1. Healthcare Information Technology Standards Panel 2006, 2007 and Beyond John D. Halamka MD Chair, HITSP

2. 2 HITSP: Harmonizing standards to support the Nationwide Health Information Network A public-private “Community” was established to serve as the focal point for America’s health information concerns and drive opportunities for increasing interoperability Healthcare Information Technology Standards Panel (HITSP) ‏ Nationwide Health Information Network Architecture Projects (NHIN) ‏ The Health Information Security and Privacy Collaboration (HISPC) ‏ The Certification Commission for Healthcare Information Technology (CCHIT) ‏ American Health Information Community HITSP includes 323 different member organizations and is administered by a Board of Directors 19 SDOs 263 Non-SDOs 28 Govt. bodies 13 Consumer groups HITSP includes 323 different member organizations and is administered by a Board of Directors 19 SDOs 263 Non-SDOs 28 Govt. bodies 13 Consumer groups The Community is a federally-chartered commission and will provide input and recommendations to HHS on how to make health records digital and interoperable, and assure that the privacy and security of those records are protected, in a smooth, market-led way.

3. 3 HITSP: Harmonizing standards to support the Nationwide Health Information Network NHIN 2 Awardees  CareSpark  Delaware Health Information Network  Indiana University  Long Beach Network for Health  Lovelace Clinic Foundation  MedVirginia  New York eHealth Collaborative  NorthCarolinaHealthcareInformationand Communications Alliance, Inc.  West Virginia Health Information Network

4. 4 HITSP: Harmonizing standards to support the Nationwide Health Information Network NHIN Trial Implementations  Participate in NHIN Cooperative -implement, test, and demonstrate core services: – Support of consumer access controls – Lookup and retrieval of clinical information – Exchange of patient summary records  A foundation for other priorities in lab result reporting, medication history exchange, quality and public health

5. 5 HITSP: Harmonizing standards to support the Nationwide Health Information Network 2006 – the First “Turn of the Crank”  Consumer Empowerment – Medications – Allergies – Demographics – Advance Directives  Electronic Health Records – Laboratory including blood banking and microbiology – Ordering and results exchange  Biosurveillance – Deidentified registrations – Labs – Radiology text results

6. 6 HITSP: Harmonizing standards to support the Nationwide Health Information Network What did we do in 2006?  Established the HITSP Organization and its committees  Created the standards harmonization process including all coordinating committee sub-processes  Harmonized standards for 3 use cases (accepted by Secretary Leavitt) and resolved three controversies along the way – To resolve CCR v. CDA, the CCD was successfully balloted – To resolve the need for Interim standards we accelerated CCD – An enhanced implementation guide for HL7 2.5.1 was successfully balloted this Summer  To align HITSP interoperability specifications with CCHIT functional criteria, the CCHIT/HITSP Joint Working group has established a joint timeline for the next 3 years

7. 7 HITSP: Harmonizing standards to support the Nationwide Health Information Network HITSP Organization The Community HHS Secretary Mike Leavitt, Chair Program/Project Management Team Executive in Charge, F. Schrotter, ANSI Program Manager, L. Jones GSI Deputy PM, J Corley, ATI Project Manager, Julie Pooley, Booz Allen Program/Project Management Team Executive in Charge, F. Schrotter, ANSI Program Manager, L. Jones GSI Deputy PM, J Corley, ATI Project Manager, Julie Pooley, Booz Allen Technical Management Joyce Sensmeier, HIMSS Technical Management Joyce Sensmeier, HIMSS Panel Secretariat and Coordination Committee Management Michelle Deane, ANSI Panel Secretariat and Coordination Committee Management Michelle Deane, ANSI HHS ONCHIT1 PO, Dr. John Loonsk HHS ONCHIT1 PO, Dr. John Loonsk HITSP Dr. John Halamka, Chair Member Populated Board and Panel HITSP Member Populated Coordination Committees Harmonization Readiness –Lynne Gilbertson Business Plan –Steve Lieber International Landscape –Bill Braithwaite CCHIT JWG –Jamie Ferguson Foundations –Bob Dolin & Steve Wagner Process Review –Lynne Gilbertson & Erik Pupo HITSP Member Populated Technical Committees Care Delivery –Jamie Ferguson –Steve Wagner –Steve Hufnagel Consumer Empowerment –Elaine Blechman, PhD –Charles Parisot –Scott Robertson Population Health –Floyd Eisenberg, MD, MPH –Peter Elkin, MD –Shaun Grannis, MD Security and Privacy WG –Glen Marshall –John Moehrke –Walter Suarez

