eTown Hall III HITSP - Past, Present, Future –

1. eTown Hall III HITSP - Past, Present, Future – The future of HIT Harmonization and Interoperability Webinar #12 January 22, 2010 | 1:00 – 2:30 pm (Eastern) Presenter: John D. Halamka, MD, MS, HITSP Chair

2. Agenda A brief overview and history of HITSP to date HITSP’s impact on the industry and valuable contributions to the national initiative through its accomplishments Conclusions and lessons learned about HIT SDOs and harmonization The future of HIT harmonization and interoperability Questions and answers

3. To serve as a cooperative partnership between the public and private sectors for the purpose of achieving a widely accepted and useful set of standards specifically to enable and support widespread interoperability among healthcare software applications, as they will interact in a local, regional, and national health information network for the United States. Mission

4. Patients Consumers Employers General Practitioners HITSP Stakeholders: Who HITSP impacts • Review Boards • Practice Guidelines • Residential Care Providers • Specialists • Payers • Suppliers • Hospitals • Outpatient Healthcare Providers • Government Agencies Current Stakeholder Participation in HITSP: 800+ organizations 1,000+ individuals Over 53,000 volunteer hours

5. HITSP Real World Use Sites as of January 2010 • Beth Israel Deaconess Medical Center (BIDMC) • Boston Medical Center • CareSpark • eHealth Connecticut • Health Bridge and HealthLinC • Kaiser Permanente Medical Group • Keystone Health Information Exchange (Key-HIE) • MedVirginia • The New York eHealth Collaborative (NYeC) • New England Healthcare EDI Network (NEHEN) • North Carolina Healthcare Information and Communications Alliance (NCHICA) • Regenstrief Institute • Social Security Administration (SSA) • Vermont Information Technology Leaders (VITL)

6. View the Complete Set of HITSP Deliverableswww.HITSP.org

7. HITSP was there . . .Supporting from “ONCHIT” to ONC • Covering two administrations and three heads of the Office of the National Coordinator David J. Brailer, M.D., PhD National Coordinator for Healthcare IT 2004 – 2006 Robert M. Kolodner, M.D. National Coordinator for Healthcare IT 2006 – 2009 David Blumenthal, M.D., M.P.P. National Coordinator for Healthcare IT 2009 - Present

8. Wave 1 of HITSP Accomplishments The Bush Administration Supporting the American Health Information Community (AHIC) Use Cases

9. Status: Interoperability Specifications Recognized Released Accepted Secretary of HHS has recognized the IS for immediate implementation Secretary of HHS has accepted for a period of testing Panel approved for submission to HHS Federal projects must use HITSP recognized standards Per Executive Order13410

10. HITSP Interoperability Specifications (IS) 2006 – 2008 Recognized

11. During Initial Planning for Interoperable EHRs . . . Something VERY Big Happened • The pain and devastating struggles were not forgotten . . . • Next time we WILL do better when someone needs to get healthcare after an evacuation • We have a plan . . . and now that plan is funded for incentives for widespread adoption of EHRs Aug 29,2005 Hurricane Katrina

12. Recognized Released / Panel Approved HITSP Interoperability Specifications (IS) 2008 – 2009

13. Wave 2 – The Impact Magnifies The Obama Administration Supporting the American Recovery and Reinvestment Act of 2009

14. HIT Standards Committee, HITSP, and NCVHS: Shared Members John HalamkaHITSP ChairHIT Standards Committee Vice-Chair Walter SuarezHITSP Board of Directors HIT Standards CommitteeNCVHS Committee Christopher ChuteHITSP VolunteerHIT Standards Committee James FergusonHITSP Board of DirectorsHIT Standards Committee John KlimekHITSP VolunteerHIT Standards Committee HITSP1,000+ technical experts HIT Standards Committee 23 members NCVHS 26 members

15. “Meaningful Use” From existing Interoperability Specifications, determine subset required for “meaningful use” as called for in the American Recovery and Reinvestment Act (ARRA) 14

16. HITSP is playing an integral role in the development of a Nationwide Health Information Network (NHIN) for the United States Part of Certification Commission on Healthcare IT(CCHIT) certification requirements includes proof of compliance to HITSP specifications “Recognized” HITSP Interoperability Specifications (IS) are required on all new federal HIT project work and federal contracts. ARRA and the HITECH act call for “meaningful use” of EHRs. HITSP worked with the HIT to help by providing reusable HIT standards. IHE Connectathons – Vendors Testing of HITSP Specifications – 2009 IHE Connectathon – 50 vendors – 2010 IHE Connectathon – 75 vendors Impact & Relationships

