Disclosures

1. The Role of Health Information Technology Accelerating the Dissemination and Translation of Clinical Research into Practice A National Institutes of Health Workshop May 9, 2008 Robert M. Kolodner, MD National Coordinator Office of the National Coordinator for Health Information Technology (ONC)

2. Disclosures Accelerating the Dissemination and Translation of Clinical Research into Practice The Following Faculty have No Relevant Financial Relationships with Commercial Interests Dr. Robert Kolodner Keynote Session III: The Role of Health Information Technology in Accelerating the Dissemination and Translation of Clinical Research into Practice

3. Today’s Agenda • The National Health IT Agenda • The 5 Critical Components for Interoperable Health IT • Building Bridges BetweenClinical Research and Practice Accelerating the Dissemination and Translation of Clinical Research into Practice

4. Office of the National Coordinator (ONC) Executive Order, April 2004: The President created the National Coordinator position • To advance the vision of developing a nationwide interoperable health information technology infrastructure • To achieve the President’s goal of widespread adoption of interoperable electronic health records (EHR) by 2014 Key Role for ONC: Provide leadership for the development and nationwide implementation of an interoperable health information technology infrastructure to improve • The quality and efficiency of health care and • The ability of consumers to manage their health Key Role for ONC: Provide leadership for the development and nationwide implementation of an interoperable health information technology infrastructureto improve • The quality and efficiency of health care and • The ability of consumers to manage their health National Health IT Agenda Accelerating the Dissemination and Translation of Clinical Research into Practice

5. FHA Federal HealthArchitecture OMH ASPR CMS FDA HIT Policy Council OCR ONC OPM AHRQ EPA NASA DOJ SAMHSA NIH DHS NIST NSF DOA DOT IHS ASPE DOD OAS PHEP SSA DOE CDC VA DOA FCC DOS OMB State’s HIE State Initiatives NHIN HISPC CCHIT State Alliance for eHealth AHIC HITSP AHIC 2.0 Public/Private Initiatives ONC-sponsored Federal Collaborations and National Health IT Initiatives Cross- Agency Federal Initiatives Other Federal Agency Initiatives HHS Initiatives HRSA Individual Accelerating the Dissemination and Translation of Clinical Research into Practice

6. Key Health IT Components to Enable Transformation A Robust, Interoperable, Health IT Environment that brings together: • Electronic Health Records (EHR) • Personal Health Records (PHR) • Population Health Information (Public Health, Biosurveillance, Quality Improvement, Research) • Standards (Data, Technical and Security) • Interoperable Health Information Exchange Network • (Nationwide Health Information Network - NHIN) Accelerating the Dissemination and Translation of Clinical Research into Practice

7. Adoption of Interoperable Health IT Five Critical Components Necessary For Nationwide Interoperable Health Information Governance Standards in Health IT Products Privacy, Security and Other Heath IT Policies Nationwide Health Information Network Accelerating the Dissemination and Translation of Clinical Research into Practice

8. Governance 1. Governance by HHS Secretary with AHIC guidance. ONC coordinates all core activities & staffs the governance functions 2. AHIC 2.0 – An early hybrid of a public-private partnership. ONC continues to coordinate all core services 3. AHIC 2.0 – Self-sustaining public-private partnership. ONC continues to coordinates Federal participation Federal government is the primary advocate of population health activities Governance & Decision-Making– Accomplishments • Inclusive of all stakeholders • Otherwise the solutions are sub-optimized • May replicate down to state, tribal, and local communities • Barrier is lack of trust across the stakeholder sectors • Manages prioritization and trade-offs • To achieve nationwide health IT infrastructure • Three Phases Accelerating the Dissemination and Translation of Clinical Research into Practice

9. Governance STAGE 1 STAGE 2 • Stakeholder Outreach • Design & Development of Governing Documents • Successfully Establish AHIC 2.0 • 4 Months • 7 Months Governance – AHIC 2.0 (“A2”) • LMI-Brookings Team to fully establish AHIC 2.0 by December 2008 www.ahicsuccessor.org • Two-stage collaborative process ensuring that all key stakeholders in the public and private sectors are engaged and represented Accelerating the Dissemination and Translation of Clinical Research into Practice

10. Privacy, Security and Other Heath IT Policies Privacy & Security Policies – Accomplishments • Health Information Security and Privacy Collaboration (HISPC) • Over 4500 participants in 42 states and territories discuss privacy and security challenges posed by exchange of health information • Identify solutions and develop implementation plans for variations in organization-level business policies and state laws • State Alliance for e-Health • Governors, state legislators, attorneys general, & health officers established advisory board to resolve state-level health IT issues • Enable states to increase efficiency and effectiveness of developed health IT initiatives • Development of Best Practices for State-level Health Information Exchange (HIE) Initiatives • Inform and advance State-level HIE Initiatives • Gather information from existing state-level HIEs and define best practices Accelerating the Dissemination and Translation of Clinical Research into Practice

11. Standards in Health IT Products Interoperability Standards into Products – Summary of the Cyclical Process American Health Information Community (AHIC) Health-related Priorities Established Certification Commission for Healthcare IT (CCHIT) Describe Health-related Scenarios • Incorporated in Health IT Products • Used in Health IT Product Certification • Required in • Federal Systems and Healthcare Contracts (Executive Order 13410) • “Stark” exceptionsand Anti- Kickback safe harbor Identify Health IT Standards Healthcare IT Standards Panel(HITSP) Acceptance by Secretary of HHS Recognition by Secretary of HHS Testing and Implementation (1 year gap) Accelerating the Dissemination and Translation of Clinical Research into Practice

