m ight need your help to po litely nudge a few fo lks. I'll send each a personal not e in t he morning t o check in and make sure they have everyth ing t hey (and understa nd the sense of urgency). If I don't have any luck, I'll let you know. I agree w ith you r q uicksand analogy. Politica lly we expect Congress to pass a budget (omn ibus) on March 23. Cerner has stro ng incent ive to sign Ma rch 31 o r ear lier (end of the ir f inancial quarte r). So as long as don't f ind any major showstoppers, I bel ieve we have a nice 2 week wi ndow to close this (and the n get the hard work started). Thanks again for all your support. At McKinsey we used to use t he term "demanding partner". You've been a great demand ing partner to make sure we get this right. Scott From: fo ) (6 ) Sent: Friday, March 16, 2018 8 :01 PM To : Blackburn, Scott R. Subject : EHR Call Update as of 8PM Good evening M r. Blackburn, As of 8PM I have received responses fro m a few mo re fo lks, t he "x" indicates t hey are available. Moskow itz Sunday Monday Tuesday X X X Perlmutter Sherm an X Reel X Huff Rasu X Man is Ko confirmed for Monday at 2 PM contract overv iew Coope r X Karson Windom Blackburn l(b)(6) I X X X X X X X X X VA-18-0298-C, VA-18-0299-C-000008 8 of 220 From: Marc Sherman To : Blackburn ScottB : BruceMoskow itz Subject : Date: [EXTERNAL] Re: FW: VA EHRCall Monday, March 19, 20 18 8:21 :56 AM Scott In response to your question, I will be on the call at noon today. Marc Marc Sherman l{b)(6) On Mar 18, 2018 3:11 PM, "Blackburn, Scott R. " wrote: Bruce/Marc - I hope yo u are both having a gre at wee kend. We have a call schedu led from noon-12: 45 tomo rrow. The inte nt of th is was to have our contr act ing guys (John W indom , l(b)(6) ~ wa lk yo u t hro ugh how t o read the gove rn men t contra ct (whic h is obvio usly very differen t from t ypica l pr ivat e sect or cont racts). I just w ant to make sur e you are clear on the purpose of th is call and check to ma ke sure yo u still want to do th is. We did this with each of t he ClOs/Docto rs last wee k. Scott i=rorn:l(b )(6) Sent: Sunday, March 18, 2018 2:36 PM To: Blackburn, Scott R. Subject: RE: VA EHR Call M r. Blackburn, I had scheduled this call w it h Dr. Bruce and Marc Sherman for the contract 6 > ove rview. Do you want to keep it or can I cance l it? Thanks JC b>< I -----Or iginal Appointment--- -From: VAC IO Executive Schedule Sent: Thursday, March 15, 2018 11 :23 AM To : VAC IO Executive Schedule;lrb){6) Blackburn, Scott R.; Windom, John H.; l(b)fu6) ~Bruce Moskowitz,MD; Marc Sherman; Bruce Moskowitz Su ject: VA EHR Call When: Mondar March 19, 2018 12:00 PM-12:45 PM (UTC-05:00) Eastern Time (US & Canada). Where :l(b)(6 t I VA-18-0298-C, VA-18-0299-C-000009 9 of 220 From: Marc Sherman To : Cc: BlackburnScott 1 Subj ect : Date: Yes, that works for me. Marc Sherman l(b)(6) On Mar 18, 2018 12:28 PM, "Blackbum , Scott R." wrote: Bruce/Marc - it is looking like Tuesday 8pm ET is going to work best for our CIOs/Doctors. We will have at least 4 people confim1ed (Manis, Reel, Shretha and Karson ; likely Stan Huff as well which would make 5). Dr. Cooper I know is a single issue SME so we can probably do that one separately. Dr. Ko has a tough schedu le all this week. Would Tuesday 8pm work for you/Marc? If so - we will press for that time. I will get everyone from VA who needs to be on the call, on the call at that time. Thanks again for the help , Scott From: ""'l(b'""' )..:....; (6;..:.. ) ____ __. Sent: Saturday , March 17, 2018 5 :29 PM To : Blackburn , Scott R. Subject: RE: [ EXTERNAL] RE: Scheduling a Call Regarding Feedback on VA EHR It looks like if we do 8PM on Tuesday we can get: Manis Reel Rasu Karson (probably joining late) VA-18-0298-C, VA-18-0299-C-000010 10 of 220 From : IP To : Cc: MarcSherman:BlackburnScottB !(b}(6) ~?mail com: Bruce Moskow jtz:l(b)(6) Subject: Date: Attachments: [ EXTERNAL] RE: VA EHR NDA IWindom JohnH ; QJ.S Tuesday, March 13, 20 18 2 :08 :25 PM Perlmutt er.EHR NDA v2 mb s.pdf Attac hed is my signed N DA. Than k yo u. From: Marc Sherman [mailtol(b)(6l lgmail.com] Sent: Tuesday, March 13, 2018 1 :40 PM To: Blackburn. Scott R. Cc: IP:!(b)(6) ka>gmail.com; Bruce Moskowitz;l(b )(6) Subject : Re: VA EHR NOA ~---~ I; Windom, John H.; DJS Sconj (b)(G) ~nd John Thank you for the NOAdraft that you sent along and the organized approach . have attached the following to close the loop: 1. a marked up version of the NOAwith a few necessary adjustments in red-line so you can see the changes that were made, 2. a blank copy of the amended NOAfor Bruce and Ike to sign, and 3. a signed version by me of the amended NOA. Thanks and happy to help as requested . Marc On Tue, Mar 13, 201 8 at 10:31 AM, Blackburn , Scott R. wro te: Ike, Bru ce, M arc: Thank eac h of yo u for agreeing to lend an extra set of outside eyes on the EHR contra ct. We appr eciate your support and wa nt to mak e sure we get to the best place poss ible for Veterans, the country and taxpayers. As we are incredibl y grateful to you for volunteering your time, we want to mak e this as easy as poss ible for yo u. Here are 3 next steps. 1) We will need you to sign the attached NDA. Please return t~~ (b-)(-G )--~~ cc 'd). 2) l(b)(6 ) jwill then send you the latest package under separate cover. 3) Given governm ent contracts are diff erent than what you are used to reading , we would pro pose a quick phon e call so that we can orient yo u to the contract and help foc us yo u on the parts where your expertise will be most valuable . lcb)(6) I(who is the gove rnment contra cting officer) and John Wind om (who is our EHR leader) will lead this from our side. I will askl{b)(6) l(cc' d) here to help set up a time. We can either do this all together, if calendars match up, or separately if nee d be. We have also connected with Steph anie Reel, Stan Huff , Dr. Karson, Dr. Ko, Dr. Shre tha, and Jon Manis who all have all received the ND A and we are working with them. I am hoping to connect with Dr . Coo per today. VA-18-0298-C, VA-18-0299-C-000011 11 of 220 Thank s again! Scott Scott Blackburn Acting CIO & Executive -in-Charge, Office of Information & Techno logy Department of Veterans Affair s VA-18-0298-C, VA-18-0299-C-000012 12 of 220 From : Bruce Moskowitz To : Cc: MarcSherman BlackburnScottB :!lbV6l @mahbarvardedu Subject: Date: Tuesday, January 02, 20 18 6: 16 :23 AM [EXTERNAL] Re: VA inte roperability - outside experts Also is there a call in number Sent from my iPad Bruce Moskowitz M.D. On Jan 2, 2018 , at 6:09 AM, Marc Sherman 1(b)(6) lwgmail.com> wrote: Scott , Andrew Karson will likely be able to attend the January 5 VA interoperability summit. Can you please send Andrew all of the details (about purpo se, logistics etc) and copy me and Bruce? I have included Andrew on this email so you each have contact info of the other. Marc Marc Sherman l(b)(6) On Dec 29, 2017 5:43 PM , "Blackburn, Scott R." wrote: Marc - Happy New Year! I hope you are enjoying the holidays. As I mentioned prev iously, M ITRE is help ing us get outs ide expert opinions on w hat we need to demand (from Cerner or elsewhere) to meet our interoperability needs. just found out they are putting together an all-day expert panel on January 5 at MITRE in McLean VA. Frank Opelka, who you recommended, w ill be there as w ill Cris Ross (CIO from Mayo Clinic) who M ITRE conf irmed independently. The list of confirmed partic ipants is below (I know they are working on confirming a few others). I know it is short notice, and over the holidays, but is there anyone else that you/Bruce wou ld recommend M ITREinclude? Current list of part icipants: VA-18-0298-C, VA-18-0299-C-000013 13 of 220 o Aneesh Chopra, President, CareJoumey, former United States Chief Technology Officer o Cris Ross, CIO, Mayo Clinic o Carla Smith, President, HMMS o Ryan Howells, Principal, Leavitt Partners, LLC (recommended by Chris Liddell, Office of American Innovation) o Paul R. Sutton, MD, PhD, University of Washington o Frank Opelka, MD, American College of Surgeons o Kenneth Mandl, MD, MPH, Boston Children's Hospital VA-18-0298-C, VA-18-0299-C-000014 14 of 220 Updated confirmed panelist list for Friday, January 5, plus emails: o Aneesh Chopra, President, CareJourney, former United States Chief Technology Officer; l(b)(6) l@carejourney.com o Charles E. !Chuck) Christian, VP Technology and Engagement, Indiana Health Information Exchange;l(b)(6) 1@ihie.org o John Doerr, Kleiner Perkins caufield & Byers;l(b)(6) l@kpcb.com o Ryan Howells, Principal, Leavitt Partners, LLC;t.: l(b:..!.: )(~6 ):...__ __J' ~-l=e=-av'"'"it....,t=pa=rt=n=e"'""rs=-.c=o~m o 6l___ Andrew Karson, M.D., MGHjL (b_)(_ l@ p,--=m=g...._h ..... h=arv'-"=ar._..d=.e=d=u o Chris Klomp, CEO,Collective Medical Technologies, Inc.; l(b)(6) l@collectivemedicaltech.com o Kenneth Mandi, MD, MPH, Professor, Boston Children's Hospital, Harvard Medical School; l(b)(6) l@childrens.harvard.edu o Frank Opelka, MD, American College of Surgeons;l(b)(6) !@facs.org o Peter J. Pronovost, MD, PhD, Johns Hopkins;l(b)(6) l@ihmi.edu o Christopher J. (Cris) Ross,CIO, Mayo~(b)(6) l@mayo.edu o Carla Smith, Executive Vice President, HIMSS;l(b)(6) !@himss.org o Paul R. Sutton, MD, PhD, University of Washington;l(b)(6) l@u.washington.edu l31?"" ~ GM,\-=> Joi-..> S~\k.,~ ~~vJJ. DIU'...Lu M _j ~G-f1 KjL'L =a;,or+ ~~~ Q..b j ( S:>\J 9 ~'t.- On Mar 15, 2018, at 9:24 AM, Blackburn, Scott R. wrote: > > Bruce, thanks for raising this. Below is what I learned about what we have for intensive care units interacting with a central monitoring system. Let me know if this sounds right to you. Also you rattled off a couple of things (nutritional layout from Tufts, field to input the serial number for items in the device registry); if you could send me those I can hunt those down as well to save time. I just got off the phone with Stephanie Reel and she is excited to help; speaking to a few others at 11:30am ET. > > The Cerner solution for ICU central monitoring , as part of the VA EHR, utilizes Cerner's CareAware iAware framework through the Apache Outcomes solution. This solution has the capability to configure dashboard views to enable monitoring of high acuity areas, specifically around perforn1ance and patient care. This capability is included in the scope of the Cerner acquisition as the Critical Care System, Cerner Apache Outcome s solution and End User License Agreement. > > Does this capability also monitors emergency rooms, recove ry rooms and tele metry beds? > The cunent acquisition solutions meet these requirements and can be configured into a central command center model. > * Emergency Room: Emergency Department (ED) Dashboard is built into the Emergency Department Care Manag ement to monitor progression of patients through the patient care process. This solution has been included as an Emergency Medicine System and End User License Agreement. > * Recovery Room: Surgical Manag ement solution has tracking boards to monitor patient progress and efficiency of care provided. This solution has been includ ed as Perioper ative System and End User License Agreement. > * Telemetry Beds: Traditional central monito1ing systems as are used in telemetry , exist within the VA's current environment. During the acquisition process it was decided that these solutions will persist into the future state to reduce costs for the VA. However, the acquisition includes integration of this capability. > > In addition to these monitoring capabilities, CareAware Patient Flow, which is Cerner 's capacity management solution that helps to operationalize patient care activities such as room cleaning offers specific dashboards that can be centralized to support a central command center model. > VA-18-0298-C, VA-18-0299-C-000016 16 of 220 To : BlackburnScottB WindomJohnH Subject : Date: FW: [EXTERNAL] Fwd: Call with Secretary Shulkin Sunday, March 11, 2018 10 :10:00 PM From: FYI. I w il l learn more tomorrow morning. From: David Shulkin [mailtoi (b)(6) @gmail.com] Sent: Sunday, March 11, 2018 5:55 PM To: Blackburn, Scott R. Subject: [ EXTERNAL]Fwd: Call with Secretary Shulkin Can you join me at mornin g report in the am- 8 or 815 am to discuss next steps on thi s Note the emai ls below Sent from my iPhone Begin forwarded me ssage: From: Bruce Mo skowit z Date: March 11, 2018 at 12:57:53 PM EDT To: Stephanie Reel ~hu. edu> ,l(b)(6) l@ima il.org . b 6 sutterhealth .ora , '~ )/ f@facs .org " <~@facs.org>, (b)(6) ma o.ed u, " arson, Andrew Scott, M. D. " (b)(6) .v > Cc: David Shulkin <1, IP ~ frenchange J59,com>, 6 l(b)( ) @gmaiJ.com ! wrote: VA-18-0298-C, VA-18-0299-C-000018 18 of 220 ~ From: To : StJl)J.ct : Date: Sn1aH 1 C,.,,,jb I FW. [EXTERN....] Re: Ope(1 API - It It CLOO0+ lerq,,ge + AMu '111111ncis,cby. M~rth 07. 20 11!.2:4.3:00 A~1 F,o m, B,vce MosJww ;tz [m,;" d/h \I F,) Sent: woone.sday. FeDr1Jar)'28. 2018 4: 53 PM To: Blackburn. Scolt R. Cc: DJS; Marc Sherman; O'Rourke, Peter M. ; IP~g Subject: Re: [EXTERNAL)Ra: Ope-nAPI o It is C~ ~mac.com) mall.com guge + Rasu Than k you prog ress is be ing made but as my gro up keep s sayi ng devi l is in 1he de.tails Seru fro m my iPhone On Feb 28, 2018. at 4:36 PM, Blackbum, Sco tt R. w rOLe: Bruc:e- as promised he,e is.more informal1on on what we wil l have to addtess. the other 4 issues you mentioned. to 1;et you on the phone directly wi th my expem. I still owe you dev.ce regis.t,y. Let me know ,f lh 1s makes ser'ISeor not. AJso happy - Scott VoiceBernrnition Our new Cerner EHR platform includes Enterprise Dragon Nuance VHA currently deploys the enterprise version which mainla n,speople voice prim and lhe Clinical Staff ~y il works very wel l (my primary c.are provider at lhe Washinglon VAMedica lC emer l.tSe'Sill Cemer will port over the voicei:i nn tssolhe clinicians that use il tocfay will be able to use It tomorrow in Cerner wilhout any rework. The Cl!nioan can use the dictation and olher fealures w ,th voice recogn ition Howwill all entered labdata fromanvsourcebeavailableon a e:raob Graphs will be available in 2 spots . 1. Workflow MPage lab Component and 2. Results review flowsheet. When outside labs are mapped we would use tht:!same names as intemal and then they would appear on the same line. Even if they are not exaaty named the same the result$ rev iew flowsheet allows for 2 different lab value$ to be graphed together. Catcbinrten duPlicationoverutilizationandmedication duPli!::ation/error'i at timeof orderinrinneadof :afterthe fag A.IIlest'S are configured to have a lime wt.ere an alert is i,ssued based on parameters we C-Oflfigureand can flex by venue Over utilization will be a1Joidecfw ,th real time alerting bu t VA. would hiwe to use a mechanism to monllor, ,..,are port. The med dupl!catlon Is configured s.mllarly to test and pa rameters will deletmin~ how lhe system acts. Tall man lettenn.g reduce'S errors In look al,ke, sound alike meds. and finally In Instances we identify errors we can configure rules to catch lhose. For meds all allergy checking, dupes, dose , ange checks. and Inle racbons are checked at time of ordeMg . As an aside. whi le the DoO Cemer implementation has been far from perfect this is one are.awhere it has been very suc:c-es.sful ; the new OoD/Cemer System has already s:irevented over 15,000 dup licat e tests at the,r initial three sites that have been implemented . StreamlinedSOAPoote:s Yes, the VA/Cemer system will have this, These are provided and will be further configured under VAd ,rection to meet VA clinician needs. From : Blaclbum , Scott R. Sent: Wednesday . February28, 2018 2:31)PM To : 'Bruce Moskowitz' Cc: DJS;MareSherman;O'Roorke, PeterM.; IP ~ omail corn Subject: RE: [EXTERNAL) Re: Open API . It Is ~ uge + Rasu Bru c:e-we certainty a,en't going to let you get tar and feathe ,e d! A1;ain. we really aps:ireciate all the supporl vou've g1Ven us. On thes-e othe r 4, I'll get vou answers on these ASAP. I know these are top ics Yo4)'ve brought I.JPin past and we were definitely li$teni ng. I've been hammering the team to make sure we incorporate all th ,s feedback into t he negoliation . Lel me send you the specifics where we have lancfed to make sure that we got them nghl. Stancf by Scott From : Bruce Moskowitz (maib. d(bl(6l ~mac@ml Sent: Wednesday . February"?ie', 20181 :13 PM To : Blackburn. Scott R. Cc: DJS;MareSherman;O'Roorke, PeterM.; IP~ omail.c:om Ra: Open API o it is ~~u Subject : Re: [EXTERN.AL) lllank you my five CIO's had loo ked forward to 1ar and featheri ng me if 1he c loud is 1101do ne correctly ! The Olhe r issues are: Voice Rccogn i1io11 All en tering lab dala on a graph from any source Catchi ng tesl duplical ion. over utiliz.arion and medicat ion duplica tion/errors at time o f o rde ring no t after t he fact S1reaml ined SOAP no tes Scnl fr om my iPad Bruce Moskowi 11.-M.D. Bl ackb urn , Scott R. <.SoonBlackhurn@va gov> wrolc: On Feb 2&. 2018, at 12:52 P.fl.'1. Bruce - thi$ lS incred ibly helpful. Thank you Yery much. I had my team d ,g into this this more this mormng . What vou have stated below is dearly the intent (we need everything to be OPEN and absolutely do not want to inadvertently create vendor lock); we've also gone back th ,s momign to confirm with Cemer that th is is the,r intent. We are going to alter the langt.Jageto m ake this more clear . We don't anticipate any pushbac.k. A few things. I learned this morn ing .. The contract does NOT lock us in to Amazon Web Serv,c.es(AWS), Rather any cloud provider or applic.ations that meet secunty and privacy requirements to protect Veteran data can interface w ,th Open APls or push data to the VNCerner system, Currently 3 cloud providers meet the Government security requirements-AWS, in cluding Google and V1rtuStrearn/Dell, Azure/Microsott At VA, we use both AWS and Azure n ght now and CSRA There are sevefal others that we e~ect to come on board soon Again, the goal here is to c.reate open environment as long as the provider mee ts certain standards (these standards are dictated by GSA.not VA). Cemer does ha1Jea partnership with AWS (which 1s why we h,ghhghted that) but it is just one e)(ample of the open could environments they are plann ,ng to work with We have confirmed that It w ,I1 be OPENand oot proprietary to their specific-AWS cloud. DoD i'Sexcited to follow our lead on all of thi'S I spent lhe morning at the Pentagon w ,th the DoD CIO/team This will he ,p not just Veterans, but servicemembers 'Still in un,form. Thanks again for the feedback and sups:iort. We are going to make sure this is crystal clear . Scott VA-18-0298-C, VA-18-0299-C-000019 19 of 220 From: BruoeMoskowitz l~ I Sent : Tuesctay,Febfuary~ To; Blaekbutn, Seou R. Cc: DJS; Marc Sherman ; O'Rourke. Peter M .: IP.~ gmail rom Subject : (EXTERNAL) Re: Open API o ft Is ct.QUO+ languge + Rasu Apo lo g ize fo r lhe. word ing ins1e.ad o f th eir co mm ercia l c lo ud a cloud based .syste.m ope n To all cnlities and instc::idof Amazon it shouJd be all phuforms working to accclcrnlc hcahh care iniativcs Sent from my iPad S mee Mosko witz M.D. On Feb 27. 2018 . at 9:20 PM. Br uce Mos kow i12 ~ > w rote : To cl arify further it states their comme rcial cloud instead a comme rcial cloud Ope n to all entities and of equal impor tance an open platform to alJ not ju st amazon but to nil Worki ng on Se1it from my iPad S mee Mosko witz M.D. On Feb 27. 2018 . at 8:20 PM. Br uce Mos kow i12 ~ > w rote: This is a problem it should say open cloud to all entities nol commercial cloud Se c ond it sho uld be o pen pl111fonn and nOIjus1 Amiizo n to all entrie-s worki ng o n he:ihh tart pl:ltrorms. On Feb 27, 2018, al 6:09 PM , Blac kbu m. S<:Ott R. <:X:011Blildhnm@va "Qy> wm te: David/ Bruce/ Marc- he re are a few updates : #1) &ulL.ii.iil in as far as st art ing to help right away. I just got off the ph one wit h him. He has UPMC commit ments rest of this week and is Chairman of HiMSS Innovatio n comm ittee bo we w ill all be at HiMSS toge ther next weel: }. Howeve r if he needs to come to Washington this week for something. he wi ll find a way t o do it (and we will use invitation travel to pay for it). He is willin 8 to start en8agi ng right away to help us. He said he doesn't have t o wait for the IPA paperwork to come through tor him to he lp I've attached Rasu's CV in case you need it #2) TheAPlsare doud based. Here Is the response fro m our Technical lead ... The Open APls t ha t VA has acce ss to from Cerne r reside in t he ir Comme rc ial Cloud env ironment . Th is env iro nm ent is des igned to scale to accommoda le Cerner's enti re remote hosteScc1ioo .S.l!i.kkl,cjS !ht ~upport 10 busints s imdl igcnce 111\d ililta aMl}1ic-.s.. Su~Jr:tj,1.\1.kf ing 10RHo $t'(;liOOS.8: .1,) Prov ide 1hc!VA EHRM dalll model. underpinning lem1iool~y model. Section S.10,4 I supports lhe shllii.ng<>f Ublcs, dcfini1ions,m>dc:urnp l~ of full)' pop thued OfltractCN" propr ie1ary infor matiutllili!ta mode l Vcttt :in da u files. Pn:wide doc11nwr11.:uioo CN" soltw:ire :itensioo poi.ms(e.g,..ingc:slion and ,w.ord I.hati.sui;cd for quality diccl.s and tllat illu.stratewh al AJ'.> I<) w1lh b(illt in1.-m;1IM)nal;,i,nd n:iti(m.al icJat.tclt:m1:n ~ ;uc l'.:l )mpulabk : o standilrds d~ i~:uing organizations. req uire St1ggestadd i11gto Scctioo 5.10.4. 1: ""n) T he Cootractor H<>wc,'er,current lllDgUilgedocs 3C<GBP o,ndtherefore increase the the ex1e.n:sion of clinical oontenl w.st1ssuch 11:1 c:-.i:halJiCofcom p11t:ible da1a w11h c.-.nn11111il) ' 1cm 1ino lc,vks,dmic al dt:d cis loo supporl nak:s. ordu :sets.etc , to lht- nlt:nl .such ~xlcnsi(ltlf an : col\5lsttnt with lhe mode-I and bc:$1 pr.u; lit:t:~ M t hi: i:on truHinK lll'.lli tlllill Sl:mdard . Th is il'lcludes t.hcability to curntc. extend. and st1:1\!" 1 1ha1kM wledgo!" with cfo1ic:il SuggeS1VA obtairi a price from the Coo1t3C101'10 pannc:rs. This fosters rapid n the StCP5in~.olY(d in IJCCC'C.S$illg ;idopiion rrom i~ ~Slry bc:sl . pn:,,,jde Q rcporl CJi:plai 1he da1;amodel, indu dmv pr(l(lucin; an eump le d;11afile, pr~ti~s._.::.g .. d uucal pro fess10Jl31 ;ind dc:moostrJling how much of the: d:ua is computable: sottcnc:s, pro,.idc:C()rsl c~lim;l!cS for l)ul~jijeJ"-ITliC.Slo :.l(:CO:..(:S the kl:it:i via lhi.s 1lW<'haJ1is1n. -Scou thaMD_v2018 02_CV and Bio2.pdf> VA-18-0298-C, VA-18-0299-C-000020 20 of 220 From: To : Subject : Date: l(b)(6) Blackburn ScottB FW: [EXTERNAL] Re: VA EHR call Sunday, March 18 , 2018 2 : 16:02 PM M r. Blackb urn, let me know if I can send t he invite out fo r Tuesday at 8PM. It looks like Dr. Coope r can now jo in for t he fi rst half of t he call. Thanks, liz From: Bruce Moskowitz[ mailto i~ (b'"'" )(_6.,,,. ) .,..,....---~ Sent: Sunday, March 18, 2018 1 :50 PM To: Blackburn, Scott_ R_.------. Cc: Marc Sherman; ~l (b~)(~6~ ) ----~ Subject: [ EXTERNAL] Re: VA EHR call @mac.com] Ok Sent from my iPad Bruce Moskowitz M.D. On Mar 18, 2018, at 12:28 PM, Blackburn, Scott R. wrote: Bruce/Marc - it is look ing like Tuesday 8pm ET is go ing t o work best fo r ou r CIOs/Doctors. We w ill have at least 4 people confirmed (M anis, Reel, Shretha and Karson; likely Stan Huff as well which wou ld ma ke 5). Dr. Cooper I know is a sing le issue SM E so we can pro bably do that o ne separately. Dr. Ko has a to ugh schedule all th is week . Wou ld Tuesday 8pm work for yo u/ M arc? If so - we wil l press for t hat t ime. I w ill get everyone from VA who needs t o be on the cal l, o n t he call at t hat t ime. Than ks again for the help, Scott I From: l(b)(6) Sent: Saturday , March 17, 2018 5:29 PM To: Blackburn, Scott R. Subject: RE: [EXTERNAL] RE: Scheduling a Call Regarding Feedback on VA EHR It looks like if we do 8PM on Tues day we can get: Ma nis Reel Rasu Karson (probably jo ining lat e) I know Dr. Ko is o n t ravel Tuesday, but I have n't heard what time he lands. I t hin k Dr. Cooper is also o n t ravel and has not responded to t he last email. Dr. Huff has not responded to t he last email. VA-18-0298-C, VA-18-0299-C-000021 21 of 220 So maybe we go with Tuesday at 8PM. Depending on what Ko, Cooper and Huff say we can let Dr. Bruce engage wi t h them if needed. Let me know ... l(b)(6) From: Blackburn , Scott R. Sent: Saturday , March 17, 2018 2:28 PM TO* b)(6) SubJect: FW:[EXTERNA L] RE: Scheduling a Call Regarding Feedback on VA EHR Importance: High 7 Maybe pulse Monda y/Wednesday nights as well (seems after 6pm might work best for these folks)? Then i think we should just pick one (either Mon, Tue s or Wed night) and just go with it. Sent with Good (www.good.com) From: Karson, Andrew Scott ,M.D. Sent: Saturday , March 17, 2018 2:23:32 PM To~(b)(6) Cc: Blackburn , Scott R.; !(b)/6) jWindom , John H. Subject: [EXTERNAL] RE: Scheduling a Call Regarding Feedback on VA EHR I Deaj~b)(6l1 am participat in g in a ceremony at 630 pm on Tuesday, but I could be on the VA call any t im e before th at. (Also, I'll try to learn mo re abou t th e t iming of my oth e r event to see if/w hen I co uld break away af t er 6:30 if needed.) Thanks and best, Andy Froml~(b:1: )(~6') ______________ Sent : Saturday, Ma rch 17, 2018 12 :15 PM _F@'-"v.,.,a..,g..><-Lov.l To: Karson, Andrew Scott, M.D. l..,_ (b..,_ )("-6.,_ ) _ __,.l @ ~ m....,g...., h~. h~a~ r~ va~r~d~.e=d=u > Cc: Blac kburn , Scott R. ; Truex, M atthew l(b)(G) l@va gov>; W ind om, John H. Subject: RE: Schedu ling a Call Regardi ng Feedback on VA EHR Importance: High Good afternoon Dr. Karson, Thank you again for conf irming Tuesday works best for you. If we started the call later in the even ing, between 5-8PM ESTwould you sti ll be availab le? So far Tuesday seems VA-18-0298-C, VA-18-0299-C-000022 22 of 220 to work best for eve ryo ne. Than ks again! l(b)(6) From: Karson, Andrew Scott,M.D. l(b)(6) l@mgh.harvard.edu ] Sent: Friday, March 16, 2018 7:22 PM To: l{b)(6l I Subject: [EXTERNAL] RE: Scheduling a Call Regarding Feedback on VA EHR 5 Dea r!C b>C >lso sorry for the delay getting back to you; I have been on t he road most of yesterday/ t oday and fi rst catch ing up on emails now. The o nly time among thos e th ree t hat I ca n do is the Tuesday t ime. (I will be part of an o ut of town fam ily even t on Sunday and in t he air on Monday.) Many than ks and best, Andy From~L(b..:...: )(.....:6 )_____________ ___j"l @_v~a,_,_..g=o~v .J Sent : Friday , Marc h 16, 2018 7:12 PM To: Stan Huff (b)(6) $=~===,---1" >; Cooper, Leslie T., M .D. :::c.u.=.,,.._,_,_..lod..l,GBP >; Karson, Andrew Scott ,M.D. @mg h.harvard .edu>; Shrestha, Rasu B ~,(b-)(-6)--...., Shre stha 1 Cc: Blackburn, Scott R.; ; Rasu Windom, John H. gov>: Truex, Matthew 4(b)(6) Wva gov> Subject: RE: Schedu ling a Call Regarding Feedback on VA EHR Importance: High Good evening, Another friendly rem inder to please let me know which dates works best for your schedule. Have a great evening, l(b)(6) I From =-l{ b~l( ~6l~----~ Sent: Friday , March 16, 2018 1 :06 PM To: 'Stephan ie Reel'; 'Stan Huff': Ri>>D@tacs.org': 'Cooper , Leslie T., M.D.'; 'Karson , And rew Scott ,M.D.'; 'Shrestha, Rasu B'; 'Rasu Shre~ st,_.ha .._ '---~ Scott R.; Windom, John H. j(b)(6) 'Bruce Moskowitz'; l(b)(6) @Bruce Moskowitz ,MD'; 'Ashley Johnson'; 'Mary Riordan'; 'Mehwesh Khalid'; 'Marc Sherman'; 'IP' Subject: RE: Scheduling a Call Regarding Feedback on VA EHR Importance : High Cc:Blackburn, I Good afternoon, VA-18-0298-C, VA-18-0299-C-000023 23 of 220 A friend ly rem inder to please let me know whic h date works best for your schedu le. Please fee l free to call me with any questio ns. Than k yo u, l(b)(6) I From =~l (b_)(_6)____ ~ Sent: Thursday, March 15 , 2018 7:27 PM To: Stephanie Reel; 'Stan Huff' ; 'Manis, Jonathan (Jon)';[?% facs,org'; 'Cooper, Leslie T., M.D.' ; 'Karson, Andrew Scott,M.D.'; 'Shrestha. Rasu B': 'Rasu Shrestha' Cc: Blackburn, Scott R.; Windom, John H.;l(b)(6) Bruce Moskowitz; i(b)(6) @Bruce Moskowitz,MD'; 'Ashley Johnson'; Mary Riordan; 'Mehwesh Khalid'; Marc Sherman; IP Subject: Scheduling a Call Regarding Feedback on VA EHR I Good evening, We wo uld like to sched ule a call in the next few days to share fee dbac k on t he VA EHR cont ract. I have bee n correspond ing w ith ma ny of you on different dates and t imes next week, but we are going to schedule t he call fo r eith er Sund ay 3/18 at 4PM EST, Mo nday 3/19 at 4PM ESTor Tuesday 3/20 at 4PM EST.Please let me know which date will work best fo r you r schedu le. Feel free to call me with any quest ions and I loo k forwa rd to hearing from yo u. Than k yo u, l(b)(6) I l(b)(6) Executive Assistant t o the Assist ant Secretary Off ice of Info rmati on and Technology US Departme nt of Veterans Affairs Desk: 202-4 61-6288 CeIlj(b)(6) The informat ion in this e-mail is intended only for the person to whom it is addressed. If you believe this e-mail was sent to you in error and the e-mail contains patient information , please contact the Partn ers Complianc e HelpLine at http:Uwww ,partners,org/comp)ianceline . If the e-mail was sent to you in error but does not contain patient inform ation, please contact the sender and properly dispose of the e-mail. VA-18-0298-C, VA-18-0299-C-000024 24 of 220 From: To : Subject : Date : BlackburnScottB ZenoozAshwini: Short John/VACO\ FW: [EXTERNAL ] Re: VA EHR Friday, March 23, 2018 12:16: 16 PM I already sent to Windom and DepSec . I told Windom to get with the Secretary today to gauge his reaction s. Sent with Good (www.good.com) From: Marc Sherman Sent: Friday, March 23, 2018 9:47:39 AM To: Blackburn, Scott R. Cc: Bruce Moskowitz; DJS Subject: [ EXTERNAL ] Re: VA EHR Scott , Than ks for inviting me to listen in on your calls this week with the subject matter experts. I was happy to make time to participate as requested and always happy to provide my thoughts for your consideration when requested. I read carefully your email about the efforts to work out the holes raised by the experts. You are on the way to kicking off an exciting project with a highly respected Contractor/vendor and a VA team that has worked very hard ; and I know ever one has the oal to build the best next eneration s stem for the veterans ' healthcare . b 5 (b)(5) The experts are recommending a system for the VA that has various enhancements to today's standard system functionality. At a minimum , I heard those experts express their opinions that the contract dangero usly lacks definitions , standards and a clear expression of this required, defined enhanced (non-standard) functionality (they articulate it much better than I). Failing to express this type of definitional clarity in the contract is an invitation to ambiguity, disputes and ultimate failure of purpose. The best "oversight and management of the contract" will not turn a contract lacking specificity into a vision of clarity . Including contractual clarity allows the Contractor to understand TODAY what is expected so that today it can confirm its agreement to provide the full functionality desired and have a better understanding of what is expected of them . Clarity in the contract is a healthy ingredient for the VA and the Contractor. (b)(5) I would be delighted to be wrong and welcome a demonstration of where Section 5.1 of the contrac t provides this specificity that Ors. Cooper and Huff , for example , urged . In light of the system requirements that these experts say must be included , which are enhancements of today 's standard deliverables, the contract language is ambiguous . You say that "risk cannot be 100% driven out of any transformation of this magnitude," a concept to which I subscribe. However , when you substitute this concept for clear , written and defined functionality , especially for a design that is expected to be unique in many respects , you are doomed to disappointment and conflict. VA-18-0298-C, VA-18-0299-C-000025 25 of 220 I am sorry to be so harsh in my opinions, but the experts are so united on this point; and together with my historical observations of fa ilures in nearly identical situations I just see warning flares going off. Scott, I want to see this project get started, and quickly , as much as anyone, but with the clarity that equally serves the VA and the Contractor, and prevents evident problems down the road . I also believe these things are easy to resolve in the contract language in relatively minimal time . Just my opin ion and food for thought as you make your decisions . Marc On Wed , Mar 2 1, 2018 at 10:19 PM, Blackburn , Scott R. wrote: Marc/ Bruce, Thank you once again for all yo ur suppor t and especially fo r linking us up with t hese CIOs/experts. This was incred ibly valuab le. Secretary Shulkin, John W indom and I got toget her earlier today as we ll to talk about the path ahead. A few notes: o In order to make sure we understand some of the more specific detailed points, members of our team reached out today for ind ividual fo llow ups with Dr. Cooper, Dr. Karson, Dr. Shrestha, Jon Ma nis and Stephanie. Each have been so gene rous w it h thei r t ime - St ep hanie w ill host us for a visit on April 4 and Dr. Cooper offered t o do t he same at Mayo. o Dr. Zenooz did connect with Dr. Cooper today on the po int Marc highlights below t o make sure we are on t he same page and have t he language right (part was us better understanding his point; part was pointing him to the specific language in 5.1.1 and giving him t he broader context with what we are do ing wit h Lighthouse as our API gateway and the VA Open API Pledge t hat 11 healt hcare inst itutio ns signed two wee ks ago include Cris Rossat Mayo as well Stan Huff at lnt ermou nta in and Dr. Karson at Partners). o We w ill also fol low up wit h Stan on some of the issues he raised as well. For examp le: Stan w ill be excited to learn that Cerner has prioritized an addit ional 40 enginee rs to accelerate FHIR APls for VA in support of t his cont ract . l(b)(5) l(b}(S} o Per Stephanie's suggestion, we are going to start mov ing forwa rd ASAPon formaliz ing VA-18-0298-C, VA-18-0299-C-000026 26 of 220 an Advisory Committee so that we can get these insights on an ongoing basis. Formalizing this wil l allow for continuity of expertise throughout our journey. Obviously we wi ll want Stephanie, John, Andy, Rasu, etc. Cris Ross (Mayo}, Wi ll Morris or Ed Marx (Cleveland Clinic), Frank Opelka (Amer ican College of Surgeons) are others you've introduced us to along the way that we would love to include. We wou ld like to work with you to make sure we get this right. o As recommended last night, an interoperabi lity sandbox/test bed wi ll be estab lished during our Initial Operating Capabilities (IOC) implementation/deployment process to solidify the requisite interoperab ility requirements prior to full enterpr ise deployment. This is a great suggestion and very consistent with what we have been hearing from many experts. o Our team is reviewing all the feedback (both ora l from the calls and the written notes that some provided) and cross-walking this against the language in the RFP/contract documents (both EHRand also Lighthouse). We are not seeing any major changes to the contract nor do we see any showstoppers. Upon receiving the feedback, we fee l very good that we have a solid contract from which we wi ll just need to make minor revisions. o After discussing this with Secretary Shulkin today, we feel stro? EUR1Y about movi ? EUR forward quickly. We wil l make any necessary tweaks with Cerner ASAP(we absolutely do not anticipate any push back; and Cerner has promised to turn things around immediately) and will move forward to siEUR ? the overarchi ? EUR 1D10 contract. Assuming Congress approves the Omnibus bil l by Friday (and President Trumps signs it), we wi ll then have the funding and authority to do so - and Secretary Shulkio could sign as early as next w..e.e.k. If the Omnibus fal ls through (which let's hope not}, then we would have to request a transfer from the Congressional appropriation committees which wil l then take ~2 weeks. Signing the initial task orders will allow us to start moving forward with Cerner on the initia l 3 hospita ls (which will be in Washington state) on things like site surveys, infrastructure readiness, data hosting, change management (w ith w ill include w ide involvement from clinicians inside and outside VA...something we heard loud and clear from Bruce!), help desk establishment, and project oversight (which we've heard loud and clear from Stephanie/Jon). As a reminder, given the IDIQ structure of the contract we would not be signing the f ul l contract (rather just Year 1- which is ~s%of the value of the contract). But this will allow us to get mov ing and out of the "qu icksand" . o Marc makes a great point below on turning DoD's strugg les into a positive. We have been working very closely with the DoD team over the past 9 months (I now have my own Pentagon ID pass I am there so much; John and I work very closely with their EHR lead VA-18-0298-C, VA-18-0299-C-000027 27 of 220 Stacy Cummings; John Windom talks to her several times a week) . We have incorporated a lot of their stumbles into our contract (e.g., data migrat ion was a big issue with Congressman Phil Roe and we addressed that; and most rece ntly we have made some adju st ment s on trouble t icket management based on what you've read in t he papers). We are paying very close atte ntio n to their implementation issues (workflow, change manageme nt, governance) to make sure we don't make t he same mistake tw ice. DoD's biggest problems are around impleme ntation and change manageme nt. This underscores Bruce's point of making sure we have clin ician buy-in and involvemen t from the get-go (I couldn't agree more) . This w ill make getting move on change management in Task Order #1 so impo rtant. o As yo u both know, risk cannot be 100% driven out of any tra nsformatio n of th is magnit ude. Stepha nie Reel so succinctl y captu red, "it is t he ove rsight and management of t he cont ract t hat wil l be of the utmos t importance, as well as the VA'S access to senior industry advisors." I th ink we have a great plan. The biggest th ing I worry about w ill be executing and we are def initely goi ng to need all t he help we can get. Again, we believe t he construct of th e contr act, and more impor t ant ly t he prope r overs ight and managemen t of t he cont ract wil l greatly mit igate cost, schedu le and performance concerns, as we ll as suppo rt the timely inj ectio n of tec hnolog ical advancements (e.g. cloud, A Pis, etc.) at the approp riate pace and balance necessary to support our Vet era ns w it hout jeopard izing our overall care. Inte rope rabil ity remai ns at t he forefron t or our concerns, and your comme nts, the MITRE study and various other ext erna l inp uts contr ibuti ng significant ly to our RFPlanguage and correspondi ng req uirements. Interoperabil ity w ill be a mov ing target for years to come, but our cont ract allows us to leverage the best of ideas of industry t hrougho ut the cont ract's life without incurring t he exorb ita nt cost s yo u have alluded t o, as we ll as not be bo und by potentially anti qu at ed def init ions . Bruce/Marc, thank you for everyth ing. As I mentio ned to Bruce recent ly, yo u have been tremendo us "demand ing partners" on th is jo urney and we are incredibly apprec iate. We loo k fo rward to continu ing t his relationshi p as we take the next st eps. Scott From: Marc Sherman [ mailto!(b)(6) @gmailcom] Sent: Wednesday, March 21, 2018 9:31 AM To : Blackburn, Scott R. Cc: DJS Subj ect: Re: [EXTERNAL] Re: St an Huff I agree t hat th e call was very helpf ul. I spent the night afte r th e call refl ectin g VA-18-0298-C, VA-18-0299-C-000028 28 of 220 on some of the discussion and thought I would offer some reaction/feedback that still seems unsettled. I will outline my nighttime thoughts below in case you find them useful. 1. I thought that Dr. Cooper made a good case for inserting specific definitions and standards on the meaning and use of "interoperability," especially since that term has as many meanings in the industry as those who speak it. It is so easy for the contractor to proceed down a design path using one definition or standard while the users will require a totally different standard. That runs the risk of not being discovered until later, erha s even u to im lementation, aver costl result. (b)(S) (b)(5) (b)( 5) I agree with Dr. Cooper, why not set the critical definitions and standards in the contract (PWS)now and eliminate the chance for any confusion or ambiguity. It wi II pay dividends later in terms of less arguments, better initial design, happier user community, less overall cost, better healthcare delivery , etc. Then, with the standard fully defined and set in the original PWS,the mock-up test will be much sooner in time and much more complete the first time, allowing the users to provide input sooner and better , eliminating costly design mistakes from the beginning. The user community can tell you today what is needed to accomplish this "next generation" system that will be a model for the country and the future of healthcare (as Ms. Reel envisioned on the call last night). Why would you not want to tell the contractor the specifics of that now, in fairness to them, the VA, the patients and healthcare, so they can proceed with that standard from day one or express any concerns they may have now instead of in the future after costly design has occurred? Why would you not want to be specific in the contract to prevent ambiguity? Dr. Shulkin pushed back on Dr. Cooper's view as already accomplished in the PWSand cited Section 5 (I believe he said section 5.1.1) of the PWS. Dr. Cooper, as a physician user and not a technician , deferred on the effectiveness of the existing contract language to others, but commented that the CIO of MAYOread the contract and also did not think it adequately contained the right defining language to set out unambiguous definitions and standard. I have read the contract again last night and happen to agree, or am missing it. If I am wrong, it would be useful for someone to point me in the right direction . 2. I was also thinking about the current reported problems of the DOD implementation seemingly caused by a user (clinician) revolt over inadequacy (or unsuitability) for their needs. The VA runs that same risk. Perhaps that problem could be a benefit to your effort. Why not accumulate all of the user complaints/issues in the DODimplementation identified by the users and chart them out. Then identify which of those issueswould be issues if they existed in the VA implementation and include them in the contract as definitional requirements. You have the benefit of knowing the failures in the very system upon which you are modeling your system... and you have an added advantage and opportunity to contractually prevent similar mistakes. 3. I have other thoughts as wel I that we should discuss, but these are the ones VA-18-0298-C, VA-18-0299-C-000029 29 of 220 that I felt more pressing to highlight since I will be unavailable today. Best Marc On Wed , Mar 21, 2018 at 8:24 AM, Blackburn, Scott R. wrote: No pro blem Marc. Thanks for all yo ur help. Very helpf ul call last night. W,g mailcom] From: Marc Sherman [ma ilto *b )(6) Sent: Wednesday, March 21, 2018 12:12 AM To : Blackburn, Scott R. Subject: [EXTERNAL] Re: Stan Huff Scott I won't be able to join the call tomorrow as I have a previou s commitment that I can not move. I will catch up with you or Bruce after. Marc Marc Sherman l(b)(6) On Tue, Mar 20, 2018, 10:30 PM Blackbum, Scott R. wrote: Bruce/Marc - thanks for introducing us to all the experts we talked to tonight. It was extremely valuable. We have Stan Huff from Intermou3tain tomorrow at 10am. I rum e you have the calendar invite , but ju st in case it is(b)(G) _ We have been unable to schedule anything with Dr. Ko (very busy calendar). We will trying. VA-18-0298-C, VA-18-0299-C-000030 30 of 220 Scott Scott Blackbum Exec utive in Charge , Office of Inform ation & Technology US Department of Veterans Affairs VA-18-0298-C, VA-18-0299-C-000031 31 of 220 Blackburn Scott B l(b)(6) Windom John H From : To : Cc: Subj ect : Date: FW: [EXTERNAL] RE: VA EHR Tuesday, March 13, 2018 11:06:00 PM Let's try to get everyo ne else lined up on the timel ine I previous ly laid out. I don't want to ruin his vacatio n. At the same t ime I don't wa nt this to d rag o n. From: Cooper, Leslie T., M.D. [ mailto l_ (b~)(._,6,_ ) --~ Sent : Tuesday , March 13, 2018 11 :04 PM To: Blackburn, Scott R. @mayo.edu ) Cc:! (b)(6) Subject: Re: [ EXTERNAL ] RE: VA EHR Tomorrow or next Thursday? I am on the Big Sur coast now on vacation. Cell coverage spotty. Leslie Cooper Sent from my iPhone On Mar 13, 2018, at 1:46 PM, Blackburn, Scott R. wrote: Leslie - thank yo u so muc h ! 2 next steps. 1) l(b)(6) l(cc'd here) wil l send yo u the latest package of mater ial to rev iew. 2) ~ (also cc'd here) w ill reach out to you to schedu le some time this week so t ha~ team can or ient you t o wha t Matt wil l be sending to yo u. Government contracts are very differe nt t han typ ical private sector co ntracts (longer and some wou ld say mo re bureaucrat ic). So in order to help we' ll jump on the phone so that l(b)(G) lean walk you t hrough what sect ions to look at and wha t you can igno re. Thanks again! Scott From: Cooper, Leslie T. , M.D. [..,_m,..,a""ilt..,.o -t:l (.,,.:b ),.:., (6..:.. ) __ Sent: Tuesday, March 13, 2018 12:43 PM To: Blackburn, Scott R. Subject: Re: [EXTERNAL ] VA EHR _Fl@=m.....,..,.ayuo ....""'ed....,u ] Than k yo u fo r t he invita ti on to provide inp ut . I am glad fo r accept. Please let me know how I can be of service. I wil l be trave ling largely o ut of cell coverage the next day. Leslie Cooper Sent from my iPhone On Mar 12, 2018, at 6:55 AM , Blackburn, Scott R. wrote: Dr. Cooper: VA-18-0298-C, VA-18-0299-C-000032 32 of 220 From : To : Subject : Date: Attachments: BlackburnScottB !(b)(6) WindomJohnH : ZenoozAshwini; IShortJohnIVACO}:MyklegardDrew FW: [ EXTERNA L] Stan Huff Wednesday, March 2 1, 2018 1 :23:33 PM SJJg~stionsto VA on the contract.dQcx. Be.aue.s1s _lor_C.emeL.El::\B_o lattoI1IL1o_fuioo .octJnnQv.ation.aodlote.rno.e.rabUltv_smb,doc2(. Copyof 003 - VA EHRMNon-FunctionalBTM (Amended2 16 2018)smh xlsx In case you guys didn't get these note from Stan Huff ... -----Original Message----From: Blackburn, Scott R. Sent: Wednesday , March 21, 20 18 I :09 PM To : 'Bruce Moskow itz' Cc: IP;!/b)/6) @gmail.com Subject: RE: [EXTERNAL] Stan Huff Figured it out. Here are the files/notes that Stan wrote up for us... -----Original Message-----~--------~ From: Bruce Moskowitz ~(b)(6) Sent: Wednesday , March 21, 20 18 11:30 AM To : Blackburn, Scott R. Cc: IP; ! Date : Th ursday, FEUR6"ruary l, 2018 at 7:00 PM To: Bruce Mo skow itz !ib}/ 6} Cc: Jay Sch nitzer l(b)(6) l@ic loud com> l@mitre org> Subject: Re: I rev iewed aga in and th is is t he w ay fo rwar d Bruce l(b)(5) Rich From : Bruce M oskow itz l(b)(6) l@idoud com> Date : Th ursday, February 1, 2018 at 6:29 PM To: Rich Byrne Cc: Jay Schnitzer j/b) /6) Fj)mitre o rg> Subject: I rev iewed again and t his is the way fo rward I than k you t he more I thought about your points the more conv inced I am That all is in place fr om a pat ient and physician stand point in the doc ument Below to get us to where we need to be. Again my only cont ributi on to The EMR is as an end user. Sent from my iPad Bruce Moskowitz M .D. On Jan 31, 2018, at 8:44 PM, Byrne, Rich ~ > wrote: Bruce Thanks fo r the great paper on EHR challenges. Jay and I have been wor king to underst and and strengthen whe re VA can best incorporate yo ur many excellent ideas to improve Veteran health care. We see at least two major contr acts that are centra l to achieving these ideas. The VA EHR (Cerner) contract goal is to replace VISTAconsistent ly across the VA, provide seamless interoperabi lity with the Cerner implementation at DOD, and build an open, standards based architecture to share data, inte rfaces, and enco urage innov at ion fr om t hird parties across t he healthc are commun ity. It is unde rstoo d tha t t he curren t state of practice rolled out today will need to be cont inuous ly evo lved to improve the Veteran and clinician experience, increase over time the amount of interop erability possible, and enable innovati on to make a positive improvement on t he challenging, current Veteran and clinician exper ience (as you vividly illustrated to us with the VA-18-0298-C, VA-18-0299-C-000035 35 of 220 To : Blackburn Scott B Littlefield Patrick Subject : Date: FW: Presidential Management Council - notes on Modernization/EO Monday, May 15, 2017 9:30:00 AM From : See high lighted below From: Blackburn, Scott R. Sent: Thursday, May 11, 201711:13 PM ,........JL..U.......IULl..w. LI.It , Vivieca (Simpson); Merchant, Robert; Giddern":'-s~G=-:re= .,_._-'-'-'-"-=---'l.l.::.l.l..:..'---.---..,... va.gov); ___ .......... ACO; Medve, John VACO; Muir, Thomas M.; (b)(6) VACO); l(b)(6) (b)(6) Asgedom, Surafeal ~~-~ c: ' osie Beets - M1X'; Mary Reding - M1X Subject: Presidential Management Council - notes on Modernization/EC I had a "PMC" meeting today with all the Deputy Secretaries at the WH. Below are some big t hemes and more specif ic notes from specif ic agenc ies. I've cc'd Josie/ Mary too as t hey can help connect us t o some of t hese great oppo rt un it ies across govern men t. My apologies for short hand ...note t aking is not my stre ngth and I want to go to bed (C) Bigthemes: o Great opportun ity for more best practice sharing. Lots of agencies doing diffe rent stuff and no need to re invent th e whee l. We should steal shamelessly where we can. Lot s of posit ive energy and openness t o share. But my sense is that eve ryone is a bit stretched/overwhelmed ...so it won't happen unless someone is proact ive about it. We should be the proact ive ones. o Cross-agency opportu nit ies due June 2. Howeve r we sho uld start working with our respect ive agency cou nterparts to share ideas earlier. "Bo nus points" wi ll go fo r ideas that m ultip le agencies are excited about. l(b)(5) (b)(5) o Several t hemes came up:l(b)(5) l(b)(5) o Offic e of America n Innovat ion. Great update from Chris Lidde ll (forme r M icrosof t/GM CFO, working with Jared Kushner). Got a lot more clarity on what this office is. It is on ly 4 people and focused on big ideas. 1) Mode rn ization of government/IT services (e.g., our EMR). 2) Infrastr uct ure plan. 3) Workforce of t he f ut ure - whi ch includes ret rainin g/apprent iceship/et c. It is most ly conveni ng and bring ing in private sector (CEOs, academ ics, etc) . They have a CIO techno logy day on June 19 t hat we sho uld get plugged into. Specificagencybest practices that we shouldleverage(just some highlights) o (b)(5) VA-18-0298-C, VA-18-0299-C-000036 36 of 220 ?31(5) 37 Of 220 b)(5) Team - dependi ng on what piques your interest, let's discuss more. Also we shou ld leverage Josie/Mary to help us connect to othe rs. Scott VA-18-0298-C, VA-18-0299-C-000038 38 of 220 From: To : Subject : Date: BlackburnScottB ltbV6) FW: SecVA Shulkin Friday , Octo ber 20, 20 17 9: 2 1 :00 AM Will have to juggle the calendar a litt le bit. From: Blackburn, Scott R. Sent: Friday, October 20, 2017 9:21 AM To: !{b)(6) I Windom , John H. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline; l~ (b_)(_6_ ) ----------~ Subject: RE: SecVA Shulkin Yes, works for me. Then once we know wha t the Secretary wants to accompl ish w it h this meet ing, we' ll have the right materia ls to get us there. From: ~! (b~ )(~6 )___ ~ Sent: Friday, October 20, 2017 9:20 AM To: Blackburn , Scott R.; Windom , John H. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline; l._ (b_)_ (6_ ) _________ Subject: RE: SecVA Shulkin ___. Great idea. Can yo u chat w/SecVA briefly at 2pm on Monday? Than ks. From: Blackburn, Scott R. Sent: Friday, October 20, 2017 9:13 AM To:! (b)(6) I; Windom , John H. Cc: Prince-Wheeler , Latriece R.; Colli, Jacqueline; l(b)(6) Subject: RE: SecVA Shulkin .____________ __. We sure can. John wil l take the lead. However it might be good for the Secretary, John and I to hudd le for 10 minutes sometime today or Monday. I am not sure that we know exact ly w here they want to take the conversation (maybe John knows but this is my first time in one of these WH/EHR meet ings). I From: !(b)(6) Sent : Friday, October 20, 2017 9:09 AM To: Blackburn , Scott R.; Windom , John H. Cc: Prince-Wheeler, Latriece R.; Colli, Jacquelinel(b)(G) Subject: RE: SecVA Shulkin ._ __________ _. Thanks much!! To prepare the Secretary for meeting, can you all prepare mater ials for his meeting w/Jared? Thank you From: Blackburn, Scott R. VA-18-0298-C, VA-18-0299-C-000039 39 of 220 Sent: Friday. October 20, 2017 9:07 AM To: l{b)(6) Windom , John H. I Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline j~ (b_)(_6_ ) ---------~ Subject : RE: SecVA Shulkin Done! From: ..,_! (b-'-)(,_6._ ) ___ __, Sent: Friday, October 20, 2017 8:40 AM To: Windom, John H.; Blackburn , Scott R. Cc: Prince-Wheeler , Latriece R.; Colli, Jacqueline; l._ (b_)(_6_ ) _________ Subject: RE: SecVA Shulkin __. Scott and John - can yo u both fill ou t yo ur Vit als fo r ent ry to WH? Please confirm once comple t ed. Thanks! From: Windom , John H. Sent: Thursday , October 19, 2017 3:19 PM To:j (b)(6) Blackburn , Scott R. I Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline ~(b)(6) Subject : RE: SecVA Shulkin .._ ___ _, Honored to joi n. I w ill be the re. Vr John John H. W indom, Senio r Executi ve Service (SES) Prog ram Executive fo r Elect ron ic Healt h Record M odernizatio n {PEO EHRM) Spec ial Adviso r to the Unde r Secre t ary fo r Healt h 810 Vermo nt Avenue NW (Suite 375X) Washi ngto n, DC 20420 John Wiodom@vagov Office: (20 2) 46 1-5820 M ob ile :l._ (b_)(6_ )___ _. From: !"( b..:..: )( """"'6 )___ __. Sent : Thursday , October 19, 2017 2:44 PM To: Blackburn , Scott R.; Windom , John H. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline ,,_J (b_)(_6)__ Subject : SecVA Shulkin __. Hel lo - t he Secreta ry w ill be mee t ing w/Ja red Kushner o n Tuesday, Oct obe r 24 th at 5:30pm to d iscuss EHR, spec ifically ce rn er and epic. The Secretary asked if yo u bot h coul d jo in h im in meet ing. VA-18-0298-C, VA-18-0299-C-000040 40 of 220 Please let us know if yo u are available to atttend. Tha nk yo u. VA-18-0298-C, VA-18-0299-C-000041 41 of 220 From : l(b )(6) To : Cc: !(b)(6) Blackburn ScottB Subj ect : Date: FW: Summit next Tuesday - brief ly mentioned this befo re! Monday, December 04, 2017 12:55:47 PM Good afternoon Mr. Blackburn, Confi rming you wou ld like to attend th is meet ing next week? We can modify your schedule so you can attend the ent ire t ime. Please let me know if you wou ld like to bring anyone. Thanks, j(b)(6) I From: Moorhead, Quellie U. EOP/WHO[mailtol(b)(6) @who.eop.gov] Sent: Monday, December 04 , 2017 11 :46 AM To: !{b}(6} I Subject: [ EXTERNAL ] Summit next Tuesday - briefly mentioned this before! Hij(b)(6) Thanks for all of your help t oday! I forget who I briefly mentioned t his to , but Chris, Jared, and Seema are host ing this event next week and would love it if Scott cou ld attend if interested. Please let me know if he w ill be able to! We understand if he could only go fo r t he kick off at 1 PM and w rap up at 4 PM, but t here will be in depth, inte resti ng discussions from 2-4 wh ich he may f ind interest ing. Best regards, Quellie On behalf of Jared Kushner and Seema Verma, we are pleased to invite you to a listening session on Electro nic Healt h Reco rds Int erope rability t o be held at the White House on December 12th from 1.00-5.00pm. We are hold ing a series of these sessions w ith leaders in the healt h care sector. We are interested in unde rstand ing the op portu nity fo r the governme nt to help further progress inte rope rability with t he goal of positi vely impacti ng qua lity of care fo r Ame rican patients. We wil l have a group discussion on t he overall to pic, fo llowed by breako ut work ing sessions that address specific aspects of the top ic. We w ill send out those topics next week and upon your confirmation of atte ndance. PleaseRSVPnolater thanDecember 6th to OAl@who.eop.gov . We hope t hat you can joi n us and welcome your inp ut. VA-18-0298-C, VA-18-0299-C-000042 42 of 220 Sincerely, Jared Kushner Seema Verma Senior Advisor to th e President Adm inist rato r, CMS Office of Ame rican Innovat ion 202-88 1-7080 VA-18-0298-C, VA-18-0299-C-000043 43 of 220 BlackburnScottB WindomJohnH From : To : Subject : Date: FW: VA EHR Wednesday , March 2 1, 201810:20:00 PM Let's hope thi s lands well ... From: Blackburn, Scott R. Sent: Wednesday , March 21, 2018 10:20 PM To: 'Bruce Moskowitz'; 'Marc Sherman' Cc: DJS Subject: VA EHR Marc/ Bruce, Thank you o nce again fo r all you r support and especial ly for link ing us up with these ClOs/experts. This was incredib ly valuab le . Secret ary Shu Iki n, John W indom and I got together earlier today as we ll to talk about t he path ahead. A few notes: o In order to make sure we understand some of the more specific detai led points, members of o ur t eam reached out today fo r ind ividua l follow ups with Dr. Cooper, Dr. Karson, Dr. Shrestha, Jon Manis and Stephanie. Each have been so genero us w ith their time Stephanie will host us for a visit on Apr il 4 and Dr. Cooper offered to do the same at Mayo. o Dr. Zenooz did connect with Dr. Coope r today on the point Marc highlights below to make sure we are on th e same page and have the la nguage right (part was us better unders t andi ng his point; part was pointing him t o t he specific language in 5 .1.1 and giv ing him the broader context w ith what we are doing with Lighthouse as our API gateway and the VA Open API Pledge t hat 11 healthcare inst itutions signed two weeks ago include Cris Ross at Mayo as we ll St an Huff at lntermo unta in and Dr. Karson at Part ners). o We will also fo llow up with Stan on some of the issues he raised as wel l. For examp le: Stan wil l be excited to learn that Cerner has prior it ized an addit iona l 40 eng ineers to acce lerate FHIR APls for VA in suppo rt of th is co ntra ct. l(b)(5) o Per Step hanie's suggest ion, we are going to start moving forward ASAP on formaliz ing an Adv isory Comm ittee so t hat we can get these insights on an ongoing basis. Forma lizing th is wi ll allow fo r contin uity of expe rti se t hroughout our jo urney. Obviously we will wan t Stephanie, John, Andy, Rasu, etc. Cris Ross (Mayo), Will Morris or Ed Marx (Cleveland Clin ic), Frank Opelka (American College of Surgeo ns) are others you've introduced us to along the way t hat we wo uld love to incl ud e. We would like to work with you to ma ke sure we get th is rig ht. o As recommended last night, an interoperab ility sandbox/test bed will be estab lished d uring our Init ial Operating Capab ilities (IOC) implementat ion/dep loyment process to solidify t he VA-18-0298-C, VA-18-0299-C-000044 44 of 220 From : Bruce Moskowitz To : Cc: Black burn ScottB ~ gmail com kbl/6) Subject: Date: Fwd: [EXTERNAL] Follow up meeting Monday, November 27, 20 17 10:23: 10 AM I should point out this would be ideal functionality requirements of any EMR contract if not part of what has been reviewed by the VA we need to discuss these points further since they are derived from the previous meeting points made by the CIO's and we can again cover them in the agenda Sent from my iPad Bruce Moskowitz M.D. Begin forwarded message: From: Bruce Moskowitz Date: November 27, 2017 at 8:41:19 AM EST To: "Blackbum , Scott R." Cc: '](b)(6) l@gmail.com" Subject: Re: [EXTERNAL] Follow up meeting Plior to any meeting we need to know what is not in the contract so we can make progress: Cerner Contract has to have the responsibility of 100% connectivity to all EMR platforms for Choice to work Cerner has to have telemedicine built into the system Cerner needs to tract duplicate diagnostic testing Cerner needs to have medication error, tracking of controlled substances and duplicate presc ription monit oring Cerner needs to tract appointm ent times between the VA and the Choice Program. Cerner needs to have voice recognition built in These are the basics we need to know prior to writing an agenda and meeting. Thank you Sent from my iPad Bruce Moskowitz M.D. On Nov 26, 2017 , at 9:23 AM, Blackburn, Scott R. VA-18-0298-C, VA-18-0299-C-000045 45 of 220 wro te: Bru ce - thanks for the note. I hope you and M arc both had a grea t Thank sgiv ing. So unds goo d on all below . Let's shoot for the week of Decemb er 11th or December 18th in Was hin gton. If the CIO s can get us the list of issues by Decemb er 5th, we will turn aroun d the gap analys is quickly. Happy to work with Stephani e, Andr ew and Marc on the agenda deve lopme nt - that would be very helpful. Scott -----Ori g inal M essage ----)(...:6 )________ From: Bru ce Mos kowitz IL(b.:..: .f~""'m=ac=.