17. What is ARRA? What is HITECH? A portion of ARRA referred to as the Health Information Technology for Economic and Clinical Health (HITECH) Act TITLE XIII—Health Information Technology TITLE IV—Medicare and Medicaid Health Information Technology Contains numerous provisions related to Health Information Technology (HIT) and privacy with aggressive timelines for completion • Also known as the “economic stimulus package” • Signed into law by President Obama on February 17, 2009

18. HIT Standards Committee Recommendations Work Flow: A High-Level View HIT Policy Committee National Coordinator Secretary Organizations conducting standards development or harmonization, certification criteria development, or composition of implementation specifications Pilot testing

19. GOAL: Design where the Puck needs to go It is not enough to follow the puck . . . or go in the direction of the puck . . . We are designing where the puck needs to go! 2015

20. Eight Technology Priority areas for HIT in ARRA • Privacy and Security • HIT Infrastructure • Certified Health Record • Disclosure Audit • Improve Quality • Individually Identifiable Health Information (IIHI) Unusable • Demographic Data • Needs of Vulnerable

21. 2009: The HITSP Tiger Teams • The Office of the National Coordinator (ONC) asked HITSP to assist it in meeting its requirements for designating standards that support designated ARRA focus areas for healthcare, and ultimately, that support ARRA’s notion of “meaningful use” • HITSP paused its assigned 2009 work, and directed essentially all efforts toward this end • HITSP organized into focused, quick-moving “Tiger Teams” that accomplished their tasks, and submitted their results to the ONC in mid-July.

22. The Power Behind the “HITSP Nation”Technical Committee/Tiger Team Membership – 914 individuals

23. HITSP NATION The “HITSP Nation”Powered by 54,730 Hours in 3 years!! Day Jobs . . . What’s that!!

24. EHR-Centric IS Addresses ARRA / HITECH Priority Areas * Individually Identifiable Health Information (IIHI) Unusable

25. EHR-Centric IS Facilitates Achievement ofARRA / HITECH Meaningful Use

26. Service Collaborations and Capabilities in Action Base and Composite Standards Capabilities Service Collaborations Constructs Component, Transaction, or Transaction Packages

27. Multiple Capabilities = Interoperability Specification Interoperability Specification

28. Education, Communication and Outreach Website

29. HITSP Education Materials www.hitsp.org/webinars • Archives of 2008 and 2009 Webinar Series • Newly Published Large Wall Posters with description and size posted • HITSP Cross- Reference Matrices • Summary of HIT Standards and HIT Policy Committee Recommendations • Data Elements in CDA, CCD and CCR

30. Webinar Series www.hitsp.org/education_outreach Postponed

31. The HITSP Story in Plain English PLEASE!! What does all this mean to patients, families, and providers?

32. Steve’s Story The story of what standardizing the sharing of healthcare information between electronic medical records will mean to Patients, Families and Providers . . . and the impact of interoperable Electronic Healthcare Records across our nation

33. Steve’s story . . . Before interoperability • Patient is a 27-year-old man who had a brain tumor removed as a child • Over the years, he has been seen by many different doctors and visited many healthcare facilities • Steve’s health information is generally not available to these organizations. Whether paper or electronic, his medical history is not easily shared among providers who need it in order to provide the best care • Data such as registration, patient’s problems, allergies, medications, etc. must be repeatedly collected • Tests and procedures must be repeated due to a lack of previous test results and procedures for comparison

34. Healthcare in an interoperable world . . . The Future is Now HIT data exchange is becoming transparent so that the quality of care delivered by providers and hospitals can be known no matter where the patient is located Consumers are empowered to get the right information at the right time find appropriate, quality and safe care for themselves and their families assume that repeatable information will be safe and secure while also being accessible by those who need it – before, during and after a visit to a care provider Care providers are empowered to provide safe, effective and evidence-based care with information integrated within a clinical care workflow

36. HITSP 2004-2009: Lessons Learned • The HITSP experience has taught us the value of bringing stakeholders together to harmonize standards and facilitate adoption • Working with two administrations and 3 leaders at the head of Office of the National Coordinator • Achieving adoption requires much more than a named list of standards • Unclear how to integrate multiple standards • Standards are not constrained for the use case – ambiguous • Implementation guidance is not provided

37. HITSP 2009 Accomplishments Include: • EHR Centric Interoperability Specification • Re-organizes all relevant HITSP constructs around EHR requirements to facilitate ARRA EHR certification and meaningful use goals. • Improved Specifications in Support of ARRA • Security, Privacy, & Infrastructure • Improved Quality Measures • Improved HITSP infrastructure definition • Data Architecture (Element, Template, and Value Set) • Exchange Architecture and Harmonization Framework • New Interoperability Specifications • Clinical Research and Newborn Screening • Medical Home Requirements Design and Standards Selection