8. 8 HITSP: Harmonizing standards to support the Nationwide Health Information Network Standards Harmonization Work Plan Tasks I Harmonization Request II Requirements Analysis III Identification of Candidate Standards IV Gaps, Duplications and Overlaps Resolution V Standards Selection VI Construction of Interoperability Specification VII Inspection Test VIII Interoperability Specification Release and Dissemination IX Program Management 3 months 3 weeks 3 months4 weeks 2 months On-going Requirements, Standards Selection, and Design Public Review and Input Inspection Test and Public Comment Implementation Support and Testing Comment Resolution and Panel Approval Interoperability Specification Construct Development IS Docs V 1.0 Review Draft Summary of comment resolution IS Docs V 1.0 Summary of comment resolution Requirements, Standards Selection, and Design Consolidated comments Annual Updates as Required PROCESS TASKS DOCUMENTATION

9. 9 HITSP: Harmonizing standards to support the Nationwide Health Information Network HITSP Comments Received CY 2007 Population Health TC 73 Consumer Empowerment TC 30 Care Delivery TC218 Security & Privacy WG240 Misc (Project Mgmt, Cross TC, Process) 37 Total598

10. 10 HITSP: Harmonizing standards to support the Nationwide Health Information Network Example Interoperability Specification Overview

11. 11 HITSP: Harmonizing standards to support the Nationwide Health Information Network National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard Version 8.1 Logical Observation Identifiers Names and Codes (LOINC®) ‏ Integrating the Healthcare Enterprise (IHE) Patient Care Coordination (PCC) Technical Framework Revision 1.0 Integrating the Healthcare Enterprise (IHE) Laboratory Technical Framework Supplement 2006-2007 Revision 1.0 Health Level Seven (HL7) EHR System Functional Model Draft Standard for Trial Use (DSTU) ‏ Health Level Seven (HL7) Version 2.5 Health Level Seven (HL7) Version 3.0 Clinical Document Architecture (CDA/CDA R2) ‏ Health Level Seven (HL7) Version 3.0 Continuity of Care Document (CCD) ‏ Federal Medication Terminologies Council for Affordable Quality Health Care (CAQH) Committee on Operating Rules for Information Exchange (CORE) Phase I Operating Rules American Society for Testing and Materials (ASTM) Standard Specification for Continuity of Care Record (CCR): # E2369-05 Accredited Standards Committee (ASC) X12 Standards Release 004010 Accredited Standards Committee (ASC) X12 Insurance Subcommittee (X12N) Implementation Guides Version 004010 plus Addenda 004010A1 HITSP Named Standards * Example Interoperability Specification Standards

12. 12 HITSP: Harmonizing standards to support the Nationwide Health Information Network 2007 – The second turn of the crank  Privacy and Security standards  Emergency Responder  Personal Health Records  Medication Management  Quality

13. 13 HITSP: Harmonizing standards to support the Nationwide Health Information Network Security Standards  Collect and Communicate Security Audit Trails  Consistent Time  Document Integrity  Manage and Control Data Access  Manage and Control Privacy Consents  Manage Entity Identity Credentials  Non-Repudiation  Secure Communications Channel  User Authentication

14. 14 HITSP: Harmonizing standards to support the Nationwide Health Information Network Consumer Access to Clinical Information

15. 15 HITSP: Harmonizing standards to support the Nationwide Health Information Network Medications Management