=co=m= ] Sent: Fri day , Nove mb er 24, 20 17 7:08 PM To: Blackb urn, Sco tt R. Cc: l(b)(6) @gmaiJ.com Subj ect: [EX TERNA L] Follow up mee ting I am speaki ng for myself and it wo uld see m to me that holding it at Ce mer wo uld restrain an ope n honest discussio n of what is needed to insure that we have all the key pieces to have the the EMR that we all see as a necess ity to pro vide the end users with all tools necessa ry to provi de quality care. Th e five CIO 's are very know ledgeab le regar ding all capabiliti es of Cerner. I have been an end user of Cerner and know as do the CEO 's the process to quickly move the agen da forwar d. We are committed to your adoption of Cerner as the EMR howeve r being ru shed into a contrac t witho ut due dil igence o n our part wo uld be probl ematic. We ca n be ava ilable for a mee ting in Was hin gto n ASA P fully realizing some will nee d to be on a conference call. I wo uld reco mm end an agenda that reflects the way forwar d by bo th groups and wou ld recomme nd you allow Stepha nie Reel,Andrew Karso n and M arc Sherman to assist in the agenda developme nt. VA-18-0298-C, VA-18-0299-C-000046 46 of 220 from my iPad Bruce Moskowitz MD. 47 of 220 Cc: Windom,JohnH Black burn ScottB ZenoozAshwinj : MyklegardDrew:Short John/YAGO} Subj ect : Date: Imp ortan ce : Meeting with Secretary Shulkin Wednesday, March 2 1, 2018 9:15:37 AM High From : To : Sir, I recomme nd using the 1100-1130 meet ing wit h Shulkin to get clear direct ion from him on what it ta kes to close out the cont ract. The only comments I wo uld make from an act ion perspect ive: 1. We will be assemb ling the EHRM industry advisory council as discussed. Participants likely to include: Stephan ie Reel (Hopkins) Jon Manis (Sutter) Rasu (UPMC) Shafiq Rab (Rush) Chris Ross (Mayo) Vivek Reddy (lnt ermountain) Aneesh Chopra Ryan Howells (Leavitt Partners) Frank Opelka (America n College of Physicians) Will Morris or Ed Marx (Cleveland Clinic) Dr. Andy Karson (Mass General Hospital) Dr. Bruce Mo skowitz (Tenet) Alistai r Erskine (Geisinger) Daniel Barchi (New York Presbyterian) 2. We will set up t he recomme nded interoperab ility test platform/sandbox as part of our IOC effor t s and associated t esting requiremen t s. 3. We will solid ify t he DVP req uirements and associated API strategies based on comme nt s from the ext ernal experts. 4. 5. Re-validate interope rability, device regist ry, etc. language contained in the contract. Conti nue to sol idify our PEOstaffing st ruct ure in support of present and f ut ure contract oversight requ iremen ts. Mr. Secreta ry, w hat else did your hear? I believe we are ready. Thoughts .....? John John H. W indom, Senior Executive Service (SES) Program Executive fo r Electron ic Healt h Record Mode rnizatio n (PEO EHRM) Special Advisor to the Under Secretary for Health VA-18-0298-C, VA-18-0299-C-000048 48 of 220 811 Vermont Avenue NW (5th Floo r Suite 5080 ) Washi ngto n, DC 20420 Joh n.Windo m @va.gov Office: (202) 461 -5820 Mo bile: l(b)(6) ~--'--~;:::=:::::!.....-----, Execut ive Assistant : l(b)(6) l(b)(6) ~ Appo int ments and Schedu ling @va.gov Office: 202-382-3792 VA-18-0298-C, VA-18-0299-C-000049 49 of 220 NON-DISCLOSLR~: AGREEMENT 1. I acknowledge that I have been selected to participate in the planning for an electronic health record acquisition. In the course of participating in this acquisition, I may be or have been given access to or entrusted with Source Selection Information (as defined in Federal Acquisition Regulation (FAR) 2.10 l and 3.104). and/or other sensitive Government data marked or considered as "proprietary" (e.g., restrictive legend per FAR 52.215-1) that I cannol release to others nor can l use for the financial benefit of others or myself. Source Selection Information is defined in FAR 2.101 & 3.104 and other sensitive Government data includes data marked or considered as "proprietary" (e.g., restrictive legend per FAR 52.215-1). Data includes all data, information and sofuvare, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is derived from, based on, incorporates, includes or refers to such Source Selection and/or p.-oprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates, includes or refers to data shall be treated as Source Selection, or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. 2. I understand that 41 U.S.C. ? 423, commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101-2107, and provisions FAR 3.104 govern the release of proprietary and source selection information . I certify that I will not disclose any contractor bid, solicitation, proprietary, or source selection information directly or indirectly to any person other than a person authorized by the head of agency or the contracting officer to receive such infonnation. I understand that unauthorized disclosure of such information may subject me to substantial administrative, civil and criminal penalties, including fines, imprisonmcnl, and loss of employment under the Procurement Integrity Act or other applicable law~ and regulations. 3. I certify that I will not discuss evaluation of source selection matters with any unauthorized individuals (including Government personnel), even after contract award, without specific prior approval from proper authority. 4. These provisions are consistent with, and do not supersede, conflict with, or othernise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classifa:d information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection. The definitions, requirements, obligations, rights, sanctions, and liabilities created by controlling Executive orders and statutory provisions arc incorporated into this agreement and are controlling. These statutes and Executive orders include the following: ? Executive Order No. 12958; ? The Privacy Act (5 U.S.C. ? 552a); ? The Trade Secrets Act (18 U.S.C. ? 1905); ? Section 7211 of title 5, United States Code (governing disclosures to Congress); ? Section 1034 of title 10, United States Code, as amended by the Military Whistlcblower Protection Act (governing disclosure to Congress by members ofthc military); VA-18-0298-C, VA-18-0299-C-000050 50 of 220 ? Section 2302(b)(8) of title 5, United States Code, as amended by the Whistleblower Protection Action (governing disclosures of illegality, waste, fraud, abuse or public health or safety threals); ?The Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosures that could expose confidential Government agents); and ?The statutes which protect against disclosure that may compromise the national security, including sections 641, 793, 794, 798, and 952 oftitlc 18, Cnitel{e.ti i:al tu~ 'cS l offt'U-r Organization: ~It~ L,U 'r)~-6,_~ ~ ~-e__ Organizational Conflict(s) of Interest (OCis): AJ~ ~ Name Printed.: VA-18-0298-C, VA-18-0299-C-000051 51 of 220 NON-DISCLOSURE AGREEMENT 1. I acknow ledge that I have been selected to part icipate in the planning for an electronic health record acquisition. In the course of participating in this acquisition, I may be or have been given access to or entrusted with Source Selection Information (as defined in Federa l Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked or considered as "proprietary" (e.g., restrictive legend per FAR 52.215-1) that I cannot release to others nor can I use for the financial benefit of others or myself. Source Selectio n Information is defined in FAR 2.101 & 3.104 and other sensitive Government data includes data marked or considered as "propri etary" (e.g., restrictive legend per FAR 52.215- 1). Data includes all data, infmmation and software, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is derived from, based on, incorporates, includ es or refer s to such Source Selection and/o r proprietary data (collectively referred to herein as "the data") . Any data which is derived from , based on, incorporates, include s or refers to data shall be treated as Source Selection , or proprietary data and shall be subject to the terms of this Non-D isclosure Agreement. 2. I understand that 41 U.S.C. ? 423, common ly referred to as the Procur ement Integrity Act, and now codified at U.S.C.A. ? ? 2 101-2 107, and provisions FAR 3.104 govern the release of proprietary and source selection information . I certify that I will not disclose any contractor bid, solicitat ion, proprietary, or source selection information directly or indirectly to any per son other than a person authorized by the head of agency or the contracting officer to receive such information. I understand that unauthori zed disclosure of such information may subject me to substantial adminis trative, civil and crimina l penalties, including fines, impri sonment , and loss of employment under the Procurement Integrity Act or other applicable laws and regulations . 3. I certify that I will not discuss evaluation of source selection matters with any unauthori zed individual s (including Government personnel), even after contract award, without specific prior approva l from prope r authority. 4. These provisions are consistent with, and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Exec utive order relating to (1) class ified information, (2) communi cations to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantia l and specific dang er to public health or safety, or (4) any other whistleb lower protection. The definition s, requirem ents, obligations, rights, sanctions, and liabilities created by contro lling Executive orders and statutory provi sions are incorporated into this agreement and are controlling. These statutes and Execut ive orders include the following: ?Executive Order No. 12958; ?The Privacy Act (5 U.S .C. ? 552a); ?The Trade Secrets Act (18 U.S .C. ? 1905); D Section 7211 of title 5, United States Code (govern ing disclosures to Congress); ? Section 1034 of title 10, United States Code, as amended by the Military Whi stleblower Protection Act (governing disclosure to Congre ss by members of the military) ; VA-18-0298-C, VA-18-0299-C-000052 52 of 220 ? Section 2302(b)(8) of title 5, United States Code, as amended by the Whi stleblower Protection Action (gove rn ing disclosures of illegality , waste, fraud , abuse or publi c health or safety threats); ?The Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosur es that could expose confidential Governmen t agents); and ?The statute s whic h protect against disclosure that may compromi se the national sec urity , includin g section s 641, 793, 794, 798, and 952 of title 18, United St ates Code, and section 4(b) of the Subver sive Activities Act of 1950 (50 U.S.C. ? 783( b)). Additiona lly, pur suant to 38 Code of Fed eral Regul ation s 1.201, all VA employ ees with knowl edge or inform ation about actua l or possib le violation s of crimin al law related to VA program s, operat ions, fac ilities, contracts, or information technology systems shall immediately report such knowledge or information to their supervi sor, any management officia l, or directly to the Office of In spector General. Signature: Name Prin ted: Title: Organization: Organiza tional Conflic t(s) oflnterest (OCis): VA-18-0298-C, VA-18-0299-C-000053 53 of 220 \o o NON-DISCLOSURE AGREEMENT (Dated March 13, 2018) 1. I acknowledge that I have been selected to participate in the plamting for an electronic health record acquisition. In the course of participating in this acquisition, I may be or have been given access to or entrusted with Source Selection Information (as defined in Federal Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1) that I cannot release to others nor can I use for the financial benefit of others or myself. ' o Source Selection Information is defined in FAR 2. 101 & 3.104 and other sensitive Government data includes data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1). Data includes all data, information and software, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is derived from, based on, incorporates, includes or refers to such Source Selection and/or proprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates, includes or refers to data shall be treated as Source Selection, or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. 2. I understand that 41 U.S.C. ? 423, commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101-2107, and provisions FAR 3.104 govern the release of proprietary and source selection information . As it relates to the information that has been made available to me pursuant to this Non-Disclosure Agreement, I certify that I will not disclose any contractor bid, solicitation, proprietary, or Source Selection Information directly or indirectly to any person other than the President of the United States or a member of his administration to whom the President authorizes, another person subject to an equally restrictive Non-Disclosure Agreement related to the subject matter of this Agreement, the Secretary of the Department of Veterans Affairs or a person authorized by the head of agency or the contracting officer to receive such information. I understand that unauthorized disclosure of such information may subject me to substantial administrative, civil and criminal penalties, including fines, imprisonment, and loss of employment under the Procurement Integrity Act or other applicable laws and regulations. 3. I certify that I will not discuss evaluation of source selection matters with any unauthorized individuals (including Government personnel other than those set out in Paragraph 2 above), even after contract award, without specific prior approval from proper authority. 4. These provisions are consistent with, and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection. The definitions, requirements, obligations, rights, sanctions, and liabilities created by controlling Executive orders and statutory provisions are incorporated into this agreement and are controlJing. These statutes and Executive orders include the following: VA-18-0298-C, VA-18-0299-C-000054 54~ef- 220 NON-DISCLOSURE AGREEMENT Planning for an electronic health record acquisition , Dated Tuesday March 13, 2018 Page ll [::Executive Order No. 12958; [Jibe Privacy Act (5 U.S.C. ? 552a); [Jfhe Trade Secrets Act (18 U.S.C. ? 1905); [);ection 7211 of title 5, United States Code (governing disclosures to Congress); [);ection 1034 of title 10, United States Code, as amended by the Military Whistl~blower Protection Act (governing disclosure to Congress by members of the military); , [J;ection 2302(b)(8) of title 5, United States Code, as amended by the Whistleblower Protection Action (governing disclosures of illegality, waste, fraud, abuse or public health or safety threats); []The Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosures that could expose confidential Government agents); and [Jibe statutes which protect against disclosure that may compromise the national security, including sections 641, 793, 794, 798, and 952 of title 18, United States Code, and section 4(b) of the Subversive Activities Act of 1950 (50 U.S.C. ? 783(b)) . ., Additionally, pursuant to 38 Code of Federal Regulations 1.20 I, all VA employees -with knowledge or information about actual or possible violations of criminal la\v related to VA programs, operations, facilities, contracts, or information technology systems shall immediately report such knowledge or information to their supervisor, any management official, or directly to the Office of Inspector General. Signature: (b)(S) I' Name Printed: Isaac Perlmutter Organizational Conflict(s) of Interest (OCis): ~ ------------------------------------- VA-18-0298-C, VA-18-0299-C-000055 ??-ef-220 From: iTo: Cc: Subject: Date: W~ d~~ff John H ; YAC!OExecutjye Schedule; l(b)(6J I ~--~ 0 l(b)( S) ls1ackbum ScottB PHI RE: [EXTERNAL] RE: EHRVA Call Wednesday,March21, 2018 10:00:15 AM Secure Message Delivery From : Stan Huff Subject: PHI RE: [EXTERNAL]RE: EHRVA Call View Message Message available online until 05/20/2018 . Use your password to access the message. VA-18-0298-C, VA-18-0299-C-000056 56 of 220 To : Cc: BlackburnScottB Short John/VACO) : Zenoo z Ashwin i WindomJohnH Subject: Date: Thursday, March 15, 20 18 9:25:00 AM From : RE: [EXTERNAL] EMR calls Thanks. I passed t his on. From: Short , John (VACO) Sent: Wednesday, March 14, 2018 8:45 PM To: Zenooz, Ashwini Cc: Blackburn, Scott R.; Windom , John H. Subject: RE: [ EXT ERNAL] EMR calls Ash - Take a look at this DRAFT Response. Cerner's proposed solution for ICU central monitoring, as part of the VA EHR, utilizes Cerner's CareAware iAware framework through the Apache Outcomes solution. This solution has the capab ility to configure dashboard views to enable monitoring of high acuity areas, specifica lly around performance and patient care. This capability is included in the scope of the Cerner acquisition as the Critical Care System, Cerner Apache Outcomes solution and End User License Agreement. Does this capab ility also monitors emergency rooms, recovery rooms and tele m etry beds? The current acquisition solutions meet these requirements and can be configured into a central command cente r model. o Emergency Room : Emergency Department (ED) Dashboard is built into the Emergency Department Care Management to monitor progression of patients through the patient care pro cess. This solution has been included as an Emergency Medicine System and End User License Agreement. o Recovery Room : Surgical Management solution has tracking boards to monitor patient progress and efficiency of care provided. This solution has been included as Perioperative System and End User License Agreement. o Telemetry Beds: Tradit ional cent ral monito ring systems as are used in telemetry, exist within the VA's current environment. During the acqu isition process it was decided t hat these solutions wil l persist into the future state to reduce costs for the VA. However, the acquisition includes integration of this capability. In addition to these monitoring capabilities, CareAware Patient Flow, which is Cerner's capacity management solution that helps to operational ize patient care activities such as room cleaning offers specific dashboards that can be centralized to support a central command center model. From: Windom , John H. Sent: Wednesday, March 14, 2018 7:00 PM To: Zenooz, Ashwini; Blackburn, Scott R.; Short , John (VACO) VA-18-0298-C, VA-18-0299-C-000057 57 of 220 Subject : RE: [ EXTERNAL] EMA calls I would it make the response overly complex. Jw Sent with Good (www .good.com) From: Zenooz , Ashwin i Sent: Wednesday, March 14, 2018 3:44:50 PM To: Windom , John H.; Blackburn , Scott R.; Short , John (VACO) Subje ct : RE: [ EXTERNAL] EMA calls John Sho1t and I are worki ng on a response. He should have something back from John Short by 8p. Thx Sent with Good (www.good.com) From: Windom , John H. Sent: Wednesday, March 14, 2018 3:31 :07 PM To: Blackburn , Scott R.; Zenooz, Ashw ini; Short , John (VACO) Subje ct : RE: [ EXTERNAL] EMA calls Ash Did you closeout this request from Mr Blackb um? I was not copied on anything. This is a docto r to doctor tasking. Thx Jw Sent with Good (www.good.com) From: Blackburn, Scott R. Se nt: Wednesday, March 14, 2018 9:55:20 AM To: Zenooz, Ashwini; Windom, John H.; Short, John (VACO) Subje ct : RE: [ EXTERNAL] EMA calls Thanks. Can you guys wri t e me a shor t respo nse to Bruce tha t I can cut/paste? I wa nt to ni p th ese t hings in the bud so we can get t his damn t hing over t he goalline ! It is cru nch time. From: Zenooz , Ashwin i Sent : Wednesday, March 14, 2018 12:54 PM To: Windom , John H.; Blackburn , Scott R.; Short , John (VACO) Subje ct : RE: [ EXTERNAL] EMA calls That is correct. Through LightsOn and system config we would be able to view enterprise VA-18-0298-C, VA-18-0299-C-000058 58 of 220 wide ICU, ED activity etc. at a central command . Sent with Good (www good com) From: Windom , John H. Sent: Wednesday, March 14, 2018 9:50:28 AM To: Blackburn , Scott R.; Short , John (VACO); Zenooz, Ashwini Subje ct: RE: [ EXTERNAL] EMR calls This is part of contract and standard EHR implementation practices/solutions. The team will validate. John Sent with Good (www .good.com) From : Blackburn , Scott R. Sent : Wednesday, March 14, 2018 9:37:42 AM To: Windom , John H. ; Short , John (VACO); Zenooz, Ashwini Subje ct : FW: [EXTERNAL] EMR calls -----Orig inal Message ----From: Bruce Moskowitz .-l (b-)-(6_)_______ _,l@mac com] Sent: Wednesday, March 14, 2018 12:18 PM To : Blackburn, Scott R. Subject: [EXTERNAL] EMR calls To save time can you tell me if the Cerner contract has a provis ion to have the EM R that is in Intensive care units interact with a centra l monitoring system? Currently all major institutions have a command and contro l center staff that mon itors intensive care units located in different hospitals in their system. The future is expanding this to monito r emergency rooms , recovery rooms and telemetry beds . If it is not in place which should be a standard part of the contract we will have billions in further costs to the system. Sent from my iPad Bruce Moskowitz M.D . VA-18-0298-C, VA-18-0299-C-000059 59 of 220 From : To : Cc: Subj ect : Date: Zenoo z Ashwin i Short John/VACO) Blackbu rn ScottB : WindomJohn H RE: [ EXTERNAL] EMR calls Wednesday , March 14, 2018 8:52 :21 PM Thanks. Thi s looks accurate. Sent with Good (www.good.com) From: Short , John (VACO) Sent: Wednesday, March 14, 2018 5 :44:58 PM To: Zenooz, Ashwi ni Cc: Blackbu rn, Scott R.; Windom , John H. Subject : RE: [ EXTERNAL] EMR calls Ash - Take a look at this DRAFTResponse. Cerner's proposed solution for ICU cent ral monito ring, as part of the VA EHR, utilizes Cerner's CareAware iAware framework through the Apache Outcomes solution. This solution has the capability to configure dashboard views to enable monitoring of high acuity areas, specifica lly around performance and patient care. This capability is included in the scope of the Cerner acquisition as the Critical Care System, Cerner Apache Outcomes solution and End User License Agreement. Does this capab ility also monitors emergency rooms, recovery rooms and tele m etry beds? The current acquisition solutions meet these requirements and can be configured into a central command center model. o Emergen cy Room : Emergency Department (ED) Dashboard is built into the Emergency Departm ent Care Management to monitor progression of patients through the patient care process . This solution has been included as an Emergency Medicine System and End User License Agreement. o Recovery Room : Surgical Management solution has t racking boards to monitor pat ient progress and effic iency of care provided. This solution has been included as Perioperative System and End User License Agreement. o Telemetry Beds: Tradit ional central monitoring systems as are used in telemetry, exist within the VA's current environment. During the acqu isition process it was decided that these solutions wil l persist into the futu re state to reduce costs for the VA. However, the acquisition includes integration of this capability. In addition to these monitoring capabil ities, CareAware Patient Flow, which is Cerner's capacity management solution that helps to operational ize patient care activities such as room cleaning offers specific dashboards that can be centralized to suppo rt a central command center model. VA-18-0298-C, VA-18-0299-C-000060 60 of 220 From: QJ.S. To : BlackburnScottB Subject : Date: RE: [EXTERNAL] Follow up meeti ng Saturday, November 25 , 2017 8:52:54 AM Yes sound s right And agree eve ryth ing needs to be done within the correct confines Sent with Good (www.good.com) From: Blackburn, Scott R. Sent: Friday, November 24, 2017 5:09:19 PM To: DJS Subject: RE: [ EXTERNAL] Follow up meeting How about this for next step s ...? + I respond with "so unds good, let 's shoot for week of 12/ 11 or 12/18 in Was hington" + W indom, myself and Jay from MITRE (he has done a goo d job as faci litator) work with the folks he names below on the agenda for the full day session + ask Bruce /Marc /CI Os to move forward ASAP with the list of issues that he mentioned they wo uld deve lop. Ask for the se by 12/5. We will turn around the gap analysis by 12/ 11. I know Bob Fleck and OGC had some conce rn s about the extent we solicit outs ide op inions on a contract being negot iated (after we mention ed it in testimony). Also they expressed concern s abo ut triggeri ng FACA rule s. Wil l also work with them to make sure we do this in an appropriate way. Thou ghts? Se nt with Good (www .good.com) From: DJS Sent: Friday, November 24, 2017 7:52:54 PM To: Blackburn , Scott R. Subject : RE: [ EXTERNAL] Follow up meeting Thanks Sent with Good (www .good.com) VA-18-0298-C, VA-18-0299-C-000061 61 of 220 To : Windom,JohnH BlackburnScottB Subject : Date: RE: [EXTERNAL] Fwd: Call with Secretary Shulkin Sunday, March 11, 2018 11:19:59 PM From: Thank you for sharing. Jw Sent with Good (www.good.com) From: Blackburn , Scott R. Sent: Sunday, March 11, 2018 7:10:57 PM To: Windom , John H. Subject: FW: [EXTERNAL] Fwd: Call with Secretary Shulkin FYI. I will learn more tomorrow morning. From: David Shulkin [mailtoj (b)(6) l@gmail.com] Sent: Sunday, March 11, 2018 5:55 PM To: Blackburn, Scott R. Subject : [EXTERNAL] Fwd: Call with Secretary Shulkin Can you join me at morning report in the am- 8 or 815 am to discuss next steps on this Note the emai ls below Sent from my iPhone Begin forw arded message: From: Bruce Mo skowit z i(b)(6) l@mac.com> Date: March 11, 2018 at 12:57:53 PM EDT To: Ste hanie Reel ~ hu.edu> .l(b)(6) l@imail.org . .o-, lfwfil@facs.org " ~ facs.org>, (b)(6) (b)(6) m , "Karson, And rew Scott, M. D. " (b)(6) m h.ha . Cc: David Shulkin (b)(S) mail.com>, IP ~frenchang: 6 l(b)( ) tglgmail.com,1, ~reagan.com The Secr etary will send out an email to set up a conference call to discuss the review of the EMR contract for the VA. Thi s has treme ndou s importanc e not ju st for the VA, but setting a standard for interoperab ility for the nation and also EMR innovation. I want to take the opportun ity to thank everyone for their service to the Veterans and adva ncing health care for the nation Sent from my iPhone VA-18-0298-C, VA-18-0299-C-000062 62 of 220 l(b )(6) From: To: BlackburnScottB : Colli Jacque line !ib)/6) I Cc: Subject : Date: Scott- RE: [EXTERNAL] Fwd: Call with Secretary Shulk in Monday, March 12, 2018 7:34:14 AM what time are you back at VACO? He would like to speak with you in person vice d ialing in. You are on the calendar at 4:30p t his afternoon to talk about Cerner. From: Blackburn, Scott R. Se nt : Monday, March 12, 2018 5 :49 AM To:! (b)(6) I; Colli, Jacqueline Subje ct : RE: [ EXTERNAL] Fwd: Call with Secretary Shulkin Great Sent with Good (www.good. com) From:!~(b_)(6 _)___ ~ Se nt : Monday, March 12, 2018 5:20:59 AM To: Blackburn , Scott R.; Colli, Jacqueline Subje ct : RE: [ EXTERNAL] Fwd: Call with Secretary Shulkin Will do. Will call you on your cell when they are ready, which may be at 8ish. Thank s Sent with Good (www.go od.com) From: Blackburn, Scott R. Se nt : Sunday, March 11, 2018 7 :10:17 PM To : l(b)(6) ~ Colli, Jacqueline Subje ct : FW: [EXTERNAL] Fwd: Call with Secretary Shulkin Can you see if they can ring my ce ll whenever they are ready to talk about this? From: Blackburn, Scott R. Se nt : Sunday, March 11, 2018 9:31 PM To: David Shulkin Subje ct : RE: [ EXTERNAL] Fwd: Call with Secretary Shulkin Do you mind if I call in? Or you guys dial my cell? I have a dentist appointment at 7am. Sent with Good (www.good.com) From: David Shulkin VA-18-0298-C, VA-18-0299-C-000063 63 of 220 From: BlackburnScottB DayjdShulkin To: Subject : Date: Attach ments : RE: [EXTERNAL] Fwd: Contact review Monday , March 12, 2018 9:15:00 PM ND.A,__b[an k EHBM.JQLlig~ Attached is the NOA. Let me know if you'd like me to send it to Ike/Bruce/Marc direct ly. You can have them send it back to me direct ly and then I' ll get someone from Wi ndom's team to send them the package and wal k them t hro ugh it. Stan Huff responded positively and we sent him t he NOA. The only person that is yet to respond is Dr. Leslie Cooper from Mayo. My goal is for each of t hem to have th e NOA signed, cont ract in hand, and someone has wa lked t hem thro ugh how to read t he co ntra ct - by EOD tomorrow if possible. if From: DavidShulkin~b)(6) gmail.com] Sent : Monday,Marc 12, 2018 4:18 P To: Blackburn, Scott R. Subje ct : [ EXTERNAL] Fwd: Contact review Can we get them the nda as well? Sent from my iPhone Begin forwarded message: From: IP ~frenchange159.corn> Date: Mar'cni'2 , 2018 at 2:50 :52 PM EDT To: David Shulkin (b)(6) mail.c m> Cc: (b)(6) mail.com" (b)(6) mail.com>, 6 l@gmaij com>, Bruce Mo skowitz (b)( ) " 1(b)(6) Subject: RE: Contac t review David , How quick can yo u send the NDA to the people? And why not send it to Bruc e, Marc and myself so we can work arou nd the clock to fini sh this? Thank you. -----Original Message ----~----------~ From: Bru ce Moskow itzl(b)(6) Sent: Mo nday , Ma j.ch J 2 ?QJ8 2:03 PM To: David Shu lkin (b)(G) l@gma il.com> l(b~~l:IP ~ =a~~~~~9.corn> j(b)(6) kwmac.com] @gmail.com; Subject: Re: Contact review The following may be discussed on the review however if not , we need to be sw-e VA-18-0298-C, VA-18-0299-C-000064 64 of 220 From : To : Subject : Date: BlackburnScottB SandovalCamiloJ RE: [EXTERNA L] Fwd: EMR Wednesday , March 07, 2018 2:44:00 AM I like it. W ill do. Also just fo rwarded wha t we shared with Bruce last week. We are close. We w ill get t here. Bruce seems posit ive . I am hope f ul Rasu and Manis wi ll help. From: Sandoval, Camilo J. Sent: Tuesday, March 06, 2018 7: 12 PM To: Blackburn, Scott R. Subject: RE: [ EXTERNAL ] Fwd: EMR Is Bruce's email one of the questions you t hink we've alr eady answered in the past? Can I offer a suggest io n? Could we possib ly create a t racker on all t he incom ing quest io ns/answe rs? I believe th is might clar ify the question and he lp get a qu icke r rep ly and keep everyone on the same page. Example below based on w hat Bruce requested to day. Thoughts? Question/Topic Follow-Up Questions Response/Comments 1. o o o Strategy? o POC? Cloud Are we gett ing the clo ud co rre ctly 2. 3. CIO Physician Inp ut 4. 5. App le Project o o o o o o o o o o Candidate Poo l? Document ref erence? o Key Qualif icat io ns? Separat ion of roles? Pat ient Centric? o Physician Usability Scope? o Who is POC? o Project upda t e? Menta l Health Strategy and Portable EMR Solution tha t works wi t h DOD & VA & Community? 6. 7. o o o o VA-18-0298-C, VA-18-0299-C-000065 65 of 220 To : MqUiganRicci BlackburnScottB : MyklegardDrew Subject : Date: RE: [EXTERNA L] Fwd: EMR Tuesday, March 06, 2018 10:01:04 AM From: Scott, Drew and I will put something together, btw , Patty in VHA has been trying to set up the conversatio n with Bruce. Ricci Sent with Good (www.good.com) From: Blackburn , Scott R. Sent: Tuesday , March 06, 2018 5:42:23 AM To: Mulligan , Ricci; Myklegard , Drew Subject: FW: [EXTERNAL] Fwd: EMR See note be low on Apple project. Thought s on how to respond? Sent with Good (www .good.com) From: David Shulkin Sent: Tuesday , March 06, 2018 7:09:43 AM To: Blackburn , Scott R. Subject: [ EXTERNAL] Fwd: EMR Can we begin to address and then ill respond back ? Sent from my iPhone Begin forwarded message: From: Bruce Mo skowitz j(b)(6) Date: March 5, 2018 at 6:49:58 AM EST To!(b)(G) Cc:l(b)(G) l(b)(G) @mac .com> @gmail.com!(b)(6l ~~~~~~~ ~ = ii.com, IPt'.j @french O 5 l@gma'--- - >, Subject: EMR I would like to underscore the importance of getting the "Cloud "correctly and the other four issues with the new CIO ' s. Also the compos ition of the phy sician input has to change immediately so that the EMR is patient centric and usable from the physician perspective. Second this is going to take years to implement and especia lly in mental health we need a portabl e EMR solution that works with the DOD , the VA and the privat e sector. No one at the VA got back to me on what the Apple project can and can VA-18-0298-C, VA-18-0299-C-000066 66 of 220 To : MyklegardDrew MulliganRicci:BlackburnScottB Subject : Date: Tuesday, March 13, 20 18 11 :56:53 PM From : RE: [EXTERNAL]Fwd: EMR Where are we with Dr. Mo skowitz? Sent with Good (www .good.com) From: Mulligan, Ricci Sent: Tuesday, March 06, 2018 10:01 :05 AM To: Myklegard, Drew; Blackburn, Scott R. Subject: RE: [ EXTERNAL ] Fwd: EMR Agree , when? Ricci Sent with Good (www .good.com) From: Myklegard, Drew Sent: Tuesday, March 06, 2018 6:02:25 AM To: Blackburn, Scott R.; Mulligan, Ricci Subject: Re: [ EXTERNAL ] Fwd: EMR Have a meet ing w here our VA team and Apple (Ric ky and/or Jacky) walk Bruce th rough the ir slide deck that explai ns w hat t hey are doing. Use it as an opportunity for Shaman to build a relat ionship w it h him as VA gets closer to making our annou ncement. M aybe an email like this : We wou ld like to get our t eam, App le, and you on a pho ne call to walk you t hro ugh th e Veteran/pat ient experience and how it wil l improve the ir care. On t his ema il is our clinical leadf or the App le engagement, Dr. Shaman Singh MD. He w ill take the lead fo r coord inat ing a meeting. From: " Blackburn, Scott R." Date : Tuesday, March 6, 2018 at 5:42 AM To: Ricci Mulligan , "Myklegard, Drew" Subject : FW: [EXTERNAL] Fwd: EMR See note below on App le project. Thoug hts on how to respond? VA-18-0298-C, VA-18-0299-C-000067 67 of 220 To : ZenoozAshwini Windom JohnH : Blackburn Scott8 : Short John /VACO\ Subject : Date: RE: [EXTERNA L] Fwd: EMR Tuesday, March 06, 2018 9:45:40 AM From : On physician and patient centric EHR: creating workflo ws with front line provide rs in-mind and engaged is the core part of change management strategy . Business and Clinical Requirements for Phase 1 of the acq uisition were prov ided by Integrated Teams comprised of 200+ front line clinicians. Phase 2: in-depth workflow development for Cerner to implement at each site with follow a similar model. We are NOT adopting run-of-the-mill Cemer workflow s. They will be configured based on requirements set forth by VA Clinical teams and Clinical Practice Guide lines. Patient Perspective: We have engaged with VA patient centered design teams since day 1 of the project and our baseline discussio ns with Cerner started with the Veteran journey. Additionally, VS Os have been very engaged and have been/will be part of the design input and review as we implement pat ient portal, mobile scheduling etc. Patient Centric EHR: Our focus is on providing high quality , value-based care and that was the basis of the "Choose VA" campaign. The goal of this implementation is to enable reliable metric s and data return s, measure outcome s so that patients have faster, access to quality care. Please let me know if there are questions. I' II be at the Venetian all day .l(b ...._)(_6_ ) _________ __. Ash Sent with Good (www .good.com) From: Windom, John H. Sent: Tuesday, March 06, 2018 6:16:13 AM To: Blackburn, Scott R.; Zenooz, Ashwini; Short, John (VACO) Subject: RE: [ EXTERNAL ] Fwd: EMA Ash and John S., Please prov ide a one short paragraph technical and functional response for Mr. Blackburn to these eleme nts t hat we have covered as part of ou r efforts. I can tell that our journey is coming to a close in the good Doctor's m ind. Please do not create any ambigu ity or open up any cans of worms in your responses. "Clear and conc ise." Thank you. Break Mr. Blackburn/ I provided you the Apple comparison matrix awhi le back but wi ll send you again. My e-mail highlighted that the App le sol ut ion that was announced is effective ly portable electron ic file cabinet not an EHR/EMR. V/r, John John H. W indom, Senior Executive Service (SES) VA-18-0298-C, VA-18-0299-C-000068 68 of 220 Program Executive for Electron ic Health Record Modernization (PEO EHRM) Specia l Advisor to the Under Secretary for Health 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 John.Wiodom@va.gov Off ice: (202) 461 -5820 Mobile J(b)(6) '----:---:--:--:--:-~-------, Executive Assistant: MS.l(b)(6) l(b)(6) ~y a.gov Office: I-Appo intments and Schedu ling (202) 461 -6618 From: Blackburn, Scott R. Sent: Tuesday, March 06, 2018 8:42 AM To: Windom, John H.; Zenooz, Ashwini; Short, John (VACO) Subject: FW: [EXTERNAL] Fwd: EMR See email below . Any thoughts on how to respond? Sent with Good (www.good.com) From: David Shulkin Sent: Tuesday, March 06, 2018 7:09:43 AM To: Blackburn , Scott R. Subject : [ EXTERNAL]Fwd: EMR Can we begin to address and then ill respond back ? Sent from my iPhone Begin forwarded message: From: Bruce Mo skowitz ~(b)(6) Date: March 5, 20 18 at 6:49:58 AM EST To: kbl/6} @gma il.com,l(b)(6) Cc: l(b)/6} Jf::!.il.com, IP ~french l(b)(6) tg)gm~.:___ Subject: EM R ~=~~!: @mac.com> >, I would like to underscore the importance of getting the "Cloud"correctly and the other four issues with the new CIO ' s. Also the compos ition of the physician input has to change immediate ly so that the EMR is patient centric and usable from the physician perspective. Second this is going to take years to implement and especia lly in menta l health we need a portabl e EMR solution that works with the DOD , the VA and the private sector. No one at the VA got back to me on what the Apple project can and can not do in terms of solving this problem . VA-18-0298-C, VA-18-0299-C-000069 69 of 220 From : Marc Sherman To : Cc: Blackburn ScottB Schn itzer JayJ: If; BruceMoskowit z Subj ect : Date: Wednesday , January 17, 2018 4:52: 23 PM Re: [ EXTERNAL] Re: CIOs I got your dial in and that works. Talk to you at 7:30 On Wed , Jan 17, 2018 at 10:45 AM, Blackb urn, Scott R. wrote: That wor ks. Talk to you t hen. If you have a dia l in th at yo u prefer, let us know. Otherw ise I can ask my assistant to send one out. From: Marc Sherman d(b)(6) @gmail.com] Sent: Wednesday, January 17, 2018 10:37 AM To : Blackburn, Scott R. Cc: Schnitzer, Jay J; IP; Bruce Moskowitz Subject: RE: [ EXTERNAL]Re: CIOs If toda y, 7:30pm? Marc Sherman ~b)(6) On Jan 17, 2018 9:28 AM , "Blackburn , Scott R." wrote: M arc - t hanks so m uch for t he suppo rt. Good idea to jump on the pho ne to discuss. Today is best fo r me, but I can make t omo rrow wor k as we ll. Am sure Jay will be flexib le as well. Do you want t o propose a ti me? Scott From: Marc Sherman l(b)(6) l@gmail com] Sent: Wednesday, January 17, 2018 9:12 AM To: Blackburn, Scott R. VA-18-0298-C, VA-18-0299-C-000070 70 of 220 Cc: Schnitzer, Jay J; IP; Bruce Moskowitz Subject: [EXTERNAL ) Re: CIOs Scott I understand the goal, but not certain I understand the process or approach to solving the goal. Would you and Jay be available late today or t omorrow to discuss so I know better what you are asking? I am copying Bruce and Ike so they know what my tho ughts/ questions are as we ll. Marc On Mon, Jan 15, 2018 at 3:23 PM, Blackburn , Scott R.< Scott.BJackbum@va. gov> wrote: Marc, I hope you had (or are still having) a nice MLK weeke nd. One thing that came out of discussions with the Secretary last week that I was wonder ing if we could get you/Bruce's help on. The Secretary asked MITRE to help us understand what it would take for one of the large Epic based health care systems (e.g., John s Hopkins, Cleveland Clinic, Kaiser Permanent e, Partners, Mayo Clinic, Geisinger) to be able to "plug into" (my words) the future VA/Ce rner based systems to seamlessly excha nge data. We keep hearing that it would only be a modest technolo gy investme nt and would instead require these provide rs to demand this as a requirement of Epic (we will be able to demand it of Cerner). He has asked MITREto better under stand this and estimate how much would it cost (is it a $100k investment, a $ Im, $ 10m, $100m or a $lb investment?). In order to do this, MITRE would need the help of the CIOs. Ideally the Secretary would love to announce commitme nts of these healthcare systems to do this when he gives the keynote at HIMSS in Las Vegas on March 9. Is this something you guys would be willing to help with? I am cc'ing Dr. Jay Schnit zer from MITRE who is helping us out (I believe you met Jay at least via phone last week). VA-18-0298-C, VA-18-0299-C-000071 71 of 220 Thank s, Scott Scott Blackburn Executive in Charge , Offi ce of Information & Technology US Departm ent of Veterans Affairs VA-18-0298-C, VA-18-0299-C-000072 72 of 220 From: To : Subject : Date: !ib}/6} Blackburn ScottB RE: [EXTERNAL] Re: CIOs Wednesday , January 17, 20 18 2:2 3 :53 PM Okay, ju st sent. I didn' t inc lude M r. Pel mu tter so please let me know if they decide he nee ds t o be added . From: Blackburn, Scott R. Sent: Wednesday, January 17, 2018 2:12 PM I To:! (bl(6l Subject: RE: [ EXTERNAL] Re: CIOs Importance: High Please do I From: j(b)(6) Sent: Wednesday, January 17, 2018 1 :45 PM To: Blackburn , Scott R. Subject: RE: [EXTERNAL] Re: CIOs 6 Yes, you can use~l (b_)(_ _ ) ------~I .Should I sen d a calenda r inv ite? From: Blackburn, Scott R. Sent: Wednesday Januar 17, 2018 1 :42 PM To: l(b)(6) Subject: FW: [EXTERNAL] Re: CIOs Importance: High Can yo u set up a dia l in fo r t his call tonig ht at 7:30pm? I t hin k it is j ust me, Jay Schnitzer, Ma rc She rman and Dr. Moskow it z. I do not thi nk t hat M r. Pe l mut t e r is planni ng t o d ial in (Ma rc o r Bruce w ill te ll us if they are) . From: Blackburn, Scott R. Sent: Wednesday , January 17, 2018 10:46 AM To: 'Marc Sherman ' Cc: Schnitzer , Jay J; IP; Bruce Moskowitz Subject: RE: [ EXTERNAL] Re: CIOs That wo rks. Tal k to you then. If yo u have a dia l in that you prefer, let us know . Ot he rwise I can ask my assist ant to send one ou t. From: Marc Sherman l(b)(6) t@gma il com] Sent: Wednesday, January 17, 2018 10 :37 AM To: Blackburn , Scott R. Cc: Schnitzer , Jay J; IP; Bruce Moskowitz Subject: RE: [EXTERNAL] Re: CIOs If today , 7:30pm ? Marc Sherman VA-18-0298-C, VA-18-0299-C-000073 73 of 220 From: Schnitz er, Jay J To: BlackburnScottB Subject : Date: Wed nesday , January 17, 2018 10:48:22 AM RE: [EXTERNAL] Re: CIOs Perfect , thank s. Jay J. Schnitzer, M.D ., Ph .D. MITRE From : Blackburn, Scott R. Date: Wednesday, Jan 17, 2018, 10:46 AM To: Schnitzer, Jay J l(b)(6) @mitre .org> Subject: RE: [EXTERNAL ] Re: CIO s Yep, let's plan on 7:30pm. I'm assumi ng it w ill be M arc/Bruce (rather than Ike). From: Schnitzer, Jay J j(b)(6) @mitre.org] Se nt: Wednesday, January 17, 2018 10:42 AM To: Blackburn, Scott R. Subjec t : RE: [EXTERNAL]Re: CIOs Hi Scott , I will mak e 7:30 pm today work, if yo u wish. Be st, Jay Jay J. Schnit zer, M.D., Ph .D. MITRE From: Marc Sherman <1/h)lf;, @gmail.com> Date: Wednesday , Jan 17, 2018, 10:37 AM To: Blackburn, Scott R. Cc: Schnitzer , Jay J (mitre .org>, IP ~ l(b)(6) c,con > Subject : RE: [EXTERNA L] Re: CIO s ~:a frenchange l59.com>, Bruce Moskowitz If today, 7:30pm? Marc Sherman l(b )(6) On Jan 17, 2018 9:28 AM, "Blackburn, Scott R." wrote : M arc - than ks so muc h fo r the suppor t. Good idea to j ump on t he phone t o discuss. Today is best for me, but I can make tomorrow work as well. Am sure Jay w ill be flexible as we ll. Do yo u wa nt to propose a time? Scot t VA-18-0298-C, VA-18-0299-C-000074 74 of 220 From: l(b)(6) To : BlackburnScottB Subject : Date: Thursday, March 15, 2018 2:24:45 PM RE: [EXTERNA L] Re: EHRVA Call Okay, I w ill start ove r and get Mr. Marc and Dr. Bruce's availability first. From: Blackburn, Scott R. Se1t: Thursday,March15, 2018 2:21 PM To: (b)(6) Subject: FW: [EXTERNAL]Re: EHR VA Call Importance: High I Let' s see if we can do one big call next week. Sent with Good (www.good.com) From: Bruce Moskowitz Sent: Thursday, March 15, 2018 1:27:32 P~M ____ ~ To: Windom, John H.; Blackburn, Scott R.; k...b._.)1...,6..._) ___ _. Cc: !/bJ/61 @gmailcom; IP; O'Rourke, Peter M. Subject : [ EXTERNAL]Re: EHRVA Call I want to make sure we are all in agreement of how this is strnctured . Marc and I want to be on every call that the group is on to discuss the contract. The who le group needs to be on the same call so we all give input to the whole contract and hear the same consideratio ns and comme nts. Let me know if there is any discrepancy to this. Thank you Sent from my iPad Bruce Moskow itz M.D. On Mar 15, 2018, at 12:28 PM , VACIO Executive Schedu le wrote: VA-18-0298-C, VA-18-0299-C-000075 75 of 220 From : To : Wynn , Jackie Cc: MoorheadOuellie U EOP/WHO : Blackburn ScottB SullivanMaryJo Subj ect : Date: Thu rsday, January 04 , 20 18 12 :08:31 PM RE: [EXTERNAL] RE: Friday afternoo n Thank you! Thank s in advance Jackie ----- Origina l Mes sage----From: Moorhead , Quellie U. EOP/WH q (b)(6) l@who eop i:ov] Sent: Thursday, January 4, 2018 10:28 AM To: 'Blackburn, Scott R.'; Wynn , Jackie j(b)(6) ~mitre .org> Subject: RE: [EXTERNAL] RE: Friday afternoon Hi Scott and Jackie, Chris is still planning on attending this event that starts at 1:30! Thank you for keepin g me in the loop. Kind regards, Quellie ----- Original Message ----From: Blackburn , Scott R. [maj)to.Scott BJackburn@va i:ov] Sent: Wednesday, January 3, 2018 8:44 PM To: Moorhead, Quellie U. EOP/WHO ~--(b-)-(6_)____ _, @who.eop.gov>; Wynn , Jackie 4(b)(6) Subject: RE: [EXTERNAL] RE: Friday afternoon @mitre.org> Hi Quellie - my apologies . The Secretary asked that we move this up to start at 1:30pm. I hope this doesn 't screw up Chris' sche dule on Friday. We would really love for Chris to attend. Scott Sent with Good (>www .good.com<) From: Moorhead , Quellie U. EOP/WHO Sent: T uesday, January 02, 20 18 7:26:40 PM To: Wynn , Jackie Subject: [EXTERNAL] RE: Friday afternoon Thank s for the introduction , Scott! To bee Hi Jackie , I currently have 3 PM held on Chris 's schedule for the read out (with an hour of travel time before ). Please let me know when the details are finalized so we can confirm his participation in this event! Thank you, VA-18-0298-C, VA-18-0299-C-000076 76 of 220 Quellie From: Blackburn , Scott R. [mailto:Scott.Blackburn@ va.~ov] Sent: Tuesday, January 2, 2018 1:16 PM To: Wynn, Jackie l(b)(6) !@mi tre.org> Cc: Moorhead, Quellie U. EOP/W HO 1,... (b_)_(6-)-----.. ~who.eop.gov> Subject: RE: Friday afternoo n Hi Jack ie - I'm cc' ing Quellie Moorhead (Chr is' assistant). Quellie - this is in regard to the email excha nge Chr is/I had this morning. MITRE is hosting a panel on Friday with experts spec ifically on VA's Electron ic Health Reco rd Jnteroperability issues. Many of the expe rts are over lapp ing w ith who you invited to the White House a few weeks ago. l invited Chr is to come to the "debrief' with the Secretary later in the afternoon. I know he is interested but we are still working out time/ logist ics (wh ich Jackie from MITR E is working to fina lize). Happy New Year! Scott From: Wynn, Jack ie tl(b)(6) u!)mitre.ore;) Sent: Tu esday, Januar y 02, 20 18 l:ll PM ,------.. To: Blackburn, Scott R.; Colli, Jacquel ine:l._ (b_)(_6_) ___ Subject: [EXT ERNAL ] RE: Friday afternoon _.. Scott Can you send me Chris Liddell's ema il? Sent with BlackBerry Work (>>www.blackberry.com<) From: Blackburn , Scott R. > @w.p~m e;ov>> _____ _.. or >> One more thing . Chris Lidde ll is interested in attend ing as well. I invited him to come to the Secretary's report out and are just waiti ng on time/logistics. From: Blackburn , Scott R. Sent: Tuesday, January 02, 20 18 9:18 AM To: Colli, Jacque lineJ(b)(6) Cc: 'Wynn, Jackie' Subject: Friday afternoon I Hi Jackie C - Happy New Year once aga in. Friday afte rnoon's sess ion w ill be at MITRE in McLean . I am cc'ing Jackie Wynn for the exact address (they have a few different buildings and I don't want to give you the wrong one) . We can be flexible arou nd the Secretary"s ca lendar . I am guessing 3pm wou ld be opt imal but I w ill let you work that out with Jackie W. Ideally 90 minutes on the ground (but we will take 60). Th is is a pretty big meeting. Below are some more details. All day Friday, MITRE will be conven ing a group of experts to we igh in on interoperability. At the end of the day , we are going to ask them to share what they are recommending directly to the Secretary. We w ill also invite DepSec Bowman , Dr. Clancy, John Windom and Ricci Mulligan (in place of me, I will be out with back surgery) . Below is the information I already sent to the Secretary with a few updates in red. VA-18-0298-C, VA-18-0299-C-000077 77 of 220 From: To: Cc: Subject : Date: BlackburnScottB MarcSherman: BruceMoskowitz I l(b)(6) RE: [EXT ERNAL] Re : FW: VA EHR Call Monday, March 19, 2018 8:40:56 AM Great. Talk to you then. Sent with Good (www .good.com) From: Marc Sherman Sent : Monday, March 19, 2018 8:21 :07 AM To: Blackburn, Scott R.; Bruce Moskowitz Subje ct : [ EXTERNAL ] Re: FW: VA EHR Call Scott In response to your question, I will be on the call at noon today. Marc Marc Sherma n l(b)(6) On Mar 18, 2018 3: 11 PM , "Blackbum , Scott R." wrote: Bruce/Marc- I hope you are both having a great weekend. We have a call schedu led from noon-12:45 tomorrow. contracting guys (John Windom, l(b)(6) The intent of th is was to have our t wa lk you through how to read the government contract (which is obvious ly very different from typica l private sector contracts). I just want to make sure you are clear on the purpose of this call and check to make sure you still want to do this. We did this with each of the ClOs/Doctors last week. Scott I From:!(b)(6) Sent : Sunday, March 18, 2018 2:36 PM To : Blackburn, Scott R. Subj ect: RE: VA EHR Call Mr. Blackburn, I had scheduled this call with Dr. Bruce and Marc Sherman for the contract overview. Do you want to keep it or can I cance l it? Thanks,l(b)(6) I -----Or iginal Appointment----From: VAC IO Executive Schedule Sent: Thursday, March 15, 2018 11 :23 AM VA-18-0298-C, VA-18-0299-C-000078 78 of 220 I: Blackburn, Scott R.; Windom, John H.; @Bruce Moskowitz,MD; Marc Sherman; Bruce Moskowitz Subject: VA EHRCall When : Monday. March 19. 20 18 12:09 PM-12:45 PM (UTC-05:00) Eastern Time (US & Canada). Wherei ..... (b_)(_6)_______ ___,j Ia . VACIO Executive Schedule; l(b)(6) l(b)( 6) VA-18-0298-C, VA-18-0299-C-000079 79 of 220 To : Windom,JohnH BlackburnScottB : QJ.S; BowmanThomas Subject : Date: RE: [ EXTERNAL] Re : Scheduling a Call Regard ing Feedback on VA EHR Friday , March 16, 20 18 7 :21 :22 AM From: Thank you Sir. Vr John John H. W indom, Senior Executi ve Service (SES) Program Executive for Elect ron ic Health Record Modernization {PEO EHRM) Special Adviso r to the Under Secretary for Health 811 Ve rmont Avenue NW (5th Floo r Suite 5080) Washingto n, DC 20420 John.W indom@va.gov Off ice: (202) 461-5820 Mobile: ............ l(b)(6) .....____ __.,----, Executive Assistant: Ms. l(b)(6) ~ Appo int ments and Schedu ling 6 l(b)( ) ~ va.gov Office: 202-382-3792 From: Blackburn, Scott R. Sent: Thursday , March 15, 20 18 8:45 PM To: DJS; Windom, John H.; Bowman, Thomas Subject : FW: [EXTERNAL] Re: Scheduling a Call Regarding Feedback on VA EHR W e are pushing to get t his do ne no later t han Tuesday so we can wr ap th is up . Talked t o Bruce and w e are perf ect ly aligned. He is go ing to he lp push t hese fo lks fo r us. Se nt w it h Good (wwwgood com) From: Bruce Moskowitz Sent: Thursday , March 15, 2018 7:27:17 PM To:l(b)(6) Cc: Stephanie Reel; Stan Huff; Manis, Jonathan (Jon):Riill]a>tacs org; Cooper, Leslie T., M.D.. Karsoo Andrew Scott,M.D.; Shrestha, Rasu B; Rasu Shrestha; Blackburn, Scott R.; Windom, John H. J(b)(6) ar_c___ l(b)(6) ~Bruce Moskowitz,MD; Ashley Johnson ; Mary Riordan; Mehwesh Khalid ; M~ Sherman; IP Subje ct : [ EXTERNAL] Re: Scheduling a Call Regarding Feedback on VA EHR I ~ All work fo r me Sent from my iPad VA-18-0298-C, VA-18-0299-C-000080 80 of 220 From: To : Subject : Date: i(b)(6) BlackburnScottB RE: [EXTERNA L] RE: Scheduling a Call Regarding Feedback on VA EHR Saturday, March 17, 2018 5:29: 13 PM It loo ks li ke if we do 8PM on Tuesday we can get : Manis Reel Rasu Karson (probab ly joi ning late) I know Dr. Ko is on travel Tuesday, but I haven't heard what t ime he lands. I t hin k Dr. Cooper is also on trave l and has not respo nded to t he last ema il. Dr. Huff has not respo nded to the last ema il. So maybe we go w it h Tuesday at 8PM. Dependi ng on what Ko, Cooper and Huff say we can let Dr. Bruce e ngage wit h t hem if nee ded. Let me know ... From: Blackburn, Scott R. Sent: Saturday, March 17, 2018 2:28 PM To: l(b)(6) Subject: FW: [EXTERNAL ] RE: Scheduling a Call Regarding Feedback on VA EHR Importance: High I Maybe pu lse Monday /Wednesday nights as we ll (seems after 6pm might work best for the se folks)? Then i think we should just pick one (either Mo n, Tues or Wed night) and just go with it. Sent with Good (www good com ) From: Karson, Andrew Scott,M.D. Sent: Saturday, March 17, 2018 2:23:32 PM To:!