38. Conclusion: HITSP is Foundational Support to ARRA On July 21, 2009 the HIT Standards Committee recommended that providers implement the HITSP endorsed standard capabilities, including: Transmitting prescriptions Structured data for discharge summary and continuity of care documents Lab test results HITSP is performing this critical function credibly in support of ARRA HITSP support of the newly-formed HIT Policy and Standards Committees HITSP in the “Real World” series Medication Management Real World Sites September 10, 2009

39. Two Key Documents Published January 13, 2010 • ONC Published –“Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” (Interim Final Rule – IFR) • Will become Final February 13, 2010 • CMS Published – “Medicare and Medicaid Programs; Electronic Health Record Incentive Program” – (Notice of Proposed Rule Making – NPRM) • Will become Final approximately April, 2010 and be in effect 60 days later

40. HITSP Work: Foundational for the IFR • The Interim Final Rule (IFR) contains the majority of base standards recommended by HITSP including: • Summaries - CCD • Problem Lists - SNOMED-CT • Medications - NCPDP Script 8.1, RxNorm • Allergies - UNII • The transmission standards - REST and SOAP. Not as specific as HITSP but consistent with its work and a good starting point. • There are still many additional standards and implementation guides up to the HIT Standards Committee to evaluate.  • Over the next 6 months, the HIT Standards Committee will work closely with ONC, HITSP, implementation guide writers, and SDOs to fill gaps in the IFR, no doubt referencing HITSP’s products. •   The IFR’s Security and Privacy section creates important policy guidance.   • As these policies are implemented, constraints will be needed standards.   It’s likely the HITSP implementation guidance will be embraced over time. • Labs - HL7 2.5.1, LOINC, UCUM, SNOMED-CT • Immunizations - HL7 2.3.1, CVX • Biosurveillance - HL7 2.5.1 • Public Health Reporting of Labs - HL7 2.5.1

41. HITSP Work: Foundational for the IFR • Two Questions: • Has HITSP's work been appropriately included? • Was the Tiger Team effort leveraged?   • Answer: • The answer to both questions is unequivocally

43. Harmonization and Standards Adoption 2010 and Beyond: What we need for Interoperable Healthcare • Engage community of experts from all the SDOs and other key stakeholders in HIT. Do not lose momentum from current engagement. • Continue and intensify efforts to harmonize and integrate standards, providing implementation specifications for all required use cases. • Active and strategic involvement in standards development to ensure U.S. priorities are met and that standards are built in a harmonious fashion. • Continue production experience with HITSP specifications and subsequent improvement of the specifications. • Develop easy to use guidance and continue to educate and reach out to the users and beneficiaries of HITSP specifications. • Provide expert advice, support, and outreach to ARRA adoption efforts such as Regional extension centers, Beacon communities, and workforce training initiatives.

44. Recommendations for Harmonization in the Future Obstacles to Harmonization: • No existing vocabulary infrastructure • SDO participation levels • Prioritization • Unclear Process Implementation remedies: • Develop a vocabulary infrastructure • Insure internal consistency and coordination of harmonization infrastructure • Work with SCO Summit/ stakeholders to develop a shared set of priorities for the harmonization of both current standards and prospective ones

45. Milestones and Next Steps • ONC Published –“Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” (Interim Final Rule – IFR) • Standards IFR for inspection published December 30, 2009 • Standards IFR published in Federal Register January 13, 2010 • Standards IFR becomes EFFECTIVE on February 13, 2010 • CMS Published – “Medicare and Medicaid Programs; Electronic Health Record Incentive Program” – Notice of Proposed Rule Making (NPRM) • EHR Incentive Program NPRM for inspection published December 30, 2009 • EHR Incentive Program NPRM published in Federal Register January 13, 2010 • Public Comment Period open until March 15, 2010 • HIT Standards and HIT Policy Committees have until March 1, 2010 to submit official response to NPRM to ONC and CMS leadership • Anticipated Publishing of Final Rule April, 2010 and becomes final 60 days later

46. Lessons Learned – Future Harmonization Recommendations • Harmonized implementation guide developers must serve the needs of policy makers and implementers; • A variety of expertise is required to develop harmonized implementation guides: • Terminology experts • Messaging and Content Standards • Subject matter experts • A clear “roadmap” outlining the process from requirements to implementation must be provided, including: • Business requirements • Vendor development • User adoption HITSP’s Foundations Committee has compiled a list of relevant concerns for future harmonization efforts, based on their work with SDOs, specifically: CONCLUSION: The process works, but it remains unclear whether SDOs can and will take steps to harmonize using agreed value sets

47. Questions

48. Sponsor Strategic Partners www.HITSP.org