16. 16 HITSP: Harmonizing standards to support the Nationwide Health Information Network Quality

17. 17 HITSP: Harmonizing standards to support the Nationwide Health Information Network MAYJUNEJULYAUGSEPTOCTNOVDECJANFEBMARAPR HITSP 2007/2008 Timeline Overview 07/09/07 HITSP Board 10/09/07 HITSP Board 05/11/07 HITSP Panel 09/07/07 HITSP Panel 5/08 – 5/10 TC F2F Arlington VA 6/18 – 6/20 TC F2F San Diego CA 09/04 – 09/06 TC F2F Arlington VA Public Comment Inspect Test and Public Comment Implementation Support, Testing, and Gap Resolution (with annual updates as required)‏ Comment Resolution and Panel Approval IS Construct Development 05/17 – 07/19 07/20 – 08/1708/20 – 10/15 Security and Privacy for All Use Cases and Emergency Responder EHR Use Case 10/15/07 HITSP Panel 07/16/07 HITSP Panel Consumer Access and Quality Use Cases S&P and EHR-ER v 1.0 05/17 – 06/14 RDSS Public Comment Inspect Test and Public Comment Implementation Support, Testing, and Gap Resolution (with annual updates as required)‏ Comment Resolution and Panel Approval IS Construct Dev 7/11 – 9/14 9/17 – 10/1210/15 – 12/13 Consumer Access and Quality v 1.0 7/20 – 8/17 Requirements Design and Stndrds Selection 05/07 – 07/10 Medication Management Use Case Public Comment Inspect Test and Public Comment Implementation Support, Testing, and Gap Resolution Comment Resolution and Panel Approval IS Construct Development 9/17 – 12/7 12/10 – 1/11 1/14 – 3/27 Medications Management v 1.0 9/17 – 10/12 Requirements Design and Stndrds Selection 6/18 – 9/14 10/29 – 10/31 TC F2F Lombard IL 12/13/07 HITSP Panel 1/23 – 1/25 TC F2F Chicago 3/24 – 3/26 TC F2F DC Area 3/27/08 HITSP Panel 2/11/08 HITSP Board 2/20/08 HITSP Panel

18. 18 HITSP: Harmonizing standards to support the Nationwide Health Information Network HIT Implementation Testing Web Site Preview

19. 19 HITSP: Harmonizing standards to support the Nationwide Health Information Network AHIC Priorities and Use Case Roadmap

20. 20 HITSP: Harmonizing standards to support the Nationwide Health Information Network Overall Timeline

21. 21 HITSP: Harmonizing standards to support the Nationwide Health Information Network Summary  Over the past year, HITSP has become an established, trusted organization with a multi-stakeholder, open, transparent process for standards harmonization  In 2007, we will complete 4 additional use cases plus security/privacy  In 2008, we will complete an additional 6 use cases  CCHIT and HITSP are now aligned via a common schedule, an ongoing joint working group and a Memorandum of Understanding  Our Foundations Committee will work on the medium to long term alignment of standards organizations and their work products in parallel with the Use Case work of the entire panel

22. 22 HITSP: Harmonizing standards to support the Nationwide Health Information Network Contact Information  For general HITSP-related questions please contact: Michelle Maas-Deane HITSP Secretariat American National Standards Institute Phone: 212-642.488 email: mmaasdeane@ansi.orgmmaasdeane@ansi.org  For ANSI Document Library related questions please contact: Alison Ziegler Program Administrator, Standards Panels American National Standards Institute Phone: 212-642.4947 email: aziegler@ansi.orgaziegler@ansi.org  For Technical Committee questions: Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS Vice President, Informatics HIMSS Phone: 312-915-9281 email: jsensmeier@himss.orgjsensmeier@himss.org or Jessica Kant Coordinator, Standards Harmonization Healthcare Information & Management Systems Society Phone: 312-915-9283 Fax: 312-915-9511 email: jkant@himss.orgjkant@himss.org