( b)/6} I I Cc: Blackburn, Scott R.; l(b)(6) Windom, John H. Subject: [ EXTERNAL ] RE: Scheduling a Call Regarding Feedback on VA EHR 5 >1i am part icipating in a ceremony at 630 pm on Tuesday, but I co uld be on the VA call any Dearl< t ime before that. (Also, I' ll try to learn more about the tim ing of my other event to see if/when I could b reak away aft er 6:30 if needed.) Than ks and best, VA-18-0298-C, VA-18-0299-C-000081 81 of 220 To : BlackburnScottB WindomJohnH Subject : Date : RE: [EXTERNAL] Re: Stan Huff Wednesday, March 21, 2018 6:08:00 PM From: Thanks. I apprec iat e th is. Hope my note lands well wit h t hem. Fingers crossed. This has been a heck of a journey. I'm proud to have been in the foxhole w ith you. We've made a heck of a team. From: Windom, John H. Sent: Wednesday, March 21, 2018 3 :44 PM To: Blackburn, Scott R. Subject: RE: [EXTERNAL] Re: Stan Huff Here yo u go Sir : Marc, Many thanks for the fol low - up note this morn ing and your expert thoughts and orchestrat ion of the inputs from a myr iad of industry subject matter exerts over the past weeks in support of VA's EHR Modernization efforts. We are leveragi ng these expert tho ughts and comments to review/refi ne/re-validate our RFPs(EHR and DVP), strategy/management docume nts and risk management portfol ios as appropr iate. We have been coordinating our efforts over the past 9 months w ith DoD and routinely exchang ing lessons learned to ensure our overal l contract and oversight strategies further m it igates their challenges and/or concerns . This can readily be seen in a myriad of updat es to our cont ract, most recent ly t rouble ticket managemen t. As you know, risk cannot be 100% driven out of any endeavor of this magnitude or impor ta nce thus as Stephanie Reel so succinctly captured, "it is the oversight and management of the contract that will be of the utmost importance, as well as the VA'S access to senior industry advisors." As such, at the Secretary's direction we w ill be fo rming a senio r advisory to assist us t hrougho ut the process. We hope t hat you and Bruce w ill want to contin ue to advise and monitor us on our efforts, both near and long term. Some of our preliminary thoughts of membersh ip include the following and would welcome your t houghts on the makeup of this critical adv isory group: Stepha nie Reel (Hopkins) Jon Manis (Sutter) Rasu (UPMC) Shafiq Rab (Rush) Chris Ross (Mayo) Vivek Reddy (lntermountain) Aneesh Chopra Ryan Howells (Leavitt Partners) Frank Opelka (American College of Physicians) Will Morris or Ed Marx (Cleveland Clinic) Dr. Andy Karson (Mass General Hospital) Dr. Bruce Moskowitz (Tenet ) Alistair Erskine (Geisinger) Daniel Barchi (New York Presbyterian) VA-18-0298-C, VA-18-0299-C-000082 82 of 220 Again, we believe the construct of the contract, and more importantly the proper oversight and management of the contract will greatly mitigate cost, schedule and performance concerns, as we ll as suppo rt the timely inj ection of techno logical advancements (e.g. cloud, A Pis, etc.) at the appropriate pace and balance necessary to support our Vetera ns witho ut jeopard izing our overa ll care pledge. Interoperab ility remains at t he forefront or our concerns, and your comments, the MITRE study and various other external inputs contributing significantly to our RFPlanguage and cor responding requ irements. Interope rability wil l be a moving target for years to come, but ou r contract allows us to leverage the best of ideas of industry thro ughout the contract's life w ithout incurring the exorbitant costs you have alluded to, as wel l as not be bound by potent ially ant iquated defin itions . As recommended, an interoperabi lity sandbox/test bed wi ll be established during our Initial Operat ing Capabilit ies (IOC) imp lementa t ion/deployment process to solidify the requis ite interoperabi lity requi rements prio r to full ent erprise deployment. This is consistent with the desires of many of our external experts. Change management, governance, training and communicat ion remain critica l and foundational elements of business t ransfo rmat ion success. The program management office (PMO) will be t he pr imary orchestrator of these strategies but wi ll be calling for support from t he entire VA enterprise to imp lement these pract ices in support of EHR modern ization objectives. Marc, thank you for everything. We are ready to take the next step. We hope you wil l take us up on our offe r to be an advisor. Scott I thought that Dr. Cooper made a good case for inserting specific definitions and standards on the meaning and use of "interoperability," especially since that term has as many meanings in the industry as those who speak it. It is so easy for the contractor to proceed down a design path using one definition or standard while the users will require a totally different standard. That runs the risk of not being discovered until later erha seven u to im lementation aver costl result. (b)(5) I agree with Dr. ooper, why not set the critical definitions and stan ar s int e contract (PWS)now and eliminate the chance for any confusion or ambiguity. It will pay dividends later in terms of less arguments, better initial design, happier user community, less overall cost, better healthcare delivery, etc. Then, with the standard fully defined and set in the original PWS,the mock-up test will be much sooner in time and much more complete the first time, allowing the users to provide input sooner and better, eliminating costly design mistakes from the beginning. The user community can tell you todaywhat is needed to accomplish this "next generation" system that will be a model for the country and the future of healthcare (as Ms. Reel envisioned on the call last night). Why would you not want to tell the contractor the specifics of that now, in fairness to them , the VA, the patients and healthcare, so they can proceed with that standard from day one or express any concerns they may have now instead of in the future after costly design has occurred? Why would you not want to be specific in the contract to prevent ambiguity? Dr. Shulkin pushed back on Dr. Cooper's view as already accomplished in the PWSand cited Section 5 (I believe he said section 5.1.1) of the PWS. Dr. Cooper, as a physician user and not a technician , deferred on the (b)(5) VA-18-0298-C, VA-18-0299-C-000083 83 of 220 effectiveness of the existing contract language to others, but commented that the CIO of MAYOread the contract and also did not think it adequately contained the right defining language to set out unambiguous definitions and standard. I have read the contract again last night and happen to agree, or am missing it . If I am wrong, it would be useful for someone to point me in the right direction . 1. I was also thinking about the current reported problems of the DOD implementation seemingly caused by a user (clinician) revolt over inadequacy (or unsuitability) for their needs. The VA runs that same risk. Perhaps that problem could be a benefit to your effort. Why not accumulate all of the user complaints/issues in the DODimplementation identified by the users and chart them out. Then identify which of those issueswould be issues if they existed in the VA implementation and include them in the contract as definitional requirements. You have the benefit of knowing the failures in the very system upon which you are modeling your system... and you have an added advantage and opportunity to contractually prevent similar mistakes. 2. I have other thoughts as well that we should discuss, but these are the ones that I felt more pressing to highlight since I will be unavailable today. Best John H. W indom, Senior Executive Service (SES) Program Executive for Elect ron ic Healt h Record Modernization (PEO EHRM) Special Adviso r to the Under Secretary fo r Health 811 Vermont Avenue NW (5 th Floor Suite 5080) Washington, DC 20420 John.W indom@va .gov Office: (202) 461 -5820 Mobile: l(b)(6) ~---:--:---:--::-:--::::'.---~t-Appo int ments Execut ive Assista nt: Ms.!(b)(6) Kb)(6) wva.gov and Schedu ling Office: 202-382-3792 From: Blackburn, Scott R. Sent: Wednesday, March 21, 2018 9 :35 AM To: Windom, John H. Subject: FW: [EXTERNAL] Re: Stan Huff From: Marc Sherman [~)(6)~gmail,com] Sent: Wednesday, March 21, 018 9 :31 A To: Blackburn, Scott R. VA-18-0298-C, VA-18-0299-C-000084 84 of 220 Cc: DJS Subject: Re: [EXTERNA L] Re: Stan Huff I agree that the call was very helpful. I spent the night after the call ref lect ing on some of the discussion and thought I would offer some reaction/feedback that still seems unsettled. I w ill outline my nightt ime thoughts below in case you f ind them useful. 1. I thought that Dr. Cooper made a good case for inserting specif ic def init ions and standards on the meaning and use of "interoperability," especially since that term has as many meanings in the industry as those who speak it . It is so easy for the contractor to proceed down a design path using one definition or standard while the users will require a totally different standard. That runs the risk of not being discovered unt il late r, perhaps even up to implementat ion, a very costly result. (b)(5) (b)(5) (b)(5) agree w1 r. ooper, w y no se e en 1ca e 1n1ions an s an ar the contract (PWS)now and elim inate the chance for any confusion or ambiguity . It will pay dividends later in terms of less arguments, better initial design, happier user community, less overall cost, better healthcare delivery , etc. Then, with the standard fu lly def ined and set in the original PWS, the mock-up test will be much sooner in t ime and much more complete the f irst t ime, all owing the users to provide input sooner and better, eli minat ing costly design mistakes from the beginning. The user community can te ll you~ what is needed to accomplish this "next generation" system that will be a model for the country and the future of healthcare (as Ms. Reel envisioned on the call last night) . Why wou Id you not want to tell the contractor the specifics of that now, in fa irness to them , the VA, the patients and healthcare, so they can proceed w ith that standard from day one or express any concerns they may have now instead of in the futu re after costly design has occurred? Why would you not want to be specif ic in t he contract to prevent ambiguity? Dr. Shulkin pushed back on Dr. Cooper's view as already accomplished in the PWSand cited Section 5 (I believe he said section 5.1.1) of the PWS. Dr. Cooper, as a physician user and not a technician, deferred on the effectiveness of the existing contract language t o others , but commented that the CIO of MAYOread the contract and also did not th ink it adequately conta ined the right defin ing languageto set out unambiguous defin it ions and standard. I have read the contract again last night and happen to agree, or am missing it . If I am wrong, it would be useful for someone to point me in t he right direction . 2. I was also th inking about the current reported problems of the DOD implementation seemingly caused by a user (clinician) revolt over inadequacy (or unsuitability) for their needs. The VA runs that same risk. Perhaps that problem could be a benefit to your effo rt . Why not accumulate all of the user complaints/ issuesin the DODimplementat ion ident ified by the users and chart them out. Then ident ify which of those issueswould be issuesif they existed in the VA implementat ion and include them in the contract as definitional requirements . You have the benefit of knowing the failures in the very system upon which you are modeling your system... and you have an VA-18-0298-C, VA-18-0299-C-000085 85 of 220 From: To : Marc Sherman Subject : Date: Re: [EXTERNAL] Re: Thanks! Thursday, January 18 , 2018 4:30:36 PM BlackburnScottB Great to hear. Keep up the good work!!!!!!!!!!!!!!! On Thu, Jan 18, 2018 at 4:27 PM, Blackbum , Scott R. wrote: Thanks. I am feeling better every day. I had my post-op appointment this morn ing and the doctor says I'm progressing we ll. From: Marc Sherman [mailtof (b)(6) @gmail.com ] Sent: Thursday , January 18, 2018 4:25 PM To: Blackburn, Scott R. Cc: Bruce Moskowitz; Schnitzer , Jay J Subject: [EXTERNAL] Re: Thanks! Thank you Scott. We really appreciate the feedback and your and Jay's openness. I hope you both know that our interest is the VA's best interest (and the interest of those charged with its oversight). We stand ready to help as things move forward. I hope your recovery is progressing from the surgery ... forgot to inquire last night and apologize for that. All the best Marc (and on behalf of Bruce) On Thu , Jan 18, 2018 at 3:34 PM, Blackburn , Scott R.< Scott.Biackbum@va.gov> wrote: Marc/Bruce - I ju st want to say thank you once again for the support , partnership, and sage advice. Great conversation last night and I appreciate you guys being direct/blunt in your feedback. As I mentioned- being a fonn er college QB (w/ tough coaches), a former Army officer, and having spent 10 years in McKin sey's feedback culture - you don't ever have to worry about my feelings being hurt. I had a good conversation with the Secretary this morning and he too appreciates the VA-18-0298-C, VA-18-0299-C-000086 86 of 220 feedback. We will adjust and are working on refining our next steps. Thank s again, Scott Scott Blackburn Action CIO US Department of Veteran s Affairs VA-18-0298-C, VA-18-0299-C-000087 87 of 220 BlackburnScottB From: To : !ib\16\ Subject : Date: RE: [EXTERNAL] Re: VA EHR call Sunday, March 18, 2018 2:19:00 PM Yes p lease From:l~ (b_)(_6 )____ ~ Sent: Sunday, March 18, 2018 2:18 PM To: Blackburn , Scott R. Subject : RE: [EXTERNAL] Re: VA EHR call Yes, I thi nk t hat wil l work. I am going to inv ite everyone jus t in case folks have last mi nute changes to their schedu les. Do we want to do 90 minute s? From : Blackburn , Scott R. Sent: Sunday, March 18, 2018 2:17 PM To:!/ b}(6} I Subject: RE: [ EXTERNAL] Re: VA EHR call Importance: High Yes, let's do it. I know Stan Huff can't join. Perhaps we have a second call on Wednesday for anyone who couldn't join. ) ____ ___. From d"'-(b....a. ) .;_ ( 6.:.... Sent: Sunday, March 18, 2018 2:16 PM To: Blackburn , Scott R. Subject : FW: [EXTERNAL] Re: VA EHR call Mr. Blackburn, let me know if I can send t he inv ite out fo r Tuesday at 8PM. It looks like Dr. Coope r can now jo in for the first half of the call. Than ksj (b)(6) From: Bruce Moskowitz ll.:l(b:..GBP.)(1..:::6'-) ______ Sent: Sunday, March 18, 2018 1 :50 PM To: Blackburn , Scott R. Cc: Marc Sherman; ~l( b-)(_6_ ) ----~ Subject: [EXTERNAL] Re: VA EHR call I __J tg)~ m ..... a.... c.... ,c... o....... m] Ok Sent from my iPad Bruce M o skow it z M .D. On M ar 18, 2018, at 12:28 PM, Blackbu rn, Scott R. wro t e: Bruce/Marc - it is looking like Tuesday 8pm ET is go ing to work best for our CIOs/Doctors. We w ill have at least 4 people confirmed (Man is, Reel, Shretha and Karson; likely Stan Huff as well which wou ld make 5). Dr. Cooper I know is a single issue VA-18-0298-C, VA-18-0299-C-000088 88 of 220 SME so we can probably do that one separately. Dr. Ko has a to ugh schedu le all this week. Wou ld Tuesday 8pm work for you/Marc? If so - we wil l press for t hat t ime. I w ill get everyone from VA who needs to be on the call, on the call at t hat t ime. Than ks again for the help, Scott From: ~l (b~)(~6)~----~ Sent: Saturday, March 17, 2018 5:29 PM To: Blackburn, Scott R. Subject: RE: [ EXTERNAL ] RE: Scheduling a Call Regarding Feedback on VA EHR It looks like if we do 8PM on Tuesday we can get: Man is Reel Rasu Karson (probably joining late) I know Dr. Ko is on travel Tuesday, but I haven't heard what time he lands. I th ink Dr. Cooper is also on travel and has not responded to t he last email. Dr. Huff has not responded to the last email. So maybe we go with Tuesday at 8PM. Depending on what Ko, Cooper and Huff say we can let Dr. Bruce engage with them if needed. Let me know ... From: Blackburn, Scott R. Sent: Saturday, March 17, 2018 2:28 PM To:l( b)(6) I Subject: FW: [ EXTERNAL]RE: Scheduling a Call Regarding Feedback on VA EHR Importance: High Maybe pulse Monday/W ednesday nights as well (seems after 6pm might work best for these folks)? Then i think we should ju st pick one (either Mon, Tues or Wed night) and ju st go with it. Sent with Good (www.good .com) VA-18-0298-C, VA-18-0299-C-000089 89 of 220 From: Karson, Andrew Scott ,M.D. Sent: Saturday, March 17, 2018 2:23:32 PM To~(b}(6} J Cc: Blackburn, Scott R.; l(b)(6 !Windom, John H. Subject: [EXTERNAL] RE: Scheduling a Call Regarding Feedback on VA EHR Dea~~b)(6l1 am participat ing in a ce remony at 630 pm on Tuesday, but I could be on the VA call any t ime before that. (Also, I'll t ry to learn more about the timing of my ot her event to see if /when I cou ld break away after 6:30 if needed.) Thanks and best, Andy From:Ll(b_)(_6)______________ ___J~-Y~a_g_o~v .J Sent: Saturday, Marc h 17, 2018 12:15 PM To: Karson, And rew Scott,M.D. l(b)(6) l@mgh. harvard.edu> Cc: Blackburn, Scott R. J,_ (b_)(_6)____ _. l@va.gov>; W indom, Joh n H. l(b)(G) Subject: RE: Schedu ling a Call Regardi ng Feedback on VA EHR Importance: High Good afternoon Dr. Karson, Than k yo u again for confirm ing Tuesday works best fo r you . If we st art ed t he call later in the eve ning, between 5-8PM ESTwould you st ill be availab le? So fa r Tuesday seems to wo rk best for everyo ne. Than ks again! l(b)(6) From: Karson, Andrew Scott,M.DJ(b)(6) l@mgh.harvard.edu ] Sent: Friday, March 16, 2018 7:22 PM To :l(b)(6l Subject: [EXTERNAL ] RE: Scheduling a Call Regarding Feedback on VA EHR I Dear~o sorry for the delay get t ing back to you; I have bee n on t he road most of yesterday/ t oday and fi rst catch ing up on emails now. The only time among t hose th ree t hat I can do is the Tuesday t ime . (I will be part of an o ut of town fam ily event on Sunday and in t he air on Monday.) Ma ny than ks and best, Andy From:u..:!( b:.l}.)(..:::.6L) ______________ Sent: Friday, Marc h 16, 2018 7 :12 PM To: Stan Huff ~(b)(6} (b)(6) (b)(G) Shrestha 1/b}/6} ...,. @"-v=a.,_.,.g...,o"-'-v] pljmail org>; Cooper, Leslie T., M.D. >; Karson, Andrew Scott ,M.D . h.harvard .edu>; Shrestha, Rasu B 1r(b-)(_6_ ) ---, f> upmc.edu>; Rasu rciJgmail.com> VA-18-0298-C, VA-18-0299-C-000090 90 of 220 Cc: Blackburn , Scott R.< Scott.B lackbu rn @va.gov >; W indom, Joh n H. ;l(b)(6) @va.gov > Subject: RE: Schedu ling a Call Regarding Feed back o n VA EHR Importance: High Good evening, Anot her friendly rem ind er to please let me know whic h dates works best for your schedule. Have a great evening, l(b)(6) I From :J(b)(6) Sent: Friday, March 16, 2018 1 :06 PM To: 'Stephanie Reel'; 'Stan Huff': Kbill@tacs.org': 'Cooper, Leslie T., M.D.'; 'Karson, Andrew Scott,M.D.'; 'Shrestha, Rasu B'; 'Rasu Shres~t_ ha_.---~ Cc: Blackburn, Scott R.; Windom, John H. ;l(b)(6) 'Bruce Moskowitz' ; !rb}/6} l@Bruce Moskowitz.MD'; 'Ashley Johnson'; 'Mary Riordan' ; 'Mehwesh Khalid'; 'Marc Sherman'; 'IP' Subject: RE: Scheduling a Call Regarding Feedback on VA EHR Importance: High I Good afternoon, A friend ly rem inde r to please let me know whic h date works best for your schedu le. Please fee l free to call me with any questions. Thank yo u, j(b)(6) :l.... From (b_)(_6)_____ _. Sent: Thursday, March 15, 2018 7 :27 PM To: St ephanie Reel; 'Stan Huff'; 'Manis, Jonathan (Jon)';Riill] @facs.org'; 'Cooper, Leslie T. , M.D.'; 'Karson, Andrew Scott,M.D.'; 'Shrestha, Rasu B'; 'Rasu Shrestha' Cc : Blackburn, Scott R.; Windom, John H.;j(b)(6) Bruce Moskowitz; l(b)(6) l@Bruce Moskowitz.MD'; 'Ashley Johnson'; Mary Riordan; 'Mehwesh Khalid'; Marc Sherman; IP Subj ect: Scheduling a Call Regarding Feedback on VA EHR I Good even ing, W e wo uld like t o sched ule a call in t he next few days t o sha re f eedbac k o n t he VA EHR co ntract. I have bee n co rr espond ing w it h many of you on d iffe rent dat es and t imes next w eek, b ut we are go ing to sched ule t he call fo r either Sunday 3/ 18 at 4PM EST, Mo nday 3/19 at 4 PM EST or Tuesday 3/20 at 4 PM EST. Please let me know w hich d at e w ill work best fo r you r schedu le. Fee l fr ee t o call me wi th any q uest io ns and I look for w ard to hearin g from yo u. VA-18-0298-C, VA-18-0299-C-000091 91 of 220 Thank yo u, l(b )(6) I l(b)(6) Executive Assistant to the Assistant Secretary Office of Informatio n and Technology US Departme nt of Veterans Aff airs Desk: 202-461 -6288 Ce11:l(b)(6) I The information in this e-mail is intended only for the person to whom it is addressed. If you believe this e-mail was sent to you in error and the e-mail contains patient information, please contact the Partners Compliance Helplin e at http://www.partners.org/complianceline . If the e-mail was sent to you in error but does not contain patient information, please contact the sender and properly dispose of the e-mail. VA-18-0298-C, VA-18-0299-C-000092 92 of 220 From: To : Subject : Date: Zenoo z Ashwini BlackburnScottB : Short John/VACQ) RE: [EXTERNAL] Re: VA EHR Friday, March 23 , 2018 12:36:45 PM Will do Sent with Good (www .good.com) From: Blackburn, Scott R. Sent: Friday, March 23, 2018 9:34:21 AM To: Zenooz, Ashwini; Short, John (VACO) Subject: RE: [ EXTERNAL]Re: VA EHR Share this with Windom so he has this when he talks to the Secretary. Marc doesn't understand what is in the contract. Sent with Good (www .good.com) From: Zenooz , Ashwin i Sent: Friday , March 23, 2018 12 :24:36 PM To: Blackburn , Scott R.; Short , John (VACO) Subject : RE: [ EXTERNAL ] Re: VA EHR Intere sting. Btw, I think Dr. Cooper's questions were answered in 5.5.1 but I will double check. Dr. Karson was very happy we had drilled down into medical device s and integration. I had forwarded you the sections I discussed with him. I know Short was connecting with Stan and Rasu on technica l elements but you saw my note that Cerner will stand up the FHIR term server. Stephanie has been supportive and I have already sent her our mock cases and she said she will volunteer her people to help us with it. I'm very lost in what else is missing here. Thank you for sending this to us. Ash Sent with Good (www .good.com) VA-18-0298-C, VA-18-0299-C-000093 93 of 220 From: Blackburn, Scott R. Sent: Friday , March 23 , 2018 9 :16: 15 AM To: Zenoo z, Ashwini; Short, John (VACO) Subject: FW: [EXTERNAL] Re: VA EHR I already sent to Windom and DepSec. I told Windom to get with the Secretary today to gauge his reactions. Sent with Good (www.good.com) From: Marc Sherman Sent: Friday , March 23 , 2018 9 :47:39 AM To: Blackburn , Scott R. Cc: Bruce Moskowi tz ; DJS Subject: [ EXTERNAL] Re: VA EHR Scott , Tha nks for inviting me to listen in on your calls this week with the subject matter experts. I was happy to make time to participate as requested and always happy to provide my thoughts for your consideration when requested. I read carefully your email about the efforts to work out the holes raised by the experts. You are on the way to kicking off an exciting project with a high ly respected Contractor/vendor and a VA team that has worked very hard; and I know eve one has the oal to build the best next eneration s stem for the veterans ' healt hcare . b 5 (b)(5) s e expe s are recomm en mg a sys em or e a as va rious enhancements to today's standard system functionality. At a minimum, I heard those experts express their opinions that the contract da ngerously lacks defin ition s, standards and a clear exp ressio n of this requ ired, defined enhanced (non-standard) functionality (they articulate it much better than I). Failing to express this type of definitional clarity in the contract is an invitation to ambiguity, disputes and ultimate failure of purpose. The best "oversight and manag ement of the contract" will not turn a contract lacking specificity into a vision of clarity. Including contractual clarity allows the Contractor to understand TODAY what is expected so that today it can confirm its agreement to provide the full functionality desired and hav e a better understanding of what is expected of them . Clarity in the contract is a healthy ingred ient for the VA and the Contractor. b I would be delighted to be wrong and welcome a demonstration of where Section 5.1 of the contract provides this specificity that Ors. Cooper and Huff, for example, urged. In light of the system requirem ents that these experts say must be included, which are enhancements of today 's standard deliverables, the contract languag e is ambiguous. You say that "risk cannot be 100% driven out of any transformation of this magnitude," a concept to which I subscribe. How eve r, when you substitute this concept for clear , written and defined functionality , especia lly for a design that is expected to be unique in many respects , you are doomed to disappoin tment and conflict. VA-18-0298-C, VA-18-0299-C-000094 94 of 220 l(b)(6) From : I To : Cc: Black6urn Scott B :l(b )(6) WindomJohnH ~----~ Subj ect : Date: RE: [EXTERNAL] RE: VA EHR Wednesday , March 14, 20 18 7:4 1 :12 AM Good morning, I believe we have everyone scheduled for tomorrow here is the breakdown: 8:30AM Reel Ko 11:30AM Huff Karson Cooper I have yet to hear back from the t hree fo lks you emai led last night. t Thanks, ) 1 se1. From: Blackburn, Scott R. I11esdavMarch 13 2018 11.ozP~ To: b)(6) Cc: Windom , John H. Subject: FW: [EXTERNAL]RE: VA EHR Importance: High Let's try to get everyone else lined up on the timel ine I previous ly laid out. I don't want to ruin his vacation. At the same time I don't want this to drag on. From: Cooper, Leslie T., M.D. l(b)(6) ~ mayo edu] Sent: Tuesday, March 13, 2011... g~,~,~ :0~4~P-M~----1- ......... _.,,""""'..,,. . To: Blackburn , Scott R. Cc:l (b)(6) Subject: Re: [ EXTERNAL ] RE: VA EHR Tomo rrow o r next Thu rsday? I am on t he Big Sur coast now on vacati o n. Cell cove rage spotty. Leslie Cooper Sent from my iPho ne On Mar 13, 2018, at 1:46 PM, Blackburn, Scott R. wro t e: Leslie - thank you so much! 2 next steps. 1) l(b)(6 ) l(cc'd here) wil l send you the latest package of mater ial to review. 2) r XO) l(also cc'd here) w ill reach out to you to schedu le some time this week so VA-18-0298-C, VA-18-0299-C-000095 95 of 220 t hat l(b)(G)~team can or ient you to whatl(b)(6 )1wil l be sending to yo u. Governmen t contracts are very diff ere nt t han t yp ical privat e sector contracts (longer and some wou ld say mo re bureaucrat ic). So in order t o hel p we' ll j um p on the phone so tha ~ an walk you t hrough what sections to look at and what you can ignore. Thanks again! Scott From: Cooper, Leslie T., M.o.l1...,, (b_)(~6_) ~~---.l" Sent : Tuesday, March 13, 2018 12:43 PM To: Blackburn, Scott R. Subject: Re: [EXTERNAL ] VA EHR k@=m~ay,_,o~.e~d-u] Thank yo u for t he invitat ion to provide inp ut . I am glad for accept. Please let me know how I can be of service. I wil l be t raveling largely out of cell coverage the next day. Leslie Cooper Sent from my iPhone On Mar 12, 2018, at 6:55 AM, Blackburn, Scott R. wrote: Dr. Cooper : I hope t his finds yo u well. On behalf of Secretary Shulkin I wa nted to see if we could enlist yo ur help. We are very close t o f inalizing our EHRdeal wit h Cerner; however we want to make sure we get a few extra set of eyes on it to make sure we are doing right by Veterans, t he country and taxp ayers. Would yo u have the t ime/abil ity to conduct a quick high level review and provide inp ut in the next week or so? You were referred to us by Dr. Bruce Moskowitz. Thanks so much, Scott Scott Blackburn Act ing CIO & Executive-in-Charge, Off ice of Informat ion & Technology Depart ment of Veterans Affairs VA-18-0298-C, VA-18-0299-C-000096 96 of 220 F,om: To: WfndPm lpt]n H C<: ~: Subj.ct ; Dillte: RE; [EXTEflttO.l ] Re: VA EHR Sat1.m;iay. March 24, 2018 8;03;38 AM RJad dJ11m&au R . fkrnmamThomas Short lobn (VAOOI S ir Thank you sir. Her change in health was incredib ly abrup t. I am back Sunday and in the office Monday. Your though ts and prayers are definitely felt. Great news that the doc tors were able to take her off the ventila tor and she is breathi ng on her own. Flu id in her lungs has:subsided . Te st being r un on causes of fluid. Pneumonia or hc:an f ail ure are the-anricipated outcomes. More to follow but I am feeling good and optimistic now. Vr John Sent with Good (www.good.com) From : Blackbum, Scott A. Sent: Friday, March 23. 20 18 2 :22 :28 PM To : Windom, John H.: Bowman, Thomas Cc: Zenooz. Ashwini: Short. John (VACO) Subj~t : RE: (EXTERNA L) Re: VA EHR Oh no. So sorry to hear that. My thoug)lls and prayers are with you and your family. Sent with Good (www.good.com) From: Windom, John H. Sen t: Friday, March 23, 20 18 4 :32 :06 PM To: Blackburn . Scott A.; Bowman, Thomas Cc: Zenooz . Ashwini; Short . John (VACO) Subj~t: RE: [EXTERNAL) Re: VA EHR Sir. Mo m adm illed to the hospita l. In ICU. Flying out to see her this even ing. I will connec t with SECV A/DEPSEC on Monday. My concerns are tru ly elsew here right now. I to ld DEPSEC and Danny that l was headed out. Thank you for your understanding and sorry you are dealing with Lhis "nonsense.. during your time with the family. Availab le by phone and email all weeken d. Vr John Sent with Good (www.good.com) From : Blackbum, Scott A. Sen t: Friday, March 23, 20 18 12 :08:22 PM To : Windom, John H.: Bowman, Thomas Cc: Zenooz. Ashwini; Short. John (VACO) Subj ~ t : RE: (EXTER NAL] Re: VA EHR I agree. Please connect with the Secretary today to make sure we are all on the same page. (b)(5) From : Windom, John H. Sent: Friday, March 23, 2018 1 :55 PM To: Black.burn, Scott A.; Bowman, Thomas Cc: Zenooz , Ashw ini ; Short , John (VACO) Subj~I: RE: (EXTERNAL) Re: VA EHR Mr. Blackburn, I went back and read Mr. Sherman's emai l and reviewed my notes. push to perform an interoperabi lity ~ndbox/test I see no recommended language for insertion in the contract to address his concerns What it appears to be is a plat fo rm in advance of contract award. Vr John John H. Windom, Senior Executive Service (SES} Program Executive fo r Electronic Health Record Modernization (PEO EHRM) Special Advisor to the Under Secretary for Health 811 Vermont Avenue NW (5th Floor Suite 5080) Wal!. wrote: MarcI Bruce, Thank you once agam for all your support and especialty for linking us up with these CIOs/experts. This was incredibly valuable. Secretary Shulkin, John Windom and I got together earlier today as well to talk about the path ahead. A few notes: In order to make sure we understand some of the mo re specific detailed po ints, members of our team reached out today fo r individual follow ups with Or. Cooper, Dr. Karson, Or . Shrestha , Jon Manis and Stephanie. Each have been so generous with their time -Stephanie wi ll host us for a visit on Apnl 4 and Dr. Cooper offered to do the same at Mayo. o Dr. Zenooz did connect with Dr. Cooper to day on the po int Marc highlights below to make sure we are on the same page and have the language right (part was us better understa nding his point; part was po inting him to the spe-cific language in 5.1.1 and giving him the broader context with what we are doing with lighthouse as our API gateway and the VA Open API Pledge that 11 health care institutio ns signed two weeks ago inclu de Cris Ross at Mayo as well Stan Huff at lnt ermountain and Dr . Kar.sonat Partners) . ' .ll.z.ec..a.a..ililCJ.llWlilUlJ,_ _~ o We will also fol low up with Stan on some of th e issues he raised a.~ 'U'el!..J:llu:;SllIW!f!:..:ll;a.Q..u.uJl.lll=l:Jlf=c.!f:a.a:Ll!lill.!..eGBPJlf!L=i.C!Jl: . . 1!:J enRineers to accelerate FHIRAPls for VA in su ort of th is co ntra ct b (b)(5) Per Stephanie's suggestio n, we are going to start movmg forward ASAPo n formalizi ng an Advisor,oCommittee so that we can get these insight s on an ongoing basis. Formalizmg th is will allow for conti nuity of expertise throug hout ou r journey . Obviousty we will want Stephanie. John, Andy, Rasu, etc. Cris Ross (Mayo}, Wil l Moms or Ed Ma rx {Cleveland Clinic}. Frank Opelka (American College of Surgeons} are others you've introduced us to along the way that we would love to include. We wou ld like to work with you to m;;ike sure we get this right . o As recommended last night, an int eroperability sandbox/t est bed will be established during our Initial Operati ng Capabilities {IOC) imple menta tio n/de ploym ent process to solidify the requ isite interoperability requirements prior to f ull ente rpri se deployment . This is a great suggestion and very consistent with what we have been hearing from many experts . o Our team is reviewing all the feedback (both oral from the calls and the written notes that some provided) and crossowalking this against the language in the RFP/contract documents {both EHRand also Lightho use}. We are nnt seeing any major changes to the co ntr act nor do we see any showstoppers . Upon receiving the feedback, we fee l very good that we have a sohd contract from which we will just need to make minor r evisions. stronelyabout movineforwardquid:,ly. We will make any necessary tweaks with Cerner ASAP(we absolutely do will moveforwardto SIP? the pyerarcbine !PIPcontract Assuming Congress Shulkin rnuld sign as eaclv as next approves the Omnibus bill by Fr iday (and President Trumps signs it), we will th en have the fundi ng and authority to do so - and Seccetarv week. If the Omnibus falls thro ugh {which let's hope not), then we would have to req uest a transfer from the Congressional app ropria tion comm itt ees which will then take "'2 o After d1scuss1ngth is with Secretar,oShulkin to day, we feel not antic ip ate any push back; and Cerner has prom ised to tum th ings around immediately) and weeks. Signin g the in itial task orders will allow us to start moving fo rw ard with Cerner on the inittal 3 hospita ls {which will be in Washington state) on th ings like site surveys, infrastr uct ure readiness, data hosting, change management (with will include wide mvotvement from clinicians mside and outside VA...something we heard loud and clear from Br uce!), help desk establishment, and proJect oversight (which we 've heard loud and clear from Stephanie/Jon). As a reminde r, given the IDIQ structure of the contract we would not be signing the full contract {rathe r just Vear 1-which is ~s% of the value of the cont ract) . But th is will allow us to get moving and out of t he "qui cksand". Mar c makes a great point below on turning DoD's st r uggles into a posit ive. We have bee n work ing very closely with the DoD team over the past 9 months (t now have my own Pentago n 10 pass I am there so much; John and I work very closely with their EHR lead Stacy Cummin gs; John Windom talks to her several tim es a week). We have incorpo rated a lot of thei r stumb les int o ou r con tract (e.g, data migrat ion was a big issue with Congressman Phil Roe and we addr essed that; and most recently we have made some ad1ustments on troub le ticke t management based on what you've read m the papers}. We are paying very close attention to their implementation issues (workflow, change management, governance} to make sure we don't make the ~me mistake twi ce. DoO's biggest problems are around impleme ntation and change management . This underscores Bruce's point of making sure we have clinician buyoin and involvement from the get.go (I couldn't agree more}. This will make getting move oo chaoee maoaeement in Task Order #l so important . o As you both know, r isk c;;innot be 100% driven out of any tra nsformation of th is magnitude . Stephanie Reel so succinctly captured , "it is th e oversight and management of the con tract that will be of the utmost importance , as well as the VA'S access to senior mdust ry advisors H I thi nk we have a great plan. The biggest thing I worry about will be executing and we are definitely going to need all the help we can get. Again, we believe the constr uct of the co ntra ct, and more importan tl y the proper oversight and management of the cont r act wi ll greatly mitigate cost, schedule and performa nce VA-18-0298-C, VA-18-0299-C-000101 101 of 220 concerns, as wel l as support the time ly inje ct ion of technolos,cal advancements (e.s . cloud, APls, etc.) at the appropr iate pace and balance necessary to support our Vete rans w ithout jeopardizing our overa ll care. Interope rabi lity remains at the fo refr ont or ou r concer ns, and your comments, the MITRE study and vanous other ext ernal mputs contr ib uting significantly to our RFP language and correspond mg requirements. ln teroperab1hty will be a movi ng target for years to come, but our contract allows us to leverage the best of ideas of indust ry throu gho ut the contract's lif e with out incurring the exorbitant costs you have alluded to, as well as not be boun d by potentially antiquated defin itions. Bruce/Marc. than k you for everyth ing. As I mentioned to Bruce recently, you have been tremendous ..dema nding partners" on this jo urney and we are incredib ly app reciate . We look forward to cont inuing this relationsh ip as we take the next steps. Scott )(6) From : Marc Sherm a~ (b l@amail com) Sent: Wednesday, March 21 , 20 18 9:31 AM To: Black.burn, Scott R. Cc: DJS Subje<:t: Re: [EXTERNAL) Re : Stan Huff I agree that the call was very helpful. I spent the night after the cal l reflecting on some of the discussion and thought I would offer some reaction/feedback that st ill seems unsettled . I will outl ine my nightt ime t houghts below in case you f ind them useful. I. I thought that Dr. Cooper made a good case for insert ing specif ic def initions and standards on the meaning and use of "interoperability, " especially since that term has as many meanings in the industr y as those who speak it . It is so easy for the contracto r to proceed down a design path using one defi nition or standard wh ile the users w ill r . . . . . . lamentat ion, aver costl result. h\/ "i\ ' any con us1on or ambiguity . It will pay divi dends later in terms of less arguments, better init ial design, happier user community, less overall cost, better healthcare delivery , etc. Then, with the standard fully defined and set in the origina l PWS, the mock- up test wil l be much sooner in time and much more complete the fi rst t ime, allowing the users to prov ide input sooner and better, eliminating costly design mistakes from the beginning. is needed to accompl ish this "next generation . system that wi ll be a model for the country and the The user community can tell you ~what futu re of healt hcare (as Ms. Reel envisioned on the call last night). Why would you not want to tell the contrac tor the specifics of t hat now, in fa irness to them, the VA, the patients and healthcare, so they can proceed with that standard from day one or express any concerns they may have now inste ad of in the futu re after costly design has occurred? Why would you not want to be specif ic in the contract to prevent ambiguity ' Dr . ShuIkin pushed back on Dr. Cooper's view as already accomplished in the PWS and cited Section 5 (I believe he said section 5. 1 .1) of the PWS. Dr. Cooper, as a physician user and not a tech nici an, deferred on the effect iveness of the exist ing contr act language to othe rs, but commented that t he CIO of MAYOread the contract and also d id not th ink it adequately conta ined the right defin ing language to set out unambiguous def init ions and standard. I have read the contract again last night and happen to agree, or am missing it. If I am wrong, it would be useful for someone to point me in the r ight direction. 2. I was also thinking about the current report ed problems of the DODimplementation seemingly caused by a user {clinic ian) revolt over inadequacy (or unsuitabi lity) for their needs. The VA runs that same risk. Perhaps that proble m could be a benefit to your effort. Why not accumulate all of the user complaints/ issues in the DOD implementat ion ident ified by the users and chart them out. Then identify which of those issues would be issues if they existed in the VA implementation and include them in the cont ract as defi nitional requirements . You have the benefit of knowing the failures in the very system upon which you are moce ling your system ... and you have an added advantage and opportun ity to cont ractual ly prevent similar mistakes. 3. I have other thoughts as we ll that we should discuss, but these are the ones that I felt more pressing to highlight since I will be unavailable tocay . Best Marc On Wed , Mar 21, 2018 at 8:24 AM. Bla ckbum , Sco u R. wrot e: No problem Marc. Thanks for all your help. Very helpfu l call last night. From: Marc Shermank h \I ~ \ b amail com] Sent: Wed nesday, March 21, 2 018 12 :12 AM To: Blackburn, Scott A. Subject : [EXTERNAL) Re: Stan Hutt Scou I won' t be ab le to j o in the call 1omorrow as I have a prev ious commitmen t that I cannot move. I w ill catch up wit h yo u o r Bruce after. Marc Marc Shc nnan !tbl/Gl On Tue, Mar 20. 2018, 10:30 PM Blackburn. Scott R. wrote: Bruce/Marc - thank s fo r introdu c ing us to all the expert s w e ta lked to ton ig ht. II wa..~extr emel y valuab le. We have Stan Huff fro m Intcrmounrnin tomorrow at 10am. I assume you have the calendar invite. but j ust in ca..~c it isl_ (_ b~ )~ (6_ )~-------~ W e have been unable to schedu l e any thin g wi Lh Dr. Ko (very busy calendar) . W e w ill try in g. Scott Scott Blackbum Exec utive in Charge, Offi ce o f l nfonn al ion & Tec hno logy US Depanment of Veterans Affairs VA-18-0298-C, VA-18-0299-C-000102 102 of 220 From : Schnitzer, Jay J To : Cc: Blackburn ScottB Wynn Jackie Subject : Date: Tuesday, Jan uary 02, 20 18 9 :23 :27 AM RE: [ EXTERNAL] Re : VA inte roperability - outside expe rts Hi Scott , I have a phone call schedu led with Andy later today. Best, Jay Jay J. Schnitzer, M.D., Ph .D. MITRE From: Blackburn , Scott R. Date: T uesday, Jan 02, 201 8, 9:20 AM To: M arc Sherman ~(b}/6} @ gmail.co m> @ mg h.harva rd.ed u j(b)(6) tg)rngb harvard.edu>, Bruce M oskow itz Cc : l(b)(6) !, Schnitzer, Jay J j(b)(6) !@mitre .or g>, Wynn, Ja ckie l(b)(6) ~ mitr e.or g> Subject: RE : [EXTE RNA L] Re : VA interop erab ility - out side exper ts Marc/Bruce/ Andrew - t hank yo u so muc h! We are very excite d t hat Andrew might be able to j oin. have cc' d Jay/Jackie from MITRE who w ill be host ing th is. Jay/Jackie - can you send And rew/Marc/ Bruce the deta ils? Thanks, Scott From: Marc Sherma~(b)(6) l@gm ail.com] Sent: Tuesday , January 02, 2018 6 :09 AM To: Blackb urn , Scott R. Cc: !lbl/ 6) @mgh .harvard .edu; Bruce Moskow itz Subje ct : [ EXTERNAL] Re: VA interoperabil ity - outs ide experts Scott , Andrew Kar son will likely be able to attend the Janu ary 5 VA interoperability summit. Can you please send Andrew all of the details (about purpose, logistics etc) and copy me and Bruce? I have includ ed Andrew on this email so you each have contact info of the other. Marc Marc Sherman l(b)(6) On Dec 29, 2017 5:43 PM , "Blackbum , Scott R. "< Sco tt.Blackbum @va .gov> wrote : Marc - Happy New Year ! I hope you are enjoyi ng th e holidays. VA-18-0298-C, VA-18-0299-C-000103 103 of 220 As I mentioned previously, MITRE is helping us get outside expert opinions on what we need to demand (from Cerner or elsewhere) to meet our interoperability needs. I just found out they are putting together an all-day expert panel on January 5 at MITRE in McLean VA. Frank Opelka, who you recommended, wi ll be there as wi ll Cris Ross(CIO from Mayo Clinic) who MITRE confirmed independently. The list of confirmed participants is below (I know they are working on confirming a few others). I know it is short notice, and over the holidays, but is there anyone else that you/Bruce would recommend MITRE include? Current list of part icipants: o Aneesh Chopra, President, CareJourney, former United States Chief Technology Officer o Cris Ross, CIO, Mayo Clinic o Carla Smith, President, HMMS o Ryan Howells, Principal, Leavitt Partners, LLC (recommended by Chris Liddell, Office of American Innovation) o Paul R. Sutton, MD, PhD, University of Washington o Frank Opelka, MD, American College of Surgeons o Kenneth Mandl, MD, MPH, Boston Children's Hospital VA-18-0298-C, VA-18-0299-C-000104 104 of 220 From : To : Bruce Moskowitz MarcSherman !ib)/61 IBlackburnScottB : lP: LauraPerlmutter:WindomJohn H : "-! (b-'-)(.6 :.... .:.... ) ___ Cc: Subj ect : Date: __. Re: [ EXTERNAL] Re: VHA EHR - 2 calls t hat my assistant will set up Thursday, March 15, 20 18 11 :13:49 AM Thank you ju st received Sent from my iPad Bruce Moskow itz M.D. On Mar 15, 2018, at 11 :08 AM , Marc Sherman 4(b)(6) Than ks l(b)(G) @gmail.com> wrote: I On Mar 15, 2018 8:01 AM, " l(b)( 6 ) ~ va.gov> wrote: Mr. Sherman - The notice was just resent to Dr. Moskowitz . He should receive an email from the following address, usarmv.redstone.rdecom amrdec.mbx.s afe-team@mail.mil. Thanks , (b)(6) Contracting Officer Department of Veterans Affairs Office of Procurement , Acquisition and Logistics Technology Acquisition Center 23 ChristopherWay Eatontown. NewJersey 07724 Office: 732-440-9650 Mobile: ..... l(b_)(_G )_____ 6 e-mail j..... (b_)(_ )___ __, ~ ~ va,gov VA-18-0298-C, VA-18-0299-C-000105 105 of 220 "For Internal VA Use Only- Working Draft, Pre-Decisional, Deliberative Document: This e-mail and any attachments are intended only for the use of the addressee(s) named herein and may contain privileged and/or confidential information. If you are not the intended recipient of this e-mail, you are hereby notified that any dissemination, distribution or copying of this e-mail, and any attachments thereto, is strictly prohibited. If you have received this e-mail in error, please notify me via return e-mail or telephone (732) 440-9650, and permanently delete the original and any copy of any e-mail and any printout thereof ." From: Marc Shermarl(b)(G) l@gmail.com] Sent : Thursday , March 15, 2018 10:54 AM To: Blackburn, Scott R. Cc: IP; Laura Perlmutter; Bruce Moskowitz; l(b)(6) Windom , John H.; l(b)(6) Subject: [ EXTERNAL] Re: VHA EHR - 2 calls that my assistant w ill set up ! Scott and l(b)(6 ) I I I received a document download email with a password from AMRDEC Safe Access File Exchange However, Bruce has not received a similar email. Can you plea se get that to him? Marc On Mar 13, 2018 2:04 PM, "Blackburn , Scott R."< Scott,BJackburn @va.gov> wrote: Marc/Bruce/ Ike - thank you so much for the prompt replies. I just spoke to Bruce. VA-18-0298-C, VA-18-0299-C-000106 106 of 220 We've got 100% participatio n (Stepha nie Reel, Stan Huff, Jon Manis, Dr. Ko, Dr Karson, Dr. Coope r, and Dr. Shretha) and we are mov ing forward. (cc'd, (b)(G) 5 > my ou r con t racti ng officer) is making sure eve ryone has t he right material. C b>C assistant, cc'd here) wi ll be organizing a few phone calls in 2 steps: Step 1 - Basic orientat ion to the government contract structure . Th is w ill be a 30-45 m inut e orie nt atio n so th at folks know w hat t hey are looking at. John Wi ndom and lwi ll host th is and clue people into t he parts to focus on and pa rts t hat are l(b)(6) standard government th ings that are less relevant. (ideally) or in one-offs to fit to accommodate This can be done in groups 6>lhas people's busy schedules. 1C b>C already scheduled 2 times in case these wo rk for you. If t hey do not , she wi ll work w ith your schedulers t o f ind other times in the next 24-48 hou rs (sooner the better). o Thursday 8:30 -9:lSam ET- Stephan ie Reel confirmed o Thursday 11:30am-12:15pm ET- Stan Huff confirmed Step 2 - Feedback calls. Per Bruce's idea, we'l l schedule 2 separate feedback calls for early next week. Both 90 minutes each. We are aim ing for Monday, Tuesday or Wednesday at the latest. !C b>C 6>!Afil l set these up. o ClOs (Reel, Huff, Manis, Shretha - and of co urse each of yo u are encouraged to join) o Doctors (Dr. Karson, Dr. Ko, and Dr. Cooper - and of course each of yo u are encouraged to join) Let me know how this sounds. Thank you aga in for your support and assistance on this cr it ical matter. Scott From : Marc Sherman l(b)(6) ~ gmail.com ] Sent: Tuesday , Marcli 13, 2018 1 :40 PM To: Blackburn, Scott R. Cc: IP;l(b)(6) ~ gmajl.com ; Bruce Moskowitz; ~l (b_)(_6l___ ~l windom , John H.; DJS VA-18-0298-C, VA-18-0299-C-000107 107 of 220 Subject: [ EXTERNAL] Re: VA EHR NOA Scott, l(b)(G) land John Thank you fo r the NOAdraft that you sent along and the organized approach. I have attached the fo llow ing to close the loop: 1. a marked up version of the NOAwith a few necessary adj ustments in red-line so you can see the changes that were made, 2. a blank copy of the amended NOAfor Bruce and Ike to sign, and 3. a signed version by me of the amended NOA. Thanks and happy to help as requested . Marc On Tue, Mar 13, 20 18 at 10:31 AM , Blackbum , Scott R. wrote: Ike, Bruce, Marc: Thank each of you for agreeing to lend an extra set of outside eyes on the EHR contract. We appreciate your support and want to make sure we get to the best place possible for Veterans, the country and taxpayers. As we are incredibly grateful to you for volunteering your time, we want to make this as easy as possible for you. Here are 3 next steps. 1) We will need you to sign the attached NOA. Please return to ~ _b_)(_6)__ (cc'd ). 2) Ej _ will then send you the latest package under separate cover. 3) Given government contracts are different than what you are used to reading, we would propose a quick phone call so that we can orient you to the contract and help focus ou on the parts where your expertise will be most valuable.(b)(6) (who is the government contracting officer) and John Windom (who is our EHR leader) will lead this from our side. I will ask~ l(b-)(-6)-~ l(b)(6) l(cc' d) here to help set up a time. We can either do this all together, if VA-18-0298-C, VA-18-0299-C-000108 108 of 220 calendars match up, or separately if need be. We have also connected with Stephanie Reel, Stan Huff, Dr. Karson, Dr. Ko, Dr. Shretha, and Jon Manis who all have all rece ived the NDA and we are working with them. I am hoping to connec t with Dr. Cooper today. Thanks again! Scott Scott Blackburn Acting CIO & Executive -in-Charge, Office oflnfonnation & Technology Department of Veterans Affairs VA-18-0298-C, VA-18-0299-C-000109 109 of 220 From : To : Cc: Subject: Date: Attachments: BlackburnScottB BruceMoskowitz ~ Jb JCS> !@?mail com RE: [EXT ERNAL] Stan Huff Wednesday , March 2 1, 20 18 1 :03 :43 PM PHI RE EXTERNA L RE EHR VA Call.msg Attached is what Stan sent me . I haven't been able to ope n it. I'm goi ng to have to go back to him and have him resend. Scott ----- Origina l M essage----(b-)-(6_)_______ From: Bruce Moskowitz .-l _,l@maccom) Sent: Wednesday, March 21, 2018 11:30 AM To: Blackburn, Scott R. Cc: IP ;!ib)/6) ~gmail.com Subject: [EXTERNAL] Stan Huff Can you send his notes to us? Thank you Sent from my iPad Bruce Moskow itz M.D. VA-18-0298-C, VA-18-0299-C-000110 110 of 220 From : To : Cc: Subject : Date: Bruce Moskowitz BlackburnScottB .lf;l(b )(6) r?majl com:t:Jw trenchan gel59com Re: [EXTERNAL] Stan Huff Wednesday, March 2 1, 2018 1 :46 :14 PM Thank you Sent from my iPad Bruce Moskowitz M.D. > On Mar 21, 2018, at 1:08 PM, Blackburn, Scott R. wrote: > > Figured it out. Here are the files/notes that Stan wrote up for us ... > > -----Original Message----~- ---------~ > From: Bruce Moskowitz l(b)(6) l@maccom] > Sent: Wednesday, March 21, 2018 11:30 AM > To: Blackburn, Scott R. > Cc: IP i(b)(6) @gmail.com > Subject: [EXTERNAL] Stan Huff > > Can you send his notes to us? Thank you > > Sent from my iPad > Bruce Moskowit z M. D . > > > VA-18-0298-C, VA-18-0299-C-000111 111 of 220 From : Bruce Moskowitz To : Cc: BlackburnScottB Subject: Date: Re: [ EXTERNAL] VA-CIO CALL Monday, November 20, 20 17 6: 10 :47 PM Thank you for your response. I will be available for a phone call at a conven ient time for both of us. Carolyn will set it up Sent from my iPhone On Nov 20, 2017 , at 5:33 PM, Blackburn, Scott R. wrote: Dr. Moskowitz, Thank yo u so much for the note and for all the help/support. I wou ld love to meet you in person. Do you have any plans to be in Washington anytime soon? I thought t he call last week was ext remely valuab le. The experience and wisdom of t he participants is such a great asset - we wo uld be fools to not take f ull advantage of it. I do agree ful ly that there was a lot to cover in on ly two hours. I think the moderator was doing the best he cou ld to get as much out of it as possible, wh ile trying to be respectf ul of the time t hat so many importan t peop le we re volunteer ing. If th e 5 CIOs were will ing to fo llow up, perhaps we schedu le another session(s) on var ious deep dive top ics? We wou ld absolute ly love that. Just by way of introduction - I jumped into t he CIO role less t han 2 months ago whe n our previous CIO (Rob Thomas) abrupt ly retired to deal with some persona l issues. I am a disab led Army Veteran (M IT ROTC). After getting out of service I went to business schoo l and then to McKinsey where I made partner and spent 9+ years there leading large business transformat ions in industr ial clients. Bob McDonald (the former P&G CEO and former Secretary) convinced me to jo in VA to lead th e turnaround aft er the 2014 Phoenix scandal. From Feb-Sept, I served as Secretary Shulkin's Deputy until a politica l appo intee was put in place. Then jumped into the CIO role to work w ith the team and make sure this gets done. We are sti ll await ing a permanent CIO. I wou ld be happy to jump on the phone this week to if you wo uld like. Thanks again for your support! Scott Scott Blackburn Act ing CIO and Executive in Charge, Office of Informat ion & Technology US Departme nt of Veterans Affairs VA-18-0298-C, VA-18-0299-C-000112 112 of 220 From: To : Subject: Date: Clancy Carol yn Black burn Scott B RE: [EXTERNA L] VA-CIO CALL Monday, November 20, 2017 8:38:27 PM W-o-w Sent with Good (www .good.com) From: Blackburn, Scott R. Sent: Monday, November 20, 2017 1 :43:25 PM To: Windom, John H.; Clancy, Carolyn; Lapuz, Miguel H. Subject: FW: [EXTERNAL] VA-CIO CALL FYI Sent with Good (www .good.com) From: Bruce Moskowitz Sent: Monday, November 20, 2017 6:01 :58 AM To: Blackburn, Scott R. Subject: [ EXTERNAL] VA-CIO CALL Dear Scott: I thought the VA-CIO call November 15 to help you with practical industry expertise relating to your proposed Cemer implementation generated some valuable conversation. The participants were some of the most highly experienced CIOs with deep EMR backgrounds, together with physicians who focus on medical error prevention and improving the EMR experience. I hope and expect that you found it of great value. Since we have not spoken before, you may not be aware that I am the person who personally recruited the Academic Medical Centers to provide the VA with advice, intended to help the VA create and implement a path to fix its care delivery issues, as well as advise on other areas where they can be of value to better veterans' care. I have been a central point for the group and was the collection point for the participants' post-call debrief. Also, for reference purposes, each of the people on yesterday's call has performed flawless implementations of state of the art EMR systems on behalf of their respect ive healthcare delivery systems, some more than once. Since the call was structured to focus the discussion on the few direct questions set forth in your age nda, and the moderator controlled the timing of each question very tightly , the breadth of the discussion was somewhat limited. As a result, you only had the benefit of the experts' advice in the areas that the moderator put on the table ... and the participant's want to make sure you have the benefit of their complete thoughts and feedback. Everyone felt good about the discussion on the agenda questions and felt that the scope and implementation issues relating to DOD I VA interoperab ility were well in hand. However, some of the participants' questions raised about other areas left them uneasy about the readiness of the system for implementation VA-18-0298-C, VA-18-0299-C-000113 113 of 220 To : Blackburn Scott B Prince-Whee ler LatrieceB Subject : Date: RE: 5 CIOs Wednesday , October 25, 2017 7:46:58 PM From : Good idea. Sent with Good (www .good.com) From: Prince-Wheeler , Latriece R. Sent: Wednesday, October 25, 20 17 6:28:35 PM To: Blackburn , Scott R. Subject: RE: 5 CIOs Ok sounds good. Do you want your team to look up on Google thier name s first so you can say Chris do you have jacks contact info from so and so? From: Blackburn , Scott R. Sent: Wednesday , October 25 , 20 17 5:18:01 PM To: Prince-Whee ler, Latr iece R. Subject : RE: 5 CIOs Thanks. I just want to make sure David is cool with my plan. I will email them telling them we want to do this and asking for their contact info or introductions. Chris/Jared will be exc ited as this is exactly the type of thing they wanted us to do after yesterday. We just didn 't come up with this idea until after the meetin g with David/Tom/Windom/ I huddled to figure out what to do next. Sent with Good (www .good.com) From: Prince-Wheeler , Latriece R. Sent: Wednesday, October 25 , 2017 4:52:02 PM To: Blackbu rn , Scott R. Subject: RE: 5 CIOs Yes, here you go Liddel l, Chr istophe r P. EOP/WHO '= l(b_)(~6 )_____ Kushner, Jared C. EOP/WHO f>1@who.eop.gov> ..... rrowho .eop.gov ) 10 > From: Blackburn, Scott R. Sent : Wednesday, October 25, 2017 4:51 PM To: Prince-Wheeler, Latri ece R. VA-18-0298-C, VA-18-0299-C-000114 114 of 220 Subject : RE: 5 CIOs Importance: High Do you have an emai l address for Chris and/or Jared? Sent with Good (www.goo d.com) From: Prince-Wheeler , Latriece R. Sent: Wednesday, October 25, 2017 4:15:43 PM To: Blackburn , Scott R. Subject: RE: 5 CIOs Chris probably would be able to do that or send contact info. Or staff may be able to ju st googl e it. From: Blackburn , Scott R. Sent: Wednesday, October 25, 2017 4 :12:57 PM To: Prince-Whee ler, Latriece R. Subject: RE: 5 CIOs No problem. Would Jared/Chri s be able to make those introd uction s? At our meeting yesterday the Kaiser guy was on the phone. Sent with Good (www .good.com) From: Prince-Wheeler , Latriece R. Sent: Wednesday, October 25, 20 17 3:24:03 PM To: Blackburn , Scott R. Subject : FW: 5 CIOs I m isspoke on contact info rmat ion for these particu lar CIO's. I have CIOs that left cerner and went to epic. Apo logies. From: Windom , John H. Sent: Wednesday, October 25, 2017 3:18 PM To: Blackburn , Scott R.; DJS Cc: Prince-Wheeler , Latriece R.; Bowman , Thomas Subject : RE: 5 CIOs All sounds great Sir. Vr John VA-18-0298-C, VA-18-0299-C-000115 115 of 220 Sent with Good (www goodcom) From: Blackburn, Scott R. Se nt: Wednesday, October 25 , 20 17 12:08:07 PM To: DJS Cc: Prince-Wheeler, Latriece R.; Bowman, Thomas; Windom, John H. Subje ct : 5 CIOs Here is my plan. I just want t o make sure you are good w it h it before I execute it. If so, I'll get the ema il addresses from Latriece. Step 1- send an email to Jared Kushner and Chris Liddell know ing that we do th is. We didn't te ll t hem directly yesterday and I don' t wa nt to blindside them. Step 2 - send the below ema il to the 5 ClOs (Kaiser, Cleveland Clinic, Partners, Mayo, Johns Hopkins). Follow up with calls to confirm them. Step 3 - set up this 90 min ute meeting somet ime in the next 10 days. Invite them to join either phone or in person. If Chris/Jared want to join, we can have them join as we ll. We w ill host here at 810 Vermont. This sound like a good plan? This is Scott Blackburn, the Act ing CIO for the Department of Veterans Affairs (VA). On behalf of the Secretary David Shulkin, I wou ld like to invite you to participate in a crit ical review of our Electron ic Health Record (EHR)modernization strategy and correspond ing Request for Proposal (RFP)to Cerner. Your organizations have been at the forefron t of t he evo luti on high quality IT-based health care services and delivery for decades, and t hus we would be remiss if we did not seek to gain your insight prior to our final contracting decision. I anticipate a round tab le st yle engagement/discussion in the Washingto n, D.C. area that wi ll last approx imate ly two ho urs. I will be accompanied by the Program Executive Officer for VA Electronic Health Record Modernization {PEO EHRM), John Windom, and his key staff members including his Chief Medica l Officer (CMO), Chief Techno logy Officer (CTO) and Director of Contracts. We have spoken to many comme rcial health care industry leaders regarding EHRimplementation and deployment, and continue to mainta in a strong relat ionsh ip w ith our Department of Defense (DoD) counterparts, with regards to their EHRdeployment activit ies and related challenges. We believe that we have deve loped a comprehensive RFPwith particular emphasis on notable "fail points" EHRdeploymen t arena such as Governa nce, Training, Change Management, Data Mig ration, Funding, etc. to name only a few, but look forward to your tho ughts on t hese and others. I ask that you please prov ide me your primary schedu le manager or point of contact to coordinate a date and time t hat maximizes our overa ll participat ion at t his all-impo rtant review forum. Thank VA-18-0298-C, VA-18-0299-C-000116 116 of 220 you in advance for your attention to this note, participation and willingness to help our Veterans continue to receive the very best healthcare. Scott Blackburn Scott Blackburn Executive in Charge, Off ice of Informat ion & Technology US Department of Veterans Affa irs VA-18-0298-C, VA-18-0299-C-000117 117 of 220 To : Cc: Windom,John H BlackburnScottB : QJ.S Prjnce-Whee ter Latriece B : BowmanThomas Subj ect : Date: Wednesday , October 25, 2017 4 :15:49 PM From : RE: 5 CIOs Sir, I believe I respon ded, but plan looks goo d t o me . Vr John John H. W indom, Senior Executi ve Service (SES) Prog ram Executive fo r Elect ron ic Healt h Record Mo derni zatio n (PEO EHRM) Special Adviso r to the Under Secretary fo r Health 810 Vermo nt Avenue NW (Suite 375X) Washi ngto n, DC 20420 John.W indom@va.gov Off ice: (202) 46 1-5820 :I Mob ile ._ (b_)(_6)___ __, From: Blackburn, Scott R. Sent: Wednesday, October 25, 2017 3:08 PM To: DJS Cc: Prince-Wheeler, Latriece R.; Bowman, Thomas; Windom, John H. Subject: 5 CIOs Here is my pla n. I jus t wan t to make sure you are good w it h it befo re I execute it. If so, I'll get the ema il add resses fr o m Lat riece . Step 1- send an email to Jared Kush ner and Chris Lidde ll know ing th at we do t his. We did n't te ll t hem d irectly yest er day and I do n' t wa nt t o b lindside them . Step 2 - send t he below email to the 5 Cl Os (Kaiser, Cleveland Clinic, Part ners, Mayo, Johns Hopk ins). Follow up w it h calls to confi rm them. Step 3 - set up th is 90 min ute meet ing somet ime in t he next 10 days. Invite th em to joi n either p hone or in person. If Chris/Jared want to join, we can have t hem j o in as we ll. We w ill host he re at 810 Vermo nt. This sound like a good p lan? This is Scott Blackb urn, t he Act ing CIO for t he Departme nt of Veterans Affairs (VA). On be half of the VA-18-0298-C, VA-18-0299-C-000118 118 of 220 From: To : Subject : Date: Blackburn ScottB RE: Bruce M + Mark Sherman Wednesday , November 22 , 2017 5 :39:05 PM I tried you - call me atl..