1. Healthcare Information Technology Standards Panel General Introduction June 15, 2007

2. 1 Topics  HITSP Mission within ONC Interoperability Initiatives  HITSP Organization  HITSP Process  Introduction to Current Interoperability Specifications  HITSP 2007/2008 Work Plan

3. 2 Evaluation of Standards Harmonization Process for HIT HHS 2005 Contracts

4. 3 Evaluation of Standards Harmonization Process for HIT The American Health Information Community 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 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. 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

5. 4 Evaluation of Standards Harmonization Process for HIT President’s Executive Order August 22, 2006 Executive Order: Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs Sec. 3. Directives for Agencies. Agencies shall perform the following functions: Health Information Technology - For Federal Agencies. As each agency implements, acquires, or upgrades health information technology systems used for the direct exchange of health information between agencies and with non-Federal entities, it shall utilize, where available, health information technology systems and products that meet recognized interoperability standards.

6. 5 Evaluation of Standards Harmonization Process for HIT HITSP Mission and Role 1.Identify a pool of standards for a general breakthrough area 2.Identify gaps and overlaps for a specific context 3.Make recommendations for resolution of gaps and overlaps 4.Develop interoperability specifications for using the selected standard for a specific context 5.Test the instruction for using the standard Mission: To harmonize relevant standards in the health care industry to enable and advance interoperability The standards harmonization process is an open, inclusive, collaborative, use case driven process www.hitsp.org

7. 6 Evaluation of Standards Harmonization Process for HIT Technical Standards Not Policy  HITSP focuses on technical standards and NOT on policy definition  A standard specifies a well defined approach that supports a business process and... –has been agreed upon by a group of experts –has been publicly vetted –provides rules, guidelines, or characteristics –helps to ensure that materials, products, processes and services are fit for their intended purpose –is available in an accessible format –is subject to ongoing review and revision process  Harmonization is required when a proliferation of standards prevents progress rather than enables it

8. 7 Topics  HITSP Mission within ONC Interoperability Initiatives  HITSP Organization  HITSP Process  Introduction to Current Interoperability Specifications  HITSP 2007/2008 Work Plan

9. 8 Evaluation of Standards Harmonization Process for HIT HITSP Governance Model  HITSP Panel –The Panel brings together experts from across the healthcare IT community –All strategic decisions are made by consensus within the Panel  HITSP Board of Directors –A Board of Directors provides governance and administrative guidance  Technical and Coordination Committees –Much of the work is accomplished by volunteers that lead and serve on Technical Committees and Coordination Committees  Project Team –The project team defines and manages the HITSP process in accordance with the ONCHIT1 contract from the U.S. Department of Health and Human Services

10. 9 Evaluation of Standards Harmonization Process for HIT HITSP Overview The Community HHS Secretary Mike Leavitt, Chair 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 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 Committee Management Joyce Sensmeier, HIMSS Technical Committee Management Joyce Sensmeier, HIMSS Panel Secretariat and Coordination Committee Mgmnt Michelle Deane, ANSI Panel Secretariat and Coordination Committee Mgmnt Michelle Deane, ANSI HHS ONCHIT1 PO, Dr. John Loonsk HHS ONCHIT1 PO, Dr. John Loonsk HITSP Dr. John Halamka, Chair Member populated Technical Committees Eleven Tasks are included in this contract: 1.Comprehensive Work Plan 2.Conduct a Project Start Up Meeting 3.Deliver Recommended Use-Cases 4.Participate in related meetings and activities, including AHIC Meetings 5.Develop a Gap Analysis 6.Standards Selection, Evaluations and Testing 7.Define a Harmonization Approach 8.Develop Interoperability Specifications 9.Develop and Evaluate a Business Plan for the self-sustaining processes 10.Submit Monthly Reports 11.Assist with communications Current Focus

11. 10 Evaluation of Standards Harmonization Process for HIT HITSP Technical Committees  HITSP Care Delivery Technical Committee –James Ferguson, Kaiser Permanente –Steve Hufnagel, Department of Defense/Medical Health System –Steve Wagner, Department of Veterans Affairs –Current focus is on Emergency Responder EHR, Laboratory Message, Medications Management  HITSP Consumer Empowerment Technical Committee –Elaine Blechman, PhD, University of Colorado, Boulder –Charles Parisot, EHR Vendor Association –Scott Robertson, Kaiser Permanente –Current focus is on Consumer Access to Clinical Information

12. 11 Evaluation of Standards Harmonization Process for HIT HITSP Technical Committees (continued)  HITSP Population Health Technical Committee –Floyd Eisenberg, MD, MPH, Siemens Medical Solutions –Peter Elkin, MD, Mayo Clinic College of Medicine –Shaun Grannis, MD, Department of Family Medicine, Indiana University School of Medicine –Current focus is on Quality  HITSP Security and Privacy Technical Committee –Glen Marshall, Siemens Medical Solutions –John Moehrke, GE Healthcare –Walter Suarez, MD, Institute for HIPAA/HIT Education and Research –Current focus is on Security and Privacy constructs for EHR, BIO, and CE Interoperability Specifications

13. 12 Evaluation of Standards Harmonization Process for HIT HITSP Coordination Committees  Foundations Committee –Steve Wagner, Department of Veteran Affairs –Bob Dolin, Kaiser Permanente –Current focus is on Security and Privacy framework and small scale harmonization of demographic data  HITSP Process Review Committee –Lynne Gilbertson, NCPDP –Erik Pupo, Vangent Inc. –Current focus is on HITSP process definition and evaluation  HITSP-CCHIT Joint Work Group –Jamie Ferguson, Kaiser Permanente –Current focus is on alignment of HITSP and CCHIT schedules, processes, and products