12. Standards in Health IT Products Interoperability Standards in Products– Accomplishments • 2 “cycles” of standards harmonization • 1st set recognized by HHS Secretary in January 2008 • Over 150 EHR products certified in 2 years since program launch • 9 inpatient EHRs certified in first 6 months • 4 more pending (total >50% of U.S. market) • Ambulatory EHRs >75% of the U.S. market • Executive order requires Federal departments to use recognized standards and include them in contracts Accelerating the Dissemination and Translation of Clinical Research into Practice

13. Adoption of Interoperable Health IT Adoption of Health IT Solutions – Accomplishments • Standardized, repeatable method developed to measure EHR adoption • Conflict of interest regulations modified to facilitate donations of certified EHRs by hospitals to small health care providers Accelerating the Dissemination and Translation of Clinical Research into Practice

14. Increase in AMBULATORY EHR Adoption Rates 2005 - 2007 Percent of Outpatient Physicians Using (minimally functional) EHRs 15% 14% 10% 9.2% 5% 0% 2005* 2007** • * http://www.rwjf.org/files/publications/other/EHRReport0609.pdf • ** http://www.hhs.gov/healthit/documents/m20080115/04-blumenthal.html Accelerating the Dissemination and Translation of Clinical Research into Practice

15. Nationwide Health Information Network NHIN Trial Implementations (Phase II) • “NHIN Cooperative” formed to implement, test, and demonstrate core services by September 2008 • Support of consumer access controls • Lookup and retrieval of clinical information • Exchange of patient summary records • Contracts and grants • 13 state & regional Health Information Exchanges (HIEs) • 2 Integrated Delivery Systems • Federal agencies & departments are collaborating to participate in implementations Accelerating the Dissemination and Translation of Clinical Research into Practice

16. Different “Network” Models Accelerating the Dissemination and Translation of Clinical Research into Practice

17. Initial HIEs Carespark [TN/VA] Delaware Health Info Network Indiana University Long Beach Network for Health [CA] Lovelace Clinic Foundation [NM] MedVirginia NCHICA [NC] New York eHealth Collaborative West Virginia Health Info Network Federal Participants (VA, DoD, SSA, IHS) -(4) New NHIEs Cleveland Clinic Community Health Information Collaborative [MN] HealthBridge [OH] HealthLINC (Bloomington Hospital) [IN] HealthLink RHIO (Wright State University) [OH] Kaiser Permanente Nationwide Health Information Network NHIN Cooperative – 16 (19) Members Organizational “Network” Accelerating the Dissemination and Translation of Clinical Research into Practice

18. State and Local Gov Health Bank orPHR Support Organization Community Health Centers VA CDC CMS DoD SSA Community #1 Labs IntegratedDelivery System Pharmacies The Nationwide Health Information Network Mobilizing Health Information Nationwide Community #2 The Internet Standards, Specifications and Agreementsfor Secure Connections Accelerating the Dissemination and Translation of Clinical Research into Practice

19. 2008 – A Banner Year Accelerating the Dissemination and Translation of Clinical Research into Practice

20. Building Bridges • NHIN • Use Cases • 2008 Personalized Healthcare • ? 2009 Clinical Research ? • Interoperability Agenda • Strategic Plan Accelerating the Dissemination and Translation of Clinical Research into Practice

21. Personalized healthcare begins with health IT and the EHR Standards for interoperable integration of genomic test information into personal e-health records U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology Personalized Healthcare Detailed Use Case March 21, 2008 2008 Personalized Healthcare Use Case Accelerating the Dissemination and Translation of Clinical Research into Practice

22. Information Needs Relevant to Clinical Researchin Existing Use Cases • Extraction of relevant clinical informationfrom EHRs (2008 Consultations and Transfers of Care) • Ability to automatically route de-identified information to the appropriate provider (2008 Consumer Access to Clinical Information Use Case and 2007 Quality) • Use of Genomic Standards (2008 Personalized Healthcare) • Adverse Event Reporting Standards (2008 Public Health Case Reporting) • Delivery of a summary care record to an EHR (2007 Emergency Responder EHR) • Delivery of prescriptions, current medications, and allergies to an EHR (2007 Medication Management Use Case) Accelerating the Dissemination and Translation of Clinical Research into Practice

23. Information Needs Relevant to Clinical Researchin Existing Use Cases, Cont. • Delivery of discharge documentation to next provider of care (2007 Medication Management and 2008 Consultations and Transfers of Care) • Delivery of a core set of patient data between EHRs (2008 Consultations and Transfers of Care) • Delivery of remote monitoring information to an EHR (2008 Remote Monitoring) • Delivery of immunization information to an EHR (2008 Immunizations and Response Management) • Communications between patients and providers including health reminders for patients (2008 Patient-Provider Secure Messaging) Accelerating the Dissemination and Translation of Clinical Research into Practice

24. Coming Soon: Health IT Strategic Plan • Lays out the health IT agenda: the Collaboration • 2008 - 2012 • Two goals, eight objectives, 43 strategies with milestones • Details current activities of Federal agencies Accelerating the Dissemination and Translation of Clinical Research into Practice

25. EHR Adoption Transformational Change in Health Care Delivery & Health Moving Toward the Tipping Point: How Transformational Change Occurs Health IT Tipping Point TIME Accelerating the Dissemination and Translation of Clinical Research into Practice

26. William Stead, M.D.* “Try, fail. Try, fail. Try, succeed, deploy.” *Associate Vice Chancellor for Health Affairs & Professor of Medicine and Biomedical Informatics Vanderbilt University Accelerating the Dissemination and Translation of Clinical Research into Practice

27. For More Information: www.hhs.gov/healthit Accelerating the Dissemination and Translation of Clinical Research into Practice