__ (b____ )(__ 6)___ _. Sent with Good (www .good.com) From: Blackburn , Scott R. Sent: Wednesday, November 22, 2017 1 :43:33 PM To: DJS Subject: Bruce M + Mark Sherman 6 (b_ )(_ l___ When yo u have a mi nute, can yo u give me a call? ._l ___, I ju st had a conversation w ith Bruce and Mark Sherman (both jo ined in on t he CIO call last week). They have a suggestio n t hat I need to ru n by you. From: Bruce Moskowitz [mailto:brucemoskowitzmd@mac.com] Sent: Monday, November 20, 2017 6:02 AM To: Blackburn, Scott R. Subject: [ EXTERNAL ] VA-CIO CALL Dear Scott: I thought the VA-CIO call November 15 to help you with practical indu stry expertise relating to your propo sed Cerner implementation generated some valuab le conversation. The participant s were some of the most highly experienced CIOs with deep EMR background s, together with physicians who focus on medical error prevention and improvin g the EMR exper ience. I hope and expect that you found it of great value. Since we have not spoken before , you may not be aware that I am the per son who personally recruit ed the Academic Medical Centers to provid e the VA with advice , intended to help the VA create and implement a path to fix its care delivery issues, as well as advise on other areas where they can be of value to better veteran s' care. I have been a centra l point for the group and was the collection point for the particip ants' post-call debrief. Also, for reference purpo ses, each of the people on yesterday's call has performed flawle ss implementation s of state of the art EMR systems on behalf of their respective healthcare delivery systems, some more than once. Since the call was structured to focus the discussion on the few direct questions set forth in your agenda, and the mod erator contro lled the timing of each question very tightly, the breadth of the discussion was somewha t limited . As a result , you only had the benefit of the experts' advice in the areas that the moderator put on the table ... and the participant' s want to make sure you have the benefit of their comp lete thoughts and feedback. Everyon e felt good about the discussion on the agenda questions and felt that the scope and implementation issues rel ating to DOD I VA interoperabi lity were well in hand. Howev er, some of the participant s' questions raised about other areas left them uneasy about the readine ss of the system for implementation VA-18-0298-C, VA-18-0299-C-000119 119 of 220 To : Cc: Blackb urn ScottB Sandova l Camilo J WindomJohnH Subj ect : Date: RE: Contract Language Monday, April 02, 2018 9:40:00 AM From: Morr is, Genevieve (OS/0 NC/10 )K i:... b..:..:) (~6):.....____ ___,t' l@ "'"h ..... b...s.... g..,.o .... v I do n't th ink I have a p hone numbe r for her, but wi ll let you know if I can fi nd it. From: Sandoval, Camilo J. Sent: Monday, April 02 , 2018 9:03 AM To: Blackburn , Scott R. Cc: Windom , John H. Subject : RE: Contract Language Scott .Do you have Genevieve' s work emai l address and phone number? I need to contact her today and not sure where I can find her or if she at the VA yet. Thank you, Camilo From: Blackburn, Scott R. Sent: Sunday, April 01, 2018 6:28:05 PM To: Sandoval, Camilo J. Cc: Windom , John H. Subject : RE: Contract Language Yep, I know Genev ieve. She is good. W ill give it some tho ught. Is she detailed in to VHA I assume? From: Sandoval, Camilo J. Sent: Sunday, April 0 1, 20 18 8:39 PM To: Blackburn , Scott R. Cc: Windom , John H. Subject : RE: Contract Language Exce llent, I' 11touc h base with Windom tomorrow mornin g. Also, there' s someone by the name of Genevieve Morr is from the Office of Natio nal Coordinator (ONC) joining the VA tomonow on a 120 day detail. I believe she will be helping us review the contract as well, at least with regards to interoperabi lity, and already working with the EHR team. Do you know (of) her? Any thoughts on how we might utilize her expert ise in comb ination with Rasu, beyond j ust reviewin g the Cerner contract? She seems to have a solid policy backgrou nd in her respect ive space . Do you see Genev ieve and Rasu working together to cover the policy and funct iona l aspects of Interoperability ? Camilo VA-18-0298-C, VA-18-0299-C-000120 120 of 220 From: Blackburn, Scott R. Sent: Sunday, April 01, 2018 4:38:47 PM To: Sandoval, Camilo J. Cc: Windom, John H. Subject: RE: Contract Language Not sure we did. John? What he m ight be talking about is the feedback from the calls we had 2 weeks ago. I believe John and team have created a thorough matr ix to reconci le that feedback (and Ash did follow ups w ith each to make sure we understood their feedback and then understood how we were reconc iling that feedback}. There was also the language that we rece ived via OGC. I' ll leave it to John to weigh in. From: Sandoval, Camilo J. Sent: Sunday, April 01, 2018 7:35 PM To: Blackburn, Scott R. Cc: Windom, John H. Subject: Re: Contract Language Scott , I ju st spoke with Bruce Mo skowit z regarding where things are with EHR and he mentioned you recen tly received language provide d by several CIOs (Leslie Cooper, Stan Huff , Stephanie Reel, Jon athan Mani s). Could you kindly forward me those emails and documents? I believe it was in regards to interoperab ility. Hope you had a great Easter Sunday. Thank you. Camilo VA-18-0298-C, VA-18-0299-C-000121 121 of 220 To : Sandov al Camilo ,I Blackburn ScottB Subject : Date: RE: Contract Language Sunday, Apri l 01 , 2018 9:31 :07 PM From: Yes, she begins tmrw. No idea where she will be in the morning, but was asked to meet with her e asap . From: Blackburn, Scott R. Sent: Sunday, April 01, 2018 6:28:05 PM To: Sandoval, Camilo J. Cc: Windom , John H. Subject: RE: Contract Language Yep, I know Genevieve. She is goo d. W ill give it some t ho ught. Is she det ailed in t o VHA I assume? From: Sandoval, Camilo J. Sent : Sunday, April 0 1, 2018 8:39 PM To: Blackburn, Scott R. Cc: Windom , John H. Subject: RE: Contract Language Exce llent, I'll touch base with Windom tomorrow morning. Also, there's someo ne by the name of Genevieve Morris from the Office of National Coordinator (ONC) joining the VA tomoITow on a 120 day detail. I believe she will be helping us review the contract as well, at least with regards to interoperabi lity, and already working with the EHR team. Do you know (of) her? Any thoughts on how we might utilize her expert ise in comb ination with Rasu, beyond j ust reviewing the Cerner contract? She seems to have a solid policy background in her respective space. Do you see Genevieve and Rasu working together to cover the policy and functional aspects of Interop erabili ty? Camilo From: Blackburn, Scott R. Sent : Sunday, April 0 1, 2018 4:38:47 PM To: Sandoval, Camilo J. Cc: Windom , John H. Subject: RE: Contract Language Not sure we did. Joh n? Wha t he m ight be t alking abo ut is the feedbac k from the calls we had 2 wee ks ago. I be lieve Joh n and t eam have creat ed a t horough matri x t o reconci le that fee d back (and Ash did fo llow ups w it h each t o make sure we understood t heir feedback and then unders t ood how we we re reco nciling that feedbac k). The re was also the language that we rece ived via OGC. VA-18-0298-C, VA-18-0299-C-000122 122 of 220 To : Windom,John H BlackburnScottB Subject : Date: RE: Contract Language Monday, April 02, 2018 7:32:48 AM From: Negative Sir. Vr John Sent with Good (www.good.com) From: Blackburn, Scott R. Sent: Sunday, April 0 1, 20 18 7:26:06 PM To: Windom, John H. Subject: FW: Contract Language Did you know anyth ing about Genevieve Mo rris coming in? From: Sandoval, Camilo J. Sent: Sunday, April 0 1, 20 18 8:39 PM To: Blackburn , Scott R. Cc: Windom , John H. Subje ct: RE: Contract Language Excellent , I' ll touch base with Windom tomorrow morning. Also, there's someone by the name of Genevieve Morris from the Office of National Coordinator (ONC) joining the VA tomoITow on a 120 day detail. I believe she will be helping us review the contract as well, at leas t with regards to interoperabi lity , and already working with the EHR team . Do yo u know (of) her? Any thou ghts on how we mi ght utiliz e her expertise in comb inatio n with Ra su, beyond j ust reviewing the Cerner contract? She seems to have a solid poli cy background in her respective space. Do you see Genevieve and Ra su working together to cover the policy and functional aspects of Interoperability? Camilo From: Blackburn, Scott R. Sent: Sunday, April 0 1, 20 18 4:38:47 PM To: Sandoval, Camilo J. Cc: Windom , John H. Subject: RE: Contract Language Not sure we did. Joh n? What he might be t alking about is t he feed back fr om t he calls we had 2 wee ks ago. I believe Joh n VA-18-0298-C, VA-18-0299-C-000123 123 of 220 To : Cc: Sandova l Camilo ,I Black burn ScottB Windom JohnH Subj ect : Date: RE: Contract Language Monday, April 02 , 2018 9:04:49 AM From: Scott,Do you have Genevieve's work email address and phone number? I need to contact her today and not sure where I can find her or if she at the VA yet. Thank you, Camilo From: Blackburn, Scott R. Sent: Sunday, April 0 1, 2018 6:28:05 PM To: Sandoval, Camilo J. Cc: Windom , John H. Subject : RE: Contract Language Yep, I know Genevieve . She is good. W ill give it some thought. Is she detailed in to VHA I assume? From: Sandoval, Camilo J. Sent: Sunday, April 01, 2018 8:39 PM To: Blackburn , Scott R. Cc: Windom , John H. Subject : RE: Contract Language Excellent, I'll touch base with Windom tomorrow morning. Also, there's someone by the name of Genevieve Morris from the Office of National Coordinator (ONC) joining the VA tomorrow on a 120 day detail. I believe she will be helping us review the contract as well, at least with regards to interoperabi lity, and already working with the EHR team. Do you know (of) her? Any thoughts on how we might utilize her expertise in combination with Rasu, beyond just reviewing the Cerner contract? She seems to have a solid policy background in her respective space. Do you see Genevieve and Rasu working together to cover the policy and functional aspects of Interoperability? Camilo From: Blackburn, Scott R. Sent: Sunday, April 01, 2018 4:38:47 PM To: Sandoval, Camilo J. Cc: Windom , John H. Subject : RE: Contract Language Not sure we did. John? What he might be talking about is the feedback from the calls we had 2 weeks ago. I be lieve John VA-18-0298-C, VA-18-0299-C-000124 124 of 220 From : To : Cc: Blackburn ScottB BowmanThomas:Wright Yiyieca Cc:!(b)/6} @va.gov> Subject : RE: FOIA Request 18-07440- F (M cGrath ) Good Morning Jacqueline, Please p rovide names and if possible em ail addresses for the accounts to be searched: Assista nt Secretary for 01& T and CIO (we need names). You listed "Accounts to be searched: Assistant Secretary for 0 1& T and CIO and t heir calendars. l(b)(6) Off ice Automation / E-Messag ing Services , End User Operatio ns 0 1& T, IT Operat ions & Services (ITOPS) U.S. Departme nt of Veterans Affairs Office: (202) 46 1-5193 National Service Desk: 855-NSD HELP(855-673-4357) From: Short, Jacqueline Sent: Thursday, May 17, 2018 8:29 AM ToJPY b)(6) ~ya gov> VA-18-0298-C, VA-18-0299-C-000128 128 of 220 Subject : RE: FOIA Request 18-07440 - F (McGr at h) Good mo rn ingl(b)(6) I I have to extend th is req uest to add: Accounts to be searched: Assista nt Secretary fo r 01& T and CIO and t heir calendars. Searched items to be used: Dr. Bruce Mos kow itz, Isaac " Ike' Perlmu tter , Bruce M oskow itz and Jared Kushner Jacqueline (Jackie) Short VACO FOIA Service Quality , Privacy, and Risk (QPR) Office of Info rma ti on and Techno logy (01& T) Office: (202) 632- 7426 / Fax: (202) 632-758 1 vacofo iaservice@va.gov FOIA Service Hotl ine: 1-877-7 50-3642 From: Short, Jacqueline Sent: Tuesday, M ay 08, 2018 2:07 PM To:l(b)(6 ) wiv agov> Subject : FOIA Request 18-07440-F (McGrath) Good aft ernoo ~ Please do a search on the fo llow ing: Accounts to be searched: Assistant Secretary for 0 1& T and CIO Searched items to be used: ema ils, email attachments. txt mgs, mgs on mgs platforms; Slack, GChat or Google Hangouts, Lyne, skype or WhatsApp. Dates/Time Frames: May 15, 2017 to the date of t he search Jacqueline (Jackie) Short VACO FOIA Service Quali ty, Privacy, and Risk (QPR) Office of Informa tio n and Techno logy (01& T) Office: (202) 632-7426 / Fax: (202) 632-7581 VA-18-0298-C, VA-18-0299-C-000129 129 of 220 vacofoiaservice@va.gov FOIA Service Hotl ine: 1-877 -750 -3642 Please take a moment and let us know how we did by completing a quick evaluation: Got a minute? Rate Our Serv ice! OPR'sMissionStatement: 'To instill and promote a cultu re of quality , privacy and risk management in collabora tion with our business partners to enable a better Veteran experience." VA-18-0298-C, VA-18-0299-C-000130 130 of 220 From : To : Subject : Date : Attachments: if~)~g) ,Jacguelioj RE: FOIA Request 18-07440-F (McGrat h) Thursday, May 17, 20 18 9:26:00 AM ~ 1. Qng Scott R. Blackb urn Eric D. Huwear t From._l (b_)(_5 l____ __. Sent: Thursday, May 17, 2018 8:58 AM To: Shor t , Jacqu el in e ~va.gov> Cc :l(b)(6) Subject: RE: FOIA Request 18-07440 - F (McGrath) Good Morning Jacqueline, Please provide names and if possible email addresses for the accounts to be searched: Assista nt Secretary fo r 01& T and CIO (we need names). You listed "Accountsto be searched: Assistant Secretary for 0 1& T and CIO and t heir cale ndars. l(b)(6) Office Automation/E-Messaging Services , End User Ope ratio ns 0 1& T, IT Operat ions & Services (ITOPS) U.S. Department of Veterans Affairs Office: (202) 461-5 193 Nat ional Serv ice Desk: 855 - NSD HELP (855 -673 -4357) From: Short, Jacqueline Sent: Thursday, May 17, 2018 8:29 AM ToJPY b)(6) lwva.g ov > Subject: RE: FOIA Request 18-07440 - F (M cGrath) Good mo rni ngl(b)(6 ) I have to extend this request to add: Accountsto be searched: Assista nt Secretary for 01& T and CIO and t he ir calendars. Searcheditems to be used: Dr. Bruce Mos kow itz, Isaac " Ike' Perlmu tte r, Bruce Moskow itz and Jared Kushner VA-18-0298-C, VA-18-0299-C-000131 131 of 220 Jacqueline (Jackie) Short VACO FOIA Service Quality, Privacy, and Risk (QPR) Office of Informat ion and Techno logy {01& T) Off ice: (202) 632-7426 / Fax: (202) 632-7581 vacofoiaservice@va.gov FOIA Service Hot line: 1-877 -750-3642 From: Short, Jacqueline Sent: Tuesday, May 08, 2018 2:07 PM To: ~b)(6) l@vagov> Subject : FOIA Request 18-07440 -F (McGrath) Good afternoon l(b)(6 ) Please do a search on the fo llow ing: Accounts to be searched: Assistant Secretary for 0 1& T and CIO Searched items to be used: ema ils, email attachments . txt mgs, mgs on mgs platforms; Slack, GChat or Google Hangouts, Lyne, skype or WhatsApp. Dates/Time Frames: May 15, 2017 to t he date of t he search Jacqueline (Jackie) Short VACO FOIA Service Quality, Privacy, and Risk (QPR) Office of Informat ion and Techno logy {01& T) Off ice: (202) 632-7426 / Fax: (202) 632-758 1 vacofoiaservice@va.gov FOIA Service Hot line: 1-877 -750-3642 Please take a moment and let us know how we did by completing a quick evaluation: Got a minute?RateOur Service! QPR's MissionStatement: 'To instill and promote a cultu re of quality , privacy and risk management in collaboration with our business partners to enable a better Veteran expe rience." VA-18-0298-C, VA-18-0299-C-000132 132 of 220 From : To : Subject : Date: QJ.S. BlackburnScottB RE: Follow up Friday , Novembe r 24, 20 17 4: 11 :20 PM Thank s Sent with Good (www .goo d.com) From: Blackburn , Scott R. Sent: Friday, November 24, 20 1710:34:31 AM To: DJS Subject: FW: Follow up Sent with Good (www.good.com) From: Blackburn , Scott R. Sent: Wednesday , November 22, 2017 6:49:19 PM To: Bruce Moskowitz; l(b)(6) j@gmail.com Subject : Follow up Bruce/ Ma rc - t han ks again for all your support. We really app reciat e what you are do ing to bring the best of the healt hcare ind ust ry to help Veterans/VA. I spoke with David and he gave th e green light to move fo rward. We absol utely wa nt t o get this f eedbac k and great ly apprec iate t he he lp. The only caveat is that we move as aggressively/quickly as poss ible. There are st ill a few things we need to figu re out with respect to timing o n signing the contract w ith Congress/budget/fundi ng/etc (e.g., one of the reasons for starting soon is to get in sync w it h Do D's rollo ut to leve rage syne rgies; another variable is t he Conti nui ng Resoluti on and t im ing of when the government budget is fi nalized whic h could poss ibly push out to Jan/Feb rat her than December as currently projected). But we wi ll figu re that out. The po int be ing is that we love t he idea, do want the f eedbac k, and agree w it h th e logic we discussed on the p ho ne . We will de lay t he signi ng as long as we can t o make sure we get th is right (the co ncern is ma king sure we don't m iss the w indow). If you cou ld reach o ut t o th e 5 CEOs/Cl Os, it wou ld be greatly apprec iated. I will commit to mak ing sure the VA t urns aro und the gap analys is as fast as possible. Do you t hink it could th e n be poss ible to shoot fo r a full day session in mid - December (week of 11 th th or 18 )? David had the idea of poss ibly doi ng it at t he Cerner Innovat ion Labora to ry in Kansas City so we can t est/challenge someth ings on th e spot. Thanks again for all your support! I hope yo u and your fam ilies have a great Thanksg iving. VA-18-0298-C, VA-18-0299-C-000133 133 of 220 Scott Scott Blackburn Act ing CIO & Executive-i n-Charge, Off ice of Info rmation & Techno logy Department of Veterans Affa irs VA-18-0298-C, VA-18-0299-C-000134 134 of 220 From : To: Subj ect: Date: Blackburn SoottR. Sandoval Camilo J. RE: I reviewed again and this is th e way forwa rd Th ursday , February 01, 2018 10:50:0 5 PM Yep. They finished it today. Let.me send it. Sent with Good (www.good .com) From: Sandoval, Camilo J. Sent: Thursday, February 01 , 2018 9:17:46 PM To : Blackburn, Scott R. Subje ct : RE: I reviewed again and this is the way forw ard Is t he M ITRE repo rt availab le yet? From: Sandoval, Camilo J. Sent : Thursday, February 01 , 2018 9:17 PM To: Blackburn, Scott R. Subject: RE: I reviewe d again and t his is the way forward I a lso floated the id ea we discussed and is bei ng cons idered. Ho pe fully w ill get d irect ion on that by to morrow as we ll. From : Sandoval, Camilo J. Sent: Thursday, February 01 , 2018 9:16 PM To : Blackburn, Scott R. Subject : RE: I reviewed again and this is the way forward I j ust p inged Ma rk and Bruce t o clar ify, but I t hin k the re are a few ang les. The prov ider perspect ive from Br uce, and t he dyn amic system design (techn ology per spective) and IDIQ cont ract (Mar k). I had a long dis cussion with Ma rk last night, and I do n' t be lieve ou r conversa t ion is reall y inclu ded in t he d iscussion be low . But I did ask Mark for confirm ati on as we l l. This wou ld be an amaz ing b reakt h rough if so. I should hear back from t he m by t omor row morn ing. Than k you . From : Blackburn , Scott R. Sent: Thursday, February 01 , 2018 7:43 PM To: Sandova l, Camilo J. Subje ct: FW: I reviewed again and th is is t he way forward How do you interp ret this? From: Byrne, Rich!ib) / 6 ) @mitre org] Sent : Thursday, February 01 , 2018 7:03 PM To: Blackburn, Scott R. Cc : Schnitzer, Jay J Subject : [EXTERNAL] FW: I reviewed again and this is the way forward Scott If I read Bruce's note cor rec tl y, the re has been a significant chang e. Jay and I t hink h e now sup ports t he way ahead tha t we d iscussed wi t h you t hat connects t he EHR an d DVP efforts to addr ess his conce rns! Rich From : Ric h Byrn e ~ mjtre org> Date : Th ur sd ay , Feb ru a ry 1, 20 18 at 7:00 PM To: Br uc e Mo skow it z ] (b )( 6 ) Cc:Jay Sch n itz e rl (b)( 6_ l@icloud com> l @m itre .org> Subject: Re: I rev iewed again a nd th is is the way fo rwar d Bruce VA-18-0298-C, VA-18-0299-C-000135 135 of 220 From : To: Sandova l Camilo J. Blackburn Scott R. Sub j ect: RE: I reviewed again and this is the way forwa rd Thursday, February 01, 2018 11:38 :56 PM Date: (b)(5) From: Sandoval, Camilo J. Sent : Thursday, February 01 , 2018 6:54:06 PM To: Blackburn, Scott R. Subject: RE: I reviewed again and this is the way forward Bruce explaine d t he comments in red are his own wo rds, and he is refe rring t o t hose comments as the path forward. Still wa it ing for Ma rk to op ine. From : Blackburn, Scott R. Sent: Thursday, February 01, 2018 7:43 PM To: Sandoval, Camilo J. Subject: FW: I reviewed again and th is is the way forward How do you interp ret this? From: Byrne, Ric~(b)( 6) lmmit re org] Sent : Thursday, February 01 , 2018 7:03 PM To: Blackburn, Scott R. Cc : Schnitzer, Jay J Subject : [EXTERNAL] FW: I reviewed again and th is is the way forward Scott (b)(5) Rich From : Rich By rn el(b)( 6) i@mjtre org> Date : Th urs day, February 1, 20 18 at 7:00 PM To: Br uce Mo skow it z 1(b)(6) Cc: Jay Schnitzed (b)( 6) t@icloud, com> f@m it r e.org> Subject: Re: I rev iewe d again and th is is the way fo rwar d Bruce l(b)(5) Rich From: Bruce Mo sko w itz 41bV6) [a)jd oud com> Date : Th ur sday, Feb ruary 1, 2018 at 6:29 PM To: Rich ByrnP !/b)/6) Cc:Jay Schnitzer l(b)(6) @m it re.o r g> l@mitre org> Subject: I rev iewed again and t his is the way fo rward I than k you th e mo re I t hought about you r points the more convinced I am VA-18-0298-C, VA-18-0299-C-000136 136 of 220 BlackburnScottB WindomJohnH ZenoozAshwin i : Myklegard Drew:Short John/YAGO} From : To : Cc: Subj ect : Date: RE: Meeting with Secretary Shulkin Wednesday, March 2 1, 20 18 9:17 :00 AM Sounds like a plan. I wil l come in and be there in person. From: Windom, John H. Sent: Wednesday, March 21, 2018 9:16 AM To: Blackburn, Scott R. Cc: Zenooz, Ashwini; Myklegard, Drew; Short, John (VACO) Subje ct: Meeting with Secretary Shulkin Importance: High Sir, I recommend using t he 1100 -113 0 meet ing wi t h Shulkin to get clear direction from him on w hat it takes to close out the contract. The only comments I wo uld make from an act ion perspect ive: 1. We will be assemb ling the EHRM industry advisory council as discussed. Parti cipants likely t o include: Stepha nie Reel (Hopkins) Jon Manis (Sutter) Rasu (UPMC) Shafiq Rab (Rush) Chris Ross (Mayo) Vivek Reddy (lnte rmountain) Aneesh Chopra Ryan Howells (Leavitt Part ners) Frank Opelka (America n College of Physicians) Will Mo rris or Ed Ma rx (Clevela nd Clinic) Dr. Andy Karson (M ass Gene ral Hospital) Dr. Bruce Mos kowitz (Tenet ) Alistai r Erskine (Geisinge r) Danie l Barchi (New York Presbyte rian) 2. We will set up t he recommended intero perab il ity t est platform/san dbox as part of ou r IOC effor t s and associated testi ng requ iremen t s. 3. We will solid ify the DVP requireme nts and associated API strategies based on comments from the external experts. 4. Re-validat e int erope rabilit y, device registry , et c. language conta ined in the contract. 5. Conti nue to sol idify our PEO staffing st ru ct ure in suppo rt of present and f ut ure cont ract oversight req uirements. M r. Secreta ry, what else did your hear? I believe we are ready. Thoughts .....? VA-18-0298-C, VA-18-0299-C-000137 137 of 220 ~'5bo1'. I MboCYMXJl From : lo : FidCtitllmSOOUB Cc, $ubjffl : Re; Open API o 11I; C~OU:, + li!fQ l,lpe + A;i1;1,1 , . Up;l;lte All 4 An~ w~~. lmpoo-t - : Febru;iry 28, .:018 3:li:33 ~o High 1. Vo ice Recogn iti on? The EHRM p latform includes Enterp rise Dragon Nu ance . VHA alre.ady dep loyed the enterprise version whic h maintai ns peo ple voice prin t ,rnd the Cl inical Staff say it wo rks \'e ry wel l. Cem er wi ll po rt ov er the ,.o ice print~ ~o the clinichrns that use it today will be ab le to use it tomo rrow in Cemer witho ut any rewo rk . 'rbe Cli nician can use the d ictat ion and o ther features with voice recogn ition . 2. How will all entered lab data. fro m any so urce. be availab le on a graph? Graph s are gene rally ava ilable in 2 spo ts. 1. Wo rknow MPage lab Compo nerll and 2. Res ults re.view nows heet . Whe n outs ide labs are mapped we wo uld use the same n ames as internal and then they wo uld appear on the same line. Even if 1hey arc no t cx:tclly named the same lhe resu lts review now sheel allows for 2 di.fforenl lab values to be grap hed toge ther. 2. Can Cemer 's system catching tes t d uplica tjon, ove r ulili:tatio n and med ica1ion dupl ica1ion/errors a1 time of ordering instead of after the fact? Yes. All tests are con figured to have a time whe re.and alert is issued based o n paramet ers we con figure and can flex by ven ue. Over utiliza lion is ge nera lly avo ided with real 1ime aler1ing bUI we would have to use some mech an_ism to monitor. via report, usually . TI1e med dup lication is co nfigured simi larly to te.st and parameters detennine how 1he sys1em acts . Tai.I man n instances we id entify un_ique ins tances o f errors we can co nfigure rules 10 ca1ch those. For meds all allergy checking , leu er i.ng red uce.s erro rs in look alike, so und alike meds, and finally i_ du pes, dose range checks. and internclion.s are checked at lime of ordering . .,. Also, at DoD Cerner has already p revented over 15,000 dup licate test at the th r ee sites . 3. Docs Cerne r have streaml ined SOA P no tes? Yes . Thc.sc arc prov ided and w ill be fun hcr co nfig urcd under VA d irect ion to mce l VA c linic ian needs. From: Blackbum, 54::ottR. Sent : Wednesday,February 2s, 2018 2 :33 PM To : Vfindom. John H.: Short. John (VA.CO):Zenooz, Ashwlnl Subject: FW; [EXTERNAL)Re: Open API o it is CLOUD+ languge + Rasu Where did we land on the 4 top ics below? I want to make sure thev understand that you guys did a hell of a Job so we have a warm and fuzzy that we are getting che best deal for Veterans. From : BruceMoskowitz.fmaH10 .bwcempskQWllmtd@mac; com) Sent: Wednesday, February 28, 2018 1:13 PM To : Blackbum. Scott A. Cc: DJS; Marc Sherman; 0 'Rourke, Peter M.; IP; lrerl?526@amai l mm Subject: Re: [EXTERNAL) Re; ~e n API . it is CLOllD + languge-+ Aa.su T hank yo u my five CIO"s had looked forward to tar tmd feathering me if lhe clo ud is not do ne correctly ! T he Other is.sues arc: Voice Recognition All entering lab data o n a g raph from any source Catching lest dup licatio n, over utiliza tio n ar\d medication dup licatiortlerro rs at time of orderi r\g 110 1a fter the fact Stream lined SOAP no tes Sent from my iPnd Brncc Mosk.owi1z M.D. On Fe b 28 . 2018. ttl 12:52 PM. Black.burn. S0011R. wrote: Srvce this is incredibly helpf1,1I.Thank vou very mt.Jch. I had my tei:lm dig into th is this more this morning . What yov have stated below Is clearly the int ent (we need everyth ing 10 be OPENand abso1ucelydo noc want to inadvertently creace vendor lock): we've also gone back this mornign to confirm wich Cerner that th ,s is their intent We are going to alter the langt.Jageto make th is more clear. We don't anticipate any pushback. A few things I learned this morning ... o The concract does NOT lock t.JSIn to Amazon Web Services(AWS), Rather any cloud provider or applications thac meet security and privacy requiremen ts to protecc Veteran data can lntertace with Open APls or push data to the VNCernersyscem. Currently 3 cloud prov iders meet the Government se-curityrequirements -AWS. Azure/Microsoft and CSRA. There are several others chat we eJCileCt to come on board soon lncl1,1d 1ng Google and V1rtuStream/Dell. At VA, we use both AWS and Azure nght now. Again, 1hegoal here Is to create open environment as long as the provider meets certain standards (these standards are dictated by GSA, not VA) o Cerner does ha...e a partnership wit h AWS {which Is why we highlighted that) but It 1s Just one e,campleof the open could en,..Ironmentsthey are planning to work with. We have confirmed that it will be OPENand not proprietary to cheir specificAWS clood. o DoD Is excited to followoor lead on all of this. I spent the morning at the Pentagon with the DoD CI0/team . Th1sw 1IIhelp not just Veterans, but serVJcemembersstill in un ifo rm Thanksagain tor th e feedback and support. We are going to make sure this is crystal clear. Scott From: BruceMoskowitz [mallto.bmcemoskowltzmd@mac com] Sent : Tuesday, February 27, 2018 9 :29 PM To: Blackbum, Scott R. Cc: DJS: Mare Sherman; o.Aourke. Peter M.: IP. Joer'f252B@oma ll com Subject : (EXTERNAL) Re: Open API o It Is CLOUD+ languge + Rasu Apolog ize for the wordin g instead or their commercial cloud a cloud base d sys tem o pen be all p latfon ns working to accele rate health care iniatives To all entities and instead of Amazo n it shou ld Sent from my iPad Bruce Mos kow itz M.D. On Feb 27. 20 18, at 9:20 P:M. Bruce Mos kowi tz wro te: T o clarify further it s1a1es1he i.r commerc ial clo ud i.ns te.ad a commercia l clo ud Open to all entities and of equa l impo rtance an open platform to all no t ju st amazon b Ul 10 al l Wor king on Sent from my iPad VA-18-0298-C, VA-18-0299-C-000138 138 of 220 lo : Cc, FidC titllm SOOUB Re ; Open API o III; C~OU'.l+ li!fQl,lpe+ A;i1;1,1 , . Up;l;l te w~ ~ . Febru;iry 28, .:018 3:1)4. :16 ~ o $ubjffl : lmpoo-t- ~:5bo1'. I MboCYM XJl From : : High Two additional answers below. From: Short, John (VACO) , Febn.iary 2S, 2018 2 :54 PM Sent : Wedne:Ktay To: Blad!bum. Soott R. Cc: Windom, John H.; Zenooz, Ashwini Subject: RE: Open API - it is ClOUO + langvge + Ra5,1.1 t hadn' t seeo these other questions unti l now. See below fo, one answer . I am work ing the others as we ll. From: Blackbum. Scon R. Sent: Wednesday,February 26, 2018 2:33 PM To: Windom, ..k:l hn H.; Short, ..k:l hn (VAOO); Zenooz, Ashwini Subject: FW: (EXTE.RNA LJ Re: 0t,en API o ii is CLOUD + lan9uge + Rasu Where did we land on the 4 top,c:sbelow? I want to make sure they understand that you guys did a hell of a Job so we have a warm and fuzzv that we are getting the best deal for Veterans. From:BruceMoskowit J( b )(6) b maccom) Sent: Wednesday,Febroary 26, 2018 I ; 13 PM ~~ ~t:1: r~ '~~!:~ :O'Routke, Pete, M.; IP.fiwF7 @omail mm SubJeet: Re: [EXTERNAL)Re: Open API o It Is CLOUD + languge + Rasu Thank you my five CIO"s had looked forward to tar and feathe.ring me if lhe clo ud is nm done c.orrectly! T he other issues are: Vo ice RecogoitiO r\ oo The EHRM platfor m includes Enterprise Dragon Nuance. VHA already deployed t he ent erprise versio n which maintai ns.people vo ice prin t and the Clinical Staff say it wor ks.very well. Cemer will port over the voice pr ints so the cli nicians lh at use ,t today will be able to use it tomo rrow 1n Cer ner wilh out any rework. The Clinician can use the dictation and ot her featu res wit h vo ice recognit ion. All entering lab darn on a graph from a1,ysoul'Ce oo Every lab has diffe rent reference ton ges so grap hing tose ther can cause pati ent safety concer ns. However, tre ndrns patt erns can be bui lt w ith alerts based off diffe rent lab sou rce data. Catching test duplicatio n. over utilization and med ication dup lication/errm~ at time of ordering not after the fact o oYes Cern er does this.. At DoD Cemer has already prevented over 15,000 duplicate test at the three sites. Yes.,at point of RXorder Cerner wi ll indicate if a duplicate RX is about to be ordered. Stream lined SOAP notes Sent from my iPn wrote; Sruce this i$ incredibly helpf1,1I.Thank yo1,.1 very m1,.1ch . I had my team dig into this this more this morning. What you have stated below ,s dearly the intent (we need everyth,ng lO be OPENand abso1utelydo not want to inadvertently create vendor lock): we've also gone back this mornign to confi rm with Cerner that th ,s is their intent We are going to alter the lang1,.1age to make this more clear. We don't anticipate any pushback. A few things I learned this morning... o o o The contract does NOT lock us ,n to Amazon Web Services(AWS), Rather any cloud provider or applications that meet security and privacy requirements to protect Veteran data can lntertace with Open APls or push data to the VNCernersystem. C1,.1rrently 3 cloud pfoviders meet the Government se-c:urityrequifements -AWS . Azure/Microsoft and CSRA. There are several others that we eXileCtto come on board soon lnclud,ng Google and V1rtuStream/Dell. At VA, we use both AWS and Azure nght now. Again, 1hegoal here 1sto create open environment as long as the provider meets certain standards (these standards are dictated by GSA,not VA) Ceroer does ha...e a partnership with AWS{which Is why we highlighted that) but 1t Is Justone e,campleof the open could en,..Ironmentsthey are planning to work with. We have confirmed that it will be OPENand not proprietary to theirspe-c:ificAWScloud. DoD Is excited to follow our lead on all of this. I spent the morning at the Pentagon with the OoOCIO/team . Th1sw1IIhelp not just Veterans, but serVJcemembersstill in uniform Thanksagain tor the feedback and support. We are going to make sure this is crystal clear. Scott From: BruceMoskowitz [mallto.bmcemoskowltzmd@mac com] Sent: T1,.1 esday, February 27, 2018 9:29 PM To: Blackburn, Scott R. Cc: DJS:Mare Sherman; o.Rourke. Pe1er M.; IP. Joer'f252B@omall com Subject : (EXTERNAL) Re: Open API o It Is CLOUD+ languge + Rasu Apologize for the wording instead or their commercial cloud a cloud based sys tem open be all platfon ns working to accele rate health care iniatives To all entities and instead of Amazo n it should Sent from my iPad Bruce Moskow itz M .D. On Feb 27, 20 18. at 9:20 P:M. Bruce Mos kowi tz wro te: To clarify fur1her it stares 1he ir commerc ial clo ud i.ns te.ad a commercia l clo ud Open 10 all entities and of equa l importance an open platform to all not ju st amazon bUl 10 al l Wor king on Sent from my iPad VA-18-0298-C, VA-18-0299-C-000139 139 of 220 From: To : lJJ2ct4PhnCYM',,01= f!liRPum%211B Subje-cl : RE: Rf ::~ Oato: W~y API o ii isa.ooo + languge + R.a9U . February 28. 2018 12:26:22 PM Concur . Jw Sent wi th Good (www .good .com) From : Short . John (VACO) Sent: Wednesoay, Febn.iary28, 20t8 9:24:15 AM To: Blackburn, Scott R. C<:: Windom, John H. Subject : RE:: Open API o it is CLOUD+ languge + Rasu Validated by Cerner. Cerner's Op en API in te rfaces are hosted in a hig hly scalab le clou d enviro nme nt . In t he case of Cerner's pro posed servic es for VA, t he APls will be accessible by any application and from any cloud environm ent tha t meet s t he requi site secur ity and pr ivacy req uireme nt s to prot ect Vete r an dat a. Also, the r e have been pub lic announ cemen ts about Cerner and Amazo n's Cloud, but that is j ust one examp le of the ope n clo ud environ ments that Cerner is wo r king wi t h, Cerner inte rfa ces wi th many pub lic and pri vate cloud s in the US and abroa d. From : Blackbum, Seou R. Sent : Wednesday, February 28, 20 18 6:0 4 AM To: Windom, John H.; Short, John (VACO) Subject : RE: [EXTERNAL] Re: Open API - it is CLOUD + languge + Rasu Ok Se.nt wilh Good (www 00d com) 0 From : Windom. John H. Sent : Wednesday, Febn.iary28, 2018 5:38:57 AM To: Short, John (VACO): Blacld>urn,Seotl R. Subject : RE: [EXTERNAL) Re: Open API o it is CLOUD + languge + Rasu Si r None of what I read is hard. Howe ver, I canno t meet un1il afler pentagon session . Me troing to the pentago n this mornin g . Vr John Sent with Good (WWW eoodcom) From : Short . John (VACO) Sent: Tuesday, February 27, 2018 7:04:56 PM To: Blackburn. Scott R.: Windom. John H. Subject: RE: (EXTERNAL]Ro: Open API - it Is CLOUD + languge + Rasu Rogertha t' From : Blackburn, Scott R. Sent : Tuesday, February 27, 2018 t 0:05 PM To : Shorl, John (VACO); Windom, John H. Subj ect : RE: (EXTERNAL]Re: Open API o it is CLOUD + languge + Rasu Sure . I sho uld be in the office around 7am. We can also ride over toge ther. Sent wi th Good (wwwgood com) From : Short, John (VACO) Sent : Tuesday, February 27, 20 18 10:03:32 PM To : Blackburn, SoottR.; Windom, John H. Subj ect : RE: [EXTERNAL)Re: Open API o it is CLOUD + languge + Rasu Do you w,;1ntto meet before w e go to the Pent<1gon? Tran spo leaves at 0730 from VACO. From : Blackburn, Scott R. Se nt: Tuesday, February 27, 2018 10:02 PM To: Short, John (VACO): Windom. John H. Subject: RE: (EXTERNAL]Ro: Open API - it Is CLOUD+ languge + Rasu Let's talk in AM. I want to gel this right so we can close and move forward. Sent with Good (www eoodcom) From : Short, John (VACO) Sent : Tuesday, February 27, 2018 t 0:00:49 PM To : Blackburn, Scott R.: Windom, John H. Subj ect : RE: (EXTERNAL]Ro: Open API o It is CLOUD + languge + Rasu VA-18-0298-C, VA-18-0299-C-000140 140 of 220 It is ope n to any Clou d or non. cloud conn ect ion as long as it meets th e security re quirements . Cerner is operat ing the ir own Commerc ial Cloud and are in ta lks with m ult ip le Cloud provide rs to have a prese nce t here. However, rega rdless of what cloud pr ov id er someone is usingthey can connect t o our Cerner platform. fr om : Blackburn. Scott R. Sent : Tuesday, February 27, 2018 9:15 PM To : Short, John (VACO): Windom. John H. Subje ct : FW: [EXTER NAL] Re: OpenAPI - it is CLOUD + languge + Rasu Reactions? Sent wilh Good (wwwgood com) from : Bruce Moskowitz Sent: Tuesday, February 27, 2018 8:20:26 PM To : Blackburn. Scott R. Cc: DJS; Marc Sherman;O'Rourke, Peter M. Subj ect : [EXTERNAL ] Re: Open API o it is CLOUD + languge + Rasu TI1isis a problem it should say opencloud to al l entities not commercial cloud Secondit should be open platform and not just Amazon Sent from my iPhone On Feb 27. 20 18. a l 6:09 PM. Blackburn. Scou R. wrOle : David/ Broce/Marc- here are a few opdates: #1 } 8..a.s..u..ii.. in as far as sta rt ing to help right away . I just got off t he phone with him. He has UPMC comm it ments rest of this week and is Chairm an of HiMSS Innovation comm ittee (so we will all be at H1MSStogether next week). However if he needs to cometo Washington this week torsometh ing, he will find a way to do 1t (and we will use invitatio n trave l to pay for it) . He is wi lli ng to start engaging right away to help us. He said he doesn't have to wait for the IPA paperwo rk to come through fo r him to help. I've attached Rasu's CVin case you need it. #2}The APISare d oud based. o Here 1sthe response from our Techrucal lead ... Th e Open APls t hat VA has access to from Cerner reside in the ir Comm er cial Cloud environment . This enviro nme nt is designed to scale to accommo dat e Cerner's ent ire remote host ed custom er base. In a recent press release Cerner and Ama2on announced that they would be working together in cooperation to accelerate HealthCare Innovations. #3) Below Is th e~ that we negoti ated. This is what ca\Jsed Aneesh Chopra [one of the e)Cpert.son our MITRE panel) to jump oot of his chair last week . He claims th is is th e holy grail that no other health care system has been able to get from eit her Cemer or Epic. Aneesh claims th at as a result of what we've negotiated below, th at othe r healthcare systems will be w illing to j oin us in the atta ched pledge (shall we decide to go forward with it) and we could do th is next week at HiM S.S.When I spoke to Rasu, he to ld me Aneesh had already called him aboot th is and that UPMCwo uld be wi lling to sign th is pledge. Of impor tance: Thirdl.!.1Jll)party API developers shall re tain their IP rights when their API is used to co nnect to the Cerner inte rf ace, and there will be no derivative Contractor IP ownership when third part ies consume Cerner termi nology thro ugh open APls. Rega rdi ng the ques tion on sharing deve lopme nt wi th ot hers, see PWS Section 5.5.4 open ing pa ragraph: To accelerate bette r and more responsive service to th e Veteran, VA is making a deliber ate shift towa rds becomin g a standardSJMlUJ.based API driven digital enterprise. A corners tone of this effort is the setu p of a strategic OpenAPI Progr am, The Digital Vet eran Platfor m API Gateway, that is adopti ng an outs ide.in, value.t o.bus iness drive n approach to create APl's that are managed as pro ducts to be consumed by developers with in and outside of VA. Finally, Cemer's response and the final negotiat ion language on sharing their data mode l as a result of the Inte rope rability Pane l findings is as follows, Gerner agreed to suggested addition of PWS paragraph 5.8(h) as highl ighted at no add itional cost: 49 1unOON.tMd how Cerner will RfP Sec1ior1 5.8 ;)(Jdress 1he suppot110 1~rovi dc the VA wi th 3CCe8Sto b us iness intclligcnct 3nesl pi-a dict>S ort h e-rn nt rolli n~ ad0pt 1011 from indus lr y be st proctice s. e .g .. dime-al 1rt11Honalsla nd u i-d. This inc ludes pl'Ofess io nal socie ties.'' ltJ,e ,,bilit)' to uu.ue. e:i11end. and ~hart" lh at l.::nowlcd _g e wilh cli nic.al Sugges1 VA obl:iin ::i pri<< fro m the Contrnctor to tpartn~rs . This tostc=rsrapid provitle a re port exp lain the s teps in volved in actc=ssing adop ~tOfl from m~i!stry best . the d ata mode l, inc luding prod ucing an exa mple da1a file. lPr~tl~e s ...e .g .. cl m 1c11. I p rofes.~1ona l and de monstrnt ing how much of the da ta is co mp utab le: ~ letic=s. the= provitle rnst c=stimates for oulside pa.r1ics to aoc-e:..ss darn\'ia this mechanism. -Scou VA-18-0298-C, VA-18-0299-C-000141 141 of 220 Windom,JohnH From: To : Cc: I l(b)(6) BlackburnScottB LatrieceB : Colli Jacqueline :l(b)(6) Prince-Wheeler I '--------------------' !l h\ /F,\ RE: SecVAShulkin Monday , October 23 , 2017 6:0 4 :23 PM Subje ct: Date : Copy all. Thank you. V/r, John John H. W indom, Senior Executive Service (SES) Program Executive for Electron ic Health Record Modernization (PEO EHRM) Special Adviso r to the Unde r Secretary for Healt h 810 Vermont Avenue NW (Suite 375X) Washington, DC 20420 John,Windom@vagov Office: (202) 461 -5820 (b_)(6_ )___ Mobile: l._ ____, From:!~(b~)(~6~ ) ---~ Sent : Monday, October 23 , 2017 1 :24 PM To: Windom, John H. ; Blackburn , Scott R. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline;!(b)(6) l(b)(6) SubJect : RE: SecVA Shulkin 7 ~---------------' Scott and John - Secretary wil l depar t VACO at 5pm tomorrow for meeting. Please plan to be up here before 5. You both have been cleared thro ugh . (b)(6) ______ ._ l I __. -is Tom p lanning on riding w/SecVA? Than ks. From: ~l (b_)(_6)___ ~ Sent: Friday, October 20, 2017 2:06 PM To: Windom, John H. ; Blackburn , Scott R. Cc: Prince-Wheeler , Latriece R.; Colli, Jacquelinej(b)(6) !(b)(6) I ~--------------~ Subject: RE: SecVA Shulkin Hello - we w ill need to move prep with SecVA to 12:30pm on Monday. Please confirm your availabi lity. Thank you! From: Windom , John H. Sent: Friday, October 2017 9.22 AM To: Blackburn , Scott R.; ~b)(6) .-b- -------------. 6 Cc: Prince-Wheeler, Latriece R.; Colli, JacquelineJ._ ( _)_ ( _) __________ ~0 I _, VA-18-0298-C, VA-18-0299-C-000142 142 of 220 From: To : Cc: Subj ect : Date: I f b)(G) WindomJohnH; -61-ac=kb~u""':rn ~ sc~ot~t == B=---------------~ Prince-Wheeler LatrieceB : Colli Jacqueline:l(b)(6) <=-L>-C..4-.---------------' RE: SecVA Shulkin Monday, October 23 , 20 17 1 :25 :34 PM Thanks- we w ill have t he DEPSECride separate . _. From: ._l (b_)(_6 )___ Sent: Monday, October 23 , 2017 1 :24 PM To: Windom, John H. ; Blackburn , Scott R. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline;l(b)(6) l(b)(6) I ,_______________ _. Subject: RE: SecVA Shulkin Scott and John - Secretary wil l depar t VACO at 5pm tomorrow for meeting. Please plan to be up here before 5. You both have been cleared thro ugh . ._l (b_)(_6)____ ___.I - is Tom p lanning on riding w/SecVA? Than ks. From: Pham, Katherine Sent: Friday, October 20, 2017 2:06 PM To: Windom, John H.; Blackburn , Scott R. Cc: Prince-Wheeler , Latriece R.; Colli, Jacqueline; O'Brien, Milli; Callaghan, Elizabeth; Carrington , Belinda L; Isaac, Charlyn Subject: RE: SecVA Shulkin Hello- we w ill need to move prep with SecVA to 12:30pm on Monday. Please confirm yo ur availabi lity. Thank you! From: Windom , John H. Sent: Friday, October 20, 2017 9:22 AM To: Blackburn , Scott R.; Pham, Katherine Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline; O'Brien, Milli; Callaghan, Elizabeth Subject: RE: SecVA Shulkin Will be there 2pm Monday of course. Vr John John H. W indom, Senior Execut ive Service (SES) Program Executive for Elect ron ic Healt h Record Modernization {PEO EHRM) Special Advisor to the Under Secretary fo r Healt h 810 Vermont Avenue NW (Suite 375X) Washington, DC 20420 JohnWiodom@vagov Office: {202) 46 1-5820 VA-18-0298-C, VA-18-0299-C-000143 143 of 220 From: To: Cc: Subjec t: Dat e: Windom John H BlackburnScottB l(b)(6) 6) j(b Pri n ce -Whee l er Latriece B : ColliJacouenne kb)(6) ! .._)(_______________ I _, RE: SecVA Shulkin Saturday , Octobe r 21 , 2017 12:42: 19 PM I will support. Vr John Sent with Good (www .good.com) From: l._ (b_)(_6)____ _. Sent : Friday, October 20, 2017 11 :05:48 AM To: Windom, John H.; Blackburn , Scott R. i(b)(6) Cc. Pcioce-Wbeelec I atriece R.; Colli, Jacqueline ~ l(b)(6) I .__ _____________ __. Subje ct : RE: SecVA Shulkin Hello- we w ill need to move prep with SecVA to 12:30pm o n Monday . Please confirm yo ur availabi lity . Thank you ! From: Windom , John H. Sent : Friday, October 20, 2017 9:22 AM To: Blackburn , Scott R.;l(b)(6) I ~ Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline; ~l (b_)(_6_) _________ Subje ct: RE: SecVA Shulkin Will be t here 2pm Monday of course. Vr John John H. W indom, Senio r Execut ive Service (SES) Program Executive fo r Elect ron ic Healt h Record Modernizatio n (PEO EHRM) Special Adviso r to the Unde r Secretary fo r Healt h 810 Vermo nt Avenue NW (Suite 375X) Washi ngto n, DC 20420 John Windom@vagov Off ice: (202) 46 1-5820 ~ Mob ile :l._ (b_)(_ 6)___ From: Blackburn, Scott R. Sent : Friday, October 20, 2017 9:21 AM To: i(b)(6) Windom , John H. I VA-18-0298-C, VA-18-0299-C-000144 144 of 220 l(b)(6) From: To : Cc: BlackburnScottB Subj ect : Date: RE: SecVA Shulkin Friday, Octo ber 20, 20 17 2 :06:30 PM Wor ks for Mr . Black burn . From: '-'-! (b....;.. )('-6'-) ___ _.. Sent: Friday, October 20, 2017 2:06 PM To: Windom, John H. ; Blackburn , Scott R. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline; l(b)(6) I l(b)(6) '------------------' Subject: RE: SecVA Shulkin Hel lo - we w ill need to move prep with SecVA to 12:30pm on Monday. Please confirm yo ur ava ilabi lity. Thank you! From: Windom , John H. Sent: Friday, October 20, 2017 9:22 AM To: Blackburn , Scott R.; l(b)(6) I Cc: Prince-Wheeler , Latriece R.; Colli, Jacqueline j,_ (b_)_ (6_ ) __________ _. Subject: RE: SecVA Shulkin Will be t here 2pm Monday of course. Vr John John H. W indom, Senior Execut ive Service (SES) Program Executive for Electron ic Health Record Modernization (PEO EHRM) Special Advisor to the Under Secretary for Health 810 Ve rmont Avenue NW (Suite 375X) Washington, DC 20420 John.W indom@va .gov Office: (202) 461-5820 (b_)(6_ ) ___ Mobile :l.__ __, From: Blackburn , Scott R. Sent : Friday, October 20, 2017 9:21 AM To: l(b)(6) t Windom , John H. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline;l ,_ (b_)_ (6_ ) _________ ___, Subject: RE: SecVA Shulkin Yes, works for me. Then once we know what the Secretary wants to accompl ish with this meeting, we' ll have the right VA-18-0298-C, VA-18-0299-C-000145 145 of 220 From: To : Subject : Date: l(b)(6) BlackburnScottB RE: SecVA Shulkin Friday, Octo ber 20, 20 17 9: 26 :19 AM Not a pro b lem. From: Blackburn, Scott R. Sent: Friday, October 20, 2017 9:22 AM To:l( b)(6l Subject : FW: SecVA Shulkin Importance: High I Will have to juggle the calendar a litt le bit. From: Blackburn, Scott R. Sen~: Frida:. Oc;ober 20, 2017 9:21 AM To:l (b)(6) I Windom , John H. Cc:nnce: hee er,1atriece R.; Colli, Jacqueline;l(b)(6) Subje ct: RE: SecVA Shulkin .____________ ___, Yes, works for me. Then once we know what t he Secretary wan t s to accompl ish w ith this meet ing, we' ll have th e right materia ls to get us t here. I Fromj(b)(6) Sent: Friday, October 20, 2017 9:20 AM To: Blackburn, Scott R.; Windom , John H. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline;l(b)(6) Subject: RE: SecVA Shulkin ~----------~ Great idea. Can yo u chat w/SecVA briefly at 2pm on Monday? Thanks. From: Blackburn, Scott R. Sent: Friday. October 20, 2017 9:13 AM To~(b)(6) Windom, John H. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline;l(b)(6) Subject: RE: SecVA Shulkin ~----------~ I We sure can. John wil l take the lead. However it might be good fo r the Secretary, Joh n and I to hudd le for 10 minutes sometime today or Monday. I am not sure that we know exact ly where they want to take the conversation (maybe John knows but this is my first time in one of these WH/EHR meet ings). From:l~ (b_)(_6 )___ ~ Sent: Friday, October 20, 2017 9:09 AM To: Blackburn, Scott R.; Windom , John H. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline;l(b)(6) Subject: RE: SecVA Shulkin ~----------~ VA-18-0298-C, VA-18-0299-C-000146 146 of 220 From: To : Subject : Date: Windom,JohnH BlackburnScottB RE: SecVA Shulki n Friday , Octo ber 20, 20 17 9: 2 1 :45 AM Copy all Sir. Vr John John H. W indom, Senior Executi ve Service (SES) Program Executive for Elect ron ic Health Record Modernization {PEO EHRM) Special Adviso r to the Under Secretary for Health 810 Vermont Avenue NW (Suite 375X) Washi ngto n, DC 20420 John.W indo m@v a.gov Office: (202) 46 1-5820 Mobile: "-l (b"""' )("""'6 )___ __. From: Blackburn, Scott R. Sent: Friday, October 20, 2017 9:20 AM To: Windom, John H. Subject: RE: SecVA Shulkin That is why we need 10 minute prep with the Secretary either today/Monday so we understand from him what it is about. Then we w ill have the mater ials. MY guess is that Jared/W H wants to know where we are with co ntra ct. But I am not sure. From: Windom , John H. Sent: Friday, October 20, 2017 9:18 AM To: Blackburn, Scott R. Subject: RE: SecVA Shulkin What materials Sir ? I do not even know what the meet ing is about. Vr John John H. W indom, Senior Executive Service (SES) Program Executive for Electron ic Health Record Modernization (PEO EHRM) Special Adviso r to the Unde r Secret ary for Healt h 810 Vermont Avenue NW (Suite 375X) Washington, DC 20420 John.W iodom@va.gov Off ice: (202) 461 -5820 Mobile: ~~ b_)(_6 )___ ~ VA-18-0298-C, VA-18-0299-C-000147 147 of 220 From : Windom,JohnH To : Cc: l(b)(6) Subj ect : Date: RE: SecVAShulkin Comp leted. I Blackburn ScottB Prince-Wheeler LatrieceB : Colli Jacqueline )(6) l(b __________ I._ _. Friday, October 20, 20 17 8:42:44 AM Thank you. RSVPConf ir mation received. Vr/Joh n John H. W indom, Senior Executive Service (SES) Program Executive for Electron ic Health Record Modernization (PEO EHRM) Special Adviso r to the Unde r Secretary for Healt h 810 Vermont Avenue NW (Suite 375X) Washington, DC 20420 John.Wiodom@va.gov Office: (202) 461 -5820 (b_)(_6l____ Mobile: l._ _, From: i.._ (b"'"" )(_. 6 )___ _. Sent: Friday, October 20, 2017 8:40 AM To: Windom, John H. ; Blackburn , Scott R. Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline*b )(6) Subje ct: RE: SecVA Shulkin ._____________ _. Scott and John - can you both fill out yo ur Vitals for entry to WH? Please confirm once completed. Thanks! l(b)(6) From: Windom , John H. Sent: Thursday, October 19, 2017 3:19 PM Blackburn, Scott R. To~(b)(6) Cc: Prince-Wheeler, Latriece R.; Colli, Jacqueline._l (b_)(_6_ ) __ Subject: RE: SecVA Shulkin I _. Honored to join. I w ill be there. Vr John John H. W indom, Senior Executive Service (SES) Program Executive for Electron ic Health Record Modernization {PEO EHRM) Special Adviso r to the Under Secret ary for Healt h 810 Vermo nt Avenue NW (Suite 375X) Washington, DC 20420 VA-18-0298-C, VA-18-0299-C-000148 148 of 220 From : ~b)(6) To : Black burn Scott B Subject : Date: RE: SecVA Shulkin Thursday, October 19, 2017 3 :13:35 PM No prob lem, wi ll do ! From: Blackburn, Scott R. Sent: Thursday. October 19, 2017 2:46 PM To: kb)(6) I Subject : FW: SecVA Shulkin Importance: High Will have to push Patrick Littlefield to another night. Sent with Good (www .good.com) From :.,_l (b-'-' )(..... 6)___ __. Sent: Thursday , October 19, 2017 2:44:15 PM To: Blackburn , Scott R.; Windom , John H. Cc: Prince-Wheeler, Latriece R. ; Colli, Jacque line ; l(b)(6) Subject : SecVA Shulkin .__ ___ _. Hello - the Secretary w ill be meeting w/Jared Kushner on Tuesday, October 24 th at 5 :30pm to discuss EHR, specifically cerner and epic. The Secretary asked if you both could join him in meeting. Please let us know if you are available to atttend. Thank you. VA-18-0298-C, VA-18-0299-C-000149 149 of 220 Windom,JohnH BlackburnScottB : )(6) kb)/ 6) IMulliganRicci From : kb To : Cc: Subj ect : Date: RE: Summit next Tuesday - briefly ment ioned this before! Monday, December 04, 2017 2:19:27 PM I will per sonally attend. A top priority. Vr John Sent with Good (www.good.com) From: Blackburn, Scott R. Sent: Monday, December 04, 2017 9:59:00 AM To:,.............. _____ Cc: b)(6) ,_J Windom, John H.; Mulligan, Ricci Subject: RE: ummit next Tuesday - briefly mentioned this before! Yes please, I do want to attend. I would like t o also include John W indom (o r proxy from the EHRM team) and Ricci (or proxy to represent DVP). Hopefully that is ok. I From:l (b)(6) Sent: Monday, December 04, 2017 12:56 PM To: Blackburn, Scott R. Cc: l(b)(6) I Subject: FW: Summit next Tuesday - briefly mentioned this before! Good aft ernoon Mr. Blackburn, Confirming you wou ld like to attend th is meet ing next week? We can modify your sched ule so you can attend the entire t ime. Please let me know if you wou ld like to bring anyone. Thanks, l(b)(6) I From : Moorhead, Quellie U. EOP/WHOl(b)(6) Sent: Monday, December 04, 2017 11 :46 AM To:l (b)(6) 1@who.eop.gov] I Subje ct: [ EXTERNAL] Summit next Tuesday - briefly mentioned th is before! H ij(b)(6) Thanks for all of your help to day! I forget who I br iefly mentioned t his to , but Chris, Jared, and Seema are host ing this event next week and wo uld love it if Scott cou ld attend if interested. Please let me know if he w ill be able to! We understand if he could only go fo r t he kick off at 1 PM and wrap up at 4 PM, but there will be in dept h, inte resti ng discussions from 2-4 wh ich he may fi nd interest ing. VA-18-0298-C, VA-18-0299-C-000150 150 of 220 Best regards, Quellie On behalf of Jared Kushner and Seema Verma, we are pleased to invite you to a listening session on Electron ic Healt h Reco rds Int erope rability t o be held at the White House on December 12th from 1.00-5.00pm . We are hold ing a series of th ese sessions w ith leade rs in the healt h care sect or . We are interes t ed in understand ing the opport unity for the governme nt to help further progress interoperability with t he goal of posit ively impacting qua lity of care for Amer ican patients. We wil l have a group discussion on t he overall to pic, fo llowed by breako ut work ing sessions t hat address specific aspects of the top ic. We w ill send out those t opics next week and upon your confirmatio n of atte ndance. Please RSVP no later than December 6th to OAl@who.eop.gov . We hope t hat yo u can joi n us and welcome you r inp ut. Sincere ly, Jared Kushner Seema Verma Senior Advisor to t he Preside nt Adm inistrator, CMS Office of Ame rican Innovat ion 202-88 1-7080 VA-18-0298-C, VA-18-0299-C-000151 151 of 220 MqUiganRicci BlackburnScottB : J(b)(6) i(b)(6) WindomJohnH From: To : Cc: I Subj ect : Date: RE: Summit next Tuesda y - bri efly ment ioned th is befo re! Monday, December 04 , 20 17 1 :01 :36 PM Scott, I would like to attend. Ricci Ricci L. M ulliga n Acting Principa l Deputy Assista nt Secretary VA Ol&T 202-461-1538 (O) Ice ll J(b)(6) From: Blackburn, Scott R. Sent: Monday, December 04, 2017 12:59 PM To~ (b)(6) Cc: l(b)(6) I IWindom, John H.; Mulligan, Ricci Subject : RE: Summit next Tuesday - brief ly mentioned this before! Yes please, I do wan t t o atte nd. I wo uld like t o also include John W indom (o r proxy from th e EHRM t eam) and Ricci (or proxy to represent DVP). Hopefully that is ok. I From:l (b)(G) Sent: Monday, December 04, 2017 12:56 PM To: Blackburn, Scott R. Cc~(b)(6) I Subject: FW: Summit next Tuesday - briefly mentioned this before! Good aft ernoon Mr. Blackburn, Confirming you wou ld like to attend th is meet ing next week? We can modify your sched ule so you can attend the ent ire t ime. Please let me know if you wou ld like to bring anyone. Thanks, l(b)(6) I From: Moorhead, Ouellie U. EOP/WHOfovs, Sent: Monday, December 04, 2017 11 :46 AM To:!