0 enabling healthcare interoperability Webinar Series Sponsored by the HITSP Education, Communications and Outreach Committee 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

Slide 1 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 2 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 3 HITSP – enabling healthcare interoperability Webinar Series  Patients  Consumers  Employers  General Practitioners  Outpatient Healthcare Providers  Government Agencies HITSP Stakeholders: Who HITSP impacts  Review Boards  Practice Guidelines  Residential Care Providers  Specialists  Payers  Suppliers  Hospitals Current Stakeholder Participation in HITSP: 800+ organizations1,000+ individuals Over 53,000 volunteer hours

Slide 4 HITSP – enabling healthcare interoperability Webinar Series 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)

Slide 5 HITSP – enabling healthcare interoperability Webinar Series View the Complete Set of HITSP Deliverables

Slide 6 HITSP – enabling healthcare interoperability Webinar Series HITSP was there... Supporting from “ONCHIT” to ONC  Covering two administrations and three heads of the Office of the National Coordinator David Blumenthal, M.D., M.P.P. National Coordinator for Healthcare IT Present 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

Slide 7 HITSP – enabling healthcare interoperability Webinar Series Wave 1 of HITSP Accomplishments The Bush Administration Supporting the American Health Information Community (AHIC) Use Cases

Slide 8 HITSP – enabling healthcare interoperability Webinar Series Released Accepted Recognized Federal projects must use HITSP recognized standards Per Executive Order Panel approved for submission to HHS Secretary of HHS has accepted for a period of testing Secretary of HHS has recognized the IS for immediate implementation Status: Interoperability Specifications

Slide 9 HITSP – enabling healthcare interoperability Webinar Series IS 01 Electronic Health Record (EHR) Laboratory Results Reporting IS 02Biosurveillance IS 03Consumer Empowerment IS 04 Emergency Responder Electronic Health Record (ER-EHR) IS 05 Consumer Empowerment and Access to Clinical Information via Media IS 06Quality HITSP Interoperability Specifications (IS) 2006 – 2008 Recognized

Slide 10 HITSP – enabling healthcare interoperability Webinar Series Aug 29,2005 Hurricane Katrina 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

Slide 11 HITSP – enabling healthcare interoperability Webinar Series Released / Panel Approved Recognized IS 07Medication Management IS 08Personalized Healthcare IS 09Consultations and Transfers of Care IS 10Immunizations and Response Management IS 11Public Health Case Reporting IS 12Patient – Provider Secure Messaging IS 77Remote Monitoring IS 107EHR Centric HITSP Interoperability Specifications (IS) 2008 – 2009

Slide 12 HITSP – enabling healthcare interoperability Webinar Series Wave 2 – The Impact Magnifies The Obama Administration Supporting the American Recovery and Reinvestment Act of 2009

Slide 13 HITSP – enabling healthcare interoperability Webinar Series HIT Standards Committee, HITSP, and NCVHS: Shared Members HIT Standards Committee 23 members HITSP 1,000+ technical experts John Halamka HITSP Chair HIT Standards Committee Vice-Chair Walter Suarez HITSP Board of Directors HIT Standards Committee NCVHS Committee Christopher Chute HITSP Volunteer HIT Standards Committee James Ferguson HITSP Board of Directors HIT Standards Committee John Klimek HITSP Volunteer HIT Standards Committee NCVHS 26 members

Slide 14 HITSP – enabling healthcare interoperability Webinar Series 14 “Meaningful Use” From existing Interoperability Specifications, determine subset required for “meaningful use” as called for in the American Recovery and Reinvestment Act (ARRA)

Slide 15 HITSP – enabling healthcare interoperability Webinar Series  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

Slide 16 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 17 HITSP – enabling healthcare interoperability Webinar Series Work Flow: A High-Level View SecretaryNational Coordinator Organizations conducting standards development or harmonization, certification criteria development, or composition of implementation specifications Pilot testing HIT Standards Committee Recommendations HIT Policy Committee

Slide 18 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 19 HITSP – enabling healthcare interoperability Webinar Series 1. Privacy and Security 2. HIT Infrastructure 3. Certified Health Record 4. Disclosure Audit 5. Improve Quality 6. Individually Identifiable Health Information (IIHI) Unusable 7. Demographic Data 8. Needs of Vulnerable Eight Technology Priority areas for HIT in ARRA

Slide 20 HITSP – enabling healthcare interoperability Webinar Series 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.

