HITSC Update Precision Medicine Task Force August 31, 2015 Leslie Kelly Hall, Co-Chair Jon White, Co-Chair.

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HITSC Update Precision Medicine Task Force August 31, 2015 Leslie Kelly Hall, Co-Chair Jon White, Co-Chair

Precision Medicine Task Force Membership MemberOrganization Co-Chairs Leslie Kelly HallHealthwise Jon WhiteONC / Agency for Healthcare Research and Quality (AHRQ) Members Mary BartonNational Committee for Quality Assurance (NCQA) Lisa GallagherHealthcare Information and Management Systems Society (HIMSS) David McCallie, Jr.Cerner Corporation Andrey OstrovskyCare at Hand Eric RoseIntelligent Medical Objects Andrew WiesenthalDeloitte Consulting, LLP Federal Ex Officio James BreelingVeterans Health Administration (VHA) Josh DennyNational Institutes of Health (NIH) Christina HeideHHS Office for Civil Rights (OCR) Betsy HumphreysNational Library of Medicine (NLM) Mitra RoccaFood and Drug Administration (FDA) Invited Guests Mina HsiangUnited States Digital Service (USDS) / Office of Management and Budget (OMB) Claudia WilliamsWhite House Office of Science & Technology Policy ONC Staff Maya UppaluruONC – Federal Staff Lead Debbie BucciONC - Technical Advisor 1

Precision Medicine Initiative Mission Statement To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized treatments. 2

Task Force Charge Identify opportunities for innovative collaboration around pilots and testing of standards that support health IT interoperability for precision medicine Recommend existing standards that are currently ready to support PMI Identify emerging standards and reference implementations that may require further pilot testing in order to support PMI Identify gaps in available data standards related to PMI 3

MeetingsTask July 17, :00 am - 1:30 pm ET Kick-off Meeting Review charge, work plan Overview of the Precision Medicine Initiative - White House Office of Science & Technology Policy & National Institutes of Health Wednesday July 29, :30 - 3:00 pm ET Presentations from experts - 23andMe; NIH Precision Medicine Workshop; Institute of Medicine Genomics Roundtable Wednesday August 5, :00 - 1:30 pm ET Presentations from experts - Intel Corporation; Intermountain Healthcare; National Library of Medicine Wednesday August 19, :00 - 1:30 pm ET Presentations from experts o Duke Me Tree Project o eMerge Network o New York Genome Center o Sage Bionetworks Monday August 31, :00 - 1:30 pm ET Develop Preliminary Task Force Recommendations Thursday September 10, :30 - 3:00 pm ET Finalize recommendations to HITSC September 22, 2015 – HITSC Meeting Present final recommendations Precision Medicine Task Force Workplan 4

Focus and Questions for Presenters 5 Focus The exchange of genomic and phenomic data among: – Patients/Participants – EHRs – Researchers – Testing labs (for both research and clinical care) Questions for Presenters What is the key problem or set of problems your organization is attempting to solve? What is the minimum interoperable data set of genome and phenome data for these data exchanges? Are there standards that can support this movement today? What gaps are there and what is needed in the future?

Overview of Presentations 6 White House Office of Science & Technology Policy and National Institutes of Health 23andMe IOM Genomics Roundtable Intel Corporation Intermountain Healthcare National Library of Medicine Duke Sage Bionetworks eMERGE New York Genome Center

Overview of Presentations 7 Major challenges and topics: Patient access and return of study results Electronic consent Privacy, security, and de-identification of data Minimum set of EHR/clinical data needed to support scientific inquiry Representation of genomic and family history data in the EHR for primary care and how to implement clinical decision support, pharmacogenomics Use of APIs for patient access and data exchange Data storage and transportation

Areas of Focus for Recommendations How can ONC make the most impact to support Precision Medicine? – Standards development – Pilots – Security Highlights from NIH ACD Workshops: – What is the minimum core dataset needed from the EHR to support research – i.e. what should the “core PMI dataset” be? – What are the best automated ways to acquire clinical data, patient-mediated or otherwise? – What are the best existing tools that let individuals access, send, or update/edit their clinical data for research? 8

Next Steps 9 Hearings are completed, now developing recommendations Alignment with NIH ACD Work Group recommendations process Initial recommendations will be presented at HITSC meeting on Sept 22 More detailed recommendations later this winter

Resources NIH Precision Medicine: SMART App Articles can be found at this link:

Q&A 11