{ bl/61 @who.eop.gov) I Subject: [ EXTERNAL ] Summit next Tuesday - briefly mentioned this before! Thanks for all of yo ur hel p to day! I for get wh o I briefly menti oned t his t o, but Chris, Jar ed, and Seema are hosting th is event next w eek and wou ld love it if Scott could att end if interested . Please let me know if he w ill be able t o ! W e VA-18-0298-C, VA-18-0299-C-000152 152 of 220 To : Cc: MyklegardDrew BlackburnScottB l A < c..... ar....,,e~jo""'u.._. r..,_n ,.,.e+y..,,c""o.L.l..Lm ] To: Scott R. Blackburn ; Shrestha, Rasu B kbV6l grahame 4(b)(6) l@healt hintersections com au>; M icki Tripath i 4 (b)(6) @11pmc.edu>; t@maehc org>; Culbertson, Adam 1(b)(6) p?bimss org> Subject: Thanks fo r Part icipat ing in t he HIMSS2018 CIO Roundtable Discussion on Accelerating Open APls Tea m , On behalf of Grahame , Ras u, Micky, and our HIM SS host, Adam Cu lbe rt so n , I wanted to thank you for participating in our ClO Rou ndt able on th e s ubjec t of accelerating th e work to design/deploy o pen API standards. If helpful, J thought to sha re thr ee items in follow- up : I) Discus sio n Summary: Several participants shared positive early experiences in using vendor-suppo rt ed FHIR APis for app developers, including for clinician use that isn't a feature regulated under MU/MIPS ; one example - the use of "SMART on FHIR" apps to overlay eithe r legacy information or from an HIE while a clinician is working on a patient chart caugh t some attention and might benefit from more knowledge sha r ing; and though early, one CIO has already shifted focus towards adding the ability to write back FHIR resources into an EHR 's database to be used in exist ing decision support or other applications. 2) The VA "Open API Pledge :" Today, VA Secretary Shulkin posted thi s update tappin g Dr. Ra s u Shre s tha of UPMC to lead what mi ght affectionately be called the "coalition of the willing," to join the 11 initial signatories he announced at HIMSS pled ging to accelerate open API standards de velopment to for u se when veteran s seek community care. Pl ease connect dire ctly with Ra s u and/or Scott Blackburn (VA's CIO) should you wish to join . As you might h ave guessed during our roundtable, th e key point s for participants are: sig natori es commit to open up FHIR APis as con s trained by the Argonaut Proje ct impl ementation guide s; will be actively testing/designing resources an d access methods that are not yet com plete (including "bulk access"); and will work collaboratively to lower th e cos t burden for others to follow suit. 3) Consum er -Directed Exchange: Our di sc ussion took p lace as White House advisor Jar ed Kushn er a nd CMS Administrator Seema Verma announced th e "MyH ea lthEData" initiative (I shar ed my VA-18-0298-C, VA-18-0299-C-000154 154 of 220 response ~). Earlier today , former VP Joe Biden added hi s perspectives with emphasis on makin g the sys tem work better for cancer patients here. CMS already report s a doublin g of developer s (200 +) now working on Blue Button 2.0 applications - a topic we will certainly take up at the HIMS$' developer conference in Cleveland (Ap ril 30 th -May 1st) . We hope you will continue to engage as our community works to accelerate the development a nd deployment of open APis, particularly as we conve rge on a technical approach - FHIR resources cons trained by the Argonaut Project. Please connect with Ras u/Scott on any spec ific commitments, or participate in any of th e ongoing testing and acceleration activities of the Argonaut Project. Thank s, once again, for your participation. Regard s, Aneesh Chopra President (703) 672-1315 ICareJourney,com 'ca reJourney This email is intended onl} for the pcr,on or entit) to which it i, addressed and may contain infonnation that i, pri\'ilcgcd, confidential or otherwise protected from disclosure. Dissemination. distribution. or copying of this email or the infonnation herein by anyone other than the intended recipient. or an employee or agent responsible for delivering the message lo the intended recipient, is prohibited. If you have received this email in error. please immediately notify us. Links contained in this email have been replaced by ZixProtect Link Protection . If you click on a link in the email above, the link will be analyzed for known threats. If a known threat is found, you will not be able to proceed to the destination. If suspicious content is detected, you will see a warning. VA-18-0298-C, VA-18-0299-C-000155 155 of 220 From: l(b)(6) To: BlackburnScottB Subject : Date: RE: VA EHRCall Sunday, March 18 , 2018 2 :35:51 PM Mr. Blackburn, I had schedu led this call with Dr. Bruce and Marc Sherman for the contract overview. Do you want to keep it or can I cance l it? Thanks, l\b)(GI -----Original Appointment ----From: VAC IO Executive Schedule Sent : Thursday , March 15, 2018 11:23 AM To: VAC IO Executive Schedule: l(b)(6) Blackburn, Scott R.; Windom , John H. ;j(b)(6) ~Bruce Moskowitz,MD; Marc Sherman; Bruce Moskowitz Subje ct : VA EHRCall When : Monday, March 19, 2018 12:00 PM-12:45 PM (UTC-05:00) Eastern Time (US & Canada). Wher e : !(b)(6) I I VA-18-0298-C, VA-18-0299-C-000156 156 of 220 BlackburnScottB From : To : RE: VAEHR Subject : Date: Wednesday , March 2 1, 2018 11 :22 :00 PM Hopefully in a good way From: DJS Sent: Wednesday, March 21, 2018 10:26 PM To: Blackburn, Scott R. Subject : RE: VA EHR Wow that's quite an email Sent with Good (www.good .com) From: Blackburn, Scott R. Sent: Wednesday, March 21, 2018 7:20:26 PM To: DJS Subject : FW: VA EHR Hopefully th is lands wel l. Let me know what you hear back. From : Blackburn, Scott R. Sent: Wednesday, March 21, 2018 10:20 PM To: 'Bruce Moskowitz'; 'Marc Sherman' Cc: DJS Subject: VA EHR Marc/ Bruce, Thank you once again for all your support and especially for link ing us up with these ClOs/experts. This was incredib ly valuab le. Secretary ShuIkin, John W indom and I got together earlier today as we ll to talk about the path ahead. A few notes: o In order to make sure we understand some of the more specif ic detai led points, members of our team reached out today for ind ividua l follow ups with Dr. Cooper, Dr. Karson, Dr. Shrestha, Jon Manis and Stephanie. Each have been so generous with their time Stephanie will host us for a visit on Apr il 4 and Dr. Cooper offered to do the same at Mayo. o Dr. Zenooz did connect with Dr. Cooper today on the point Marc highlights below to make sure we are on the same page and have the language right (part was us better understanding his point; part was pointing him to the specific language in 5.1.1 and giving him the broader context with what we are doing with Lighthouse as our API gateway and the VA Open API Pledge that 11 healthcare institutions signed two weeks ago include Cris Ross at Mayo as well Stan Huff at lntermounta in and Dr. Karson at Partners). o We will also follow up with Stan on some of the issues he raised as well. For examp le: VA-18-0298-C, VA-18-0299-C-000157 157 of 220 BlackburnScottB StanHutt ~---~ 5 WindomJohnH : l(b)( ) From : To : Cc: RE: VAEHR Subj ect : Date: IFosterMichelefSESll(b~----~ )(6) . . Wednesday , March 14, 20 18 12:56:00 PM Thanks so much, Stan! From: Stan Hutf l(b)(6) @imail.org ] Sent: Wednesday, March 14, 2018 11 :52 AM To: Blackburn, Scott R~------~ Cc: Windom , John H. ;l(b)(6) Foster, Michele (SES);~l (b_)(_6_ ) ----~ Subje ct: [ EXTERNAL] RE: VA EHR I Scott, I have attached my signed N DA. I look forward to visiting tomorrow. Thanks, Stan From: Blackburn, Scot t R. [mailto:Scot t.B lackb urn@va .gov] Sent: Monday, March 12, 2018 7:08 PM To: Stan Huff j(b)(6) @im ail,org > 6 Cc: Windom, John H. ..:: ;l:: (b:::: )(::::: ::::: ) ====================~ hv~v a~go:'""'"y .>; Foster, M ichele (SES);l(b)(6) @va.gov> Subject: RE: VA EHR Stan: Thank you for agree ing to be an extra set of o utside eyes as we at VA finalize ou r EHR cont ract. We app reciate you r vast expe rience and expertise; and wa nt to make sure we get to t he best place possible for Vet e rans, th e country and taxpayers. As we are in credib ly grat ef ul to you for vo lunt eering yo ur ti me, we wan t to make t his as easy as possib le fo r yo u. Here are 3 next steps. 1) We w ill need yo u to sign the attac hed NDA. Please retu rn to l(b)(6) l(cc'd). 2) Mat t w ill then send you t he latest package under separat e cove r. 3) Given government co ntra cts are diffe ren t t han w hat you are used to readi ng, we wo uld p ropose a qu ick phone call so that we can orient you to the co ntract and help focus you o n t he parts where your expert ise wil l be most valuab le. l(b)(6) !wil l lead t his from our side and has t o ld me is available between tom o rrow from 9:30 -llam ET or I am sure he can also fi nd ot he r t imes if th ese don 't wo rk fo r you. I wil l askl(b)(6) l(cc'd) here to he lp set up a time. Thanks again ! Scott From: Stan Huffl(b)(6) l@imail.org] Sent: Monday, March 12, 2018 4:34 PM To: Blackburn, Scott R. Subject: [ EXTERNAL ] Re: VA EHR VA-18-0298-C, VA-18-0299-C-000158 158 of 220 BlackburnScottB StanHutt WindomJohnH fb )(6) From: To: Cc: !FosterMichelefSESJ: l(b ...._)_ (6_) ___ __. RE: VAEHR Subject : Date: Monday, March 12, 2018 9:44:00 PM Thanks Stan. We w ill make one of those times work. We w ill confirm tomorrow . Thanks so much for doing this. Scott From: Stan Huff!(b)(6) @imail.org] Se nt : Monday, March 12, 2018 9:25 PM To: Blackburn, Scott R,.... .------. Cc: Windom, John H.!b )(6) Foster, Michele (SES);(b)(G) Subje ct : [ EXTERNAL]RE: VA EHR .__ _____ I I _, Scott, I am at t he AMIA Joint Summit in San Francisco so it w ill be Wednesday morning before I can return the signed NDA. I am currently available for a call on Wednesday 11:00 am to noon, 2:002:30 pm, or 3:30 -4:00 pm. If none of t hose times work I am free on Thursday morn ing. Let me know . Thanks, Stan From : Blackburn, Scott R. [mailto.Scott Blackburn@va gov] Sent : Monday, March 12, 2018 7:08 PM To : Stan Huff ~(b)(6) @imail.org> Cc: Windom, John H. ~!(~b::)(6 ::::: )====================~ M ichele (SES) ;l(b)(6) Subject : RE:VA EHR (R)=v:'.::a .::"g~ov .>;Foster, l@va gov> Stan: Thank you fo r agree ing to be an ext ra set of outside eyes as we at VA finalize our EHRcontrac t. We appreciate your vast exper ience and expertise; and want to make sure we get to t he best place possible fo r Veterans, the country and taxpayers. As we are incred ibly gratefu l to you for volunteering yo ur ti me, we want to make t his as easy as possible fo r you. Here are 3 next steps. 1) We w ill need you to sign t he attached NDA. Please retu rn to l(b)(6) l cc'd) . 2) l(b)(6) iw ill then send you t he latest package under separate cover . 3) Given government contr acts are diffe rent t han what you are used to readi ng, we wou ld propo se a qu ick pho ne call so tha t we can orient you to the contract and help focus you on t he parts where your expert ise will be most valuab le. l(b)(6) ~ il l lead t his from our side and has to ld me is available between tomorrow from 9:30-l lam ET or I am sure he can also find ot her t imes if th ese don't work for you. I wil l as~(b)(6) l(cc'd) here to help set up a time. Thanks again ! VA-18-0298-C, VA-18-0299-C-000159 159 of 220 From : To : Subject : Date: Blackburn ScottB RE: VAEHR Wednesday, March 2 1, 201810: 25:50 PM Wow that's quite an email Sent with Good (www .good.com) From: Blackburn, Scott R. Sent: Wednesday, March 21 , 2018 7 :20 :26 PM To: DJS Subject: FW: VA EHR Hopef ully t his lands wel l. Let me know w hat yo u hear back. From: Blackburn, Scott R. Sent: Wednesday, March 21 , 2018 10:20 PM To: 'Bruce Moskowitz'; 'Marc Sherman' Cc: DJS Subject: VA EHR Marc/ Bruce, Thank you once again for all your support and especially fo r linking us up with these ClOs/experts. This was incredib ly valuable. Secret ary Shu Ikin, Joh n W indom and I got together earlier today as we ll t o tal k about t he pat h ahead. A few notes: o In order to make sure we unders tand some of th e mo re specific detai led point s, membe rs of our t eam reached out to day fo r individ ual foll ow ups wit h Dr. Cooper, Dr. Karson, Dr. Shrestha, Jon Manis and Stephanie. Each have been so genero us w it h the ir time Stephanie will host us for a visit on April 4 and Dr. Cooper offe red to do the same at Mayo. o Dr. Zenooz did connec t with Dr. Cooper t oday on the point Marc highlights below t o make sure we are on t he same page and have the language right (part was us better understandi ng his point; part was pointi ng him to the specific language in 5.1.1 and giving him the broader context w it h what we are doi ng with Light house as ou r API gat eway and th e VA Open API Pledge t hat 11 healt hcare insti t utio ns signed t wo wee ks ago include Cris Rossat Mayo as we ll St an Huff at lntermo untain and Dr. Karson at Partners). o We will also fo llow up wit h Stan on some of t he issues he raised as wel l. For examp le: Stan wil l be excited t o learn th at Cerner has prio rit ized an additi ona l 40 engineers to accelerat e FHIR APls for VA in suppo rt of t his contr act. This wil l also benefit lntermountain as Stan was tell ing us t hey've on ly had 10- 15 fo r t heir ent ire company to date. If VA/Do D/ lnte rmou ntai n work toget her we w ill quickly get to t he 200 num ber Stan ment ioned. VA-18-0298-C, VA-18-0299-C-000160 160 of 220 To : BlackburnScottB Zenoo z Ashwin i Subject : Date : RE: VA MEETING Tuesday, November 14, 2017 4:38:00 PM From : They are coming from POTUS friend/doctor. Will need to hand le sensitively and with facts. From: Zenooz, Ashwini Sent: Tuesday, November 14, 2017 4:35 PM To: Blackburn, Scott R. Subject: RE: VA MEETING Scott , thanks. I ju st landed from a trip to Orlando. I'd be happy to respo nd to this but these quest ions are ju st rid iculous. They don't make sense and there is basic lack of understa nding of interoperab ility, the solutions, radiology etc. I'm just baffled . Ashwini Zenooz, MD EHRM Program Offi ce Sent with Good (www.good.com) From: Blackburn, Scott R. Sent: Tuesday, November 14, 2017 11 :44:20 AM To: Zenooz, Ashwini Subject: FW: VA MEETING I somehow left you off (I put Windom's name twice) ... From: Windom , John H. Sent: Tuesday, November 14, 2017 2:42 PM To: Blackburn , Scott R.; Short , John (VACO) Subject : RE: VA MEETING Ok. Thanks. Not sure of the validity of any of his commen ts but will inve stigate. I could prepare a list of thin gs Cerner has that Epic does not have that would serve no purpose . What Cem er does have is interoperab ility with DOD and an overall better product. I am not go ing to be drawn into the cherry picking game that is being done with the Cem er product. Plea se send that list of Epic overrun s that I sent yo u last week to this perso n. Thx John Sent with Good (www.good.c om) From: Blackburn, Scott R. Sent: Tuesday, November 14, 2017 11 :24:58 AM To: Windom, John H.; Windom, John H.; Short, John (VACO) Subject: FW: VA MEETING VA-18-0298-C, VA-18-0299-C-000161 161 of 220 Sharing in the spirt of transparency. Dr. Bruce Mo skowitz wil l jo in t he call tomorrow. He is a Wh ite House adv isor. 1don't know much abo ut him ot he r t han he is imp o rtan t. He has asked at least one ot he r perso n to jo in (a clinicia n from MGH). See tra il to include q uestions at t he bottom (that I sent earlier). I connected with the Secretary and he is ok with Bruce and whomever he inv ites to jo in t he call. From: Schnitzer, Jay J l(b)(G) bmitre.org ] Sent: Tuesday, November 14, 2017 12:47 PM To: Blackburn, Scott R. Cc: Wynn, Jackie Subject: [ EXTERNAL ] FW: VA MEETING Hi Scott, Please see the email trail below. Just want you aware in case we have people joining the call without your knowledge or approval. Thank s, Best, Jay Jay J. Schnitzer, M.D., Ph.D. MITRE From: Noga, James 4(b)(6) @PARTNERS.ORO> Date: Tue sday, Nov 14, 2017, 11:43 AM To: Karson, Andrew Scott,M.D. Cc: Schnitzer, Jay J ~(b)(6) @mitre.org> Subject: RE: VA MEETJNG But do t he peop le hosti ng the cal l know you are going to be o n t he call? I am copying Jay as he is help ing coo rdi nat e t he call. Jim From: Karson, Andrew Scott,M.D. Sent: Tuesday, Novem be r 14, 2017 11:31 AM To: Noga, James ~(b)(6) l@PARTNERS ORG> Subject: RE: VA MEETING Dear Jim, Thanks for t he note . I th ink th at you and I may have a litt le mis-understanding. I agree t hat you can of course ha ndle t he call, but Gregg and Bruce Mo skovitz invited me to the call tom o rrow so t hat t hey can have a hands-on cli nicia ns perspective. Bruce and I spoke very briefly (between h is patients) a little while ago and Bruce sent me the below info rmation. I am hop ing to to uch base with yo u before t he call if t hat is possible for you . I am t ied up in p resentatio ns/meetings the rest of t he day, but could speak th is eve ning (6pm ?) or tomorrow if th at is okay with you. (And if needed I w ill break out of other meet ings to day). VA-18-0298-C, VA-18-0299-C-000162 162 of 220 M any thanks, Andy From: Noga, James Sent: Tuesday, November 14, 2017 11 :16 AM To: Karso n, Andrew Scott, M. D. 4L (b~)(:.:_;6 ):....___Jl ~@~m...,..g,...h=h=a=r~va=r~d=e=d..,,.u > Subject : RE: VA MEETING I had a cal l with t hem today in prep for tomorrow's call. I apprec iate the offer but I don't think it is my place to invite you. It needs to come from t he VA. From: Karson, A nd rew Scott,M.D. Sent: Tuesday, Nov embe r 14, 2017 11:11 AM To: Noga, James ~(b)(6) @PARTNERS.ORG> Subject : FW: VA MEETING Dear Jim, Given some confl icts t hat Gregg has being a sen ior adviso r for the VA, Gregg has asked me to jo in the 3pm VA call tomorrow to be ava ilable for t he clinician pe rspective. Wou ld you be up for a 15 m inu te chec k-in call w it h me at some poin t tomorrow before t he VA call? If so, then I' ll reach out to Susan Briggs to get us a time. Ma ny thanks, Andy From: Karson, Andrew Scot t,M .D. Sent: Tuesday, November 14, 2017 11:06 AM To: ' Bruce Mosk owitz' ~(b)(6) l@mac.com > Subject : RE: VA MEETING Dear Bruce, Ma ny thanks for t he note . I' ll review t he below a litt le later to day and I'l l be back in to uch. M any thanks and best, Andy From: Bruce Mo skowit z!(b)(6) ta?mac com ] Sent: Tuesday, Novembe r 14, 20 17 10:45 AM To: Karson, Andrew Scott, M. D. ~(b)(6) @mgh.harvard.edu> Subject : VA MEETING The ca ll will take place this Wednesday, November 15th between 3:00 PM and 5:00 PM Dial In Numb er: ._l (b_)(_6)____ Passcode:._l (b_)(_G )__ _. ~ VA-18-0298-C, VA-18-0299-C-000163 163 of 220 Thank you for your time and involvement. Some background information. The se are my concerns as a clinici an. Cern er does not have the ability to provide the following in the Choi ce Program: Tracking duplicate testing Trackin g over utilization by provid ers Trackin g duplicate pre scription s and medication errors. Tracking tests that were ordered, completed and results go to all physicians involved in the Veterans care Patient notification of critically abnorm al results with followup resolution Arranging appointment followup between the VA and Private sector Emergency room visits in the private sector ability to access records immediately and VA physicians notified of emergency care and followup Cerner has no registry to tract what Cardiac and orthopedic devices are implanted in case there is a recall of the device Automatic record transfer from the Choice Pro vider to the VA patient record with flagging new information to every VA health care worker A radiology platform to see films in high definition to compare X-rays and ability for radiologists to efficiently find previous films. For instance a radiolo gist needs to know if a lung nodul e is new or was there previously and the same size. Cardiologists need to access catheterization films in high definition Cerner has no system to alert VA health care workers when a patient is at a particular office or hospital to participate in care management in real time. Sent from my iPad Bruce Moskowitz M.D. The inform ation in this e-mail is intended only for the person to whom it is addressed. If you believe this e-mail was sent to you in error and the e-mail contains patient information, please contact the Partner s Compliance HelpLine at htt,p://www.partners,orgkompliance]jne. If the e-mail was sent to you in eno r but does not contain patient information , please contact the sender and properly dispose of the e-mail. VA-18-0298-C, VA-18-0299-C-000164 164 of 220 From : To : Subject : Date: QJ.S. Black burn ScottB RE: VA MEETING Tuesday, November 14, 2017 2:15: 11 PM Yes and yes Sent with Good (www .good.com) From: Blackburn, Scott R. Sent: Tuesday , November 14, 2017 10:46:39 AM To: DJS Subject: RE: VA MEETING Got it. A re you ok with Bruc e joi ning and inv iting a few others (it looks like 1-2 clin icians from MGH)? For the 5 CIOs who ask, I wi ll te ll them that Bruce is an adv isor and extension of the WH/VA team. Is t hat o k to say? From: DJS Sent: Tuesday , November 14, 2017 1:43 PM To: Blackburn , Scott R. Subject: RE: VA MEETING I don't have any real advice but to keep the conversa tion focused on the topics you need advice and value on Sent with Good (www.good. com) From: Blackburn, Scott R. Sent: Tuesday , November 14, 2017 10:38:25 AM To: DJS Subject: FW: VA MEETING The call w it h t he 5 Cl Os is Wednesday 3-Spm. On o ur p re -cal ls, 2 of the ClOs have asked abo ut Bruce and what his invo lvement is. I have never had any contact with Bruce, but it seems like a sensi t ive relationsh ip. A ny advice on how to handle? We inv ited Jared/C hr is from WH as a courtesy . I don't th ink either plan to jo in, b ut they must have invited Bruce who is now asking a few others to join (see below). Can d iscuss live lat er before or aft er hea ring prep. VA-18-0298-C, VA-18-0299-C-000165 165 of 220 To: ZenoozAshwini BlackburnScottB Subject : Date: RE: VA MEETING Tuesday, November 14, 2017 5:07: 11 PM From: Yup. Got it. I will have facts. Ashwini Zenooz, MD EHRM Program Office Sent with Good (www.good.com) From: Blackburn, Scott R. Sent : Tuesday, November 14, 2017 1:38 :51 PM To: Zenooz, Ashwini Subje ct : RE: VA MEETING They are coming from POTUS friend/doctor. Will need to hand le sensitively and with facts. From: Zenooz, Ashwin i Sent : Tuesday, November 14, 2017 4:35 PM To: Blackburn , Scott R. Subje ct : RE: VA MEETING Scott, thanks. I just landed from a trip to Orlando. I'd be happy to respond to this but these quest ions are j ust ridiculous. They don't make sense and there is basic lack of understanding of interoperability, the solutions , radiology etc. I'm ju st baffled . Ashwini Zenooz , MD EHRM Program Office Sent with Good (www.go od.com) From: Blackburn, Scott R. Sent : Tuesday, November 14, 2017 11 :44:20 AM To: Zenooz, Ashwini Subje ct : FW: VA MEETING I somehow left you off (I put Windom's name twice) ... From: Windom , John H. Sent: Tuesday, November 14, 2017 2:42 PM To: Blackburn , Scott R.; Short , John (VACO) Subj ect : RE: VA MEETING Ok . Thanks. Not sure of the validity of any of his comme nts but will investigate. I could VA-18-0298-C, VA-18-0299-C-000166 166 of 220 From : To : Subject : Date: Windom,JohnH Black burn ScottB RE: VA MEETING Tuesday, November 14, 2017 3:01 :18 PM To me the session tomorrow is just a grin and bear it session. I will have my listening hat on for 2 hours. Vr John Sent with Good (www.good.com) From: Blackburn, Scott R. Sent: Tuesday, November 14, 2017 11 :56:17 AM To: Windom, John H. Subject : RE: VA MEETING I believe th is is th e longtime personal doctor, and close friend, to POTUS From: Windom , John H. Sent: Tuesday, November 14, 2017 2:42 PM To: Blackburn, Scott R.; Short, John (VACO) Subject : RE: VA MEETING Ok. Thanks . Not sure of the validity of any of his comments but will investigate. I could prepare a list of things Cern er has that Epic does not have that would serve no purpo se. What Cemer does have is interoperab ility with DOD and an overa ll better product. I am not going to be drawn into the cherry picking game that is being done with the Cemer product. Please send that list of Epic overruns that I sent you last week to this per son. Thx John Sent with Good (www.good.com) From: Blackburn, Scott R. Sent: Tuesday, November 14, 2017 11 :24:58 AM To: Windom, John H.; Windom, John H.; Short, John (VACO) Subject: FW: VA MEETING Sharing in the spirt of transparency. Dr. Bruce Moskowitz wil l jo in t he call tomorrow. He is a Wh ite House advisor. I don't know much abo ut him other tha n he is importan t. He has asked at least one other person to jo in (a clinician from MGH). See tra il to include questions at the bottom (that I sent earlier). I connected with the Secretary and he is ok with Bruce and whomever he inv ites to jo in the call. VA-18-0298-C, VA-18-0299-C-000167 167 of 220 From: To: Subject : Date: QJ.S. BlackburnScottB RE: VA MEETING Tuesday, November 14, 20171:42:46 PM I don 't have any real advice but to keep the conversation focu sed on the topic s you need advice and val ue on Sent with Good (www.good.com) From : Blackburn , Scott R. Sent : Tuesday , November 14, 2017 10:38:25 AM To: DJS Subj ect : FW: VA MEETING The call w ith the 5 ClOs is Wednesday 3-Spm. On our pre-cal ls, 2 of the ClOs have asked about Bruce and what his invo lvemen t is. I have never had any contact with Bruce, but it seems like a sensitive relationship. Any advice on how to handle? We invited Jared/Chris from WH as a courtesy. I don't think either plan to join, but they must have invited Bruce who is now asking a few others to join (see below). Can discuss live later before or after hearing prep. Scott From: Schnitzer , Jay J l(b)(6) t?>mitre.org ] Sent : Tuesday , November 14, 2017 12:47 PM To: Blackburn , Scott R. Cc: Wynn , Jackie Subj ect : [EXTERNAL] FW: VA MEETING Hi Scott , Please see the ema il trail below . Just want yo u aware in case we have people join ing the call without your know ledge or approva l. Thank s, Be st, Jay Jay J. Schnitzer, M.D ., Ph.D. MITRE From : N oga, Jam es ~(b)(G) livPARTN ERSORG> Date: Tue sday, Nov 14, 2017, 11:43 AM To : Karso n, Andrew Scott ,M.D. ~(b)(6) ijj)mgh harvard edu> Cc: Schnitzer, Jay J ~(b)(6) @m itre.org> Subj ect : RE: VA MEETING VA-18-0298-C, VA-18-0299-C-000168 168 of 220 BlackburnScottB LiddellChristopher P EOP/WHO From : To : RE: VNCMS/OA I Meeting Subject : Date: Friday, January 19, 2018 10:50:00 AM In one sente nce ... VA will announce that we are moving forward with Cerner EHRimplementation (initial portion of the contract signed, first task order initiated) and highlight how this agreement will push the move the industry forward towards interoperability (e.g., open APls, bulk data transfer, FHIR standard adoption, requirements of Cerner to collaborate with community partners and academic affiliates on non-Cerner systems). We are wor king w ith Secret ary ShuIkin on t he specifics. We absolut ely wa nt to be alig ned wi t h CMS/ONC/o t hers. We we re hopi ng to get 2-3 Academic Med ical Cent ers on Epic/o t her systems to agree to exchange informat ion and make t hat a requi rement of t heir EHR prov ider, but we have been advised t hat t hat is way too premature. Does that sound right ? From: Liddell, Christopher P. EOP/WHO.,..l (b..... )(_G )_______ Sent: Thursday, January 18, 2018 4:55 PM To: Blackburn, Scott R. Subject: [ EXTERNAL] RE: VA/CMS/OAI Meeting ~~who.eop .gov] Scott Could you summarize in one sente nce exactl y wha t you wo uld annou nce at HIMSS on interoperabi lity? Just t rying to summarize it simp ly alongside CMS etc From : Blackburn, Scot t R.~l (b~ )(~G )~ _____ J'hv "'-v .... a...,g....,.o .... v] Sent: Tuesday, January 16, 2018 11:21 AM To: Guram, Jeet (CMS/OA) '4b)(6) l@cms.hhs.gov>; Lidde ll, Christopher P. EOP/W HO kb)(G) t@wbo eop gov> Cc: Moorh ead, Quellie U. EOP/WHO Subject : RE: VA/CMS/OAI Meet ing Thanks Jeet. Below is an out line of how we are th inking of th ings at VA. Also pre -dec isiona l and wo uld love yo ur input. What success looks like for VA (before HIMSS March 5-9 in Las Vegas, which is only an artificial forcing mechanism. The Secretary has the keynote on March 9). o o Finalize and sign t he Cerner cont ract (w/ suppo rt from external validat ors) Have 2 or 3 maj or healthcare systems on Epic (or somet hing other t han Cerne r) commit to share mea ningful data w it h VA VA-18-0298-C, VA-18-0299-C-000169 169 of 220 Majorinputsremaining: o MITRE report (fina l due NLT 31 Jan) containing the following elements: o Synthesized recommendations from all the big ideas we've gotten - to help Windom/team understand what , if anything, needs to be tweaked/ included in Cerner contact negotiations based on expert recommendations (outsiders+ government+ others). o Takeaways from the 1/5 listening forum o Results from findings from UPMC and other follow on expert conversations (e.g., Adam Boehler, commerc ial providers) o Cost estimate of point to point interoperabi lity solutions between Cerner and Epic/other. o Prospective tec hnology/interoperabi lity updates/enhancements required by the Cerner EHRsolutio n necessary to support nationa l interoperability and health information exchange object ives with an EPICEHRplatform o External legal review of the entire contract (being done now by MITRE, also NLT 31 Jan) Timeline: o Between now and 31 Jan o Finish report o Visit UPMC o Any other expert follow ups o Initiative conversat ions with Cleveland Clinic, Partners, Kaiser, Mayo, Johns Hopkins, and Geisinger about connecting in to VA/Cerner solution. Also, lnterMountain has offered support (however is a Cerner system) o Month of February o Finalize contract negotiat ions with Cerner o Finalize partnerships with 2-3 hospita l systems o Syndicate findings with key stakeholders/ validators PossiblehelpfromOfficeof AmericanInnovation: o Help getting 2-3 hospital systems to cooperate (TBD). Bruce Moskowitz and Marc Sherman may be able to help with this. o Possibly start thinking about a government subsidy that we might offer hospital systems to defray the costs? o Help managing external stakeholders and accessing validators o Continued support HHS/CMS/ONC as needed @cms.hhs.gov] From: Guram, Jeet (CMS/OA)l(b)(6) Sent: Tuesday, January 16, 2018 8:25 AM To: Liddell, Christopher P. EOP/WHO; Blackburn, Scott R. Cc: Moorhead, Quellie U. EOP/WHO Subject: [ EXTERNAL ] RE: VA/CMS/OAI Meeting PRE-DECISIONAL VA-18-0298-C, VA-18-0299-C-000170 170 of 220 Hi Chris and Scott, look forward to t ouc hing base today. Please find attached a summary of CMS' s workp lan and the fu ll workp lan for review. Jeet Gu ram, M.D. Senior Advisor I Office of the Administrator Centers for Medicare & Medicaid Services l@cmshhsgov +1 (202) 230 -0451 1l(b)(6) ----- Original Appointment ----5 From: Moorhead, Que llie U. EOP/WHo L..l (b_)(_ l________ ~ l@_w~bP~,~eo ...... p,._. ..... go~v .l Sent: Thurs day, January 11, 2018 6:15 PM To: Moorhe ad, Quellie U. EOP/WHO; Liddel l, Christo phe r P. EOP/WHO; Guram, Jeet (CMS/OA); Blackb urn , Scott R. Subject: VA/CMS/OA I Mee ti ng When: Tuesday, January 16, 2018 12:30 PM- 1:00 PM Easter ~ Where: Part icipant Dial-ln: l(b)(6) IPart icipant Code ~ *This will now be a dial in conference! Thank you and have a nice weekend!* VA-18-0298-C, VA-18-0299-C-000171 171 of 220 From : !(b )(6) MoorheadOuellie U EOP / WHO:BlackburnScott B : "GuramJeet /CMS/QA}" To : Subject : Date: RE: VNCMS/OA I Meeting Monday, January 22 , 20 18 8:11 :27 AM Hi Que llie, I ju st submitted WAVES for Mr. Blackburn, thanks! From: Moorhead, Quel lie U. EOP/WHO l(b)(6) Sent : Monday, Janua ry 22 , 2018 8:02 AM t Blackburn, To:!( b)(6) @who.eop.gov ] Scott R.; 'Guram, Jeet (CMS/OA)' Subject : [ EXTERNAL] RE: VNCMS/OAI Meet ing Importance: High Jeet - are you f urlo ug hed? Hil(b)(G)r nd Scott , I'm about to be fur loughed in 4 ho urs- co uld you please subm it your WAVEs ASAP so Chris can meet w it h yo u on Tuesday at 1:30? Hoping to get his meet ings all so rted ASA P! Thank you and hope you had a nice wee ke nd, Que llie From: ._l (b_)(_G )______________ l'""@'-'v'""'a...._.g......_ov. ] Sent: Wednesday, January 17, 2018 2:47 PM To: Moorh ead, Quellie U. EOP/WHO 4"'(b...,.. )(.6 ,.,. .,... ) -------.l ~b)(G) @whoeop gov>;Gu ram, Jeet (CMS/OA) ~ cms.hhs.gov> Subject: RE: VA/CMS/OAI Meet ing Good afternoon, 1:30PM wo rks for Scott. Thank you fb )(G) From: Moorhead, Quel lie U. EOP/WHOLl (b_)(_6_ ) _______ Sent: Wednesday, January 2018 2.43 PM To: Guram , Jeet (CMS/OA); (b)(6) '----------~ Subject: [ EXTERNAL] RE: VNCMS/OA I Meet ing 1z I J'-'hi?~w ~b-o~e~Q-P..,o~ov ] Chris and Scott to bee Hi Jeet and f.... b_)(_G )_ __. A ny cha nce that 1:30 PM o n Tuesday t he 23 rd would work for th is meet ing? I t hi nk t hat's the fi rst time that we could make it happen! VA-18-0298-C, VA-18-0299-C-000172 172 of 220 Thank you, Quellie From: Lidde ll, Christopher P. EOP/WHO Sent: Tuesday, January 16, 2018 3:52 PM To : Blackburn, Scott R. ; Guram, Jeet {CMS/OA) l(b)(6) l@cms.hhs.gov> Cc: Moo rhead, Quellie U. EOP/WHO ~(b)(G) ~who.eop .gov> Subj ect : RE:VA/CMS/OAI Meet ing Good call today I think we said that we would try and get together in person to discuss plans and try and ensure we are coordinat ed + Quellie who can suggest some t imes From: Blackburn, Scott R. [mailto.Scott Blackburn@va.gov] Sent: Tuesday, January 16, 2018 11:21 AM To : Guram, Jeet {CMS/OA) i (b)(6) l@)cms.hhs.gov>; Liddell, Christ opher P. EOP/WHO l(b)(6) l@who.eop.gov> Cc: Moo rhead, Quellie u. EOP/WHO 4~ (b-)(-6)-----~ ~who .eop.gov> Subject : RE:VA/CMS/OAI Meet ing Thanks Jeet. Below is an out line of how we are th inking of th ings at VA. Also pre-decisional and would love your input. Whatsuccesslookslike for VA (before HIMSS March 5-9 in Las Vegas, which is only an artificial forcing mechanism. The Secretary has the keynote on March 9). o Finalize and sign the Cerner cont ract (w/ suppo rt from externa l validators) o Have 2 or 3 major healthcare systems on Epic (or someth ing other than Cerner) commit to share meaningful data w it h VA Major inputs remaining: o MITRE report (final due NLT 31 Jan) cont aining the following elemen ts: o Synthesized recommendations from all the big ideas we've gotten - to help Windom/team understand what, if anything, needs to be tweaked/ included in Cerner contact negotiations based on expert recommendations (outsiders+ governme nt + othe rs). o Takeaways from the 1/5 listening forum o Results from find ings from UPMC and other follow on expert conversations (e.g., Adam Boehler, commerc ial providers) o Cost estimate of point to point interoperabi lity solut ions between Cerner and Epic/other. VA-18-0298-C, VA-18-0299-C-000173 173 of 220 Functionality Request s for Cerner EMR platform to Support Innovation and Interoperability In order t o meet the innovat ion needs of lnte rm ou nta in Healthca re t o be a model health system, several t ypes of enhancemen t s to t he Cern er EMR platform are needed. These en hancement types consist of t he foll owing : b)(5) 1 VA-18-0298-C, VA-18-0299-C-000174 174 of 220 (133(5) 2 175 Of 220 031(5) 3 176 Of 220 4 177 Of 220 (W115) 5 178 Of 220 (W5) 179 Of 220 From : To : Subject : Dat e: Myklegard Drew Blackburn ScottB fb )(5) Re: [EXTERNAL] RE...., : T= h-an _k,,.s ,_ ,o...., rP .... a....,, rti,...,. cip _a.,.,.. ting in the HIMSS 2018 CIO Roundtable Discussion on Accelerat ing Open APls Tuesday, March 20, 2018 12:40:51 PM We we lcome all! !! Harp and I w ill reach ou t. From: "Blackburn, Scott R." Date: Tuesday, March 20, 20 18 at 10:49 AM To: "Myklegard, Drew" Subject: FW: [EXTERNAL] RE: Thanks for Participating in the HIMSS 2018 CIO Roundtabl e Discussion on Accelerating Open APis Sounds like someone that wants to sign t he pledge ... Sent with Good (www.good.com) From: Rene Cabral-Daniels Sent: Tuesday, March 20, 2018 7:52:55 AM To: Aneesh Chopra; Blackburn, Scott R.; Shrestha, Rasu B; grahame; Micki Tripathi ; Culbertson, Adam Subject: [ EXTERNAL] RE: Thanks for Participating in the HIMSS 2018 CIO Roundtable Discussion on Accelerating Open APIs Thank you for yo ur outstand ing leadership. Please know I remain comm itted to this project as it ho lds tremendous promise for t he med ically underserved. Rene S. Cabral- Daniels, JD, M PH Chief Execut ive Officer Commun ity Care Network of Virginia, Inc. Suit e 1 3831 Weste rre Parkway Henr ico, VA 23233 Phone - 804-237-7686 x1219 Community Catt Nctwort o!Vuginia,Inc. VA-18-0298-C, VA-18-0299-C-000180 180 of 220 From: To : Subject : Date : BlackburnScottB ILb)l@tacsorq VAEHR Monday, March 12, 2018 9:54:00 AM Dr. Ko: I hope t his finds yo u well. On behalf of Secretary Shulkin I wa nted to see if we could enlist your help. We are very close to fi nalizing ou r EHRdeal with Cerner; however we wa nt to make sure we get a f ew ext ra set of eyes on it to make sure we are do ing right by Vet erans, t he count ry and taxpayers . Wou ld yo u have the t ime/abil ity to conduct a quick high level review and provi de input in the next week or so? You were ref erred to us by Dr. Bruce Mos kowitz. Thanks so much, Scott Scott Blackburn Act ing CIO & Execut ive-in-Charge, Off ice of Info rmat ion & Techno logy Departme nt of Veterans Affa irs VA-18-0298-C, VA-18-0299-C-000181 181 of 220 VA EHRM RTM Non- Functional Requirements Summary Updated: 22Jan2018 VA RTM Non-Functional Requirements VA Informatics Requirements Count Requirement Type Final 1 20 Access Management Data Management 4 Identity Management 21 Information Assurance/ Security 11 Interope rabil ity 19 Pharmacy Final Total Compatibility 13 Functional Suitability 15 Maintainabi lity 6 Usability 4 Final Total 38 7 Scalability/ Maintanability Synchronization: Low-Comm/ SLA Count Final 508 Compliance Reliability/ Requirement Type / Cat No-Comm 4 1 12 100 VA-18-0298-C, VA-18-0299-C-000182 182 of 220 Ref # .1. . Capa b 1 ItIes Informatics VA-NF -T13 Det.mItIon .. Informatics - Data Content VA-NF-T15 Informatics - Data Content In the process of capturing complete and accurate records , VHA must minimize unnecessary documentation burdens that clinicians face. These burdens decrease face -to-face time for clinica l care, thereby impairing care quality, patient satisfaction, and clinician satisfact ion. Integrated, re-usable , standards -based, computable termino logy allows clinicians to "document once" and the system to re-use that data "many times". (Cognitive Support) ML2 NOW Informatics - Data Content VHA must be able to ingest standards -based data and information from medical devices or via manual entr with associated metadata such as rovenance TP1 NOW VA-NF -T16 VAS tatus 1. Gerner can import VA SNOMED Extensions including VA provided versioned post-coordinated expressions as single SCTID and integrate and use that content in the same manner as current SNOMED- [NOW] 2. Gerner could provide support for the capture of postcoordinated expressions [ >3 years] Final Met/Not M t e Solution N ame Develop t men Time Categories for Informatics capabi lites below o Now: Capability Exists in Current Gerner Product o Now+ : Capability substantially exists today, progress is planned or expected o 1-3: Capability could exist in 1-3 years Ca abilit will take Ion er than 3 ears VHA must be able to capture complete, accurate , richly detailed health data in a "close to clinician meaning " manner using accepted standards in order to deliver high quality, consistent care to Vetera ns. ML 1 [>3] VA-NF -T14 RTM Cl an.1IcatIon . . Final [NOW] 1. The system will be able to ingest and display blood pressures sorted by measurement or sorted by time integrated across devices [NOW] 2. The system will be able to ingest and display oxygen saturation percentage sorted by sorted by time integrated across dev ices [NOW] Informatics - Data Content Final Final VHA must be able to access validated and unvalidated standards -based medical device data for research and analysis in development of evidenced -based practice. Validated device data should be part of the health record and unvalidated device data shou ld be stored but not part The system can be configured to export unvalidated sampled and of the patient's record [TP2] [> 3] raw device data to a 3rd party archive [>3] VA-NF-T17 Informatics - Data Content VA-NF-T18 Informatics - Data Reuse VA-NF-T19 Informatics - Data Reuse Final VHA needs to be able to track patient location in any care venue via multiple techniques such 1. System can support manual location entry [NOW] as manua l entry or radio-frequency wrist band. Data should be able to be integrated across 2. System can support automated data entry from VA-provided methods and over time . VHA also needs to be able to tie location data to organizational units RFID infrastructure [NOW] wards, clinics etc TP3 1. System can support an invokab le service that determines and VHA must be able to use clinica l data collected at the point of care (e.g., exam rooms , returns class members hip [NOW] patient's home) for clinical decision support and research regardless of the care site, clinic 2. System will provide the invokab le service with content provided type, provider type (including patients) or data entry form employed. Clinical data eleme nts by VA [1-3] must be collected in a standardized and cons istent way across venues to faci litate reuse. 3. System provides the tools to develop the content [>3] (Data exchange , CDS, quality) SHB1 [NOW] Final Final VHA must be able to access and reuse its clinical data in perpetuity without licensing restrict ions. (Data exchan e SHB2 VA-18-0298-C, VA-18-0299-C-000183 183 of 220 Capabilities Definition RTM Clarification VA Status o Informat ics - Care Integration VHA must operate with academic affiliate partners , Community Care partners, DoD, and public health agencies. Standards-based clinical terminology is required for such operations across a continuum of care. (Data Exchange, Process Continu ity) ML3 [NOW] 1. Standards-based, fine grained observations from the point of care , such as "diminished sensation to light touch on the plantar surfaces of both feet" must be able to be exported to care partners as standard-based coded data. [1-3] 2. Standards-based, fine grained observations from the point of care, such as "diminished sensation to light touch on the plantar surfaces of both feet" must be able to be imported from care partners as standards-based coded data [NOW] and formally "classified" via an invokable service [1-3] VA-NF-T21 Informat ics - Care Integration VHA must be able to provide demonstrably high-quality collaborative care in the community without delay or waste or elevated risk. (Data Exchange, Process Continuity, Quality, Safety Value) SHB6 [NOW+] 1. The system must be able to import, integrate and run dec ision support rules for quality measures such as opiate safety that include data elements regarding opiate prescriptions , urine drug screen lab test results, and the checking of state prescription drug monitoring databases. Data elements must come from at least one non-VNDoD non-Gerner healthcare provider. Rules will identify patients who have received more than one prescription for opiates in the past year who have an illicit drug found in their urine and who have not had a state pdmp check in the same time frame. [NOW+] Final VA-NF-T22 Informat ics - Care Integration VHA requires effective integration of a longitudinal record from multiple sources despite technology and information representation disparities via concurrent support of mu ltiple versions of data structures in support of both standards trans ition periods to newer releases, and interchange with systems supporting older versions of the standard (Data Exchange, Evolution) KSR2 [NOW] 1. System will support the use of multiple data models (eg, GEM, CIMI, ANF) [1-3] 2. System will support STAMP vers ioning for all data models and standard terminologies. [1-3] 3. System will support data exchange via multiple models based on the requirements of the exchange partner [1-3] Final VA-NF-T23 Informat ics - Care Integration VA must be able to seamlessly integrate with HIE and external-to-EHR shared services to provide for a seamless experience and to more effectively integrate in community care efforts, as wel l as with other parts of VA (e.g., identity management) . This includes but is not limited to the EHR product ability to support external shared services (SOA services , such as identity management , care plan service , scheduling, etc.) accessed via standards-based APls. (Process Continuity, Evolution, Extension) KSR5 [NOW +] 1. Monitor and measure the number of FHIR interfaces realized with external networks/provider organizations [NOW] 2. Demonstrate the ability to conduct shared care planning with non-VA actors, such as a care-coordination Smart on FHIR app [1-3] Final VA-NF-T24 Informatics - Care Integration VHA requires the ability to deliver seamless care via distributed care processes , both as a referrer to external care and a referra l recipient for externally-initiated care activities. (Data Exchange, Process Continuity) KSR7 [NOW+] VHA requires the ability to deliver seamless care via distributed care processes, both as a referrer to externa l care and a referral recipient for externally-initiated care activities. (Data Exchange, Process Continuity) KSR7 [NOW+] Final Met/Not Met Solution Name Develop ment VA-18-0298-C, VA-18-0299-C-000184 184 of 220 Capabilities Definition RTM Clarification Informatics - Clinical Decision Support VA providers and patients EHR experience shou ld be enhanced based on clinical knowledge , 1. System will be able to present a curated (role, venue , problem oriented view of a patient's record that includes clinically relevant analytics, context and situational awareness . (Cognit ive Support, innovation) BG3 [NOW ] medicat ions , labs, procedu res and progress notes for each problem on the problem list. [NOW] This view will be dr iven by standards-based expressions of clinical knowledge ("insuli n treats diabetes"; "HgBa1 c lab performed for diabe tes") [>3] 2. The view will change when the know ledge base changes , for example to include a new med ication that treats diabetes [>3] 3. The view will be extended to include addit ional data types , includ ing psycho-social factors that impact health [1-3] 4. Patient-facing compone nts wi ll use terms appropriate for laymen [NOW ] VA-NF -T26 Informatics - Clinical Decision Support VA must be able to utilize specialty external (non-Gerner) standards -based clinical decis ion support capab ilities, such as predictive analytics and enhanced point-of -care decision support to improve clinical qual ity management and VA clinical efficacy . (CDS , Cognitive Support , Extension, Innovation) KSR4 [1-3] VA-NF-T27 Informatics - Clinical Decision Support VA requires a sandbox to support VA developing the knowledge necessary to leverage the strengths of the new EHR and to align CDS efforts with the to-be host system. The sandbox shall facilitate the following: conform ing to national HIT standards, cap italizing on opensource resources, capita lizing on the experience and efforts of Department of Defense and other federal partners, preserving and building on decades of institutional knowledge and experience as represented in VistA and CPRS , future -proofing knowledge -based systems , custom izing CDS to account for site-spec ific var iation and available resources and determining points of necessary standardization within VA, creat ing best practices for developing multi-tiered CDS and other forms of user performance augmenta tion, deve loping process for supporting design , implementation , and evaluation of CDS to maximize impact. (CDS , Cognitive Support, Innovation) DLM4 [NOW] VA-NF-T28 Informatics - Clinical Decision Support VHA requires tools that facilitate decision making by the healthcare team and the homecare team including computerized alerts and rem inders to care providers and patients ; clinica l guide lines; cond ition-specif ic order sets; focused patient data reports and summaries; documentation temp lates ; diagnostic support , and context ually relevant reference info rmat ion CDS DLM1 NOW Enumerate commercially -available third-party COTS CDS offerings capab le of integrat ion with Gerner via standards -based interfaces (including but not necessari ly limited to support fo r FHIR AP ls and/or OMG CDS API/ HL7 CDS APls (eg , CDS Hooks 1-3 1. The EHR Sanbox will use SNOME D CT for Problem List Entries [NOW ] 2. The EHR sandbox will include open source components of lnfoButtons [NOW] 3. The EHR sandbox will include rapid prototyping tools for user centered design such as balsamiq . [1-3] VA Status Met/Not Met Solution Name Develop ment Final Final Final VA-18-0298-C, VA-18-0299-C-000185 185 of 220 Capabilities Definition RTM Clarification VA Status o Informat ics - Clinical Decision Support VHA requires informat ion that is filtered , organ ized and presented in a way that supports the current workf low, allow ing the user to make an informed decision quickly and take action . (CDS , Cognitive Support, Innovation) DLM2 [NOW] 1. Users shall be able to configure the workspace to display information that meets their individua l requirements: [NOW] data types filtered by specialty needs, timeframes, display patterns [>3] 2. Users shall be able to filter medications by drug class [NOW] 3. Users shall be able to filter progress notes by multiple parameters , such as multiple relevant specialt ies. [NOW] 4. System able to maintain and update state of user-pat ient activity in terms of contex t, setting, workflow process state, cognitive /logic tasks that are appropriate to this state , other parameters to be defined . (3+] 5. Context model defi nition in terms of axes that address aspects such as in previous bullet. (>3] 6. Abi lity to use such state descrip tions and conte xt to select appropriate CDS [>3] 7. EHR supports "snapshot or dashboard view" of individual patients that is configurab le based on user spec ialty/preferences [NOW] 8. EHR supports user selected filters for result tab les that allow quick analysis of patient information [NOW] VA-NF-T30 Informat ics - Clinical Decision Support VHA requires different types of CDS appropriate to opt imize different processes of care in different settings and across venues (CDS, Process Continu ity, Data Exchange , Extension, Innovation) DLM3 [NOW] 1. Users shall be able to view data that is comingled by data type , in time sequence , regardless of the source of the data whether it be within or outside of VHA and DoD [NOW ,+ ] 2. Users shall be able to use both custom and enterprise standard dashboards to address needs for cohorts of patients. [NOW] 3. There shall be an enterprise wide governance process that manages alerts and other CDS formats to max imize their efficiency [VA] 4. CDS tools shall be standards based , and shareab le within and outs ide of DoD and the VA [NOW,+] 6. Organization of CDS artifacts in a knowledge base with metatags indicating contex t parameters that characterize where they are appl icable (1-3] 7. EHR supports multiple CDS approaches including : o interna l alerts/ rem inders , [NOW] o access to external CDS modules via standards based data exchange (HL7 DSS/CDS Hooks , etc) , [NOW+] o context specific lnfoButton links to document based CDS [NOW] Final VA-NF-T31 Informatics - Clinical Decision Support VA requires CDS appl ications that operate as components of a comprehensive EHR system. DLM6 [NOW] 1. Abi lity to maintain and support an external shared knowledge management repository that can be accessed through EHRs, either by AP ls or by import/synchroniza tion with host EHR systems [>3] 2. CDS applications are patient context aware (eg. CCOW or SMART apps) and not requir ing multiple signon's [NOW ,+] Final Met/Not Met Solution Name Develop ment VA-18-0298-C, VA-18-0299-C-000186 186 of 220 Capabilities Definition RTM Clarification VA Status Informatics - Clinical Decision Support VA requires CDS interventions that address the CDS Five Rights by providing the right information (evidence-based guidance , response to clinical need), to the right people (entire care team - including the patient), through the right channels (e.g., EHR, mobi le device, patient portal), in the right formats (e.g., order sets, flow-sheets, dashboards, patient lists), at the right times (CDS) OLM? [NOW] 1. There shall be an enterprise wide governance process, incorporating all healthcare specialties, to manage evidence based guidance that supports clinical decision support tools. [VA] 2. Intensive usability assessment shall be done and acted upon for all CDS interventions, including careful workf low analysis that addresses all 5 rights . [VA] 3. CDS tools and EHR are equally access ible by providers, patients , and caregivers through multiple channels (desktop , mobile device). [NOW +] VA-NF-T9 1 Informatics - Content Integration VA needs to be able to purchase/acquire and easily deploy standards-based clinical decision support content such as order sets, documentation temp lates and clinical rules. (Extension , CDS) SHB3 [NOW +] 1. The system can import and execute "USPSTF Stalin Use for the Primary Prevention of CVD in Adults" ECA rule from the AHRQ CDS Connect repository (1-3] 2. The system will import and execute 1 other ECA rule from AHRQ [1-3] 3. The system will be able to import and execute one or more order sets and one or more documentat ion temp lates from a nonCerner , standards-based source [1-3] Final VA-N F-T92 Informatics - Content Integration VA must be able to integrate clinical data, knowledge resources, and workf low across care venues . (CDS, Cognitive Support , Process Continuity, Evolution, Innovation) BG1 [MISSED] 1. The system will be able model work flow e.g., for low back pain evaluation and management using BPMN, CMMN , DMN and track complet ion of each step regardless of care venue. [>3] 2. The system will be able to marshal! relevant clinica l data for each step (eg,MRI results, medications) from each care venue and integrate the results into a coherent workflow centric view. [NOW] Final VA-NF-T93 Informatics - Content Integration VHA requires extension and import of clinical knowledge (code systems, ontologies, etc.) from external sources, allowing it to more accurate ly and rapidly ingest best-practices as they are come available from clinical professional societ ies and peer healthcare delivery organizations. (CDS, Cognitive Support, Extension, Innovation) KSR3 [NOW+ ] 1. The System will be able to import SNOMED CT and use full capabilities of updates in RF2 format from NLM and deploy the updates at the point of care for use in problem lists. (1-3) 2. The system will be able to import LOINC and RxNORM and deploy the updates for use where appropr iate e.g. pharmacy, lab. [NOW] Final Met/Not Met Solution Name Develop ment VA-18-0298-C, VA-18-0299-C-000187 187 of 220 Ref# Capabilities oo Informatics - Content Management Definition RTM Clarification The VA must be able to use CDS, Process Interoperabi lity and Cognitive support mechanisms reliably and consistently over time and across venues of care. The VA must have the ability to monitor and manage all CDS, Process Interoperability and Cognitive Support mechanisms and all dependent subcomponents such as code systems and other data representations (CDS Cognitive Support, Quality, Safety) SHB7 (1-3] 1. The system will provide monito ring of the frequency of CDS rule such as colorectal cancer screening firing over time and will provide alerts when significant changes in patterns are encountered as determined by statistica l process control metrics . [NOW] VA Status Met/Not Met Solution Name Develop ment 2. CDS rule components for colorectal cancer screening will be represented using SNOMED CT with ST AMP versionin g. CDS rules for colorectal cancer screening will be ST AMP versioned. (13] 3. The system must track depende ncies between all CDS artifacts and their components using a coordinated-based declaration of dependencies, where each artifact will be given a textual group id, artifact id, and version. This coo rdinate-based delegat ion of dependencies is an industry best-practice as demonstrated by implementations of this paradigm by Maven, Gradle , and other build systems. (1-3] VA-NF-T33 Informatics - Content Management VHA must effectively integrate and manage veteran data from heterogeneous external partners that will include versioned structural representations of data, including but not limited to CIMI Model Instances and patient data constructs represented in these structures. (Data Exchange, Evolution) KSR1 [NOW Healthelintent] 1. System will support the use of multiple data models (e.g., GEM, CIM I, ANF) [NOW] 2. System will support STAMP vers ioning for all data models and standard terminologies. [NOW] 3. System will be able to import, store and reuse in CDS patient data delive red via multiple versioned data models for the triggering of a colorectal cancer screening rem inder [NOW] Final VA-NF-T34 Informatics - Content Management The VA must continuously evaluate quality, safety, and value using data sets that cover a time period of 5 years or more (5 year survival for cancer patients is an important benchmark). The VA must have the ability to manage changes in code systems and other data representations over the time period, in order to reliably and consistently assess quality, safety, and value. (Quality, Safety, Value, Evolution) KEC4 [NOW +] 1. Code systems and elements will be maintained using STAMP versioning. [NOW] 2. Upon update, the status of previous versions of the code set and code elements will be changed to reflect the update but the previous version and code elements will not be deleted from the system. [NOW] Final VA-NF-T35 Informatics - Content Management VA must be able to extend existing standards content with new codes in a timely and accurate 1. The system will support a VA "extens ion" to SNOMED that manner. The VA must also have a process by which these extensions are reconciled with the meets SNOMED extension technical requirements. [NOW] relevant standards. KEC5 [NOW] 2. The system will provide tools for terminology modelers with SNOMED modeling experience to model new pre and post coordinated concepts in a graphical environment (1-3] 3. The system will store those STAMP versioned