Slide 21 HITSP – enabling healthcare interoperability Webinar Series The Power Behind the “HITSP Nation” Technical Committee/Tiger Team Membership – 914 individuals Technical CommitteesNumber of Members Population Perspective 382 members Consumer Perspective231 members Provider Perspective265 members Security, Privacy & Infrastructure Domain347 members Care Management and Health Records Domain228 members Administrative and Financial Domain85 members Tiger Teams Number of Members Clinical Research147 members Data Architecture159 members Quality Measures123 members Consumer Preferences142 members

Slide 22 HITSP – enabling healthcare interoperability Webinar Series Year # of Volunteer Hours , , ,730 The “HITSP Nation” Powered by 54,730 Hours in 3 years!! HITSP NATION

Slide 23 HITSP – enabling healthcare interoperability Webinar Series EHR-Centric IS Addresses ARRA / HITECH Priority Areas Eight Priority Areas for HIT in ARRA HITSP Phase 1 Tasks for ARRA 1 Security + Privacy 2 HIT Infrastructure 3 Certified Health Record 4 Disclosure Audit 5 Improve Quality 6 IIHI* Unusable 7 Demographic Data 8 Needs of Vulnerable EHR Centric Interoperability Specification Security and Privacy Service (Suite) Quality Measures project Supporting Deliverables Harmonization framework and information/ exchange architecture Data Element, Template, and Value Set * Individually Identifiable Health Information (IIHI) Unusable

Slide 24 HITSP – enabling healthcare interoperability Webinar Series ARRA Title IV (Division B) – Section 401 – Medicare Incentives HITSP Phase 1 Tasks for ARRA Meaningful Use to Include e-Prescribing Exchange of Information to Improve Quality of Care Reporting Clinical Quality Measures Certified EHR Defined EHR Centric Interoperability Specification Security and Privacy Service (Suite) Quality Measures project Supporting Deliverables Harmonization framework and information/ exchange architecture Data Element, Template, and Value Set EHR-Centric IS Facilitates Achievement of ARRA / HITECH Meaningful Use

Slide 25 HITSP – enabling healthcare interoperability Webinar Series Base and Composite Standards Constructs Component, Transaction, or Transaction Packages Capabilities Service Collaborations Service Collaborations and Capabilities in Action

Slide 26 HITSP – enabling healthcare interoperability Webinar Series Multiple Capabilities = Interoperability Specification Interoperability Specification

Slide 27 HITSP – enabling healthcare interoperability Webinar Series Education, Communication and Outreach Website

Slide 28 HITSP – enabling healthcare interoperability Webinar Series HITSP Education Materials  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

Slide 29 HITSP – enabling healthcare interoperability Webinar Series Webinar Series Postponed

Slide 30 HITSP – enabling healthcare interoperability Webinar Series The HITSP Story in Plain English PLEASE!! What does all this mean to patients, families, and providers?

31 enabling healthcare interoperability Webinar Series Sponsored by the HITSP Education, Communications and Outreach Committee 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

Slide 32 HITSP – enabling healthcare interoperability Webinar Series  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 Steve’s story... Before interoperability

Slide 33 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 34 HITSP – enabling healthcare interoperability Webinar Series

Slide 35 HITSP – enabling healthcare interoperability Webinar Series HITSP : 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

Slide 36 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 37 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 38 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 39 HITSP – enabling healthcare interoperability Webinar Series 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 - HL , LOINC, UCUM, SNOMED-CT — Immunizations - HL , CVX — Biosurveillance - HL — Public Health Reporting of Labs - HL

Slide 40 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 41 HITSP – enabling healthcare interoperability Webinar Series

Slide 42 HITSP – enabling healthcare interoperability Webinar Series 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.

Slide 43 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 44 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 45 HITSP – enabling healthcare interoperability Webinar Series 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

Slide 46 HITSP – enabling healthcare interoperability Webinar Series Questions

Slide 47 HITSP – enabling healthcare interoperability Webinar Series Sponsor Strategic Partners