American Health Information Community Personalized Health Care Workgroup

1. American Health Information Community Personalized Health Care Workgroup Report to Quality Workgroup Understanding the Role of Clinical Decision Support in Personalized Health Care Gregory Downing ONC Lead, PHC Workgroup October 3, 2007

2. PHC Workgroup Overview Broad Charge: Make recommendations to the Community for a process to foster a broad, community-based approach to establish a common pathway based on common data standards to facilitate the incorporation of interoperable, clinically useful genetic/genomic information and analytical tools into electronic health records to support clinical decision-making for the clinician and consumer. Specific Charge: Make recommendations to the Community to consider means to establish standards for reporting and incorporation of common medical genetic/genomic tests and family health history data into electronic health records, and provide incentives for adoption across the country including federal government agencies.

3. Personalized Health Care (PHC) WorkgroupMember List • Co-Chairs: • John Glaser Partners HealthCare • Douglas Henley American Academy of Family Physicians • Staff Co-Chair: • Gregory Downing Office of the Secretary, HHS • Members: • Carolyn Clancy Agency for Healthcare Research and Quality • Beryl Crossley American Clinical Laboratory Association, Quest • Paul Cusenza Consultant • Andrea Ferreira-Gonzalez Virginia Commonwealth University • Becky Fisher Patient Advocate • Felix Frueh Food and Drug Administration • Emory Fry Department of Defense • Alan Guttmacher National Institutes of Health/NHGRI • Kathy Hudson Genetics and Public Policy Center • Betsy Humphreys National Institutes of Health/NLM • Charles Kennedy WellPoint • Joel Kupersmith Department of Veterans Affairs • Stephen Matteson Pfizer • Deven McGraw National Partnership for Women and Families • Amy McGuire Baylor College of Medicine • Mark Rothstein University of Louisville • Steve Teutsch Merck • Janet Warrington Affymetrix • Andrew Wiesenthal Permanente Federation • Marc Williams Intermountain Healthcare • Dennis Williams Health Resources and Services Administration

4. PHC Workgroup Senior Advisors • Senior Advisors: • Mary Beth Bigley Office of the U.S. Surgeon General • Greg Feero National Institutes of Health/NHGRI • Joseph Kelly Centers for Medicare & Medicaid Services • Muin Khoury Centers for Disease Control and Prevention • Katherine Kolor Centers for Disease Control and Prevention • Michele Lloyd-Puryear Health Resources and Services Administration • Elizabeth Mansfield Food and Drug Administration • Clement McDonald National Institutes of Health/NLM • Armando Oliva Food and Drug Administration • Dina Paltoo National Institutes of Health/NHLBI • Jonathan Perlin HCA, Inc. • Gurvaneet Randhawa Agency for Healthcare Research and Quality • Lisa Rovin Food and Drug Administration • Maren Scheuner RAND Corporation • Jean Slutsky Agency for Healthcare Research and Quality • Reed Tuckson UnitedHealth Group; SACGHS • Mollie Ullman-Cullere Harvard Partners Center for Genetics and Genomics • Grant Wood Intermountain Healthcare

5. PHC Vision and Priorities • Personalized Health Care is a consumer-centric system in which clinicians customize diagnostic, treatment, and management plans • Four perspectives were identified as important to the vision • Consumer • Clinician • Researcher • Health Plan/Payer • Four priority areas across each perspective • Genetic/Genomic Tests • Family Health History • Confidentiality, Privacy, and Security • Clinical Decision Support

6. Why Address Clinical Decision Support (CDS)? • Consumer-clinician interactions can be augmented by CDS tools • The data involved in PHC is complex • Deployment of genetic technologies into mainstream health care will depend on CDS tools • Genetic/Genomic Tests and Family Health History • Recommendation that a PHC Use Case be developed to address these two aspects was accepted at the July 31, 2007 AHIC meeting • Confidentiality, Privacy, and Security • Background documents and recommendations will be advanced to the CPS Workgroup in the next several months • Clinical Decision Support • Work with ONC, AHIC to address common goals and applications

7. How did the PHC WG Approach CDS? • Visioning Session (March-April, 2007) • CDS will be needed to facilitate evidence-based decisions by clinicians and consumers related to genetic information • Risk assessment algorithms, predictive tools, and prevention messages will increasingly use genetic information • Incentives for development of CDS to support PHC • Staff Activities/Background work (June-July, 2007) • Examined commercially available CDS tools, systems that are deploying CDS across their organization • Coordinated fact finding with CDS Roadmap team • Developed background papers on resources, issues • AHIC/ONC Activities (June-present) • Working with internal CDS team to ensure coordination of activities • AHRQ Activities • Products from previous work/projects • New RFP solicitation

8. Planning for PHC CDS Activities • PHC Workgroup meeting on CDS: September 17, 2007 • Moderated by Jonathan Teich and Jerry Osheroff • All day, in person in Washington, DC • Meeting Agenda: • Panel 1: CDS Tools – Services and Systems • Case Study: CDS for Pharmacogenomics-Guided Warfarin Dosing • Panel 2: Evidence Development for CDS • Assumptions prior to the meeting • The concepts and deployment of CDS tools and systems are still early in development • Identified clinically useful, web-based CDS tools but not embedded in electron health records • There are many complex and challenging issues involved in the development of useful CDS tools • There is a high demand for CDS tools to support PHC • CDS is recognized as a critical, and substantial unmet need

9. PHC Workgroup Findings on CDS • PHC Workgroup meeting on CDS: September 17, 2007 • Findings • Many of the CDS developers had funding or important interactions with AHRQ • Patient engagement and inclusion of patient preferences in CDS configurations will be critical in order to truly personalize healthcare • Focus on CDS applications for primary/ambulatory care • CDS tools could be used to empower the consumer • Design of CDS tools to fit into natural workflow is of high importance • Examine the use of standards or a national repository to maximize efforts and widely deploy evidence • Look for potential pilot studies or existing examples of repositories of best practice guidelines

10. Potential Future CDS Activities for AHIC WGs • Examine a shared decision-making model to connect the consumer and clinician • Examine CDS tool use in a chronic-care and prevention settings • Can best practices for workflow in CDS tools be developed? • How do we build individual variations into widely deployed systems? • Use the CDS roadmap to consider establishing a national repository of best practices in a standardized way • Examine how to present new and old knowledge in a consistent way • Discuss various CDS issues during the October and November workgroup meetings • Examine potential areas of early success • Family history tools, breast cancer risk assessment, newborn screening • See how existing CDS tools can be deployed across EHR systems • Use findings in use case development