models in a VA extens ion. [NOW] Final VA-18-0298-C, VA-18-0299-C-000188 188 of 220 Ref# Capabilities o Informat ics - Content Management Definition The VA must ensure that all uses of clinical data must be demonstrab ly safe for patient care , through the computation and evaluation of metrics, system analysis, and statistical sampling . The VA must never be faced with a circumstance where patient harm resulted from unsafe processing of clinical data, such as sending data through a defective map that may resu lt in errors of care. (Safety, Data Exchange , CDS, Process Continuity , Cognitive Support) KEC2 [NOW+] RTM Clarification VA Status Met/Not Met Solution Name Develop ment 1. When an artifact upon which CDS is dependent changes , (terminology, model, rule, etc), the system must be able to compute which other artifacts are dependent on that artifact , so that proper quality assurance can be performed on the dependent artifacts to ensure patient safety . [1-3] 2. All transformations from internal terminology to external terminology must use an equivalence table, where each entry in the table has clinical equivalent meaning. This equiva lence table must be subject to ongoing metric -based quality assurance, where inter-ra ter and intra-rater reliability statistics are provided . The VA will sample this equivalence table , and will create its own inter-rate r and intra-rater reliability statistics to confirm the clinical safety aspects of this equ ivalence table. Any discrepancies found in the equivalence table will be rapidly remedied in the interest of providing for safe operation upon and exchange of patient data. [1-3] 3. All internal terminology content that does not have a clinically equivalent transfor mation to an external standard will be part of a backlog tracker , where content in the tracker will be planned for modeling and contribution to an appropriate standard , so that we maintain clinical equivalence in exchange of data with external care partners. [1-3] VA-NF-T37 Informatics - Content Management VHA must be able to create , modify, maintain, publish, monitor and govern clinical conten t of all types including terminology, EGA rules, order sets, documentation temp lates, clinical pathways , guidelines, work flows and governance at enterprise scale. All artifacts must be versioned and their interdependenc ies known and agily managed. To achieve these goals, integrated too ling for knowledge engineering and knowledge management are required. [1-3] 1. The system will include tooling to create, curate, mainta in, publish and manage terminology, EGA rules, order sets and documentations templates includi ng STAMP versioning of each content type [1-3] 2. The system will include an integrated tooling suite to create, curate, maintain, publis h and manage terminology , EGA rules, order sets and documentations templates (1-3] 3. The system will include an integrated tooling suite with dependency tracking to create , curate, maintain, publish and manage terminology , EGA rules, order sets and documenta tions templates [1-3] 4. Additiona l content types will be added to the Knowledge engineering environment [1-3] Final VA-18-0298-C, VA-18-0299-C-000189 189 of 220 VA Status Definition RTM Clarification Informatics - Content Management VHA must be able to "mass customize" ("localization") clinical content to meet local needs without inducing undesirable variation in enterprise assets such as coded clinical observations from the point of care. Controlled mass custom ization shou ld be achieved by creating tools that separate concerns, respect architectural layers, support versioning and depende ncy management , and have the ability to classify artifact subcomponents into categories of permitted variation. [NOW] 1. The tool should be able to mass customize an order based on availability and allocation of resources. [NOW] 2. The tool should be able to mass customize an order based on local medicatio n formu lary. [NOW] 3. The tool should be able to mass customize a documentat ion template based on local informatio n requirements such as an ongo ing research study [NOW] 4. The tool should be able to mass customize an EGA rule where the prior probab ility of cond itions may vary geographica lly [NOW] 5. The tool should support additiona l types and classes of mass customization [NOW +] VA-NF-T39 Informatics - Workflow Demonstrate the ability to ingest care processes expressed in standards such as BPMN, CMMN , and/or DMN either directly imported or indirectly used to create intra-product workflows wit hin the EHR. [>3] Final VA-NF-T40 Informatics - Workflow VHA must be able to develop, extend and bi-directionally share standards -based care protocols and workflows with external care partners in order to improve care qua lity, care consistency and enhance VHA 's ability to come into compliance with best-practices in a more timely and accurate way. Expected industry standards such as BPMN, CMMN , DMN (Process Continuit , Qualit , Safet Value KSR6 >3 VHA requires CDS that is designed using a reference taxonomy of its choosing, such as The Reference Taxonomy of Clinical Workflows or the Clinical Care Onto logy that provides a common set of terms to CDS designers and implementers to support communication about CDS and its use in clinical workflows. (CDS) DLM9 [1-3] 1 . Reminders , such as the VA colorectal cancer screening reminder, will be linked to VA care processes via the clinical care ontology and into at least one standards-based (eg BPM CMN DMN) modeled workflow such as a primary care scheduled visit. (1-3] 2. These artifacts will be searchable and will be easily shared with clinical subject matter experts. (1-3] Final VA-NF -T41 Informatics - Workflow VHA requires CDS tools and repositories, to enable workflow -related organization and searches. (CDS) DLM10 [NOW +] . The system will permit searches for CDS artifacts including EGA rules, order sets and documentation templates for at least one standards -based (eg BPM CMN DMN) modeled wo rkflow such as a primary care scheduled visit. [1-3] 2. The system shall show an updated search result based on the addition of one or more CDS artifacts to the chosen wo rkflow [1-3] Final VA-NF -T42 Informatics - Workflow VHA requires CDS tools that are tagged with terms from a reference taxonomy of its choosing , such as The Reference Taxonomy of Clinical Workflows or the Clinical Care Ontology, to inform practices about the intended use of CDS. (CDS) [1-3] Final VA-NF -T43 Informatics - Workflow VHA requires CDS that is implemented using maps of workflows that have been developed using a reference taxonomy of its choosing, such as The Reference Taxonomy of Clinical Workflows. (CDS) OLM12 [1-3] 1 . Reminders , such as the VA colorectal cancer screening reminder , will be linked to VA care processes via the clinical care ontology and into at least one standards-based (eg BPM CMN DMN) modeled workflow such as a primary care scheduled visit. (1-3] 2. These artifacts will be searchable and will be easily shared with clinical sub.ect matter ex erts. 1-3 1 . Reminders , such as the VA colorectal cancer screening reminder , will be linked to VA care processes via the clinical care ontology and into at least one standards-based (eg BPM CMN DMN) modeled workflow such as a primary care scheduled visit. (1-3] 2. These artifacts will be searchable and will be easily shared with clinical sub.ect matter ex erts. 1-3 Ref# Capabilities : Met/Not Met Solution Name Develop ment Final VA-18-0298-C, VA-18-0299-C-000190 190 of 220 Capabilities VA-NF-T45 VA ~H::: T46 Definition Informat ics - Quality and Value VA must be able to support , identify and continuously advance best practices in Veteran's Care including conditions such as PTSD, TBI , MST, and Suicide Prevention (Qua lity, Safety, Value , Innovation) SHBS [NOW+ ] Informatics - Quality and Value VHA must employ enterpr ise-wide value -based analytics and management to guide investment across the health system. Th is includes the capabi lity to identify and analyze individual and populat ion health outcomes and to mode l costs at the individual and system levels utilizing Time-Driven Activ ity Based Costing. To achieve this, VHA 's EHR must be able to manage, collect and re-use enterprise -wide standards -based clinical data . Value-based methods also require VHA to manage and track healthcare activit ies, including act ivity resource inputs (e.g., personnel , it systems , materials) and activity delivery time -capture. DM1 NOW + The system shall support provenance (chain of custody or ownership) and pedigree (processing history how the data was produced or incorpomted) and enable identification, collection, and production of data according to source , custody and ownership and display of data in business , logical , legal or physical models. RTM Clarification VA Status Met/Not Met Solution Name Develop ment 1. The system will implement versioned standards-mode led workflows linked to standards -based CDS artifacts (documentation templates, ECA rules, order sets) composed of concepts from standard termino logies (e.g. SNOMED) collect ing standards encoded data from care processes for one of : PTSD, TB I, Suic ide Prevention . [>3] 2. The resu lting vers ioned standards-based patient instance and process data shall be query-able via standa rd methods such as SOL. [1-3] 3. A updated collection of versioned artifacts addressing the same condition shall be implemented and the ear lier versions shall be retired. [NOW] Final 1. The system will be able to collect and display time data for procedures represented by CPT [NOW +] 2. The system will be able to collect and display time data for nonCPT activities [NOW+ ] 3. The system will be able to model resources required for procedures. [NOW+ ] VA-18-0298-C, VA-18-0299-C-000191 191 of 220 Capabilities Definition RTM Clarification VA Status Record Control Schedule with NARA: For VHA, the electronic health records covered under the Privacy Act SORN, 24VA10P2, are temporary records with a requirement for destruction or deletion 75 years after the last episode of patient care (N1-15-02-3, Item 3). Once the electronic health records reach 3 years of inactivity the record can be archived. Archived records must meet NARA Requirements and the agency record control schedule. o NARA Definition of Archives: The noncurrent records of an organization or institution preserved because of their continuing value. The Arch ivist of the US determines the continuing value of records per the record control schedule approval process. Archived records must have the abi lity to be recovered and returned to full status in the operational system as needed and upon request (e.g., patient returns to VA for care). o Archived records must reflect the original version and cannot be altered in a manner that prevents reincorporation into the operationa l system. Data integrity must be maintained. o Archived records must be returned to full status in the operational system in a sufficiently efficient timeframe to meet clinical care needs. (e.g., emergency care after 3 years of inactivity) o Archived records may be handled through tiered storage. Final 7/24 or other local solution must contain a database pointer table For COOP/DR: The system shall be able to identify what images exist , and which of those are that can re-direct to local cache instead of CAMM and allow in the cache , when a medical center is disconnected from Gerner Data Center. access to locally-stored images. It will also indicate whether or not an image has been taken if the image is not stored locally (metadata only). Final The vendor shall provide a solution to archive the complete medical record from VistA (need to identify all of the components from within the VistA product) The archiving solution shall place the legacy data in a relational database The solution shall provide a link/API access from an individual patients Gerner Millennium chart to the patients archived record The archiving solution shall be searchable by account IDs, name, social security number, or data source The archiving solution shall be capable of archiving patient records from the Gerner Millennium system VA-NF-B04 Met/Not Met Solution Name Develop ment VA-18-0298-C, VA-18-0299-C-000192 192 of 220 Capabilities Definition VA-NF-222 The system shall be 100% compliant with the 2017 revisions for INFORMATION AND COMMUN ICAT ION TECHNOLOGY PROCUREMENTS (SECTION 508) , Section 508 of the Rehabilitat ion Act of 1998, as amended, 29 USC 794(d) and the requireme nts outlined in the Performance Work Statement. The contractor shall ensure emp loyees with disabilities are offered the same training opportunities via equivalent access and that the train ing environment is accessible to those with disabi lities and the electronic training materia ls meet section 508 requirements. When documentation is only provided in non-electronic formats, alternate formats usab le by people with disabi lities sha ll be provided by material originator upon request. VA-NF -6 The system shall conform to both DoD and VA standardized access management methods VA-NF-7 The system shall support the ability to access data elements using open standard -based interfaces including legacy data VA-NF-8 VA-NF-9 The system shall initia lly prov ide role-based access and allow for finer grained access in the future The system shall use VA-approved pub lic key infrastruc ture (PKI) certificates in PKl-based identity authentication processes for component business and mission rocesses VA-NF -10 The system shall enable role configuration to fit VA business needs VA-NF -11 The system shall provide the ability of the user to log in to the system via a VA PIV card and/or use the VA's Authentication service and trusted token VA-NF-38 VA-NF-43 The system shall be able to provis ion and deprov ision users into Gerner Act ive Directory and App lications both manua lly and automated with VA's Enter rise rovisionin service . The system shall allow users access to multiple app licat ions using a single means of authentication maintaining User context across all Gerner app lications (e.g ., valid DoD CACI VA PIV combined with ersonal identificat ion number ATM Clarification VA Status The Section 508 standards estab lished by the Architectural and Transportatio n Barriers Compliance Board (Access Board) are incor porated into, and made part of all VA orders, solicitations and purchase orders developed to procure Information and Communication Technology (ICT). These standards are found in their entirety at: http://www.section508.gov and https: //www.access -board.gov /guide lines-andstandards /communications -and-it/about -the-ictrefresh/final -rule/text-of-the-standards -andguidelines. A printed copy of the standards will be supplied upon request. Final Access Methods implementat ion will be different for VA. Gerner will need to integrate to VA's Enterprise 1AM services (SSOi, Provision in etc .. With the data migration plan and VA adding Healthelntent to its scope we believe longitudina l patient data interfaces will need to be availab le and secured using PKI bi-mutual Authentication of a trusted system or a SAML non-person entity token. Final Met/Not Met (Gerner Field) Usability DEA.040201 Human Interface (767938) Ellen Crowe 36656 Compatibility EHRM Lead Cindy Bias Final 10 Compatibility EHRM Lead Cindy Bias Attribute based access on people, places, context , environmenta l to view specific patient record elements and take action on certain functions in the a lication VA uses a different PKI infrastructure than DoD. Gerner will need to support both Final 36670 Security EHRM Lead Cindy Bias Final 36686 Security EHRM Lead Cindy Bias Role management and conf iguration needs to be robust enough to fit VA's unique business needs for providing right access to the right erson in the field. Direct PIV auth will require integration to OCSP responders and binding to attribute on certificate; if VA's Authentication service will provide a SAML token and binding wi ll occur on token attributes Integration to VA's 1AM Provisioning service using SPML and having a fallback manual provisioning process to add users to the right a lications with the ri ht roles/ ermiss ions This is an SSO requirement, not forcing users to input PIN at every app lication. Using the VA's authenticat ion Service token shou ld allow for this. Mainta ining User Context w ith related atient context is hu e. Final 36698 Security EHRM Lead Cindy Bias Final 36699 Security EHRM Lead Cindy Bias Final 38497 Functional Suitability EHRM Lead Cindy Bias Final 45884 Usability EHRM Lead Cindy Bias 36706 Solution Name (Gerner Field) VA-18-0298-C, VA-18-0299-C-000193 193 of 220 Capabilities Identity - Joint Legacy Viewer VA-NF -47 VA-NF-48 VA-NF -49 VA-NF-50 VA-NF-51 Definition The system shall integrate Jo int Legacy Viewer connectivity (e.g., launch button) with the EHR solutio n, to include context manageme nt using the user ID, atient ID and atient encounter ATM Clarification VA users and not all patients will have EDIPI. VA uses several different credentials (ID.me, Self Service appl ications shall allow for fede rated DS-Logon, USAA, VA CSP) to allow Veterans crede ntials to be used to access the system to access usin the credential the have Self Service VA 1AM offers SSOe to proxy users or can Self Service appl ications shall allow for Authentication prov ide a SSO STS token. The VA also has authentication from VA authenticat ion service authentication serv ice prov ided behind VETS. ov that could be used. Patient Context Patient context management service betwee n Maintain patient co ntext throug hout all Cerner all Cerner apps; needs to work in conjunction applications and SSO sess ions with SSO user contex1 User Logon - TAP From Cerner: Need clarification and addit ional After initial 2 factor authenticat ion , a user shall be use cases from VA due to the large tec hnical allowed to use TAP to resume sessio n gap with 2 factor authenticat ion with existing Cerner TAP ca abilities. Emergency Access NonThis might be solved with an SSO i integrat ion The system shall support a temporary non-two Two Factor that would support AD auth and pass factor authentication for emergency situations Authentication authentication token Self Service Credentials Met/Not Met (Gerner Field) VA Status 170452 Functional Suitability EHRM Lead Cindy Bias Final Usability EHRM Lead Cindy Bias Final Compat ibility EHRM Lead Cindy Bias Final Functional Suitability EHRM Lead Cindy Bias Final Security EHRM Lead Cindy Bias Final Security EHRM Lead Cindy Bias Functional Suitability EHRM Lead Cindy Bias Final Security EHRM Lead Cindy Bias Final Security EHRM Lead Cindy Bias Functional Suitability EHRM Lead Cindy Bias Final Functional Suitability EHRM Lead Cindy Bias Final Functional Suitability EHRM Lead Cindy Bias VA ~Ii; 66 VA-NF -56 Account Disable VA-NF-58 Security Audit VA-NF -39 Web Application Identity The web applicat ions for the system shall Manageme nt And access implement identity management and access manageme nt management VA-NF -46 VA-NF-S03 The time period would run as a batch job . Manual would allow adm inistrators to put a user hold to revent access at an time 24/7 This should be covered by NIST 800-53 contro ls Web applications shall be implemented with ente rprise identity and access services the same as the th ick client/C itrix XenApp a lications . Self Service Applicat ions The self-service/patie nt porta ls shall impleme nt All 1AM requirements apply to self serv ice identit mana ement and access mana eme nt a s. User Credent ials authentication will be Re-Authentication This is for revett ing the user and capt uring their electro nic acknowledgeme nt of a transaction. The system shall be able to re-authenticate a (non-level 2 contro lled substances that require user based on business needs (I.E. - electronic digita l signat ure) Business may choose to allow signature of basic orders or other types of system e-signature acknow ledgement in lieu of this requ irement. SSOi has a re-authe ntication call back in its inte ration atterns. Final 38498 Solution Name (Gerner Field) Data Management VA-18-0298-C, VA-18-0299-C-000194 194 of 220 Capabilities Definition ATM Clarification Met /Not Met (Corner Field) VA Status Security FFRDC MITRE Jack Bates Final Functional Suitability Contractor BAH Jack Bates Final Functional Suitabili ty Contractor BAH Jack Bates Final Functional Suitability DEA.04.01 .01 Jack Bates Enterpr ise Data (7679 19) For VHA , tl:le eleetroAie l:lealtl:Ireeords eo.,,ered uRder tl:le Privaey Ast SOR~J, 24VA1 0P2 , are temporary reeords will:! a requiremeAt for destruelioR or deletioR 7? years alter tl:le las! episode of patieAI eare (~J1 1? 02 3 , Item 3). ORee 11:ieeleotreRio l:lealtl:I reoords reaol:I 3 years ef iRaoti~oitytl:le reoord oaA be arol:lived. Arol:lived reoerds must meet ~JARA Tl:le veRder sl:lall pre~oidea selul ieR te arel:li.,,e11:ie RequiremeAls aAd 11:ieageRoy reoord ooAlrol sol:ledule. eemp lele medical reeerd from VislA (Reed le o ~JARA DefiRitioR of Arol:lives: Tl:le ideRlify all ef tl:le eempeReRts from w itl:liR 11:ie reoords of aA OF?laAizatioAOF VistA produel) Tl:le arel:li.,,iRgselulieR sl:lall plaee AOAGUFroRt iRstitutioR preserved beoause of tl:leir 11:ielegacy data iR a relal ieRal database Tl:le oontinuin?! value. Tl:lo Arol:lio,ist of tl:lo US selutieR sl:lall provide a liRl~IAPI assess from aR iRdio,idual patieRls Gerner MilleRRium el:larl le tl:le detormiRes tl:le ooRtiRuiRgvalue of rooords per tl:lo rnoord oontrol sol:lodulo approval proooss. palieRls arel:lio~edreeerd no arel:li.,,iRg selulieR Solution Name (Gerner Field) sl:lall be searel:lable by aeeeuRt IDs, Ramo, seeial be rooovored and returnes to full status in tl:lo secur ity Rumber, er data seuree Tl:le arel:li.,,iRg oporatioRal system as Roodes aRs upoR selutieR sl:lall be capable el arel:liviRg pat ieRt request (o.?1., patient returns to VA for oare) . reeerds from 11:ieGerner MilleRRium system o Arol:lio,oodreoords must refloot tl:le original .,ersion and oannot be alteres in a manner tl:lat preveRts reinoorporation into 11:ieoperational system. Data integrity must be maintaiRed. o Arol:lio~edreoords must be returned to full etfioient timefrarne to meet elinieal earn needs. (e.?1.,emergeRey care after 3 years of inaetiJPYity) VA-NF-134 Data Wri te Back to Legacy Systems VA-NF -137 Tape Backup and Long Term Storage VA-NF-175 VA Data Model The system shall support integration with a data synd ication mechanism to wr ite back data to VA Legacy systems Ch anged language from "shall provide" to "shall support integrat ion with" . The cur rent strategy is to utilize VA COTS lnterSystems HealthSh are as the mechanism for write back. The sys tem shall support capability for encryp ted bac k up to tape and long te rm storage , per VA mandate. The system shall conform to the VA EA Ente rprise Logical Data Model (ELDM) VA-NF-5 VA-NF-13 VA-NF -15 VA-NF-17 - The system shall use VA standard ized ide ntity mana ement framework The system shall use the DoD Ident ifier as the uniform perso n identifier w ith the VA ICN as an assoc iation The sys tem shall be able to synchro nize all patie nt identit ies to the ente rprise Identity Mana ement S stem i.e., DEERS , MV I The sys tem shall be able to retrieve patient ident ity informat ion (i.e. name , DOB , gender) from the ent erprise Identity Managem ent System (i.e ., DEERS, MV I) using the DoD Identifier (aka ED I Pl or ICN Interfac ing wil l include DoD DMDC PDWS DEERS and VA MVI serv ices Modified to add ICN as assoc iated ID Final 36655 Compat ibility EHRM Lead Cindy Bias Final 38432 Functional Suitabili ty EHRM Lead Cindy Bias Added MVI Final 38434 Security EHRM Lead Cindy Bias Added i.e. as there other tra its besides name , DOB , gender that will be required for retrieval , added MVI, added ICN Final 38436 Functional Suitabili ty EHRM Lead Cindy Bias VA-18-0298-C, VA-18-0299-C-000195 195 of 220 Capabilities Patient Identity - Perso n Identifier Definition The system shall be able to retrieve patient identity information (i.e. name , DOB, gender) from the enterpr ise Identity Management System (i.e., DEERS, MV I) using alternate identity tra its or alternate person identifiers (e.g., SSN , TI N, FIN, ICN, SeclD, DFN, etc. ATM Clarification Added i.e. as there other tra its besides name , DOB, gender that w ill be required for retrieval , added MVI, added ICN, removed DOB, mod ified to say "alternate identifiers" and updated the examples to include DFN. WI. ~IF 19 Met/Not Met (Gerner Field) VA Status 38437 Functional Suitability EHRM Lead Cindy Bias Removed 38439 Functional Suitability EHRM Lead Cindy Bias VA-NF -20 Added MVI, VA and DoD will provide a joint search mechanism - see 36655 Final 3844 1 Functional Suitability EHRM Lead Cindy Bias VA-NF-21 Added VA Final 38442 Functional Suitability EHRM Lead Cindy Bias Removed 38444 Functional Suitability EHRM Lead Cindy Bias 11-A~ii; aa VA-NF-23 VA-NF-24 VA-NF-25 VA-NF -27 v,r,,~IF as VA-NF -29 VA-NF-30 VA-NF-31 VA-NF -32 VA-NF-33 VA-NF-34 The system shall retr ieve identity tra its from the ente rprise Identity Management System (i.e. , DEERS, MVI rior to u dat in atient traits When commun ications allow , the system shall enforce a search to the enterprise Identity Management System (i.e., DEERS , MV I) prior to add in a new alien! The system shall be able to add a patient to the enterprise Identity Management System (i.e., DEERS, MVI The system shall cons ume identity maintenance notificat ions from the enterpr ise Identity Mana ement S stem i.e., DEERS , MVI IFOA'111:ie Tl:le systeffi sl:lall a1313ly iaeAlity 1,113aa1es Added MVI Final 38445 Functional Suitability EHRM Lead Cindy Bias Added MVI Final 38446 Functional Suitability EHRM Lead Cindy Bias Added MVI Final 38447 Functional Suitability EHRM Lead Cindy Bias Added MVI Final 3845 1 Functional Suitability EHRM Lead Cindy Bias Removed 38452 Functional Suitability EHRM Lead Cindy Bias When the enterprise Identity Management System (i.e. , DEERS, MVI) is not available , the system shall add patients using the DoD or VA Identifier, if it is available from a reliable source e . . from an ID card When the enterprise Identity Management System (i.e. , DEERS, MVI) is not available and no reliable source for the DoD or VA Identifier is offered , the system shall use an enterprise uni ue Inter im Patient Identifier The system shall sync hronize all Interim Patient Identifiers added during a loss of connectiv ity once connect ivity to the enterprise Identity Mana ement S stem i.e., DEERS, MVI is The sys tem shall be able to retrieve patie nt contact information (e.g. , add resses, phone numbers , email) from the VA enterp rise system usin the VA or DoD Identifier The system shall be able to retrieve patient regist ry information (e.g., prefe rred language , religion, next of kin) from the VA enterpr ise S stem usin the VA or DoD Identifier The system shall be able to retrieve patient elig ibility information (e.g. , Dates of Coverage , allowed coverage - direct care, dental , network , pha rm and current benef iciary status) from the VA enter rise S stem usin the VA or DoD Added MVI, Added VA Final 38453 Functional Suitability EHRM Lead Cindy Bias Added MVI, Added VA Final 38454 Functional Suitability EHRM Lead Cindy Bias Modified to co rrelate with DoD DOORS# 38454 lang uage, added MV I Final 38455 Reliability EHRM Lead Cindy Bias VA has a diffe rent enterpr ise system ot her than ident ity that manages patient contact information. Modif ied to include VA Final 38458 Compat ibility EHRM Lead Cindy Bias VA has a different enterpr ise system ot her than ident ity that manages patient registry information. Modif ied to include VA Final 38462 Compat ibility EHRM Lead Cindy Bias VA has a different enterpr ise system other than ident ity that manages patient eligibility information. removed DoD spec ific examples, Added VA or DoD Identif ier Final 38466 Compat ibility EHRM Lead Cindy Bias Solution Name (Gerner Field) VA-18-0298-C, VA-18-0299-C-000196 196 of 220 Capabilities Patient OHi - Retrieve VA ~IF 40 Definition The system shall be able to retrieve patient VA has a diffe rent enterprise system other than commercial health insurance information from the ident ity that manages patient eligibility VA enter nse s stem usin the VA or DoD information. Added VA or DoD Identifier Duplicate of VA-NF-40 W\ ~IF 41 VA-NF-42 VA-NF-52 VA-NF -T77 ATM Clarification Patient Identity - Updated The system shall sync hronize all identities updated during a loss of co nnect ivity once Synchronizat ion No connectivity to the enterprise Identity Comm Mana ement S stem i.e., DEERS; MVI is External Patient Identifier The system shall support the matching of External Patient IDs coming in through eHealth Manageme nt for Exchange/CommonWell and other community exchanges artner s stems. All information exchange related to a referral will Referral UID maintain the uni ue referral ident ifier. Card scan needs to ull both ident ifiers VA will require searches based on a wider variet of identit tra its to be entered manuall . Need to include MVI synchron ization in downtimes Met/Not Met (Gerner Field) VA Status 38468 Compat ibility EHRM Lead Cindy Bias Removed 40517 Functional Suitability EHRM Lead Cindy Bias Removed 40518 Functional Suitability EHRM Lead Cindy Bias Final 40519 Reliability EHRM Lead Cindy Bias This needs to support data coming in from the community (non-VA and DoD systems) and match to existing records in Healthelntent Final Compat ibility EHRM Lead Cindy Bias Sent over from Functional Requirements team for incor oration into Non-Functional RTM. Final Functional Suitability Functiona l Cindy Bias Recommend remove from RTM, addressed in RHO scope docume nt. Need Pargraph Reference prior to removal. Rene'---> Not until RHO doc fina l. .. Final Security VA Enterprise Casey Johle Recommend remove from RTM, addressed in RHO scop e docume nt. Still outstanding Critica l facilities sectio n has comment for The system shall enable the use of key Gerner to address EKMS management technologies to fac ilitate encrypt ion Rene'---> Not until RHO doc fina l. .. at scale Final Solution Name (Gerner Field) n ormation ~ssurance S curit VA-NF -165 The system shall enable the use of hardware accele rated encrypt ion VA-NF -167 V/\NFT112 All data stored by the system is encrypted using approved VA encryption methods Removed 40497 36659 38504 36658 Design Patterns: Interoperability and Data Sharing , Data Storage v1 .0 Functional Suitability 38504 VA Enterprise Casey Johle Design Patterns: Interoperability and Data Sharing , Data Storage v1 .0 Security Casey Johle VA-NF-170 Final Security DEA.04.02.03 Casey Johle Data Handling (767864) VA-NF-171 Final Security DEA.04.02.03 Casey Johle Data Handling (767864) Functional Suitability Contractor BAH VA-NF-189 Recommend removal from RTM, addressed in PWS 7. 1.4. The system shall implement common serv ices for Rene'---> No, not 7 .1.4, need correct logging, error handling, monitoring/alert ing. reference to adjudicate Final 36665-10 40514-Track Casey Johle VA-18-0298-C, VA-18-0299-C-000197 197 of 220 Capabilities Definition Systems Monito ring and Alerts - Capac ity Plann ing ATM Clarification Met/Not Met (Gerner Field) VA Status The enviro nment shall be valida ted to suppo rt the performance monitoring requ irements via The system shall provide performa nce monitoring live productio n monitoring. data suitable for capacity planning and projections at a conf igurab le interval w ith no more Recommend remove from RTM, addressed in than a 12 hour delay from real time. RHO scope document Rene'---> Not until RHO doc final. .. Need paragraph reference VA NF T106 The environment shall be valida ted to support the performance monitoring requ irements via live production monitor ing. Removed Performance Efficiency Capacity Kelly, Ed Performance Enginee ring Division/ EPMO Performance Efficiency Capac ity Kelly, Ed Performance Engineering Division/ EPMO Solution Name (Gerner Field) Recommend remove from RTM, addressed in RHO scope document Covered in Proposed Response Time Commitment and Remedy Page 47 VA ~IF 207 Recommend remove from RTM, addressed in RHO scope docume nt SoltilioA sJ:iallst113130FI J;IFIS140 2 eAep;13tieAleF data al ms! aAd dala iA lmAsil VA NF 208 VA ~I~ Removed 36658, 36659, 38504 , 40497 Security VA Enterprise Casey Johle Design Patterns: Interoperab ility and Data Sharing , Data Storage v1 .0 Removed 3667 1 Security VA Enterpr ise Casey Johle Design Patterns: Interoperability and Data Sharing , Data Storage v1 .0 Removed 36683 Functional Suitability DEA.04.04.07 Infrast ructure Standards (767850) Casey Johle Removed 36448 Security EHRM Lead Casey Johle Final 2 Security EHRM Lead Casey Johle Final 40497 Security EHRM Lead Casey Johle Covered in b.6 security (Data in Transit) and Critical Facilities (Data at Rest) Recommend remove from RTM, is validated by SCQC and shou ld be handled in PWS 5.4 rather than here and referenced in PWS 5.4 8oltilioA sJ:lallol:lseFve013emliA?sysleffi see1;1Fily Rene'---> agree remove leF data stornd iA memeFy 214 A1313 lieatioA eode shall l:le free ef hmd eeded IF! add Fesses VA ~IF T01 The system sJ:lallleel~ alleF a s13eeilied13eFiodel iAaetivily FeEURJaFeless el t:low the system is aeeessee iA aeeeFeaAeewitt:l VA GybeFseetirity eoAlrols. VA-NF -T02 This requirement applies to any software that is installed on a VA network , and would exclude softwa re hosted on a Gerner network and The system shall be compl iant with VA approved hosted via Citrix Access Gateway (which is VA software approved software ). Please Reference: One -VA Tech nical Reference Model TRM hit ://trm .oit.va. ov/# The sys tem shall employ fu ll-dev ice encryption or VA Handbook 6500 conta iner encrypt ion to protec t the confiden tiality https: //www.va.gov /vapubs/viewPublicat ion.asp and inte rit of info rmation on mobile devices. ?Pub ID=793&FT e=2 VA-NF -T03 - Recommend remove from RTM, addressed in RHO scope document Rene'---> agree remove, actually in PWS 5.4 VA-18-0298-C, VA-18-0299-C-000198 198 of 220 Capabilities Tech nical Event Manageme nt - Identify VA-NF-T 06 Definition The system shall, at a minimum, generate audit records for the follow ing events when tech nically https: //www.va.gov /vapubs/viewPublicat ion.asp possib le: Actions of system adm inistrators and ? Pub_ ID=793& FType=2 operator; product ion of printed output; new objects and delet ion of objects in user address space; security-relevant events; system conf iguratio n activit ies and events; events relating to use of priv ileges; all events relating to user identification and authent ication- and the settin VA Directive 6517 https: //www.va.gov /vapubs/viewPublicat ion.asp ?Pub_ I0 =852& FType=2 The system shall comply w ith the requirements for a "Cloud First" policy as established by the Federal CIO. The CIO has required Agencies to eva luate the feas ibility of a cloud service prior to hardware and software acquisition. VA ~ff TOB VA-NF -T 12 The system shall support wire less local-area network comm unicat ion in accordance w ith VA wireless policy VA-NF-142 VA-NF -143 ATM Clarification Met/Not Met (Gerner Field) VA Status 36665 Security EHRM Lead Casey Johle Final 21 Security EHRM Lead Casey Johle Removed 3667 1 Security EHRM Lead Casey Johle Final 36702 Security EHRM Lead Casey Johle Final Compat ibility KC Mahesh Final Compat ibility Final Compat ibility DEA.04.03.02 Messaging Standards 767863 DEA.04.03.02 Messaging Standards 767863 DEA.04.03.02 Messaging Standards 767863 DEA.04.01 .01 Enterprise Data (767919) Gerner: Recommend remove from RTM, Cloud services requirements are not in scope and removed from PWS. Gerner is not provid ing a cloud. Rene'---> No can do ... it is an 0MB policy at the Execut ive Branch level ... I suggest we include but we waive the requirement at the CIO level due to D&F/ DOD national secur ity best interest type verbiage ... VA Handbook 6500 https://www .va.gov/vapubs /viewPublicat ion .asp ?Pub ID=793&FT e=2 VA Handbook 6500 https: //www.va.gov /vapubs/viewPublicat ion .asp ?Pub_ ID=793& FType=2 Recommend remove from RTM as this is not a rovided service. SOAP-based service implementat ions shall follow WS Interoperab ility Basic Profile, and WS Interoperab ility Basic Security Profile standards XML messages sha ll conform to an XM L defin ition written in accordance with XML Schema v1.0, XML Schema v1 .1, Schema tron or the latest DISR acce ted vers ion VA-NF-144 ReST messages shall confo rm to W3C guidance VA-NF-177 The system shall support the use of the health data standards identified in the VA DoD Health Information Techn ical Standards Profile and by the VA DoD lnteragency Clinical Informat ics boa rd, including fo llowing common data standards: Nationa l Informat ion Exchange Model NIEM; Health Level 7 HL7; Logical Observat ion Identifiers, Names and Codes LOINC; Systematized Nomenclat ure of Medicine SNOMED; RxNorm, MedRT, ICD, CPT, HCPCS, Veteran Information Model VIM; and Healthca re Information Technology Standards Panel H ITSP as we ll as VA/DOD / IPO extensions to these Solution Name (Gerner Field) Gerner follows all of the common data standards with exception of the HITS P and Veteran Information Model , need clarificat ion. Final 38546 3855 1 36707 Compat ibility KC Mahesh KC Mahesh KC Mahesh VA-18-0298-C, VA-18-0299-C-000199 199 of 220 Capabilities Health Information Exchange VA-NF-T52 VA-NF-T53 VA-NF -T54 VA-NF-T55 VA-NF -T56 VA-NF-T57 VA-NF -T58 VA-NF -T66 VA-NF -T78 V./\ ~IF T107 Definition ATM Clarification System must be capable of generating the follow ing cCDA document types Care Plan includ ing Home Health Plan of Care (HHPoC), Consultation Note, Continuity of Care Document (CCD), Diagnostic Imaging Reports (DIR), Discharge Summary, History and Physical (H&P), Operative Note , Procedure Note, Progress Note, Referral Note, Transfer Summary, Unstructured Document, Patient Generated Document US The system must be capab le of bidirectional data exchan e with eHea lth Exchan e, CareOualit C-CDA Release 2 implemen tatio n guide, in conjunction with the HL7 CDA Release 2 (CDA R2) standard, is to be used for implementing the stated CDA documents and header constra ints for clin ical notes. 38546 Functional Suitabili ty EHRM Lead KC Mahesh 38554 Compatibili ty EHRM Lead KC Mahesh Final Functional Suitability EHRM Lead Donna Ellis Final Functional Suitability EHRM Lead Donna Ellis Final Functional Suitability EHRM Lead Donna Ellis Final Functional Suitability EHRM Lead Donna Ellis Final Functional Suitability EHRM Lead Donna Ellis Final Functional Suitability EHRM Lead Donna Ellis Final Functional Suitability EHRM Lead Donna Ellis Functional Suitability Functiona l Marilyn Hodge Performance Efficiency Capacity Kelly, Ed Performance Engineering Division/EPMO Health Information Exchange h rmac Pharmacy - Multiple DEAo The system shall provide the capability to enter, Numbers display , edit, and report multiple DEA numbers er rescriber Pharmacy - Institutiona l The system shall provide the capability to enter , DEA Numbers dis la , edit, and re ort instit utional DEA Pharmacy - DEA The system shall provide logic to assign the correct DEA number to a prescription based upon assignment based on location rescr iber locat ion. Pharmacy - POMP stateo The system shall support transmission of state mandated transmiss ions mandated data elements for controlled substances dispensed to the POMP of the state of the pharmacy where the prescription was enerated no less than once each ni ht. Pharmacy - POMP The system shall support filter ing and restricting tranm ission by status POMP transmissions b Veteran status. The vendor shall provide licenses and Recommend remove from ATM - or provide Pharmacy - MUL TUM profess ional services for MULTUM for VistA sites verbiage for a system requirement. Multumn licenses so the VA can have a consolidated drug database Deployment deta il is in PWS . system. The vendor will provide an access ible and computatle , and up-to-date equivalence table match ing each MULTUM medicat ion code with a clinica ll e uivalent RxNorm code. Pharmacy - Remaining The system shall not require pharmacists to Refills manually re-enter prescript ions that have remaining refills during trans ition. Existing prescr iptions w ith rema ining refills will be ava ilable in Gerner and actionable. Final Critical Care Final Includes Critica l Care - automated workflows and Sent over from Funct iona l Requirements team doc umentat ion supporting critical care multifor incorporation into Non-Functional ATM. discip linary teams; Device Connectivity automated collect ion of medical data from medical dev ices to ensure ri ht data ri ht fo rmat, Current Mission Critical Systems in VA like Heatlh Data Repository is 12 hours Recovery Time Objective . 2 hours Recovery Point Objective. Tl:le system sl:lall met elisasler reee11ery requirements wl:liel:Ispeeify betl:I RTO anel RPO Recommend remove from ATM, addressed in requirements as measureelby DR tests (annual). Met/Not Met (Gerner Field) VA Status Removed 36695-Workflow 36673 -medical device Solution Name (Gerner Field) RHO scope document and PWS 5.3.1 Agreee - RPO and RTO are clearly defined in RHO VA-18-0298-C, VA-18-0299-C-000200 200 of 220 Capabilities Definition Change Management The system shall provide a documented test solut ion for any platform/application iterat ion that introduces changes with the potent ial to impact end-user performance or compute and storage VA-NF-151 ATM Clarification Gerner: Recommend removal from RTM, not a system requirement , see change mgmt serv ices referenced in PWS 5.5 .8. and 5.5.8. 1. VA: Recommend to keep: 5.5.7 (pre. 5.5.8) refers to OCM for VA employees. This refers test and eval / configuration mgmt. for changes made to the system. Solution Scalability Low-Comm I No- Comm: Home Health Need clarificat ion and additional use cases from VA due to the technica l gap. Maintainability DEA.04.04 .06 Marilyn Hodge Capacity and Scalability (767971) Final 36679 36680 36692 38600 38604 38605 38606 38607 38616 38617 38618 38619 38620 3862 1 Portability DEA.04.04.06 Capacity and Scalability (767971) Marilyn Hodge Final 40513 Functional Suitability FFRDC MITRE Denise McLain Final VA Lead Dr. Jonathan Nebeker Final VA Lead Final VA Lead Dr. Jonathan Nebeker Dr. Jonathan Nebeker The system shall support both horizontal and vertica l solution scalabi lity. VA-NF -1 18 Met/Not Met (Gerner Field) VA Status Solution Name (Gerner Field) VA requirements that need to be addressed by low-comm or no-comm: The system shall have the capab ility to docume nt vitals , encountering/proced ure codes , labs, * Natural disaster deployment (possible orders, and medicat ions offline , and synch up theater conf iguration for deployment) later for Home Health. * Home health care (sat comm truck) requ irement * Homeless care (mob ile users on foot) oo o =&&i.l-,: VA ~II=B04 7,124or oUwr local soltJtion rntJstcontain a database pointer table that can re direct to 1EUR1EURfR!+:1JPY-'1JPYfli:IHffli:l!:teS~Hs+;-afff:HNf 1/2 fefl-eH1-Rese-afe-llocal cache instead of CAMM and allow access VA-NF -Z02 System shall support the generat ion of FHIR resources in multiple versions in para llel (e.g. : OTSU 1.0, OTSU V2.0 VA-NF-Z03 Consent VA-NF -Z04 Consent The system shall meet 45 CFR 170.315 (b)(7-8) The system will be able to manage all manner of conse nt "decrees " placed by Veterans and their prov iders. Including: Consen t to share all documents, restriction of certain types of documents, restriction of partners with whom documents can be shared revocation of consent VA-18-0298-C, VA-18-0299-C-000201 201 of 220 Capabilities - Consent VA-NF-Z06 Consent VA-NF-Z07 Consent VA-NF-Z08 Consent VA-NF-Z09 VA-NF-Z10 VA-NF-Z11 VA-NF-Z12 VA-NF-Z13 VA-NF-Z14 VA-NF-T46 Definition The system will be able to support future conversions from one consent methodology to another ie from o I-in to o I-out. System shall provide a means for patients to fill in, digitally sign (VA approved signature service), and submit electronic consent directives for chart System shall handle interfaces with external products for capture, storage, receipt and implementat ion of consent directives to enable Veteran online consent management from a number of different locations and interfaces, including kiosks, home pc's and the eBenefits portal. These only author ization will automatica lly u date the Veteran medical record As required by policy, System shall automatically opt-out those patients whose authorizat ions have ex ired until a new authorizat ion is entered System shall provide patients with VA defined online help and access to Frequently Asked Quest ions (FAQ) with answe rs for help with the online process for submitting co nsent directives or uestions about the VHIE ro ram atient The system will be capable of extracting all transact ional data related to consents to analytical warehouse for monitoring (by person, artner, status etc. The system shall support VA electron ic exchange of health records via other interoperable networks (e.g. CareQuality, CommonWe ll Health Alliance , Direc!Trust, National Association for Trusted Exchange) by supporting the ir specificat ions , securit and content s ecifications The system shall provide dashboard to monitor data exchanges and provide access to VA exchange performance reports, such as numbers of Veterans documents sent and received and response times. System shall be able to analyze, report and display the performance of outbound transact ions [PD, OD, RD, Doc Submission, Direct messages] (average response time,# of total tra nsactions/ month,# of failed tra nsactions, point of failures , why failed and where failed, error code w/explanation, other metadata: sent to which partne r, sent by which user , mode of re uest ROI/ re-fetch/ e-benefits/ MHV ur ose System shall interface with Record Locator Services provided by CommonWell and other standards -based networks as a roved throu h By IOC, the system shall connect with all current eHealth Exchan e VA artners The system shall support provenance (chain of custody or ownership) and pedigree (processing history how the data was produced or incorporated) and enable identification, collection , and product ion of data according to source , custody and ownership and disp lay of data in business, lo ical, le al or h sical models. ATM Clarification Met/Not Met (Gerner Field) VA Status VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker Final VA Lead Dr. Jonathan Nebeker EHRM Lead Dr. Jonathan Nebeker Final Functional Suitability Solution Name (Gerner Field) VA-18-0298-C, VA-18-0299-C-000202 202 of 220 Capabilities ooo Definition SLA Baseline as delivered to DoD The system shall provide, as a base line, the serv ice leve l agreement as specified in the Gerner SLA Commercial Offering and MHS Genesis / Leidos SLA. Sucoesshi/ Ti=ansaclionRatio The Mission Critical Systom shoulel return an overall 13orcontagoof transactions lor a s13ocific 013orationinitiatoel by a user that are com13lotoel cuccossfully (no timoout or other orrors elotoctoel) within a s13ocilioelmi* of 13oakanelJornon 13oal~ 13orioelwithin targets ostablishoel by tho i;lrojoct Team. JPYaluos for mission eritical systoms aro at VA fllf' 94 ATM Clarification Met/Not Met (Gerner Field) VA Status The VA has reviewed , acknowledged and accepted all of the DoD SLA and Gerner Commercial Offering as our base set of requ irements. The following requ irements define the VA's specific SLA requ irements for the acquisitio n. John Short Performance Efficiency Sou rce Ref: Gerner Leidos S LAs.docx, Commercial RHO SLAs and Performance War rant .docx How accurate is tho information obtainoel by Iha system Solution Name (Gerner Field) Performance Efficiency EHRM Lead Marilyn Hodge Reliability EHRM Lead Marilyn Hodge Performance Efficiency EHRM Lead Marilyn Hodge ..:.!!!".: . VA-NF -86 Availability --. - User Operational Availab ility - System availab ility Ava ilability - how availab le is the system for exclusive of planned downtime shall be 99.9% for use the Tier I production systems as defined in the Hosting Scope document. System availability exclusive of planned downtime shall be 99.9% for the HA-CAS production systems as defined in the Hosting Scope document. Healthelntent components required for data migration and continuity of care shall have the same SLA and penalties as Tier I production systems as defined in the Hosting Scope document. Final partial - 38423, 38582 The System shall be a,tailable (u13limeno! o>Eelueling planneel elowntimo) at a pereentage of total possible operational time at least 99.9% of VA-NF-100 Capacity & Scalability The provider -facing solutions shall scale to support 328,000 named users and to accommodate current and future VA usage patterns. Solution shall su1313ort tho e*13ecteelconcurrent 13rocessingof elata by enel users anel other connections commensurate with the rate al 190,000 concurrent users or connections. Concurrent Sessions - Concurrent sessions are every logica l connection existing at a given point in time between the database and an enduser interface dev ice. Each suc h existing connection is counted as a concurrent session whether or not it is actually in use. If an individual end user estab lishes multiple connections, each one is counted as a separate concurrent session, even if they share a common physical pathway. The number of connections is not reduced by any program or mach ine, such as a front-end server or mult iplexer, which may be used to concentrate the connections. Each batch process being executed at the same time is also considered a concurrent sess ion. Final This metric is used for corre lation purposes aga inst othe r metrics to unde rstand how many connections are active when a performance issue is exposed. Metric Source: Please refer to VA-18-0298-C, VA-18-0299-C-000203 203 of 220 Capabilities oo VA-NF -179 Definition ATM Clarification Compute Resource Consumption Compute resource consumption shall be tested against established requirements and workload projections and supported by a continuous capac ity plan to include methods, tools , and processes for monitoring , repo rting, and adjusting the o erational s stems Enterprise Service Level Criteria - Maintenance Scheduled and non-scheduled maintenance shou ld occur between the hours of 1800 and 0600 , when clinica l usa e would be Ii htest The system shall reoover as quiokly as Tho system shall reeovor within minutes (when possib le lollowing an outage. Failover system lailover is an oi,tion) and 2 8 hours (when lailover shall be in plaoe and utilized whenever leasible is no! an oi,lion) to minimize downtime VA NF 181 System maintenance shall be dur ing non-clinica l hours as coord inated through jo int governance Met/Not Met (Gerner Field) VA Status Performance Efficiency DEA.04.04.06 Marilyn Hodge Capacity and Scalability (76797 1) Maintainability EHRM Lead Marilyn Hodge Reliability EHRM Lead Marilyn Hodge Performance Efficiency eHMP NONF3 192 Kelly, Ed Reliability Capacity Kelly , Ed Performance Engineering Division/EPMO Reliability Capacity Kelly, Ed Performance Engineering Division/ EPMO Final Customer Support Enterprise Service Desk Tim Jones Final Customer Support Enterprise Service Desk Tim Jones Final Vl\ NF 228 38423 , 38582 . . '' . VA ~Ii; T11Q : o e VA ~IF T111 VA-NF -XXX1 The vendor shall maintain an environn:ienl Iha! demonstrates a reoovery i,oint objeoliJPYe (RPO) of less than 1Q minutes for any servioe loealion(s). Customer Support Average Speed to Answer will be <= 40 seconds VA-NF-XXX2 Customer Support Abandonment Rate wi ll be <=5% of all calls I '"' '"' '"'I The length of time that a ca ller has to wait on hold before the line is answered by the Millennium Service Desk anal st The percentage of times in which a person calling the Millennium Serv ice Desk gives up calling and hangs up the phone prior to a Millennium Service Desk analyst answering the call. Solution Name (Gerner Field) VA-18-0298-C, VA-18-0299-C-000204 204 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column 508 Com liance 508 Compliance Access Mana ement Access Management Access Management Access Management Access Management Access Management Access Management Access Management Access Management VA-18-0298-C, VA-18-0299-C-000205 205 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column Access Management Access Management Access Management Access Management Access Management Access Management Access Management Access Management Access Management Access Management Access Data Mana ement VA-18-0298-C, VA-18-0299-C-000206 206 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column Data Management Data Management Data Management Data Management Identity Mana ement Identity Mana ement Identity Management Identity Management Identity Management VA-18-0298-C, VA-18-0299-C-000207 207 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column Identity Management Identity Management Identity Management Identity Management Identity Mana ement Identity Management Identity Management Identity Management Identity Management Identity Mana ement Identity Management Identity Management Identity Management Identity Management Identity Management Identity Management VA-18-0298-C, VA-18-0299-C-000208 208 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column Identity Management Identity Management Identity Mana ement Identity Management Identity Management Identity Mana ement Information Assurance I Securit Information Assurance/ Security Information Assurance/ Security Information Assurance/ Securit Information Assurance/ Security Information Assurance/ Security Information Assurance/ Security VA-18-0298-C, VA-18-0299-C-000209 209 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column Information Assurance/ Security Information Assurance/ Security Information Assurance/ Security Information Assurance/ Security Information Assurance I Security Information Assurance/ Security Information Assurance/ Security Information Assurance/ Securit VA-18-0298-C, VA-18-0299-C-000210 210 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column Information Assurance/ Security Information Assurance/ Security Information Assurance/ Securit Information Assurance/ Security Interoperability Interoperabil ity Interoperabil ity Interoperabil ity Interoperabil ity VA-18-0298-C, VA-18-0299-C-000211 211 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column Interoperabil ity Interoperabil ity Pharmac Pharmacy Pharmacy Pharmacy Pharmacy Pharmacy Pharmacy Pharmacy Reliability / Scalability/ Mainta nabilit Reliability / Scalability / Mainta nability Reliability / Scalability / Mainta nability VA-18-0298-C, VA-18-0299-C-000212 212 of 220 Development Confirmed in Needed Scope Document (Gerner Field) (Gerner Field) Sort Column Reliability / Scalability / Mainta nability Reliability / Scalability/ Maintanability Synchronizatio n: Low-CommI No-Comm Synchronizatio n: Low-Comm/ No-Comm Reliability/ Scalability/ Maintanability Interoperab ility Interoperab ility Interoperab ility VA-18-0298-C, VA-18-0299-C-000213 213 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column Interoperab ility Interoperab ility Interoperab ility Interoperab ility Interoperab ility Interoperab ility Interoperab ility Interoperab ility Interoperab ility Interoperab ility VA-18-0298-C, VA-18-0299-C-000214 214 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column SLA SLA SLA SLA VA-18-0298-C, VA-18-0299-C-000215 215 of 220 Development Needed (Gerner Field) Confirmed in Scope Document (Gerner Field) Sort Column SLA SLA SLA SLA SLA SLA SLA SLA VA-18-0298-C, VA-18-0299-C-000216 216 of 220 To: Cc: BlackburnScottB MarcSherman .lf;l(b)(6) broailcom:BruceMoskow itz: l(b)(6) Rob r A.; F er Michele fSESl ~---~ Subjec t: Dat e: VHA EHR - 2 calls that my assistant will set up Tuesday, March 13, 2018 5:04 :00 PM From: Marc/Bruce/Ike I~ jwindomJohnH : .QJ.S; j(b)(6) .__ ____ __, - thank you so much for the prompt repl ies. I just spoke to Bruce. We've got 100% partic ipat ion (Stephanie Reel, Stan Huff, Jon Manis, Dr. Ko, Dr Karson, Dr. Cooper, and Dr. Shretha) and we are moving forward. l(b)(6) t he right mater ial. E] j (cc'd, our con tr acting officer) is making sure eve ryone has my assistant, cc'd here) wi ll be orga nizing a few p hone calls in 2 steps: Step 1- Basic orientation to the government contract structure. This will be a 30-45 minute o rienta t ion so tha t folks know what they are look in g at. John Windom and j(b)(6) lwi ll host this and clue people into the parts to focus on and parts that are standard government things that are less relevant. This can be done in groups (ideal ly) or in one -offs to fit to accommodate people's busy schedules. !C b)C G) jhas already schedu led 2 times in case these work for you. If they do not, she will wo rk wi t h yo ur schedu lers to find ot he r times in the next 24-48 hours (sooner the better). o Thu rsday 8:30 -9:lSam ET - St ep hanie Reel conf ir med o Thursday 11:30am - 12:15pm ET - Stan Huff confirmed Step 2 - Feedback calls. Per Bruce's idea, we' ll schedu le 2 separate feedback cal ls for ear ly next week. Both 90 minutes each. We are aiming for Monday, Tuesday or Wednesday at the latest. ,-l (b-)-(6-) --. w ill set these up. o CIOs (Reel, Huff, Man is, Shretha - and of course each of you are encouraged to join) o Docto rs (Dr . Karson, Dr. Ko, and Dr. Cooper - and of course each of you are encou raged to join) Let me know how th is sounds. Thank you again fo r you r support and assistance on th is cri t ical matte r. Scott From: Marc Sherman l(b)(6) @gmail.com] Sent : Tuesday, March 13, 2018 1 :40 PM To: Blackburn, Scott R. Cc: IP;!(b)(6) @gma il.com; Bruce Moskowitz l(b)(G) Subject : [ EXTERNAL ] Re: VA EHRNOA Scott, E:} .____ ___ ~ Windom , John H.; DJS ___. nd John Thank you for t he NOAdraft that you sent along and the organized approach. have att ached t he fo ll owing t o close t he loop: 1. a marked up version of t he NOAwit h a few necessary adj ust ment s in red-line so you can see t he changes that we re made, VA-18-0298-C, VA-18-0299-C-000217 217 of 220 2. a blank copy of the amended NOAfor Bruce and Ike to sign, and 3. a signed version by me of the amended NOA. Thanks and happy to help as requested. Marc On Tue, Mar 13, 201 8 at 10:31 AM , Blackburn , Sco tt R. wrote : Ike, Bruce, M arc: Thank each of you for agreeing to lend an extra set of outside eyes on the EHR contract. We appreciate your support and want to make sure we get to the best place possib le for Veterans, the country and taxpayers. As we are incredibly grateful to yo u for volunteering your time, we want to make this as easy as possible for you. Here are 3 next steps. 1) We will need yo u to sign the attached NDA. Please return to ._l (b_)(_6)__ _.kcc' d). 2) l(b)(G) !will then send you the latest package under separate cove r. 3) Gi ven governm ent contr acts are diff erent than what yo u are used to reading, we would propose a quick phon e call so that we can orient you to the contract and help focus you on the parts where your expertise will be mos t valuable J(b)(6) l(who is the government contractin officer and John Wind om (who is our EH R leader) will lead this from our side. I will as (b)(6) (cc' d) here to help set up a time. We can either do this all together, if calendars match up, or separately if need be. We have also connected with Steph anie Reel, Stan Huff, Dr. Karson, Dr. Ko, Dr. Shretha, and Jon Manis who all have all rece ived the ND A and we are workin g with them. I am hop ing to connect with Dr . Coo per today. Thanks again! Scott Scott Blackburn Acti ng CIO & Execut ive-in-Charge , Office of Information & Technology Departme nt of Vetera ns Affairs VA-18-0298-C, VA-18-0299-C-000218 218 of 220 Op!n!on VIEWPOINT WhatThis ComputerNeeds Is a Physician Humanism and Artificial Intelligence AbrahamVerghese,. The nationwide implementation of electronicmedi- MD cal records (EMRs) resulted in many unantfc!pated Departml!lltof Medicine.St..nford consequences,even as these systems enabledmost UniversitySdmol of Medicine,Stmford, California.o Nigam H.Sharl, MBBS, ehD Departmentof Medicine, Stanford UniversitySchoolof Mcdicinc,Stanford, California. Robert A. HJrrington, MD Department of Medicine,Stanford UniversitySchoolof Medicine, Stanford, CaliforniJ. of a patient's d.ita to be gathered in one place and made those data readily.iccessibleto clinicianscaring for that patient. The redundancyof the notes, the burden of alerts . .ind the overflowinginbox has led to the "4000 keystrolUmcountry to predict future crlm!nals-andIt's biased agalnst blaclcs.ProPublicawebsite. https,!{www.propublica ,org/artide/mad',ine-bias-risl (b) (6) To: . Cc: Bcc: Subject: RE: New FOIA Request 18-11325-F (AN Washington Post) HIGH VIZ Date: Tue Aug 21 2018 14:42:46 EDT Attachments: image001.png Yes that makes sense. :) Sent with Good (www.good.com) _____ From: (b) (6) Sent: Tuesday, August 21, 2018 11:23:58 AM To: Morris, Genevieve Subject: RE: New FOIA Request 18-11325-F (AN Washington Post) HIGH VIZ I was referring to the emails, texts, IM and all other documents but concur. From: Morris, Genevieve Sent: Tuesday, August 21, 2018 2:20 PM To: (b) (6) .; Windom, John H. Subject: RE: New FOIA Request 18-11325-F (AN Washington Post) HIGH VIZ It says all VA though, so not super focused but to be expected. Sent with Good (www.good.com) _____ From: (b) (6) Sent: Tuesday, August 21, 2018 11:17:09 AM To: Morris, Genevieve; Windom, John H. VA-18-0298-D, VA-18-0299-D-000001 000001 Subject: New FOIA Request 18-11325-F (AN Washington Post) HIGH VIZ Genevieve, John, (b) (6) missed our call today so we're rescheduling. Just received this new FOIA request from Wash Post - much more targeted and focused. From: (b) (6) Sent: Tuesday, August 21, 2018 12:27 PM To: (b) (6) Cc: VHA FOIA Subject: FW: FOIA Request 18-11325-F (AN Washington Post) HIGH VIZ Good afternoon all: The FOIA Service received electronically the attached FOIA request dated August 8, 2018, from Anu Narayanswamy with the Washington Post, who is seeking the Following: "Any and all emails incoming & outgoing including any attachments between: !) Ike Perlmutter; 2) Bruce Moskowitz; and 3) Marc Sherman or any person between January 20, 2016 to date" Per the email from OSVA, a portion of this request will be referred to OEHRM for a file Search and direct response to the requestor. The request will be transferred to your office Once FOIA Service's acknowledgment letter has been approved and uploaded. The request will be transferred under the following tracking #'s OSVA 18-11325-F OEHRM 18-11650-F Thanks for your help! VA-18-0298-D, VA-18-0299-D-000002 000002 (b) (6) FOIA Analyst, VACO FOIA Service Quality, Privacy, and Risk (QPR) Office of Information and Technology (OI&T) Cell/Office: (b) (6) (b) (6) @va.gov FOIA Service Hotline: 1-877-750-3642 Please take a moment and let us know how we did by completing a quick evaluation: Got a minute? Rate Our Service! QPR's Mission Statement: "To instill and promote a culture of quality, privacy and risk management in collaboration with our business partners to enable a better Veteran experience." From: (b) (6) On Behalf Of VACO 001B FOIA Inbox Sent: Tuesday, August 21, 2018 11:33 AM (b) (6) To: (b) (6) @va.gov> Subject: RE: FOIA Request 18-11325-F (AN Washington Post) HIGH VIZ Good morning (b) (6) , OSVA has some responsive records. I also think EHRM has some responsive records. Best, (b) (6) OSVA FOIA/Privacy Officer VA-18-0298-D, VA-18-0299-D-000003 000003 Office of the Executive Secretary Office of the Secretary, U.S. Dept. of Veterans Affairs (OSVA) (b) (6) o (b) (6) c (b) (6) @va.gov Telework Weds CWS 2nd Mon These messages and attachments are For Official Use Only, not to be shared outside intended parties, and may be exempt from disclosure pursuant to 5 U.S.C. ? 552(b)(3) prohibiting the release of information that another statute prohibits; 41 U.S.C. ? 4702(b) prohibiting the release of unincorporated proposals; 41 U.S.C. ? 423(a) prohibiting the release of bid or proposal information or evaluations before award; 26 U.S.C. ? 6103 prohibiting the release of tax identification numbers; 5 U.S.C. ? 552(b) (4) prohibiting the release of confidential commercial information; 5 U.S.C. ? 552(b)(5) under the deliberative process, attorney-client, and work product privileges; and 5 U.S.C. ? 552(b)(6) protecting personally identifiable information. If you received these messages and attachments in error, you must inform the FOIA Officer and destroy them immediately. The VA reserves its discovery rights including, but not limited to, objections, privileges, motions, etc. From: (b) (6) Sent: Friday, August 17, 2018 2:56 PM To: VACO 001B FOIA Inbox <(b) (6) @va.gov> Subject: FOIA Request 18-11325-F (AN Washington Post) HIGH VIZ Good afternoon (b) (6) ; The FOIA Service received electronically the attached FOIA request dated August 8, 2018, from Anu Narayanswamy with the Washington Post, who is seeking the Following: "Any and all emails incoming & outgoing including any attachments between: !) Ike Perlmutter; 2) Bruce Moskowitz; and 3) Marc Sherman or any person between January 20, 2016 to date" VA-18-0298-D, VA-18-0299-D-000004 000004 We have determined that records responsive to this request, if any, fall under your areas of responsibility. Please consider this a referral of this request to your office for a file search and direct response. Ms. Narayanswamy. She will be advised of this referral in our acknowledgement letter, please respond directly to Ms. Narayanswarmy. If this request should be referred to another office for a records search, please advise within 3 business days. (b) (6) FOIA Analyst, VACO FOIA Service Quality, Privacy, and Risk (QPR) Office of Information and Technology (OI&T) Cell/Office:(b) (6) (b) (6) / Fax: (b) (6) @va.gov FOIA Service Hotline: 1-877-750-3642 Please take a moment and let us know how we did by completing a quick evaluation: Got a minute? Rate Our Service! QPR's Mission Statement: "To instill and promote a culture of quality, privacy and risk management in collaboration with our business partners to enable a better Veteran experience." VA-18-0298-D, VA-18-0299-D-000005 000005 Document ID: (b) (5) Owner: Morris, Genevieve To: Morris, Genevieve Cc: Bcc: Subject: RE: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) Date: Sun Aug 19 2018 20:18:42 EDT Attachments: image002.png image003.png Thanks I have a call with (b) (6) tomorrow and should also know more from OIT on our capabilities. Hope you had a relaxing weekend! Warm regards, (b) (6) _____ From: Morris, Genevieve Sent: Sunday, August 19, 2018 6:03:41 PM To: (b) (6) . Subject: RE: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) So you're aware, I forwarded his response to the Deputy COS and OGC person who is the lead. I talked to (b) late on Friday, and he's going to loop back to this on Monday. He knows the importance (6) of getting this right. Genevieve Morris Chief Health Information Officer Office of Electronic Health Record Modernization Department of Veterans Affairs o: (b) (6) | m: (b) (6) www.ehrm.va.gov | @DeptVetAffairs VA-18-0298-D, VA-18-0299-D-000008 000008 From: (b) (6) Sent: Friday, August 17, 2018 5:39 PM To: Morris, Genevieve <(b) (6) @va.gov> Subject: FW: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) Sorry to drag this out with a series of emails - I'll talk with them next week. I'm at the KC airport - JW is here too. Our flight home is delayed for weather :-( From: (b) (6) Sent: Friday, August 17, 2018 4:36 PM To: (b) (6) Cc: (b) (6) . Subject: RE: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) Hi (b) (6) Reducing the folks on this reply - I just called but reached your VM. It's late on Friday and I'm about to board a plane for DC from KC. Tuesday I spoke with Eric Huweart, the former OIT COS, and he stated that VA does have access to the Symantec Clearwell tool that can perform a google type search on all emails and then return a file that a FOIA officer would have to search and adjudicate individually. While VA does have a large staff we know a search would return emails to/from the identified individuals. What we don't know is the exact number of emails a Clearwell search would return. Clearly if it was in the 10,000's of emails then it would be an expensive and unmanageable task but until the search is performed we don't know the number of emails that a team would have to review manually. (b) (5) but Symantec was a client when I was a consultant so I am familiar with the technology and capabilities. (b) (6) was under the impression that this tool was only available for litigation but I confirmed that OIT can and does support these FOIA requests. (b) (5) but I also realize that the VA is embarking upon a multi-Billion dollar ~10+ year modernization campaign. We receive a monthly OMB meeting, quarterly GAO audits and the House just established a special subcommittee for our program. OEHRM has pledged transparency and demonstrating our best effort to deliver upon this pledge will gain trust and confidence while hopefully averting more FOIA requests and a reputation of not providing VA-18-0298-D, VA-18-0299-D-000009 000009 transparency; a concern raised during our expended sole source contract negotiations that resulted in the Cerner ~$10B non-competitive contract award in May 2018. I'll find a time and send an appointment for at least the three of us to talk next week - emails can only go so far. Warm regards, (b) (6) VA Office of Electronic Health Record Modernization (OEHRM) Director, Program Control 811 Vermont Ave; (b) (6) M -(b) (6) From: (b) (6) Sent: Friday, August 17, 2018 4:14 PM To: (b) (6) Cc: VACO 001B FOIA Inbox; VHA FOIA; (b) (6) ; (b) (6) .; (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) Truex, Matthew; ; ; Subject: RE: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) Hello (b) (6) , I just spoke with VHA FOIA Director (b) (6) . Unlike the VA, HHS has the technology applications that can search through the email accounts of dozens of federal employees at once. However, the VA does not have such technology applications and conducts it email searches one-by-one. As attached, it usually takes the VA IT office five (5) hours just to search through the email box of one VA employee. If you ask the VA IT office to search though the email accounts of all OEHRM employees, it may take the VA IT office hundreds, if not thousands, of hours. We recommend that you explain the situation to the FOIA requester, ask the FOIA requester to clarify/narrow the FOIA request, and process accordingly. It also appears that your office would have to redact responsive records, if any exist. Regards, VA-18-0298-D, VA-18-0299-D-000010 000010 (b) (6) OSVA FOIA/Privacy Officer Office of the Executive Secretary Office of the Secretary, U.S. Dept. of Veterans Affairs (OSVA) (b) (6) o (b) (6) c (b) (6) @va.gov Telework Weds CWS 2nd Mon These messages and attachments are For Official Use Only, not to be shared outside intended parties, and may be exempt from disclosure pursuant to 5 U.S.C. ? 552(b)(3) prohibiting the release of information that another statute prohibits; 41 U.S.C. ? 4702(b) prohibiting the release of unincorporated proposals; 41 U.S.C. ? 423(a) prohibiting the release of bid or proposal information or evaluations before award; 26 U.S.C. ? 6103 prohibiting the release of tax identification numbers; 5 U.S.C. ? 552(b) (4) prohibiting the release of confidential commercial information; 5 U.S.C. ? 552(b)(5) under the deliberative process, attorney-client, and work product privileges; and 5 U.S.C. ? 552(b)(6) protecting personally identifiable information. If you received these messages and attachments in error, you must inform the FOIA Officer and destroy them immediately. The VA reserves its discovery rights including, but not limited to, objections, privileges, motions, etc. From: (b) (6) Sent: Friday, August 17, 2018 4:44 PM To: (b) (6) @va.gov> Cc: VACO 001B FOIA Inbox <(b) (6) @va.gov>; VHA FOIA <(b) (6) @va.gov>; (b) (6) (b) (6) @va.gov>; @va.gov>; H(b) (6) @va.gov>; Truex, Matthew (b) (6) @va.gov>; (b) (6) gov>; (b) (6) @va.gov>; (b) (6) @va.gov>; (b) (6) (b) (6) @va.gov> Subject: RE: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) @va. HI (b) (6) Thank you for your prompt response and yes, I'm very busy already. Matt Truex is actually the contracting officer supporting our OEHRM program; he reports to the TAC in New Jersey. I understand that OIT has the ability to electronically search our email systems with the Clearwell tool VA-18-0298-D, VA-18-0299-D-000011 000011 - Not sure exactly what this will return but assuming there is a manageable number of emails then a manual search of these emails might be manageable. Again, I'm new to VA and FOIA responsibilities but am familiar at a high level with this too. I will definitely forward your guidance to Ms. Morris for her review. Thank you, again! Warm regards, (b) (6) VA Office of Electronic Health Record Modernization (OEHRM) Director, Program Control 811 Vermont Ave; (b) (6) M -(b) (6) From: (b) (6) Sent: Friday, August 17, 2018 3:38 PM To: (b) (6) ; (b) (6) ; (b) (6) ) (b) (6) Cc: VACO 001B FOIA Inbox; VHA FOIA; (b) (6) ; (b) (6) (b) (6) (b) (6) Truex, Matthew; ; Subject: RE: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) (b) (6) , You want to manage FOIA requests, not let them spiral out of control. Per 38 CFR 1.554(d), we are allowed to ask the FOIA requester to clarify records, so that the VA can search for and locate the records in a reasonable amount of effort. I'm not sure searching through all OEHRM email accounts is a reasonable amount of effort. OSVA has seventy-four (74) employees. OSVA does not have the time or resources to search through all seventy-four (74) OSVA email accounts looking for communication with Perlmutter, Moskowitz, or Sherman. Certainly, OSVA plans to send a clarification request, and if CREW doesn't clarify, either close the FOIA request or interpret the FOIA request as applying to only the top three OSVA officials. VA-18-0298-D, VA-18-0299-D-000012 000012 FOIA Officer Truex or yourself will likely have to review all responsive records. Most VA FOIA Officers are heavily burdened and cannot take on additional cases, particularly since you have your own FOIA Officer. Regards, (b) (6) OSVA FOIA/Privacy Officer Office of the Executive Secretary Office of the Secretary, U.S. Dept. of Veterans Affairs (OSVA) (b) (6) o (b) (6) c (b) (6) @va.gov Telework Weds CWS 2nd Mon These messages and attachments are For Official Use Only, not to be shared outside intended parties, and may be exempt from disclosure pursuant to 5 U.S.C. ? 552(b)(3) prohibiting the release of information that another statute prohibits; 41 U.S.C. ? 4702(b) prohibiting the release of unincorporated proposals; 41 U.S.C. ? 423(a) prohibiting the release of bid or proposal information or evaluations before award; 26 U.S.C. ? 6103 prohibiting the release of tax identification numbers; 5 U.S.C. ? 552(b) (4) prohibiting the release of confidential commercial information; 5 U.S.C. ? 552(b)(5) under the deliberative process, attorney-client, and work product privileges; and 5 U.S.C. ? 552(b)(6) protecting personally identifiable information. If you received these messages and attachments in error, you must inform the FOIA Officer and destroy them immediately. The VA reserves its discovery rights including, but not limited to, objections, privileges, motions, etc. From: (b) (6) Sent: Friday, August 17, 2018 4:02 PM To: (b) (6) @va.gov>; (b) (6) @va.gov>; (b) (6) (b) (6) @va.gov> Cc: VACO 001B FOIA Inbox (b) (6) @va.gov>; VHA FOIA (b) (6) @va.gov>; (b) (6) (b) (6) (b) (6) (b) (6) @va.gov>; @va.gov>; (b) (6) @va.gov>; Truex, Matthew @va.gov> Subject: RE: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) Hi (b) (6) VA-18-0298-D, VA-18-0299-D-000013 000013 I was traveling all week but wanted to provide an update for all on the approach Genevieve Morris and OEHRM want to take with this FOIA request. Genevieve Morris wants to provide a comprehensive and fully transparent approach to this search and then response. She is concerned that we are late and has asked me for personal daily updates on our progress. Regarding OEHRM staff search scope, she desires that the email accounts for EVERYONE that supported OEHRM be searched. We recognize this is an exhaustive approach that will require coordination but she is committed to an open response. We will provide the names next week. This list will include contractors because they have been involved and support our effort, especially because the office was just being established. We will require coordination so her HHS email account can be searched because she was on detail and using that account. How do we search for text messages? How do we obtain the cell phone numbers for each of the individuals in our search? (b) (6) , Can you please coordinate for the VA leadership names to be included? Note, Camilo Sandoval was supporting OEHRM so she believe that his account should be one specifically that is included. (b ) (6 Can you please assist with identifying FOIA trained staff that can provide the review of the search )data after the records are accumulated. I have a very basic understanding of the Clearwell technology capabilities and know that a human will have to review what emails are found. We anticipate that this will be a lengthy process; how do we provide a cost estimate given these unknowns? Given the complexity and time involved to completely satisfy this response Ms. Morris would like to provide incremental updates so we can demonstrate / document our transparency on this response. I have cced (b) (6) because he has assisted me as our acting FOIA officer. I have this and many OEHRM responsibilities but be advised that I have not received any FOIA training. Matt Truex is our contracting officer so he is cc'ed to keep him informed. (b) (6) is a support VA-18-0298-D, VA-18-0299-D-000014 000014 contractor and will reach out to schedule a call with everyone working / supporting this FOIA request for next week, week of Aug 20th so we can discuss this plan and agree to next steps vs attempt to coordinate via email. Have a great weekend! Warm regards, (b) (6) VA Office of Electronic Health Record Modernization (OEHRM) Director, Program Control 811 Vermont Ave; (b) (6) M -(b) (6) From: (b) (6) Sent: Tuesday, August 14, 2018 1:34 PM To: (b) (6) ; (b) (6) Cc: VACO 001B FOIA Inbox; VHA FOIA; (b) (6) Subject: Referral - FOIA Request (D. Markham, 18-10887-F and 18-11384-F) Hi (b) (6) , The FOIA Service received a request from Mr. Damien Markham with the Citizens for Responsibility and Ethics in Washington (CREW) seeking: 1. Records of any and all communications from employees of the VA with Ike (or Isaac) Perlmutter and Dr. Bruce Moskowitz, or any persons representing them or their interest between December 1, 2016 - Present. 2. Records of any and all communications mentioning "Ike Perlmutter," or "Isaac Perlmutter," or "Perlmutter," "Dr. Bruce Moskowitz," or "Dr. Moskowitz," "Bruce Moskowitz," or "Moskowitz," and "Mar-a -Lago," or "Mar a Lago," or the "Mar-a-Logo guys" between December 1, 2016 - Present. The requester narrowed the scope of the search of his request to the Top Senior Officials for the Office VA-18-0298-D, VA-18-0299-D-000015 000015 of the Secretary, and, Office of Electronic Health Records Modernization. I have attached a copy of the request and our acknowledgement letter advising of this referral. I am assigning this to you in FOIAXpress as OSVA (18-10887-F and VHA OEHRM (18-11384-F. Note: The requester faxed his request to the VA on April 30, 2018; however, it was erroneously overlooked. The requester and the FOIA Service already discussed this issue. (b) (6) VA FOIA Service (005R1C) Office of Privacy Information and Identity Protection (PIIP) Quality, Privacy, and Risk (QPR) Office of Information and Technology (OI&T) Office: (b) (6) Fax: (b) (6) Hotline: 1-877-750-3642 Please take a moment and let us know how we did by completing a quick evaluation: Got a minute? Rate Our Service! QPR's Mission Statement: "To instill and promote a culture of quality, privacy and risk management in collaboration with our business partners to enable a better Veteran experience." VA-18-0298-D, VA-18-0299-D-000016 000016 Document ID: (b) (5) (b) (6) Owner: . Filename: image002.png Last Modified: Sun Aug 19 19:18:42 CDT 2018 VA-18-0298-D, VA-18-0299-D-000017 000017 Item 3 (AttaChme' of 2) Of?ce oDQMi?mic Health Record MODERNIZATION Document ID: (b) (5) (b) (6) Owner: Filename: image003.png Last Modified: Sun Aug 19 19:18:42 CDT 2018 VA-18-0298-D, VA-18-0299-D-000019 000019 Document ID: (b) (5) (b) (6) From: (b) (6) To: Cc: Windom, John H. ;(b) (6) ; Morris, Genevieve Bcc: Subject: RE: OEHRM FOIA Support Date: Wed Aug 01 2018 16:13:07 EDT Attachments: 18-08443-F - IAD_20180730.docx FOIA Routing sheet.pdf HR 4245 FOIA- 18-09663-f_20180730.docx MIRTE FOIA- 18-08454-f_20180730.docx MIRTE FOIA- 18-08574-f_20180730.docx MITRE FOIA- 18-04729-F_20180730.docx Hi (b) (6) Attached are the five current FOIA responses we have reviewed and are requesting OGC concurrence on the language. These were all drafted in coordination with (b) (6) and Ms. Morris has requested that OGC review before moving forward. Please advise if you want this request uploaded into VIEWS for routing purposes. Warm regards, (b) (6) VA Office of Electronic Health Record Modernization (OEHRM) & acting FOIA Officer Director, Program Control 811 Vermont Ave; (b) (6) M (b) (6) PS I deleted(b) (6) because I see they are OOO until Aug 17. Updating with Ms Morris' VA email VA-18-0298-D, VA-18-0299-D-000021 000021 From: (b) (6) Sent: Wednesday, July 18, 2018 9:46 AM (b) (6) To: Fleck, Robert R. (OGC); (b) (6) Cc: Windom, John H.; Morris, Genevieve (OS/ONC/IO); (b) (6) Subject: RE: OEHRM FOIA Support (b) (6) We're happy to assist, but (b) (6) Thanks. : : : :(b) (6) (b) (6) , the VHA FOIA Officer, would be the most helpful to you. :::: Deputy Chief Counsel, Information Law Group (024C) Office of General Counsel Department of Veterans Affairs (b) (6) This communication is intended for only the individual or entity to whom it is addressed and may contain information that is confidential, privileged, or otherwise protected by law. All others are hereby notified that the receipt of this message does not waive any confidentiality or privilege and that any use or disclosure of this information by anyone other than the intended recipient is strictly prohibited. If you have received this transmission in error, please destroy the message, as well as any copies or attachments, and notify the sender immediately by email or telephone. Thank you. From: Fleck, Robert R. (OGC) Sent: Wednesday, July 18, 2018 9:16 AM (b) (6) To: (b) (6) @va.gov>; (b) (6) @va.gov>; (b) (6) (b) (6) < @va.gov> Cc: Windom, John H. <(b) (6) @va.gov>; Morris, Genevieve (OS/ONC/IO) <(b) (6) @hhs.gov> Subject: RE: OEHRM FOIA Support Importance: High VA-18-0298-D, VA-18-0299-D-000022 000022 (b) (6) FOIA attorneys are on the To line ablove. Bob Robert R. Fleck Chief Counsel, Procurement Law Group Office of the General Counsel Room (b) (6) 810 Vermont Avenue, NW Washington, DC, 20420 Office (b) (6) ATTENTION: This electronic transmission may contain attorney work-product or information protected under the attorney-client privilege. Portions of this transmission may contain information also protected from disclosure under the Freedom of Information Act, 5 USC ?552. Do not release this information without prior authorization from the sender. If this has inadvertently reached the wrong party, please delete this information immediately and notify the sender. Any security screening of this email by information officers or server administrators is not intended to be consent to any party to review the content of the email or a waiver of the attorney-client privilege and/or work product privilege. From: (b) (6) Sent: Tuesday, July 17, 2018 4:47 PM To: Fleck, Robert R. (OGC) Cc: Windom, John H.; Morris, Genevieve (OS/ONC/IO) Subject: OEHRM FOIA Support Hi Bob, At our morning OEHRM staff meeting with Genevieve and John Windom we briefed that OEHRM is working 5 separate FOIA requests and they asked me to reach to you for legal assistance until we can hire a permeant FOIA officer into OEHRM. I am currently the designated OEHRM FOIA officer but this is a significant and complicated task requiring the right training to be effective. Please let me know if you require any additional information VA-18-0298-D, VA-18-0299-D-000023 000023 regarding this request. Warm regards, (b) (6) VA Office of Electronic Health Record Modernization (OEHRM) Director, Program Control 811 Vermont Ave; (b) (6) M -(b) (6) VA-18-0298-D, VA-18-0299-D-000024 000024 Document ID:(b) (5) (b) (6) Owner: Filename: HR 4245 FOIA- 18-09663-f_20180730.docx Last Modified: Wed Aug 01 15:13:07 CDT 2018 VA-18-0298-D, VA-18-0299-D-000031 000031 HR 4245 FOIA- 18-09663-f_20180730.docx for Printed Item: 6 ( Attachment 3 of 6) DEPARTMENT OF VETERANS AFFAIRS Veterans Health Administration 810 Vermont Avenue, NW Washington, DC 20420 July 30, 2018 FOIA Request No.: 18-09663-F Leo Hei (b) (6) Dear Mr. Hei: This letter is the initial agency decision to your June 26, 2018, request under the Freedom of Information Act (FOIA), 5 U.S.C. ? 552, submitted to the Veterans Health Administration for "documents submitted to [C]ongress under the passage of HR 4245; specifically; relating to the Electronic Health Record Modernization Program." (b) (5)responsible The component conducted a search for information responsive to your re n . Therefore, I am withholding the documents in their entirety under FOIA Exemption 5. FOIA Exemption 5 permits VA to withhold a document or information contained within a docum part of s ment is he agency or its activities that could occur as a result of release of the document or information. The VA Office of Electronic Health Record Modernization (OEHRM) program has a demon y, (b) (5) VA-18-0298-D, VA-18-0299-D-000032 000032 HR 4245 FOIA- 18-09663-f_20180730.docx for Printed Item: 6 ( Attachment 3 of 6) (b) (5) content, due to the ongoing contract actions. If documents of this nature were made public they o ure of reasons and rationales that Therefore, the release of this information would likely cause injury to the deliberative proces would . I these If you disagree with my determination (b) (5) please be advised you may appeal to: Office of the General Counsel (024) Department of Veterans Affairs 810 Vermont Avenue, N.W. Washington, D.C. 20420 Email: ogcfoiaappeals@va.gov If you should choose to file an appeal, your appeal must be postmarked or electronically transmitted no later than ninety (90) calendar days from the date of this letter. Please include a copy of this letter with your written appeal and clearly state why you disagree with the determinations set forth in this response. You may also seek assistance and/or dispute resolution services for any other aspect of your FOIA request, excluding the release determination, from VHA's FOIA Public Liaison and/or Office of Government Information Services (OGIS) as provided below: VHA FOIA Public Liaison: Email Address: vhafoia2@va.gov Phone Number: (877) 461-5038 Office of Government Information Services (OGIS) Email: ogis@nara.gov Fax: (202) 741-5769 Mailing address: Office of Government Information Services National Archives and Records Administration 8601 Adelphi Road College Park, MD 20740-6001 VA-18-0298-D, VA-18-0299-D-000033 000033 HR 4245 FOIA- 18-09663-f_20180730.docx for Printed Item: 6 ( Attachment 3 of 6) Thank you for your interest in VA. If you have any further questions, please feel free to contact me at(b) (6) Sincerely, (b) (6) Acting OEHRM FOIA Officer VA-18-0298-D, VA-18-0299-D-000034 000034 Document ID:(b) (5) (b) (6) Owner: . Filename: MIRTE FOIA- 18-08574-f_20180730.docx Last Modified: Wed Aug 01 15:13:07 CDT 2018 VA-18-0298-D, VA-18-0299-D-000039 000039 MIRTE FOIA- 18-08574-f_20180730.docx for Printed Item: 6 ( Attachment 5 of 6) DEPARTMENT OF VETERANS AFFAIRS Veterans Health Administration 810 Vermont Avenue, NW Washington, DC 20420 July 30, 2018 FOIA Request No.: 18-08574-F Isaac Arnsdorf (b) (6) Dear Mr. Arnsdorf: This letter is the initial agency decision to your June 7, 2018, request under the Freedom of Information Act (FOIA), 5 U.S.C. ? 552, submitted to the Veterans Health Administration for a copy of the "MITRE report on electric health record modernization." The responsible component conducted a search for documents responsive to your request. The search was conducted by utilizing the search criteria of "MITRE report on electric heath modernization." At the conclusion of the search, one document, totaling fifty one pages, was determined to be responsive to your request. (b) (5) Upon review of the responsive records, I have concluded that the report contains informa withholding the report in its entirety under FOIA Exemption 5. e, I am FOIA Exemption 5 permits VA to withhold a document or information contained within a docum part of s ment is he agency The VA Office of Electronic Health Record Modernization (OEHRM) program has a demon y, VA-18-0298-D, VA-18-0299-D-000040 000040 MIRTE FOIA- 18-08574-f_20180730.docx for Printed Item: 6 ( Attachment 5 of 6) (b) (5) In evaluating assess this request for information, the requested report contains candid ive hey o e of reasons and rationales that were not in fact ultimately the grounds for an agency's action. Therefore, the release of this information would likely cause injury to the deliberative proces uld gency nt full, If you disagree with my determination (b) (5) please be advised you may appeal to: Office of the General Counsel (024) Department of Veterans Affairs 810 Vermont Avenue, N.W. Washington, D.C. 20420 Email: ogcfoiaappeals@va.gov If you should choose to file an appeal, your appeal must be postmarked or electronically transmitted no later than ninety (90) calendar days from the date of this letter. Please include a copy of this letter with your written appeal and clearly state why you disagree with the determinations set forth in this response. You may also seek assistance and/or dispute resolution services for any other aspect of your FOIA request, excluding the release determination, from VHA's FOIA Public Liaison and/or Office of Government Information Services (OGIS) as provided below: VHA FOIA Public Liaison: Email Address: vhafoia2@va.gov Phone Number: (877) 461-5038 VA-18-0298-D, VA-18-0299-D-000041 000041 MIRTE FOIA- 18-08574-f_20180730.docx for Printed Item: 6 ( Attachment 5 of 6) Office of Government Information Services (OGIS) Email: ogis@nara.gov Fax: (202) 741-5769 Mailing address: Office of Government Information Services National Archives and Records Administration 8601 Adelphi Road College Park, MD 20740-6001 Thank you for your interest in VA. If you have any further questions, please feel free to contact me at (b) (6) @va.gov. Sincerely, (b) (6) Acting OEHRM FOIA Officer VA-18-0298-D, VA-18-0299-D-000042 000042 Document ID: (b) (5) (b) (6) Owner: on behalf of VA CIO Executive Schedule To: Sandoval, Camilo J. Cc: Bcc: Subject: FW: VA EHR Call Date: Tue Mar 20 2018 18:01:51 CDT Attachments: Here you go. Jw Sent with Good (www.good.com) All times listed are in the following time zone:(UTC-05:00) Eastern Time (US & Canada) _____ From: VA CIO Executive Schedule Sent: Sunday, March 18, 2018 2:30:57 PM To: VA CIO Executive Schedule; Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Bruce Moskowitz; 'Carolyn@Bruce Moskowitz,MD'; Marc Sherman; IP; Stephanie Reel; Mary Riordan; Ashley Johnson; Callaghan, Elizabeth; Rasu Shrestha; Manis, Jonathan (Jon); Shrestha, Rasu B; Cooper, Leslie T., M.D.; Karson, Andrew Scott,M.D.; Zuccala, Kandace (Kandi) R. Cc: Clifford Ko; Mehwesh Khalid; Stan Huff Subject: VA EHR Call When: Tuesday, March 20, 2018 8:00 PM-9:30 PM. Where: 1-800-767-1750,22712# Scheduling POC: Liz Callaghan (B6) and Elizabeth.Callaghan@va.gov All, I am including everyone in the group in case anyone has any last minute scheduling changes. Thanks, Liz M( H1( AN 000053 VERSIGHT VA-18-0298 and VA-18-0299-E-000001 Document ID: 0.7.1705.649961 (B6) From: . EOP/WHO (B6) @who.eop.gov> To: Blackburn, Scott R. (B6) Cc: EOP/WHO (B6) @who.eop.gov>; Windom, John H. ; DJS ;(B6) J. EOP/WHO <(B6 @who.eop.gov>;(B6) EOP/WHO ) (B6) < @who.eop.gov> Bcc: Subject: [EXTERNAL] Re: VA CIO advisory support for Cerner contract Date: Fri Oct 27 2017 04:35:32 CDT Attachments: We would love that. We also think you should build in some flexibility and requirements around where we think the EMR market might go so that you aren't locked into a program 10 years from now that is obsolete. ? will connect you and schedule next meeting (B6) Sent from my iPhone On Oct 27, 2017, at 1:56 AM, Blackburn, Scott R. wrote: (B6) Thank you for taking time Tuesday evening to discuss the EHR/Cerner contract. We too want to make sure we get this right and are looking back 5 years from now knowing we made the right decision. We would love to ask your help in connecting us with the CIOs of Kaiser Permanente (Dick Daniels who was on the phone Tuesday night), Cleveland Clinic (which looks to now be Edward Marx), Mayo Clinic (Cris Ross), Johns Hopkins (Stephanie Reel), and Partners Healthcare (Jim Noga). We want to have them review what we are about to do, provide feedback/advice, and especially call out anything major that we might not be structuring correctly. Our thought is to host a two-hour "red team" session sometime in the next week or two (the sooner the better) before we sign the final deal. Of course we would love for the two of you to join as well if you are available. If you would be willing to introduce us, or provide their contact information, it would be greatly appreciated. Below is a draft of the email that I would plan to send them. M( HI( AN 000054 VERSIGHT VA-18-0298 and VA-18-0299-E-000002 Also as discussed, my team would love to get together with you to discuss "Phase 2" (the Digital Veteran Platform) that would create an API gateway and enable health information exchange. As mentioned, we have issued a broad RFI to the private sector and would like to do an Industry Day. We would love to partner with you on this. Scott This is Scott Blackburn, the Acting CIO for the Department of Veterans Affairs (VA). On behalf of the Secretary David Shulkin, I would like to invite you to participate in a critical review of our Electronic Health Record (EHR) modernization strategy and corresponding Request for Proposal (RFP) to Cerner. Your organizations have been at the forefront of the evolution high quality IT-based health care services and delivery for decades, and thus we would be remiss if we did not seek to gain your insight prior to our final contracting decision. I anticipate a round table style engagement/discussion in the Washington, D.C. area that will last approximately two hours. I will be accompanied by the Program Executive Officer for VA Electronic Health Record Modernization (PEO EHRM), John Windom, and his key staff members including his Chief Medical Officer (CMO), Chief Technology Officer (CTO) and Director of Contracts. We have spoken to many commercial health care industry leaders regarding EHR implementation and deployment , and continue to maintain a strong relationship with our Department of Defense (DoD) counterparts, with regards to their EHR deployment activities and related challenges. We believe that we have developed a comprehensive RFP with particular emphasis on notable "fail points" EHRdeployment arena such as Governance, Training, Change Management, Data Migration, Funding, etc. to name only a few, but look forward to your thoughts on these and others. I ask that you please provide me your primary schedule manager or point of contact to coordinate a date and time that maximizes our overall participation at this all-important review forum. Thank you in advance for your attention to this note, participation and willingness to help our Veterans continue to receive the very best healthcare. Scott Blackburn M( HI( AN 000055 VERSIGHT VA-18-0298 and VA-18-0299-E-000003 Scott Blackburn Acting CIO & Executive in Charge, Office of Information & Technology US Department of Veterans Affairs M( H1( AN 000056 VERSIGHT VA-18-0298 and VA-18-0299-E-000004 Document ID: 0.7.1705.667850 From: Richard D. Daniels (B6) @kp.org> To: Ross.Christopher (mayo.edu) (B6) @mayo.edu> Cc: Blackburn, Scott R. ;(B6) @jhu.edu (B6) @jhu.edu>;(B6) @ccf.org(B6) @ccf.org>; (B6) @partners.org (B6) @partners.org>; (B6) EOP/WHO (B6) @who.eop.gov>; (B6) EOP/WHO (B6) @who.eop.gov>; DJS ; (B6) EOP/WHO (B6) @who.eop.gov>; Callaghan, Elizabeth ; Windom, John H. ; Browning, JoAnn K. (B6) @mayo.edu>; Judy M Gilford (B6) @kp.org> Bcc: Subject: [EXTERNAL] Re: VA Cerner contract - request for your help Date: Tue Nov 07 2017 16:46:58 CST Attachments: - - I'm happy to participate. Please connect with Judy Gilford to schedule me. Sent from my iPhone On Nov 5, 2017, at 9:18 AM, Ross, Christopher J. (B6) @mayo.edu> wrote: Caution: This email came from outside Kaiser Permanente. Do not open attachments or click on links if you do not recognize the sender. _____ Scott Thank you for asking. Glad to participate. My assistant (B6) is cc'd. Cris From: Blackburn, Scott R. [mailto:Scott.Blackburn@va.gov] Sent: Saturday, November 04, 2017 1:05 PM To: (B6) @kp.org; (B6) @jhu.edu; Ross, Christopher J.; (B6) @ccf.org; (B6) @partners.org Cc: (B6) EOP/WHO; (B6) EOP/WHO; DJS; (B6) EOP/WHO; Callaghan, Elizabeth; Windom, John H. - - M( HI( AN 000057 VERSIGHT VA-18-0298 and VA-18-0299-E-000005 Subject: VA Cerner contract - request for your help Dick/Stephanie/Chris/Doug/Jim - This is Scott Blackburn, the Acting CIO for the Department of Veterans Affairs (VA). On behalf of the Secretary David Shulkin, I would like to seek your help. We are close to finalizing our EHR contract and would like to invite you to participate in a critical review of our Electronic Health Record (EHR) modernization strategy and corresponding Request for Proposal (RFP) to Cerner. Your organizations have been at the forefront of the evolution high quality IT-based health care services and delivery for decades, and thus we would be remiss if we did not seek to gain your insight prior to our final contracting decision. I anticipate a round table style engagement/discussion that will last approximately two hours. Ideally it would be in person, but we understand that might be difficult on such short notice so we can also do phone or video conference. I will be accompanied by the Program Executive Officer for VA Electronic Health Record Modernization (PEO EHRM), John Windom, and his key staff members including his Chief Medical Officer (CMO), Chief Technology Officer (CTO) and Director of Contracts. We have spoken to many commercial health care industry leaders regarding EHR implementation and deployment , and continue to maintain a strong relationship with our Department of Defense (DoD) counterparts, with regards to their EHR deployment activities and related challenges. We believe that we have developed a comprehensive RFP with particular emphasis on notable "fail points" EHRdeployment arena such as Governance, Training, Change Management, Data Migration, Funding, etc. to name only a few, but look forward to your thoughts on these and others. I ask that you please provide me your primary schedule manager or point of contact to coordinate a date and time that maximizes our overall participation at this all-important review forum (Elizabeth Callaghan cc'd here will work this for me). Thank you in advance for your attention to this note, participation and willingness to help our Veterans continue to receive the very best healthcare. Scott Blackburn Scott Blackburn Executive in Charge, Office of Information & Technology US Department of Veterans Affairs M( HI( AN 000058 VERSIGHT VA-18-0298 and VA-18-0299-E-000006 NOTICE TO RECIPIENT: If you are not the intended recipient of this e-mail, you are prohibited from sharing, copying, or otherwise using or disclosing its contents. If you have received this e-mail in error, please notify the sender immediately by reply e-mail and permanently delete this e-mail and any attachments without reading, forwarding or saving them. Thank you. M( H1( AN 000059 VERSIGHT VA-18-0298 and VA-18-0299-E-000007 Document ID: 0.7.1705.821407 From: Blackburn, Scott R. To: DJS ; Windom, John H. ; Bowman, Thomas Cc: Bcc: Subject: FW: [EXTERNAL] Re: Scheduling a Call Regarding Feedback on VA EHR Date: Thu Mar 15 2018 19:45:19 CDT Attachments: We are pushing to get this done no later than Tuesday so we can wrap this up. Talked to Bruce and we are perfectly aligned. He is going to help push these folks for us. Sent with Good (www.good.com) _____ From: Bruce Moskowitz Sent: Thursday, March 15, 2018 7:27:17 PM To: Callaghan, Elizabeth Cc: Stephanie Reel; Stan Huff; Manis, Jonathan (Jon); (B6) @facs.org; Cooper, Leslie T., M.D.; Karson, Andrew Scott,M.D.; Shrestha, Rasu B; Rasu Shrestha; Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Carolyn@Bruce Moskowitz,MD; Ashley Johnson; Mary Riordan; Mehwesh Khalid; Marc Sherman; IP Subject: [EXTERNAL] Re: Scheduling a Call Regarding Feedback on VA EHR ? All work for me Sent from my iPad Bruce Moskowitz M.D. On Mar 15, 2018, at 7:26 PM, Callaghan, Elizabeth wrote: Good evening, We would like to schedule a call in the next few days to share feedback on the VA EHR contract. I have been corresponding with many of you on different dates and times next week, but we are going to schedule the call for either Sunday 3/18 at 4PM EST, Monday 3/19 at 4PM EST or Tuesday 3/20 at M( HI( AN 000060 VERSIGHT VA-18-0298 and VA-18-0299-E-000008 4PM EST. Please let me know which date will work best for your schedule. Feel free to call me with any questions and I look forward to hearing from you. Thank you, Liz Elizabeth M. Callaghan Executive Assistant to the Assistant Secretary Office of Information and Technology US Department of Veterans Affairs Desk: (B6) Cell: (B6) M( H1( AN 000061 VERSIGHT VA-18-0298 and VA-18-0299-E-000009 Document ID: 0.7.1705.820176 From: Blackburn, Scott R. To: IP (B6) @frenchangel59.com>; (B6) @gmail.com (B6) @gmail.com>; (B6) @gmail.com (B6) < @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Truex, Matthew ; Windom, John H. ; DJS Bcc: Subject: VA EHR NDA Date: Tue Mar 13 2018 09:31:27 CDT Attachments: NDA_blank EHRM for signature.pdf - - Ike, Bruce, Marc: Thank each of you for agreeing to lend an extra set of outside eyes on the EHR contract. We appreciate your support and want to make sure we get to the best place possible for Veterans, the country and taxpayers. As we are incredibly grateful to you for volunteering your time, we want to make this as easy as possible for you. Here are 3 next steps. 1) We will need you to sign the attached NDA. Please return to Matt Truex (cc'd). 2) Matt will then send you the latest package under separate cover. 3) Given government contracts are different than what you are used to reading, we would propose a quick phone call so that we can orient you to the contract and help focus you on the parts where your expertise will be most valuable. Matt Truex (who is the government contracting officer) and John Windom (who is our EHR leader) will lead this from our side. I will ask Liz Callaghan (cc'd) here to help set up a time. We can either do this all together, if calendars match up, or separately if need be. We have also connected with Stephanie Reel, Stan Huff, Dr. Karson, Dr. Ko, Dr. Shretha, and Jon Manis who all have all received the NDA and we are working with them. I am hoping to connect with Dr. Cooper today. Thanks again! Scott M( HI( AN 000062 VERSIGHT VA-18-0298 and VA-18-0299-E-000010 Scott Blackburn Acting CIO & Executive-in-Charge, Office of Information & Technology Department of Veterans Affairs M( H1( AN 000063 VERSIGHT VA-18-0298 and VA-18-0299-E-000011 Document ID: 0.7.1705.820176-000001 Owner: Blackburn, Scott R. Filename: NDA_blank EHRM for signature.pdf Last Modified: Tue Mar 13 09:31:27 CDT 2018 M( H1( AN 000064 VERSIGHT VA-18-0298 and VA-18-0299-E-000012 NDA_blank EHRM for signature.pdf for Printed Item: 15 ( Attachment 1 of 1) NON-DISCLOSURE AGREEMENT 1. I acknowledge that I have been selected to participate in the planning for an electronic health record acquisition. In the course of participating in this acquisition, I may be or have been given access to or entrusted with Source Selection Information (as defined in Federal Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked or considered as "proprietary" (e.g., restrictive legend per FAR 52.215-1) that I cannot release to others nor can I use for the financial benefit of others or myself. Source Selection Information is defined in FAR 2.101 & 3.104 and other sensitive Government data includes data marked or considered as "proprietary" (e.g., restrictive legend per FAR 52.215-1). Data includes all data, information and software, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is derived from, based on, incorporates, includes or refers to such Source Selection and/or proprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates, includes or refers to data shall be treated as Source Selection, or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. 2. I understand that 41 U.S.C. ? 423, commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101-2107, and provisions FAR 3.104 govern the release of proprietary and source selection information . I certify that I will not disclose any contractor bid, solicitation, proprietary, or source selection information directly or indirectly to any person other than a person authorized by the head of agency or the contracting officer to receive such information. I understand that unauthorized disclosure of such information may subject me to substantial administrative, civil and criminal penalties, including fines, imprisonment, and loss of employment under the Procurement Integrity Act or other applicable laws and regulations. 3. I certify that I will not discuss evaluation of source selection matters with any unauthorized individuals (including Government personnel), even after contract award, without specific prior approval from proper authority. 4. These provisions are consistent with, and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection. The definitions, requirements, obligations, rights, sanctions, and liabilities created by controlling Executive orders and statutory provisions are incorporated into this agreement and are controlling. These statutes and Executive orders include the following: ?Executive Order No. 12958; ?The Privacy Act (5 U.S.C. ? 552a); ?The Trade Secrets Act (18 U.S.C. ? 1905); ?Section 7211 of title 5, United States Code (governing disclosures to Congress); ?Section 1034 of title 10, United States Code, as amended by the Military Whistleblower Protection Act (governing disclosure to Congress by members of the military); AMERICAN PVERSIGHT 000065 VA-18-0298 and VA-18-0299-E-000013 NDA_blank EHRM for signature.pdf for Printed Item: 15 ( Attachment 1 of 1) ?Section 2302(b)(8) of title 5, United States Code, as amended by the Whistleblower Protection Action (governing disclosures of illegality, waste, fraud, abuse or public health or safety threats); ?The Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosures that could expose confidential Government agents); and ?The statutes which protect against disclosure that may compromise the national security, including sections 641, 793, 794, 798, and 952 of title 18, United States Code, and section 4(b) of the Subversive Activities Act of 1950 (50 U.S.C. ? 783(b)). Additionally, pursuant to 38 Code of Federal Regulations 1.201, all VA employees with knowledge or information about actual or possible violations of criminal law related to VA programs, operations, facilities, contracts, or information technology systems shall immediately report such knowledge or information to their supervisor, any management official, or directly to the Office of Inspector General. Signature: Name Printed: Title: Organization: Organizational Conflict(s) of Interest (OCIs): VERSIGHT 000066 VA-18-0298 and VA-18-0299-E-000014 Document ID: 0.7.1705.820305 From: IP (B6) @frenchangel59.com> To: Marc Sherman (B6) @gmail.com>; Blackburn, Scott R. (B6) Cc: @gmail.com (B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com>; Truex, Matthew ; Windom, John H. ; DJS Bcc: Subject: [EXTERNAL] RE: VA EHR NDA Date: Tue Mar 13 2018 13:07:06 CDT Attachments: Perlmutter.EHR NDA v2 mbs.pdf ? Attached is my signed NDA. Thank you. - From: Marc Sherman [mailto:(B6) @gmail.com] Sent: Tuesday, March 13, 2018 1:40 PM To: Blackburn, Scott R. Cc: IP; (B6) @gmail.com; Bruce Moskowitz; Truex, Matthew; Windom, John H.; DJS Subject: Re: VA EHR NDA - Scott, Matt and John Thank you for the NDA draft that you sent along and the organized approach. I have attached the following to close the loop: 1.a marked up version of the NDA with a few necessary adjustments in red-line so you can see the changes that were made, 2.a blank copy of the amended NDA for Bruce and Ike to sign, and 3.a signed version by me of the amended NDA. Thanks and happy to help as requested. Marc On Tue, Mar 13, 2018 at 10:31 AM, Blackburn, Scott R. wrote: M( HI( AN 000001 VERSIGHT VA-18-0298 and VA-18-0299-E-000015 Ike, Bruce, Marc: Thank each of you for agreeing to lend an extra set of outside eyes on the EHR contract. We appreciate your support and want to make sure we get to the best place possible for Veterans, the country and taxpayers. As we are incredibly grateful to you for volunteering your time, we want to make this as easy as possible for you. Here are 3 next steps. 1) We will need you to sign the attached NDA. Please return to Matt Truex (cc'd). 2) Matt will then send you the latest package under separate cover. 3) Given government contracts are different than what you are used to reading, we would propose a quick phone call so that we can orient you to the contract and help focus you on the parts where your expertise will be most valuable. Matt Truex (who is the government contracting officer) and John Windom (who is our EHR leader) will lead this from our side. I will ask Liz Callaghan (cc'd) here to help set up a time. We can either do this all together, if calendars match up, or separately if need be. We have also connected with Stephanie Reel, Stan Huff, Dr. Karson, Dr. Ko, Dr. Shretha, and Jon Manis who all have all received the NDA and we are working with them. I am hoping to connect with Dr. Cooper today. Thanks again! Scott Scott Blackburn Acting CIO & Executive-in-Charge, Office of Information & Technology Department of Veterans Affairs M( H1( AN 000002 VERSIGHT VA-18-0298 and VA-18-0299-E-000016 Document ID: 0.7.1705.820305-000001 Owner: IP <(B @frenchangel59.com> 6) Filename: Perlmutter.EHR NDA v2 mbs.pdf Last Modified: Tue Mar 13 13:07:06 CDT 2018 I M( H1( AN 000003 VERSIGHT VA-18-0298 and VA-18-0299-E-000017 Perlmutter.EHR NDA v2 mbs.pdf for Printed Item: 17 ( Attachment 1 of 1) o NON-DISCLOSURE AGREEMENT (Dated March 13, 2018) 1. I acknowledge that I ha ve been selecJ:edto participate in the planning for an electronic health record acquisition. In the course of participating in this acquisition , I may be or have been given access to or entrusted with Source Selection Info rmation (as defined in Federal Acquisition Regulation (FAR) 2.101 and 3.104), and/or other sensitive Government data marked as "proprietary" (e.g., restrictive legend per FAR 52.215- 1) that I cannot release to others nor can I 1 use for the financial benefit of others or myself I Source Selection Information is defined in FAR 2.101 & 3. 104 and other sensitive Government data includes data marked as "proprietary" (e.g., restrictive legend per FAR 52.215-1). Data includes all data, information and software, regardless of the medium (e.g. electronic or paper) and/or format in which the data exists, and includes data which is deriv ed from, based on, incorporates , includes or refers to such Source Selection and/or proprietary data (collectively referred to herein as "the data"). Any data which is derived from, based on, incorporates , includes or refers to data shall be treated as Source Selection, or proprietary data and shall be subject to the terms of this Non-Disclosure Agreement. 2 . I understand that 41 U.S .C. ? 423 , commonly referred to as the Procurement Integrity Act, and now codified at U.S.C.A. ? ? 2101-2107, and provisions FAR 3.104 govern the release of proprietary and source selection information . As it relates to the information that has been made available to me pursuant to this Non-Disclosure Agreement , I certify that I will not disclose any contractor bid, solicitation, proprietary, or Source Selection Information directly or indirectly to any person other than the President of the United States or a member of his administration to whom the President authorizes , another person subject to an equally restrictive Non-Disclosure Agreement related to the subject matter of this Agreement , the Secretary of the Department of Veterans Affairs or a person authorized by the head of agency or the contracting officer to receive such information. I understand that unauthorized disclosure of such information may subject me to substantial administrati ve, civil and criminal penalties , including fines , imprisonment, and loss of employment under the Procurement Integrity Act or other applicable laws and regulations . 3. I certify that I will not discuss evaluation of source selection matters with any unauthorized individuals (including Government personnel other than those set out in Paragraph 2 above), even after contract award, without specific prior approval from proper authori ty . 4. These provisions are consistent with, and do not supersede , conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information , (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule , or regulation, or mismanagemen t, a gross waste of funds, an abuse of authority , or a substantial and specific danger to public health or safety , or (4) any other whistleblower protection . The definitions , requirements , obligations , rights , sanctions, and liabilities created by controlling Executi ve orders and statutory provisions are incorporated into this agreement and are controllin g. These statutes and Executive orders include the following : AM ICA\J pVERSIGHT 000004 VA-18-0298 and VA-18-0299-E-000018 Perlmutter.EHR NDA v2 mbs.pdf for Printed Item: 17 ( Attachment 1 of 1) NON-DISCLOSURE AGREEMENT Planning for an electronic health record acquisition , Dated Tuesday March 13, 2018 Page l2 [Executive Order No. 12958; [)Ibe Privacy Act (5 U.S.C: ? 552a); [)Ibe Trade Secrets Act (18 U.S.C. ? 1905); [J;ection 7211 of title 5, United States Code (governing disclosures to Congress); [J;ection 1034 of title 10, United States Code, as amended by the Military Whistl~blower Protection Act (governing disclosure to Congress by members of the military); , CBection 2302(b)(8) of title 5, United States Code, as amended by the Whistleblower Protection Action (governing disclosures of illegality, waste, fraud, abuse or public health or safety threats); []Ihe Intelligence Identities Protection Act of 1982 (50 U.S.C. ? 421 et seq.) (governing disclosures that could expose confidential Government agents); and Ofhe statutes which protect against disclosure that may compromise the national security, including sections 641, 793, 794, 798, and 952 of title 18, United States Code, and section 4(b) of the Subversive Activities Act of 1950 (50 U.S.C. ? 783(b)). Additionally, pursuant to 38 Code of Federal Regulations 1.201, all VA employees with knowledge or information about actual or possible violations of criminal law related to VA programs, operations, facilities, contracts, or information technology systems shall immediately report such knowledge or information to their supervisor, any management official, or directly to the Office of Inspector General. (B6) Name Printed: Isaac Perlmutter Organizational Conflict(s) of Interest (OCis): 000005 VA-18-0298 and VA-18-0299-E-000019 Document ID: 0.7.1705.823668 From: Blackburn, Scott R. To: DJS ; Windom, John H. ; Zenooz, Ashwini ; Short, John (VACO) ; Bruce Moskowitz <(B6) @mac.com>; Marc Sherman (B6) @gmail.com> Cc: Callaghan, Elizabeth Bcc: Subject: EHR calls tomorrow night Date: Mon Mar 19 2018 20:55:27 CDT Attachments: We will start at 7:30pm tomorrow night. Dial in is: 1-800-767-1750,,,22712# 7:30-8:00pm: Dr. Leslie Cooper, Mayo Clinic. We will focus on the issue of using Cloud. (Bruce suggested Dr. Cooper for this specific issue) 8:00-9:30pm: Dr. Rasu Shretha (UPMC), Jon Manis (Sutter Health), Stephanie Reel (Johns Hopkins) and Dr. Andy Karson (Mass General Hospital) Scott Blackburn Executive in Charge, Office of Information & Technology US Department of Veterans Affairs M( H1( AN 000006 VERSIGHT VA-18-0298 and VA-18-0299-E-000020 Document ID: 0.7.1705.983013 From: Bruce Moskowitz (B6) @mac.com> Windom, John H. ; Blackburn, Scott R. ; Truex, Matthew (B6) @gmail.com (B6) @gmail.com>; IP (B6) @frenchangel59.com>; O'Rourke, Peter M. To: Cc: ? Bcc: Subject: Date: Attachments: [EXTERNAL] Re: EHR VA Call Thu Mar 15 2018 12:27:32 CDT I want to make sure we are all in agreement of how this is structured. Marc and I want to be on every call that the group is on to discuss the contract. The whole group needs to be on the same call so we all give input to the whole contract and hear the same considerations and comments. Let me know if there is any discrepancy to this. Thank you Sent from my iPad Bruce Moskowitz M.D. On Mar 15, 2018, at 12:28 PM, VA CIO Executive Schedule wrote: M( H1( AN 000007 VERSIGHT VA-18-0298 and VA-18-0299-E-000021 Document ID: 0.7.1705.1061276 From: Windom, John H. To: Callaghan, Elizabeth (B6) Cc: L. ; Short, John (VACO) ; Zenooz, Ashwini Bcc: Subject: RE: VA Cerner contract - request for your help Date: Tue Nov 07 2017 07:53:53 CST Attachments: Elizabeth, My primary scheduler is (B6) , copied. I would be surprised if you could make this happen this Thursday, so next Thursday seems more likely. I am "all in" if you can on either Thursday. John Short and Ash Zenooz are also primary contributors to this roundtable. Thx/John John H. Windom, Senior Executive Service (SES) Program Executive for Electronic Health Record Modernization (PEO EHRM) Special Advisor to the Under Secretary for Health 810 Vermont Avenue NW (Suite 375X) Washington, DC 20420 John.Windom@va.gov Office: (B6) Mobile:(B6) From: Callaghan, Elizabeth Sent: Tuesday, November 07, 2017 8:27 AM To: Windom, John H. M( HI( AN 000067 VERSIGHT VA-18-0298 and VA-18-0299-E-000022 Subject: FW: VA Cerner contract - request for your help Importance: High Good morning Sir, Before I start working on setting up this meeting I wanted to coordinate with you. Right now we are looking at having the meeting this Thursday afternoon or sometime next Thursday. Please let me know your thoughts and I will start working this today. Thank you, Liz From: Blackburn, Scott R. Sent: Saturday, November 04, 2017 2:05 PM To: (B6) @kp.org; (B6) @jhu.edu; (B6) (B6) @partners.org Cc: (B6) EOP/WHO;(B6) EOP/WHO; Callaghan, Elizabeth; Windom, John H. Subject: VA Cerner contract - request for your help Importance: High - - @mayo.edu; (B6) @ccf.org; . EOP/WHO; DJS; (B6) Dick/Stephanie/Chris/Doug/Jim - This is Scott Blackburn, the Acting CIO for the Department of Veterans Affairs (VA). On behalf of the Secretary David Shulkin, I would like to seek your help. We are close to finalizing our EHR contract and would like to invite you to participate in a critical review of our Electronic Health Record (EHR) modernization strategy and corresponding Request for Proposal (RFP) to Cerner. Your organizations have been at the forefront of the evolution high quality IT-based health care services and delivery for decades, and thus we would be remiss if we did not seek to gain your insight prior to our final contracting decision. I anticipate a round table style engagement/discussion that will last approximately two hours. Ideally it would be in person, but we understand that might be difficult on such short notice so we can also do phone or video conference. I will be accompanied by the Program Executive Officer for VA Electronic Health Record Modernization (PEO EHRM), John Windom, and his key staff members including his Chief Medical Officer (CMO), Chief Technology Officer (CTO) and Director of Contracts. We have spoken to many commercial health care industry leaders regarding EHR implementation and deployment , and continue to maintain a strong relationship with our Department of Defense (DoD) counterparts, with regards to their EHR deployment activities and related challenges. We believe that we have developed a comprehensive RFP with particular emphasis on notable "fail points" EHRdeployment arena such as Governance, Training, Change Management, Data Migration, Funding, etc. M( HI( AN 000068 VERSIGHT VA-18-0298 and VA-18-0299-E-000023 to name only a few, but look forward to your thoughts on these and others. I ask that you please provide me your primary schedule manager or point of contact to coordinate a date and time that maximizes our overall participation at this all-important review forum (Elizabeth Callaghan cc'd here will work this for me). Thank you in advance for your attention to this note, participation and willingness to help our Veterans continue to receive the very best healthcare. Scott Blackburn Scott Blackburn Executive in Charge, Office of Information & Technology US Department of Veterans Affairs M( H1( AN 000069 VERSIGHT VA-18-0298 and VA-18-0299-E-000024 Document ID: 0.7.1705.1061281 From: Callaghan, Elizabeth To: Windom, John H. Cc: Bcc: Subject: RE: VA Cerner contract - request for your help Date: Tue Nov 07 2017 08:01:51 CST Attachments: Are you going to the MHS Genesis Event in Tacoma next week? That's my challenge with Scott's schedule although he indicated he could participate via phone... From: Windom, John H. Sent: Tuesday, November 07, 2017 9:00 AM To: Callaghan, Elizabeth Subject: RE: VA Cerner contract - request for your help Afternoons seem to be better for these events. Thx JW John H. Windom, Senior Executive Service (SES) Program Executive for Electronic Health Record Modernization (PEO EHRM) Special Advisor to the Under Secretary for Health 810 Vermont Avenue NW (Suite 375X) Washington, DC 20420 John.Windom@va.gov Office: (B6) Mobile: (B6) M( HI( AN 000070 VERSIGHT VA-18-0298 and VA-18-0299-E-000025 From: Callaghan, Elizabeth Sent: Tuesday, November 07, 2017 8:27 AM To: Windom, John H. Subject: FW: VA Cerner contract - request for your help Importance: High Good morning Sir, Before I start working on setting up this meeting I wanted to coordinate with you. Right now we are looking at having the meeting this Thursday afternoon or sometime next Thursday. Please let me know your thoughts and I will start working this today. Thank you, Liz From: Blackburn, Scott R. Sent: Saturday, November 04, 2017 2:05 PM To: (B6) @kp.org; (B6) @jhu.edu; (B6) (B6) @partners.org Cc: (B6) . EOP/WHO; (B6) EOP/WHO; Callaghan, Elizabeth; Windom, John H. Subject: VA Cerner contract - request for your help Importance: High - - @mayo.edu; (B6) @ccf.org; . EOP/WHO; DJS; (B6) Dick/Stephanie/Chris/Doug/Jim - This is Scott Blackburn, the Acting CIO for the Department of Veterans Affairs (VA). On behalf of the Secretary David Shulkin, I would like to seek your help. We are close to finalizing our EHR contract and would like to invite you to participate in a critical review of our Electronic Health Record (EHR) modernization strategy and corresponding Request for Proposal (RFP) to Cerner. Your organizations have been at the forefront of the evolution high quality IT-based health care services and delivery for decades, and thus we would be remiss if we did not seek to gain your insight prior to our final contracting decision. I anticipate a round table style engagement/discussion that will last approximately two hours. Ideally it would be in person, but we understand that might be difficult on such short notice so we can also do phone or video conference. I will be accompanied by the Program Executive Officer for VA Electronic Health Record Modernization (PEO EHRM), John Windom, and his key staff members including his Chief Medical Officer (CMO), Chief Technology Officer (CTO) and Director of Contracts. We have M( HI( AN 000071 VERSIGHT VA-18-0298 and VA-18-0299-E-000026 spoken to many commercial health care industry leaders regarding EHR implementation and deployment , and continue to maintain a strong relationship with our Department of Defense (DoD) counterparts, with regards to their EHR deployment activities and related challenges. We believe that we have developed a comprehensive RFP with particular emphasis on notable "fail points" EHRdeployment arena such as Governance, Training, Change Management, Data Migration, Funding, etc. to name only a few, but look forward to your thoughts on these and others. I ask that you please provide me your primary schedule manager or point of contact to coordinate a date and time that maximizes our overall participation at this all-important review forum (Elizabeth Callaghan cc'd here will work this for me). Thank you in advance for your attention to this note, participation and willingness to help our Veterans continue to receive the very best healthcare. Scott Blackburn Scott Blackburn Executive in Charge, Office of Information & Technology US Department of Veterans Affairs M( H1( AN 000072 VERSIGHT VA-18-0298 and VA-18-0299-E-000027 Document ID: 0.7.1705.1061280 From: Windom, John H. To: Callaghan, Elizabeth Cc: Bcc: Subject: RE: VA Cerner contract - request for your help Date: Tue Nov 07 2017 07:59:39 CST Attachments: Afternoons seem to be better for these events. Thx JW John H. Windom, Senior Executive Service (SES) Program Executive for Electronic Health Record Modernization (PEO EHRM) Special Advisor to the Under Secretary for Health 810 Vermont Avenue NW (Suite 375X) Washington, DC 20420 John.Windom@va.gov Office: (B6) Mobile: (B6) From: Callaghan, Elizabeth Sent: Tuesday, November 07, 2017 8:27 AM To: Windom, John H. Subject: FW: VA Cerner contract - request for your help Importance: High Good morning Sir, M( HI( AN 000073 VERSIGHT VA-18-0298 and VA-18-0299-E-000028 Before I start working on setting up this meeting I wanted to coordinate with you. Right now we are looking at having the meeting this Thursday afternoon or sometime next Thursday. Please let me know your thoughts and I will start working this today. Thank you, Liz From: Blackburn, Scott R. Sent: Saturday, November 04, 2017 2:05 PM To: (B6) @kp.org; (B6) @jhu.edu; (B6) (B6) @partners.org (B6) Cc: J. EOP/WHO; (B6) EOP/WHO; Callaghan, Elizabeth; Windom, John H. Subject: VA Cerner contract - request for your help Importance: High - - @mayo.edu; (B6) @ccf.org; . EOP/WHO; DJS; (B6) Dick/Stephanie/Chris/Doug/Jim - This is Scott Blackburn, the Acting CIO for the Department of Veterans Affairs (VA). On behalf of the Secretary David Shulkin, I would like to seek your help. We are close to finalizing our EHR contract and would like to invite you to participate in a critical review of our Electronic Health Record (EHR) modernization strategy and corresponding Request for Proposal (RFP) to Cerner. Your organizations have been at the forefront of the evolution high quality IT-based health care services and delivery for decades, and thus we would be remiss if we did not seek to gain your insight prior to our final contracting decision. I anticipate a round table style engagement/discussion that will last approximately two hours. Ideally it would be in person, but we understand that might be difficult on such short notice so we can also do phone or video conference. I will be accompanied by the Program Executive Officer for VA Electronic Health Record Modernization (PEO EHRM), John Windom, and his key staff members including his Chief Medical Officer (CMO), Chief Technology Officer (CTO) and Director of Contracts. We have spoken to many commercial health care industry leaders regarding EHR implementation and deployment , and continue to maintain a strong relationship with our Department of Defense (DoD) counterparts, with regards to their EHR deployment activities and related challenges. We believe that we have developed a comprehensive RFP with particular emphasis on notable "fail points" EHRdeployment arena such as Governance, Training, Change Management, Data Migration, Funding, etc. to name only a few, but look forward to your thoughts on these and others. I ask that you please provide me your primary schedule manager or point of contact to coordinate a date and time that maximizes our overall participation at this all-important review forum (Elizabeth Callaghan cc'd here will work this for me). M( HI( AN 000074 VERSIGHT VA-18-0298 and VA-18-0299-E-000029 Thank you in advance for your attention to this note, participation and willingness to help our Veterans continue to receive the very best healthcare. Scott Blackburn Scott Blackburn Executive in Charge, Office of Information & Technology US Department of Veterans Affairs M( H1( AN 000075 VERSIGHT VA-18-0298 and VA-18-0299-E-000030 Document ID: 0.7.1705.1061261 From: Callaghan, Elizabeth To: Windom, John H. Cc: Bcc: Subject: FW: VA Cerner contract - request for your help Date: Tue Nov 07 2017 07:27:04 CST Attachments: Good morning Sir, Before I start working on setting up this meeting I wanted to coordinate with you. Right now we are looking at having the meeting this Thursday afternoon or sometime next Thursday. Please let me know your thoughts and I will start working this today. Thank you, Liz From: Blackburn, Scott R. Sent: Saturday, November 04, 2017 2:05 PM To:(B6) @kp.org; (B6) @jhu.edu; (B6) (B6) @partners.org Cc: (B6) EOP/WHO; (B6) EOP/WHO; Callaghan, Elizabeth; Windom, John H. Subject: VA Cerner contract - request for your help Importance: High - - @mayo.edu; (B6) EOP/WHO; DJS;(B6) @ccf.org; Dick/Stephanie/Chris/Doug/Jim - This is Scott Blackburn, the Acting CIO for the Department of Veterans Affairs (VA). On behalf of the Secretary David Shulkin, I would like to seek your help. We are close to finalizing our EHR contract and would like to invite you to participate in a critical review of our Electronic Health Record (EHR) modernization strategy and corresponding Request for Proposal (RFP) to Cerner. Your organizations have been at the forefront of the evolution high quality IT-based health care services and delivery for decades, and thus we would be remiss if we did not seek to gain your insight prior to our final contracting decision. M( HI( AN 000076 VERSIGHT VA-18-0298 and VA-18-0299-E-000031 I anticipate a round table style engagement/discussion that will last approximately two hours. Ideally it would be in person, but we understand that might be difficult on such short notice so we can also do phone or video conference. I will be accompanied by the Program Executive Officer for VA Electronic Health Record Modernization (PEO EHRM), John Windom, and his key staff members including his Chief Medical Officer (CMO), Chief Technology Officer (CTO) and Director of Contracts. We have spoken to many commercial health care industry leaders regarding EHR implementation and deployment , and continue to maintain a strong relationship with our Department of Defense (DoD) counterparts, with regards to their EHR deployment activities and related challenges. We believe that we have developed a comprehensive RFP with particular emphasis on notable "fail points" EHRdeployment arena such as Governance, Training, Change Management, Data Migration, Funding, etc. to name only a few, but look forward to your thoughts on these and others. I ask that you please provide me your primary schedule manager or point of contact to coordinate a date and time that maximizes our overall participation at this all-important review forum (Elizabeth Callaghan cc'd here will work this for me). Thank you in advance for your attention to this note, participation and willingness to help our Veterans continue to receive the very best healthcare. Scott Blackburn Scott Blackburn Executive in Charge, Office of Information & Technology US Department of Veterans Affairs M( H1( AN 000077 VERSIGHT VA-18-0298 and VA-18-0299-E-000032 Document ID: 0.7.1705.1217692 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Windom, John H. ; Blackburn, Scott R. ; Truex, Matthew ; Carolyn@Bruce Moskowitz,MD <(B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: EHR VA Call Date: Wed Mar 14 2018 09:29:27 CDT Attachments: StartTime: Wed Mar 21 15:00:00 Central Daylight Time 2018 EndTime: Wed Mar 21 16:30:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Windom, John H.; Blackburn, Scott R.; Truex, Matthew; Carolyn@Bruce Moskowitz,MD; Bruce Moskowitz Recurring: No ShowReminder: Yes ReminderMinutes: 15 ReminderTime: Wed Mar 21 14:45:00 Central Daylight Time 2018 Accepted: No M( H1( AN 000008 VERSIGHT VA-18-0298 and VA-18-0299-E-000033 Document ID: 0.7.1705.1217678 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Windom, John H. ; Blackburn, Scott R. ; Truex, Matthew ; Carolyn@Bruce Moskowitz,MD <(B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: Canceled: EHR VA Call Date: Wed Mar 14 2018 09:29:27 CDT Attachments: StartTime: Wed Mar 21 15:00:00 Central Daylight Time 2018 EndTime: Wed Mar 21 16:30:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Windom, John H.; Blackburn, Scott R.; Truex, Matthew; Carolyn@Bruce Moskowitz,MD; Bruce Moskowitz Recurring: No ShowReminder: No Accepted: No M( H1( AN 000009 VERSIGHT VA-18-0298 and VA-18-0299-E-000034 ( B 6 ) Document ID: 0.7.1705.1217684 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Windom, John H. ; Blackburn, Scott R. ; Truex, Matthew ; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: Canceled: EHR VA Call Date: Wed Mar 14 2018 09:29:27 CDT Attachments: StartTime: Wed Mar 21 15:00:00 Central Daylight Time 2018 EndTime: Wed Mar 21 16:30:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Windom, John H.; Blackburn, Scott R.; Truex, Matthew; Carolyn@Bruce Moskowitz,MD; Bruce Moskowitz Recurring: No ShowReminder: Yes ReminderMinutes: 15 ReminderTime: Wed Mar 21 14:45:00 Central Daylight Time 2018 Accepted: No M( H1( AN 000010 VERSIGHT VA-18-0298 and VA-18-0299-E-000035 Document ID: 0.7.1705.1218053 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz (B6) @mac.com>; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; IP (B6) @frenchangel59.com>; Stephanie (B6) Reel jhu.edu>; Mary Riordan (B6) @jhu.edu>; Ashley (B6) Johnson @jhmi.edu>; Callaghan, Elizabeth ; Rasu Shrestha (B6) @gmail.com>; Manis, Jonathan (Jon) (B6) @sutterhealth.org>; Shrestha, Rasu B (B6) @upmc.edu>; Cooper, Leslie T., M.D. (B6) @mayo.edu>; Karson, Andrew Scott,M.D. (B6) @mgh.harvard.edu>; Zuccala, Kandace (Kandi) R. (B6) @sutterhealth.org> Cc: Clifford Ko(B6) @facs.org>; Mehwesh Khalid (B6) @facs.org>; Stan Huff (B6) @imail.org> Bcc: Subject: VA EHR Call Date: Sun Mar 18 2018 13:30:57 CDT Attachments: ?- - StartTime: Tue Mar 20 19:00:00 Central Daylight Time 2018 EndTime: Tue Mar 20 20:30:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Bruce Moskowitz; 'Carolyn@Bruce Moskowitz,MD'; Marc Sherman; IP; Stephanie Reel; Mary Riordan; 'Ashley Johnson'; Callaghan, Elizabeth; 'Rasu Shrestha'; Manis, Jonathan (Jon); 'Shrestha, Rasu B'; 'Cooper, Leslie T., M.D.'; Karson, Andrew Scott,M.D.; Zuccala, Kandace (Kandi) R. Recurring: No ShowReminder: Yes ReminderMinutes: 15 ReminderTime: Tue Mar 20 18:45:00 Central Daylight Time 2018 Accepted: No Scheduling POC: Liz Callaghan(B6) and Elizabeth.Callaghan@va.gov All, I am including everyone in the group in case anyone has any last minute scheduling changes. Thanks, Liz M( H1( AN 000011 VERSIGHT VA-18-0298 and VA-18-0299-E-000036 Document ID: 0.7.1705.1218045 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz <(B6) @mac.com>; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; IP(B6) @frenchangel59.com>; Stephanie (B6) Reel @jhu.edu>; Mary Riordan (B6) @jhu.edu>; Ashley (B6) Johnson @jhmi.edu>; Callaghan, Elizabeth ; Rasu Shrestha (B6) @gmail.com>; Manis, Jonathan (Jon) (B6) @sutterhealth.org>; Shrestha, Rasu B <(B6) @upmc.edu>; Cooper, Leslie T., M.D. (B6) @mayo.edu>; Karson, Andrew Scott,M.D. (B6) @mgh.harvard.edu>; Zuccala, Kandace (Kandi) R. (B6) @sutterhealth.org> Cc: Clifford Ko (B6) @facs.org>; Mehwesh Khalid(B6) @facs.org>; Stan Huff(B6) @imail.org> Bcc: Subject: VA EHR Call Date: Sun Mar 18 2018 13:30:57 CDT Attachments: ?- - StartTime: Tue Mar 20 19:00:00 Central Daylight Time 2018 EndTime: Tue Mar 20 20:30:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Bruce Moskowitz; 'Carolyn@Bruce Moskowitz,MD'; Marc Sherman; IP; Stephanie Reel; Mary Riordan; 'Ashley Johnson'; Callaghan, Elizabeth; 'Rasu Shrestha'; Manis, Jonathan (Jon); 'Shrestha, Rasu B'; 'Cooper, Leslie T., M.D.'; Karson, Andrew Scott,M.D.; Zuccala, Kandace (Kandi) R. Recurring: No ShowReminder: No Accepted: Yes AcceptedTime: Mon Mar 19 08:23:00 Central Daylight Time 2018 Scheduling POC: Liz Callaghan (B6) and Elizabeth.Callaghan@va.gov All, I am including everyone in the group in case anyone has any last minute scheduling changes. Thanks, Liz M( H1( AN 000012 VERSIGHT VA-18-0298 and VA-18-0299-E-000037 Document ID: 0.7.1705.1218050 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz <(B6) @mac.com>; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; IP (B6) @frenchangel59.com>; Stephanie (B6) Reel @jhu.edu>; Mary Riordan (B6) @jhu.edu>; Ashley (B6) Johnson < @jhmi.edu>; Callaghan, Elizabeth ; Rasu Shrestha (B6) @gmail.com>; Manis, Jonathan (Jon) (B6) @sutterhealth.org>; Shrestha, Rasu B (B6) @upmc.edu>; Cooper, Leslie T., M.D. (B6) @mayo.edu>; Karson, Andrew Scott,M.D. (B6) @mgh.harvard.edu>; Zuccala, Kandace (Kandi) R. (B6) @sutterhealth.org> Cc: Clifford Ko (B6) @facs.org>; Mehwesh Khalid (B6) @facs.org>; Stan Huff (B6) @imail.org> Bcc: Subject: VA EHR Call Date: Sun Mar 18 2018 13:30:57 CDT Attachments: ?- - StartTime: Tue Mar 20 19:00:00 Central Daylight Time 2018 EndTime: Tue Mar 20 20:30:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Bruce Moskowitz; 'Carolyn@Bruce Moskowitz,MD'; Marc Sherman; IP; Stephanie Reel; Mary Riordan; 'Ashley Johnson'; Callaghan, Elizabeth; 'Rasu Shrestha'; Manis, Jonathan (Jon); 'Shrestha, Rasu B'; 'Cooper, Leslie T., M.D.'; Karson, Andrew Scott,M.D.; Zuccala, Kandace (Kandi) R. Recurring: No ShowReminder: Yes ReminderMinutes: 15 ReminderTime: Tue Mar 20 18:45:00 Central Daylight Time 2018 Accepted: Yes AcceptedTime: Mon Mar 19 08:23:00 Central Daylight Time 2018 Scheduling POC: Liz Callaghan (B6) and Elizabeth.Callaghan@va.gov All, I am including everyone in the group in case anyone has any last minute scheduling changes. Thanks, Liz M( H1( AN 000013 VERSIGHT VA-18-0298 and VA-18-0299-E-000038 Document ID: 0.7.1705.1218129 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz (B6) @mac.com>; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman <(B6) @gmail.com>; IP (B6) @frenchangel59.com>; Foster, Michele (SES) ; Nostrant, David K. ; Draper, Anne ; Zenooz, Ashwini ; Short, John (VACO) ; Myklegard, Drew ; Callaghan, Elizabeth ; Cooper, Leslie T., M.D. (B6) @mayo.edu> Cc: Bcc: Subject: VA EHR Call Date: Mon Mar 19 2018 12:32:31 CDT Attachments: StartTime: Tue Mar 20 18:30:00 Central Daylight Time 2018 EndTime: Tue Mar 20 19:00:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Bruce Moskowitz; 'Carolyn@Bruce Moskowitz,MD'; Marc Sherman; IP; Foster, Michele (SES); Nostrant, David K.; Draper, Anne; Zenooz, Ashwini; Short, John (VACO); Myklegard, Drew; Callaghan, Elizabeth; Cooper, Leslie T., M.D. Recurring: No ShowReminder: Yes ReminderMinutes: 15 ReminderTime: Tue Mar 20 18:15:00 Central Daylight Time 2018 Accepted: Yes AcceptedTime: Tue Mar 20 18:28:12 Central Daylight Time 2018 All, Dr. Cooper will not be able to participate in the entire session so we are going to start at 7:30PM to get feedback from Dr. Cooper. Thanks, Liz Scheduling POC: Liz Callaghan (B6) Elizabeth.Callaghan@va.gov M( H1( AN 000014 VERSIGHT VA-18-0298 and VA-18-0299-E-000039 Document ID: 0.7.1705.1218127 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz <(B6) @mac.com>; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; IP (B6) @frenchangel59.com>; Foster, Michele (SES) ; Nostrant, David K. ; Draper, Anne ; Zenooz, Ashwini ; Short, John (VACO) ; Myklegard, Drew ; Callaghan, Elizabeth ; Cooper, Leslie T., M.D. (B6) @mayo.edu> Cc: Bcc: Subject: VA EHR Call Date: Mon Mar 19 2018 12:32:31 CDT Attachments: StartTime: Tue Mar 20 18:30:00 Central Daylight Time 2018 EndTime: Tue Mar 20 19:00:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Bruce Moskowitz; 'Carolyn@Bruce Moskowitz,MD'; Marc Sherman; IP; Foster, Michele (SES); Nostrant, David K.; Draper, Anne; Zenooz, Ashwini; Short, John (VACO); Myklegard, Drew; Callaghan, Elizabeth; Cooper, Leslie T., M.D. Recurring: No ShowReminder: No Accepted: Yes AcceptedTime: Tue Mar 20 18:28:12 Central Daylight Time 2018 All, Dr. Cooper will not be able to participate in the entire session so we are going to start at 7:30PM to get feedback from Dr. Cooper. Thanks, Liz Scheduling POC: Liz Callaghan (B6) Elizabeth.Callaghan@va.gov M( H1( AN 000015 VERSIGHT VA-18-0298 and VA-18-0299-E-000040 Document ID: 0.7.1705.1219373 From: Bruce Moskowitz (B6) @mac.com> Marc Sherman @gmail.com> Truex, Matthew ; Blackburn, Scott R. ; IP (B6) @frenchangel59.com>; Laura Perlmutter (B6) @gmail.com>; Windom, John H. ; Callaghan, Elizabeth (B6) To: Cc: - ? Bcc: Subject: Date: Attachments: Re: [EXTERNAL] Re: VHA EHR - 2 calls that my assistant will set up Thu Mar 15 2018 10:10:19 CDT image001.jpg Thank you just received Sent from my iPad Bruce Moskowitz M.D. - On Mar 15, 2018, at 11:08 AM, Marc Sherman <(B6) @gmail.com> wrote: Thanks Matt. On Mar 15, 2018 8:01 AM, "Truex, Matthew" wrote: Mr. Sherman - The notice was just resent to Dr. Moskowitz. He should receive an email from the following address, usarmy.redstone.rdecom-amrdec.-mbx.safe-team@mail.mil. Thanks, Matt Matthew Truex Contracting Officer Department of Veterans Affairs M( HI( AN 000016 VERSIGHT VA-18-0298 and VA-18-0299-E-000041 Office of Procurement, Acquisition and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724 Office: (B6) Mobile: (B6) e-mail: matthew.truex@va.gov "For Internal VA Use Only - Working Draft, Pre-Decisional, Deliberative Document: This e-mail and any attachments are intended only for the use of the addressee(s) named herein and may contain privileged and/or confidential information. If you are not the intended recipient of this e-mail, you are hereby notified that any dissemination, distribution or copying of this e-mail, and any attachments thereto, is strictly prohibited. If you have received this e-mail in error, please notify me via return e-mail or telephone (732) 440-9650, and permanently delete the original and any copy of any e-mail and any printout thereof." - From: Marc Sherman [mailto(B6) @gmail.com] Sent: Thursday, March 15, 2018 10:54 AM To: Blackburn, Scott R. Cc: IP; Laura Perlmutter; Bruce Moskowitz; Truex, Matthew; Windom, John H.; Callaghan, Elizabeth Subject: [EXTERNAL] Re: VHA EHR - 2 calls that my assistant will set up Scott and Matt I received a document download email with a password from AMRDEC Safe Access File Exchange However, Bruce has not received a similar email. Can you please get that to him? Marc M( HI( AN 000017 VERSIGHT VA-18-0298 and VA-18-0299-E-000042 On Mar 13, 2018 2:04 PM, "Blackburn, Scott R." wrote: Marc/Bruce/Ike - thank you so much for the prompt replies. I just spoke to Bruce. We've got 100% participation (Stephanie Reel, Stan Huff, Jon Manis, Dr. Ko, Dr Karson, Dr. Cooper, and Dr. Shretha) and we are moving forward. Matt Truex (cc'd, our contracting officer) is making sure everyone has the right material. Liz (my assistant, cc'd here) will be organizing a few phone calls in 2 steps: Step 1 - Basic orientation to the government contract structure. This will be a 30-45 minute orientation so that folks know what they are looking at. John Windom and Matt Truex will host this and clue people into the parts to focus on and parts that are standard government things that are less relevant. This can be done in groups (ideally) or in one-offs to fit to accommodate people's busy schedules. Liz has already scheduled 2 times in case these work for you. If they do not, she will work with your schedulers to find other times in the next 24-48 hours (sooner the better). * Thursday 8:30-9:15am ET - Stephanie Reel confirmed * Thursday 11:30am-12:15pm ET - Stan Huff confirmed Step 2 - Feedback calls. Per Bruce's idea, we'll schedule 2 separate feedback calls for early next week. Both 90 minutes each. We are aiming for Monday, Tuesday or Wednesday at the latest. Liz will set these up. * CIOs (Reel, Huff, Manis, Shretha - and of course each of you are encouraged to join) * Doctors (Dr. Karson, Dr. Ko, and Dr. Cooper - and of course each of you are encouraged to join) Let me know how this sounds. Thank you again for your support and assistance on this critical matter. Scott - From: Marc Sherman [mailto:(B6) @gmail.com] Sent: Tuesday, March 13, 2018 1:40 PM To: Blackburn, Scott R. Cc: IP;(B6) @gmail.com; Bruce Moskowitz; Truex, Matthew; Windom, John H.; DJS Subject: [EXTERNAL] Re: VA EHR NDA - M( HI( AN 000018 VERSIGHT VA-18-0298 and VA-18-0299-E-000043 Scott, Matt and John Thank you for the NDA draft that you sent along and the organized approach. I have attached the following to close the loop: 1.a marked up version of the NDA with a few necessary adjustments in red-line so you can see the changes that were made, 2.a blank copy of the amended NDA for Bruce and Ike to sign, and 3.a signed version by me of the amended NDA. Thanks and happy to help as requested. Marc On Tue, Mar 13, 2018 at 10:31 AM, Blackburn, Scott R. wrote: Ike, Bruce, Marc: Thank each of you for agreeing to lend an extra set of outside eyes on the EHR contract. We appreciate your support and want to make sure we get to the best place possible for Veterans, the country and taxpayers. As we are incredibly grateful to you for volunteering your time, we want to make this as easy as possible for you. Here are 3 next steps. 1) We will need you to sign the attached NDA. Please return to Matt Truex (cc'd). 2) Matt will then send you the latest package under separate cover. 3) Given government contracts are different than what you are used to reading, we would propose a quick phone call so that we can orient you to the contract and help focus you on the parts where your expertise will be most valuable. Matt Truex (who is the government contracting officer) and John Windom (who is our EHR leader) will lead this from our side. I will ask Liz Callaghan (cc'd) here to help set up a time. We can either do this all together, if calendars match up, or separately if need be. We have also connected with Stephanie Reel, Stan Huff, Dr. Karson, Dr. Ko, Dr. Shretha, and Jon Manis who all have all received the NDA and we are working with them. I am hoping to connect with Dr. Cooper today. Thanks again! Scott M( HI( AN 000019 VERSIGHT VA-18-0298 and VA-18-0299-E-000044 Scott Blackburn Acting CIO & Executive-in-Charge, Office of Information & Technology Department of Veterans Affairs M( H1( AN 000020 VERSIGHT VA-18-0298 and VA-18-0299-E-000045 Document ID: 0.7.1705.1219373-000001 Owner: Bruce Moskowitz <(B6) Filename: image001.jpg Last Modified: Thu Mar 15 10:10:19 CDT 2018 @mac.com> M( H1( AN 000021 VERSIGHT VA-18-0298 and VA-18-0299-E-000046 Document ID: 0.7.1705.1219519 From: Callaghan, Elizabeth To: Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman <(B6) Cc: Truex, Matthew ; Windom, John H. Bcc: Subject: FW: [EXTERNAL] Re: EHR VA Call Date: Thu Mar 15 2018 13:27:32 CDT Attachments: - @gmail.com> Good afternoon, Per Dr. Moskowitz we are looking to get all 7 folks on a call at the same time. Would you be able to tell me what times are available on Monday afternoon, Tuesday before 1PM or Wednesday? I will go from there. Thanks, Liz _____ From: Bruce Moskowitz Sent: Thursday, March 15, 2018 1:27:32 PM To: Windom, John H.; Blackburn, Scott R.; Truex, Matthew Cc: (B6) @gmail.com; IP; O'Rourke, Peter M. Subject: [EXTERNAL] Re: EHR VA Call - I want to make sure we are all in agreement of how this is structured. Marc and I want to be on every call that the group is on to discuss the contract. The whole group needs to be on the same call so we all give input to the whole contract and hear the same considerations and comments. Let me know if there is any discrepancy to this. Thank you Sent from my iPad Bruce Moskowitz M.D. On Mar 15, 2018, at 12:28 PM, VA CIO Executive Schedule wrote: M( HI( AN 000023 VERSIGHT VA-18-0298 and VA-18-0299-E-000048 000024 and Document ID: 0.7.1705.1218888 From: VA CIO Executive Schedule To: Windom, John H. ; Blackburn, Scott R. ; Truex, Matthew ; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: EHR VA Call Date: Thu Mar 15 2018 11:28:02 CDT Attachments: M( H1( AN 000025 VERSIGHT VA-18-0298 and VA-18-0299-E-000050 Document ID: 0.7.1705.1217996 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Truex, Matthew ; Blackburn, Scott R. ; Windom, John H. ; Carolyn@Bruce Moskowitz,MD <(B6) @gmail.com>; Marc Sherman <(B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: VA EHR Call Date: Thu Mar 15 2018 10:23:07 CDT Attachments: StartTime: Mon Mar 19 11:00:00 Central Daylight Time 2018 EndTime: Mon Mar 19 11:45:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Truex, Matthew; Blackburn, Scott R.; Windom, John H.; Carolyn@Bruce Moskowitz,MD; Marc Sherman; Bruce Moskowitz Recurring: No ShowReminder: Yes ReminderMinutes: 15 ReminderTime: Mon Mar 19 10:45:00 Central Daylight Time 2018 Accepted: Yes AcceptedTime: Mon Mar 19 08:45:00 Central Daylight Time 2018 M( H1( AN 000026 VERSIGHT VA-18-0298 and VA-18-0299-E-000051 Document ID: 0.7.1705.1217995 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Truex, Matthew ; Blackburn, Scott R. ; Windom, John H. ; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: VA EHR Call Date: Thu Mar 15 2018 10:23:07 CDT Attachments: StartTime: Mon Mar 19 11:00:00 Central Daylight Time 2018 EndTime: Mon Mar 19 11:45:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Truex, Matthew; Blackburn, Scott R.; Windom, John H.; Carolyn@Bruce Moskowitz,MD; Marc Sherman; Bruce Moskowitz Recurring: No ShowReminder: Yes ReminderMinutes: 15 ReminderTime: Mon Mar 19 10:45:00 Central Daylight Time 2018 Accepted: No M( H1( AN 000027 VERSIGHT VA-18-0298 and VA-18-0299-E-000052 Document ID: 0.7.1705.1217992 From: VA CIO Executive Schedule To: VA CIO Executive Schedule ; Truex, Matthew ; Blackburn, Scott R. ; Windom, John H. ; Carolyn@Bruce Moskowitz,MD <(B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: VA EHR Call Date: Thu Mar 15 2018 10:23:07 CDT Attachments: StartTime: Mon Mar 19 11:00:00 Central Daylight Time 2018 EndTime: Mon Mar 19 11:45:00 Central Daylight Time 2018 Location: 1-800-767-1750,22712# Invitees: Truex, Matthew; Blackburn, Scott R.; Windom, John H.; Carolyn@Bruce Moskowitz,MD; Marc Sherman; Bruce Moskowitz Recurring: No ShowReminder: No Accepted: Yes AcceptedTime: Mon Mar 19 08:45:00 Central Daylight Time 2018 M( H1( AN 000028 VERSIGHT VA-18-0298 and VA-18-0299-E-000053 Document ID: 0.7.1705.1220026 From: Callaghan, Elizabeth To: Stephanie Reel (B6) @jhu.edu>; Stan Huff (B6) @imail.org>; Manis, Jonathan (Jon) (B6) @sutterhealth.org>;(B6) @facs.org (B6) @facs.org>; Cooper, Leslie T., M.D. <(B6) @mayo.edu>; Karson, Andrew Scott,M.D. (B6) @mgh.harvard.edu>; Shrestha, Rasu B (B6) @upmc.edu>; Rasu Shrestha (B6) @gmail.com> Cc: Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz <(B6) @mac.com>; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Ashley Johnson (B6) @jhmi.edu>; Mary Riordan (B6) @jhu.edu>; Mehwesh (B6) Khalid @facs.org>; Marc Sherman (B6) @gmail.com>; IP(B6) @frenchangel59.com> Bcc: Subject: Scheduling a Call Regarding Feedback on VA EHR Date: Thu Mar 15 2018 18:26:32 CDT Attachments: .... - -,,,#- - Good evening, We would like to schedule a call in the next few days to share feedback on the VA EHR contract. I have been corresponding with many of you on different dates and times next week, but we are going to schedule the call for either Sunday 3/18 at 4PM EST, Monday 3/19 at 4PM EST or Tuesday 3/20 at 4PM EST. Please let me know which date will work best for your schedule. Feel free to call me with any questions and I look forward to hearing from you. Thank you, Liz Elizabeth M. Callaghan Executive Assistant to the Assistant Secretary Office of Information and Technology US Department of Veterans Affairs Desk: (B6) M( HI( AN 000029 VERSIGHT VA-18-0298 and VA-18-0299-E-000054 Cem? 000030 and Document ID: 0.7.1705.1220029 From: Bruce Moskowitz <(B6) @mac.com> To: Callaghan, Elizabeth Cc: Stephanie Reel (B6) @jhu.edu>; Stan Huff (B6) @imail.org>; Manis, Jonathan (Jon) (B6) @sutterhealth.org>;(B6) @facs.org (B6) @facs.org>; Cooper, Leslie T., M.D. (B6) @mayo.edu>; Karson, Andrew Scott,M.D. (B6) @mgh.harvard.edu>; Shrestha, Rasu B <(B6) @upmc.edu>; Rasu Shrestha (B6) @gmail.com>; Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Ashley Johnson (B6) @jhmi.edu>; Mary Riordan (B6) @jhu.edu>; Mehwesh Khalid (B6) @facs.org>; Marc Sherman (B6) @gmail.com>; IP (B6) @frenchangel59.com> Bcc: Subject: [EXTERNAL] Re: Scheduling a Call Regarding Feedback on VA EHR Date: Thu Mar 15 2018 18:27:17 CDT Attachments: .,.- - - All work for me Sent from my iPad Bruce Moskowitz M.D. On Mar 15, 2018, at 7:26 PM, Callaghan, Elizabeth wrote: Good evening, We would like to schedule a call in the next few days to share feedback on the VA EHR contract. I have been corresponding with many of you on different dates and times next week, but we are going to schedule the call for either Sunday 3/18 at 4PM EST, Monday 3/19 at 4PM EST or Tuesday 3/20 at 4PM EST. Please let me know which date will work best for your schedule. Feel free to call me with any questions and I look forward to hearing from you. Thank you, Liz M( HI( AN 000031 VERSIGHT VA-18-0298 and VA-18-0299-E-000056 Elizabeth M. Callaghan Executive Assistant to the Assistant Secretary Office of Information and Technology US Department of Veterans Affairs Desk: (B6) Cell: (B6) M( H1( AN 000032 VERSIGHT VA-18-0298 and VA-18-0299-E-000057 Document ID: 0.7.1705.1219966 From: Marc Sherman (B6) @gmail.com> To: Carolyn@Bruce Moskowitz,MD <(B6) @gmail.com> Cc: Callaghan, Elizabeth ; Truex, Matthew ; Windom, John H. Bcc: Subject: Re: FW: [EXTERNAL] Re: EHR VA Call Date: Thu Mar 15 2018 14:34:27 CDT Attachments: I am available on Monday March 19th at either noon or at 4pm (but only until 6 p.m) and on Tuesday March 20th at 4 p.m. (but not at noon). Marc Sherman (B6) On Mar 15, 2018 12:04 PM, "Carolyn@Bruce Moskowitz,MD" (B6) @gmail.com> wrote: Dr. Moskowitz prefers to keep the calls at Noon or 4:00 pm. He would be available Monday (3/19) or Tuesday(3/20) at those times. On Thu, Mar 15, 2018 at 2:27 PM, Callaghan, Elizabeth wrote: Good afternoon, Per Dr. Moskowitz we are looking to get all 7 folks on a call at the same time. Would you be able to tell me what times are available on Monday afternoon, Tuesday before 1PM or Wednesday? I will go from there. Thanks, Liz _____ From: Bruce Moskowitz Sent: Thursday, March 15, 2018 1:27:32 PM To: Windom, John H.; Blackburn, Scott R.; Truex, Matthew Cc:(B6) @gmail.com; IP; O'Rourke, Peter M. Subject: [EXTERNAL] Re: EHR VA Call - I want to make sure we are all in agreement of how this is structured. Marc and I want to be on every call that the group is on to discuss the contract. The whole group needs to be on the same call so we all M( HI( AN 000033 VERSIGHT VA-18-0298 and VA-18-0299-E-000058 give input to the whole contract and hear the same considerations and comments. Let me know if there is any discrepancy to this. Thank you Sent from my iPad Bruce Moskowitz M.D. On Mar 15, 2018, at 12:28 PM, VA CIO Executive Schedule wrote: -(B6) Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Farris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116 x(B6) Fax: 561-833-6351 - M( H1( AN 000034 VERSIGHT VA-18-0298 and VA-18-0299-E-000059 Document ID: 0.7.1705.1219931 From: Carolyn@Bruce Moskowitz,MD (B6) @gmail.com> To: Callaghan, Elizabeth Cc: Marc Sherman (B6) @gmail.com>; Truex, Matthew ; Windom, John H. Bcc: Subject: Re: FW: [EXTERNAL] Re: EHR VA Call Date: Thu Mar 15 2018 14:03:58 CDT Attachments: Dr. Moskowitz prefers to keep the calls at Noon or 4:00 pm. He would be available Monday (3/19) or Tuesday(3/20) at those times. On Thu, Mar 15, 2018 at 2:27 PM, Callaghan, Elizabeth wrote: Good afternoon, Per Dr. Moskowitz we are looking to get all 7 folks on a call at the same time. Would you be able to tell me what times are available on Monday afternoon, Tuesday before 1PM or Wednesday? I will go from there. Thanks, Liz _____ From: Bruce Moskowitz Sent: Thursday, March 15, 2018 1:27:32 PM To: Windom, John H.; Blackburn, Scott R.; Truex, Matthew Cc: (B6) @gmail.com; IP; O'Rourke, Peter M. Subject: [EXTERNAL] Re: EHR VA Call - I want to make sure we are all in agreement of how this is structured. Marc and I want to be on every call that the group is on to discuss the contract. The whole group needs to be on the same call so we all give input to the whole contract and hear the same considerations and comments. Let me know if there is any discrepancy to this. Thank you Sent from my iPad Bruce Moskowitz M.D. On Mar 15, 2018, at 12:28 PM, VA CIO Executive Schedule wrote: M( HI( AN 000035 VERSIGHT VA-18-0298 and VA-18-0299-E-000060 -(B6) Patient Care Coordinator Dr. Bruce Moskowitz, MD Victor Farris Medical Building 1411 North Flagler Drive Suite 7100 West Palm Beach, FL 33401 Phone: 561-833-6116(B6) Fax: 561-833-6351 - M( H1( AN 000036 VERSIGHT VA-18-0298 and VA-18-0299-E-000061 Document ID: 0.7.1705.1219379 From: VA CIO Executive Schedule To: Truex, Matthew ; Blackburn, Scott R. ; Windom, John H. ; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: VA EHR Call Date: Thu Mar 15 2018 10:23:05 CDT Attachments: M( H1( AN 000037 VERSIGHT VA-18-0298 and VA-18-0299-E-000062 Document ID: 0.7.1705.1219329 From: Bruce Moskowitz (B6) @mac.com> Windom, John H. ; Blackburn, Scott R. IP (B6) @frenchangel59.com>; (B6) @gmail.com <(B6) @gmail.com> To: Cc: Bcc: Subject: Date: Attachments: _._ - [EXTERNAL] EMR documents Thu Mar 15 2018 09:51:08 CDT I still have not received the EMR documents to review. You have my NDA. Please send ASAP. I am a reasonable speed reader so you can include all pages. Sent from my iPad Bruce Moskowitz M.D. M( H1( AN 000038 VERSIGHT VA-18-0298 and VA-18-0299-E-000063 Document ID: 0.7.1705.1221459 From: Callaghan, Elizabeth To: Stephanie Reel (B6) @jhu.edu>; Stan Huff (B6) @imail.org>; (B6) @facs.org (B6) @facs.org>; Cooper, Leslie T., M.D. (B6) @mayo.edu>; Karson, Andrew Scott,M.D. (B6) @mgh.harvard.edu>; Shrestha, Rasu B (B6) @upmc.edu>; Rasu Shrestha (B6) @gmail.com> Cc: Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz (B6) @mac.com>; Carolyn@Bruce Moskowitz,MD <(B6) @gmail.com>; Ashley Johnson (B6) @jhmi.edu>; Mary Riordan (B6) @jhu.edu>; Mehwesh (B6) Khalid @facs.org>; Marc Sherman <(B6) @gmail.com>; IP (B6) @frenchangel59.com> Bcc: Subject: RE: Scheduling a Call Regarding Feedback on VA EHR Date: Fri Mar 16 2018 12:05:45 CDT Attachments: -- - Good afternoon, A friendly reminder to please let me know which date works best for your schedule. Please feel free to call me with any questions. Thank you, Liz From: Callaghan, Elizabeth Sent: Thursday, March 15, 2018 7:27 PM To: Stephanie Reel; 'Stan Huff'; 'Manis, Jonathan (Jon)'; (B6) @facs.org'; 'Cooper, Leslie T., M.D.'; 'Karson, Andrew Scott,M.D.'; 'Shrestha, Rasu B'; 'Rasu Shrestha' Cc: Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Bruce Moskowitz; 'Carolyn@Bruce Moskowitz,MD'; 'Ashley Johnson'; Mary Riordan; 'Mehwesh Khalid'; Marc Sherman; IP Subject: Scheduling a Call Regarding Feedback on VA EHR - Good evening, M( HI( AN 000039 VERSIGHT VA-18-0298 and VA-18-0299-E-000064 We would like to schedule a call in the next few days to share feedback on the VA EHR contract. I have been corresponding with many of you on different dates and times next week, but we are going to schedule the call for either Sunday 3/18 at 4PM EST, Monday 3/19 at 4PM EST or Tuesday 3/20 at 4PM EST. Please let me know which date will work best for your schedule. Feel free to call me with any questions and I look forward to hearing from you. Thank you, Liz Elizabeth M. Callaghan Executive Assistant to the Assistant Secretary Office of Information and Technology US Department of Veterans Affairs Desk: (B6) Cell: 2(B6) M( H1( AN 000040 VERSIGHT VA-18-0298 and VA-18-0299-E-000065 Document ID: 0.7.1705.1223600 From: VA CIO Executive Schedule To: Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz <(B6) @mac.com>; Carolyn@Bruce Moskowitz,MD <(B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; IP (B6) @frenchangel59.com>; Foster, Michele (SES) ; Nostrant, David K. ; Draper, Anne ; Zenooz, Ashwini ; Short, John (VACO) ; Myklegard, Drew ; Callaghan, Elizabeth ; Cooper, Leslie T., M.D.(B6) @mayo.edu> Cc: Bcc: Subject: VA EHR Call Date: Mon Mar 19 2018 12:32:29 CDT Attachments: All, Dr. Cooper will not be able to participate in the entire session so we are going to start at 7:30PM to get feedback from Dr. Cooper. Thanks, Liz Scheduling POC: Liz Callaghan (B6) Elizabeth.Callaghan@va.gov M( H1( AN 000041 VERSIGHT VA-18-0298 and VA-18-0299-E-000066 Document ID: 0.7.1705.1224124 From: Bruce Moskowitz (B6) Cc: @mac.com> Blackburn, Scott R. Marc Sherman (B6) @gmail.com>; Windom, John H. ; Callaghan, Elizabeth Bcc: Subject: Date: Attachments: [EXTERNAL] Re: Dr. Coooper - Cloud expertise Mon Mar 19 2018 16:59:25 CDT To: Perfect Sent from my iPad Bruce Moskowitz M.D. On Mar 19, 2018, at 2:45 PM, Blackburn, Scott R. wrote: FYI. Dr. Cooper's time tomorrow night is limited (he will be in between flights). Given he is a "single issue" guy; we are going to start the call at 7:30 and cover the Cloud issue from 7:30-8pm ET before everyone else joins at 8pm ET. I think we will have everyone except Stan Huff and Dr. Ko on the call. Liz is working a time on Wednesday to get them on a call. Scott From: Blackburn, Scott R. Sent: Monday, March 19, 2018 2:40 PM To: Callaghan, Elizabeth; Cooper, Leslie T., M.D. Cc: Windom, John H.; Truex, Matthew; Short, John (VACO) Subject: RE: [EXTERNAL] VA EHR Call Update Thank you, Dr. Cooper. Dr. Moskowitz mentioned very specifically to me that we should get your perspective on cloud so that we know we have that part correct. I am thinking we cover that issue from 7:30-8pm ET before others join at 8pm. Thank you again for the support. M( HI( AN 000042 VERSIGHT VA-18-0298 and VA-18-0299-E-000067 Scott From: Callaghan, Elizabeth Sent: Monday, March 19, 2018 1:38 PM To: Cooper, Leslie T., M.D. Cc: Blackburn, Scott R.; Windom, John H.; Truex, Matthew Subject: RE: [EXTERNAL] VA EHR Call Update Dr. Cooper, thank you for your response. I have sent two outlook invites, one starting at 7:30PM EST for you to participate in as well as the 8PM EST with the group. Please let me know if you have any questions. Thanks, Liz From: Cooper, Leslie T., M.D. [mailto(B6) @mayo.edu] Sent: Saturday, March 17, 2018 9:36 PM To: Callaghan, Elizabeth Cc: Blackburn, Scott R.; Windom, John H.; Truex, Matthew Subject: Re: [EXTERNAL] VA EHR Call Update Importance: High Tuesday I am in Rochester, MN. Meetings 10:30-2:00 and a 4 pm flight to Atlanta. If the call needs to be Tuesday, I have a layover in ATL 7:05-8:48 pm. Could I call in as soon as I land? Wednesday I could make a call after 6:30 pm. Leslie From: "Callaghan, Elizabeth" Date: Saturday, March 17, 2018 at 12:13 PM To: "Cooper , Leslie T., M.D." (B6) @mayo.edu> Cc: "Blackburn, Scott R." , "Windom, John H." , Matthew Truex Subject: [EXTERNAL] VA EHR Call Update Good afternoon Dr. Cooper, M( HI( AN 000043 VERSIGHT VA-18-0298 and VA-18-0299-E-000068 I hope you are having a nice weekend! Sorry for the extra email but we are having trouble finding a time that works for everyone. Right now, Tuesday evening seems to be the best time. If we made the call later on Tuesday starting at 5pm, 6pm, 7pm or 8pm ET would you be able to make that work? Thanks again! Liz Elizabeth M. Callaghan Executive Assistant to the Assistant Secretary Office of Information and Technology US Department of Veterans Affairs Desk: (B6) Cell: (B6) M( H1( AN 000044 VERSIGHT VA-18-0298 and VA-18-0299-E-000069 Document ID: 0.7.1705.1223957 From: Blackburn, Scott R. To: Bruce Moskowitz <(B6) @mac.com>; Marc Sherman <(B6) @gmail.com> Cc: Windom, John H. ; Callaghan, Elizabeth Bcc: Subject: Dr. Coooper - Cloud expertise Date: Mon Mar 19 2018 13:45:08 CDT Attachments: - FYI. Dr. Cooper's time tomorrow night is limited (he will be in between flights). Given he is a "single issue" guy; we are going to start the call at 7:30 and cover the Cloud issue from 7:30-8pm ET before everyone else joins at 8pm ET. I think we will have everyone except Stan Huff and Dr. Ko on the call. Liz is working a time on Wednesday to get them on a call. Scott From: Blackburn, Scott R. Sent: Monday, March 19, 2018 2:40 PM To: Callaghan, Elizabeth; Cooper, Leslie T., M.D. Cc: Windom, John H.; Truex, Matthew; Short, John (VACO) Subject: RE: [EXTERNAL] VA EHR Call Update Thank you, Dr. Cooper. Dr. Moskowitz mentioned very specifically to me that we should get your perspective on cloud so that we know we have that part correct. I am thinking we cover that issue from 7:30-8pm ET before others join at 8pm. Thank you again for the support. Scott From: Callaghan, Elizabeth Sent: Monday, March 19, 2018 1:38 PM To: Cooper, Leslie T., M.D. Cc: Blackburn, Scott R.; Windom, John H.; Truex, Matthew Subject: RE: [EXTERNAL] VA EHR Call Update M( HI( AN 000045 VERSIGHT VA-18-0298 and VA-18-0299-E-000070 Dr. Cooper, thank you for your response. I have sent two outlook invites, one starting at 7:30PM EST for you to participate in as well as the 8PM EST with the group. Please let me know if you have any questions. Thanks, Liz From: Cooper, Leslie T., M.D. [mailto(B6) @mayo.edu] Sent: Saturday, March 17, 2018 9:36 PM To: Callaghan, Elizabeth Cc: Blackburn, Scott R.; Windom, John H.; Truex, Matthew Subject: Re: [EXTERNAL] VA EHR Call Update Importance: High Tuesday I am in Rochester, MN. Meetings 10:30-2:00 and a 4 pm flight to Atlanta. If the call needs to be Tuesday, I have a layover in ATL 7:05-8:48 pm. Could I call in as soon as I land? Wednesday I could make a call after 6:30 pm. Leslie From: "Callaghan, Elizabeth" Date: Saturday, March 17, 2018 at 12:13 PM To: "Cooper , Leslie T., M.D." <(B6) @mayo.edu> Cc: "Blackburn, Scott R." , "Windom, John H." , Matthew Truex Subject: [EXTERNAL] VA EHR Call Update Good afternoon Dr. Cooper, I hope you are having a nice weekend! Sorry for the extra email but we are having trouble finding a time that works for everyone. Right now, Tuesday evening seems to be the best time. If we made the call later on Tuesday starting at 5pm, 6pm, 7pm or 8pm ET would you be able to make that work? Thanks again! M( HI( AN 000046 VERSIGHT VA-18-0298 and VA-18-0299-E-000071 Liz Elizabeth M. Callaghan Executive Assistant to the Assistant Secretary Office of Information and Technology US Department of Veterans Affairs Desk: (B6) Cell:(B6) M( H1( AN 000047 VERSIGHT VA-18-0298 and VA-18-0299-E-000072 Document ID: 0.7.1705.1225558 From: Karson, Andrew Scott,M.D. (B6) @mgh.harvard.edu> To: VA CIO Executive Schedule ; Blackburn, Scott R. ; Windom, John H. ; Truex, Matthew ; Bruce Moskowitz (B6) @mac.com>; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Marc Sherman (B6) @gmail.com>; IP (B6) @frenchangel59.com>; Stephanie (B6) Reel @jhu.edu>; Mary Riordan (B6) @jhu.edu>; Ashley (B6) Johnson @jhmi.edu>; Callaghan, Elizabeth ; Rasu Shrestha (B6) @gmail.com>; Manis, Jonathan (Jon) (B6) @sutterhealth.org>; Shrestha, Rasu B (B6) @upmc.edu>; Cooper, Leslie T., M.D. (B6) @mayo.edu>; Zuccala, Kandace (Kandi) R. (B6) @sutterhealth.org> Cc: Clifford Ko (B6) @facs.org>; Mehwesh Khalid (B6) @facs.org>; Stan Huff(B6) @imail.org>; Karson, Andrew Scott,M.D. (B6) @mgh.harvard.edu> Bcc: Subject: [EXTERNAL] RE: VA EHR Call Date: Tue Mar 20 2018 17:04:17 CDT Attachments: - ?- -- Dear Matt, Liz, et al, I will be taking the call from my car as I drive from NY to Boston. I reviewed the documents and I have two lingering questions that I may figure out between now and our call, but I thought that I would send along while I still had email access: 1.How do users who are on the legacy system see data that will be in the new EHRM/Cerner product (during the transition phase; as some VA users will be on the legacy system and others will be on the new system) 2.Do we have a list of the actual medical devices for which there will be device data integration? (I tried to find that list, but cannot seem to find it on review.) I look forward to joining the call at 8pm. Thanks and best, Andy Karson -----Original Appointment----From: VA CIO Executive Schedule [mailto:vacocioexe@va.gov] 000048 VA-18-0298 and VA-18-0299-E-000073 Sent: Sunday, March 18, 2018 2:32 PM To: VA CIO Executive Schedule; Blackburn, Scott R.; Windom, John H.; Truex, Matthew; Bruce Moskowitz; 'Carolyn@Bruce Moskowitz,MD'; Marc Sherman; IP; Stephanie Reel; Mary Riordan; Ashley Johnson; Callaghan, Elizabeth; Rasu Shrestha; Manis, Jonathan (Jon); Shrestha, Rasu B; Cooper, Leslie T., M.D.; Karson, Andrew Scott,M.D.; Zuccala, Kandace (Kandi) R. Cc: Clifford Ko; Mehwesh Khalid; Stan Huff Subject: VA EHR Call When: Tuesday, March 20, 2018 8:00 PM-9:30 PM (UTC-05:00) Eastern Time (US & Canada). Where: 1-800-767-1750,22712# Scheduling POC: Liz Callaghan (B6) and Elizabeth.Callaghan@va.gov All, I am including everyone in the group in case anyone has any last minute scheduling changes. Thanks, Liz The information in this e-mail is intended only for the person to whom it is addressed. If you believe this e-mail was sent to you in error and the e-mail contains patient information, please contact the Partners Compliance HelpLine at http://www.partners.org/complianceline . If the e-mail was sent to you in error but does not contain patient information, please contact the sender and properly dispose of the e-mail. M( H1( AN 000049 VERSIGHT VA-18-0298 and VA-18-0299-E-000074 Document ID: 0.7.1705.1225173 From: VA CIO Executive Schedule To: Windom, John H. ; Blackburn, Scott R. ; Truex, Matthew ; Carolyn@Bruce Moskowitz,MD (B6) @gmail.com>; Bruce Moskowitz (B6) @mac.com> Cc: Bcc: Subject: Canceled: EHR VA Call Date: Tue Mar 20 2018 11:33:29 CDT Attachments: M( H1( AN 000050 VERSIGHT VA-18-0298 and VA-18-0299-E-000075 Document ID: 0.7.1705.1230567 From: Windom, John H. To: Zenooz, Ashwini Cc: Bcc: Subject: FW: Contract Language Date: Mon Apr 02 2018 08:52:25 CDT Attachments: Fyi. John H. Windom, Senior Executive Service (SES) Program Executive for Electronic Health Record Modernization (PEO EHRM) Special Advisor to the Under Secretary for Health 811 Vermont Avenue NW (5th Floor Suite 5080) Washington, DC 20420 John.Windom@va.gov Office: (B6) Mobile: (B6) Executive Assistant: (B6) (B6) @va.gov Office: Appointments and Scheduling (B6) From: Blackburn, Scott R. Sent: Monday, April 02, 2018 9:41 AM To: Sandoval, Camilo J. Cc: Windom, John H. Subject: RE: Contract Language M( HI( AN 000051 VERSIGHT VA-18-0298 and VA-18-0299-E-000076 Morris, Genevieve (OS/ONC/IO) (B6) @hhs.gov I don't think I have a phone number for her, but will let you know if I can find it. From: Sandoval, Camilo J. Sent: Monday, April 02, 2018 9:03 AM To: Blackburn, Scott R. Cc: Windom, John H. Subject: RE: Contract Language Scott,Do you have Genevieve's work email address and phone number? I need to contact her today and not sure where I can find her or if she at the VA yet. Thank you, Camilo _____ From: Blackburn, Scott R. Sent: Sunday, April 01, 2018 6:28:05 PM To: Sandoval, Camilo J. Cc: Windom, John H. Subject: RE: Contract Language Yep, I know Genevieve. She is good. Will give it some thought. Is she detailed in to VHA I assume? From: Sandoval, Camilo J. Sent: Sunday, April 01, 2018 8:39 PM To: Blackburn, Scott R. Cc: Windom, John H. Subject: RE: Contract Language Excellent, I'll touch base with Windom tomorrow morning. Also, there's someone by the name of Genevieve Morris from the Office of National Coordinator (ONC) joining the VA tomorrow on a 120 day detail. I believe she will be helping us review the contract as well, at least with regards to interoperability, and already working with the EHR team. Do you know (of) her? Any thoughts on how we might utilize her expertise in combination with Rasu, beyond just reviewing the Cerner contract? She seems to have a solid policy background in her respective space. Do you see Genevieve and Rasu working together to cover the policy and functional M( HI( AN 000052 VERSIGHT VA-18-0298 and VA-18-0299-E-000077 aspects of Interoperability? Camilo _____ From: Blackburn, Scott R. Sent: Sunday, April 01, 2018 4:38:47 PM To: Sandoval, Camilo J. Cc: Windom, John H. Subject: RE: Contract Language Not sure we did. John? What he might be talking about is the feedback from the calls we had 2 weeks ago. I believe John and team have created a thorough matrix to reconcile that feedback (and Ash did follow ups with each to make sure we understood their feedback and then understood how we were reconciling that feedback). There was also the language that we received via OGC. I'll leave it to John to weigh in. From: Sandoval, Camilo J. Sent: Sunday, April 01, 2018 7:35 PM To: Blackburn, Scott R. Cc: Windom, John H. Subject: Re: Contract Language Scott, I just spoke with Bruce Moskowitz regarding where things are with EHR and he mentioned you recently received language provided by several CIOs (Leslie Cooper, Stan Huff, Stephanie Reel, Jonathan Manis). Could you kindly forward me those emails and documents? I believe it was in regards to interoperability. Hope you had a great Easter Sunday. Thank you. Camilo M( H1( AN 000053 VERSIGHT VA-18-0298 and VA-18-0299-E-000078