14. 13 Evaluation of Standards Harmonization Process for HIT HITSP Coordination Committees (continued)  Harmonization Readiness Committee –Lynne Gilbertson, NCPDP –Current focus is on updated Tier 2 criteria  Business Plan Committee –Steve Lieber, HIMSS  International Landscape Committee –Bill Braithwaite, HL7  Governance Committee – Michael Aisenberg, EWA Information and Infrastructure Technologies Inc Fairly inactive in 2007

15. 14 Evaluation of Standards Harmonization Process for HIT HITSP Project Team  HITSP activities are led by the American National Standards Institute (ANSI), a not-for-profit organization that has been coordinating the U.S. voluntary standardization system since 1918  ANSI’s strategic partners include –Healthcare Information and Management Systems Society (HIMSS) –Advanced Technology Institute (ATI) –Booz Allen Hamilton –Numerous subcontracting organizations  Funding for the Panel is being provided via the ONCHIT1 contract award from the U.S. Department of Health and Human Services

16. 15 Topics  HITSP Mission within ONC Interoperability Initiatives  HITSP Organization  HITSP Process  Introduction to Current Interoperability Specifications  HITSP 2007/2008 Work Plan

17. 16 Evaluation of Standards Harmonization Process for HIT 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 Begin Support Receive Request Standards Harmonization Process Steps

18. 17 Evaluation of Standards Harmonization Process for HIT 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 4 weeks 3 months4 weeks 2 months On-going Requirements, Design, and Standards Selection Comment Period Inspect. Test, Comnt Period Implementation Support and Testing Comment Resolution and Panel Approval Interoperability Specification Construct Development IS Docs Review Draft Summary of comment resolution IS Docs V 1.0 Summary of comment resolution Requirements Design & Standards Selection Consolidated comments Annual Updates as Required PROCESS TASKS DOCUMENTATION

19. 18 Evaluation of Standards Harmonization Process for HIT AHIC Use Cases Analysis  HITSP receives Use Cases and Harmonization Requests from AHIC  The Use Case or Request defines perspectives (scenarios), business actors, and business and functional/interoperability requirements as events and actions  HITSP analyzes the Use Case to define the Interoperability Specification requirements –Identify candidate business Actors (Stakeholders) –Identify candidate technical Actors (Sys. Components) –Identify candidate data sets –Identify candidate requirements –Identify candidate standards –Identify interactions where policies are required

20. 19 Evaluation of Standards Harmonization Process for HIT Requirements Analysis  Build Use Case Analysis Diagrams (Functional analysis)  Map Data Sets to Activities  Map Candidate Standards to Data Sets and Identify Gaps –Transport –Content  Build Use Case Roles Diagram (Object analysis)  Build Use Case Sequence Diagram (s)

21. 20 Evaluation of Standards Harmonization Process for HIT UML Development StepUML Diagram 1. Define actors & activitiesUse-Case: functional analysis 2. Refine associationsUse-Case: object (role) analysis 3. Assign data, std., priorities Sequence 4. Design transaction sets Class / Component / Sequence 5. Repeat Fill out RDSS templates Iterate Data sets refinement drill down Candidate standards refinement divide and conquer. Tier 2 standards selection criteria Ambiguous Use Case Unambiguous HITSP IS HITSP RDSS Document Requirements Analysis and UML Modeling

22. 21 Evaluation of Standards Harmonization Process for HIT HITSP Framework Use Case/Modification Request Interoperability Specification Transaction Package (1..m transactions or composite standards) Transaction (1..n components or composite standards) Component (1..c base or composite standards) Base Standard #1 Base Standard #4 Base Standard #2 Base Standard #3 Component (Composite) Standard Transaction (Composite) Standard Transaction Package (Composite) Standard Defines and Narrows Context Base Standard #5 Base Standard #6 Base Standard #7 Standards Organization Potential for Reuse in Other Contexts

23. 22 Evaluation of Standards Harmonization Process for HIT HITSP Harmonization Framework  HITSP decomposes the Use Case requirements into scenario(s) and then into transactions providing context: technical actors, actions and content  It may create or reuse a transaction or a grouping of transactions (transaction package) based on commonality at this level  Transactions are logical groupings of actions that are decomposed into components, which are groupings of base standards that work together, such as message and terminology

24. 23 Evaluation of Standards Harmonization Process for HIT HITSP Harmonization Framework (continued)  Each HITSP construct, i.e., transaction package, transaction or component, may constrain the construct or standard below it.  Constraints are specified in each construct as appropriate, additional constraints may be imposed by higher level constructs to control optionality in a specific scenario  Transaction packages, transactions and components all are potential candidates for reuse if a new set of requirements and context are successful fulfilled by the existing construct  While reuse is a HITSP goal, it is established in the context of a Use Case and its functional/interoperability requirements  HITSP constructs are version controlled and uniquely identified

25. 24 Evaluation of Standards Harmonization Process for HIT LevelDefinitionExampleRules Use Case or Harmonization Request  Defines business and functional requirements  Sets Context  ONC Harmonized EHR Use Case Interoperability Specification  Models business/ functional/ interoperability requirements  Identifies technical/system requirements to meet use-case  Identifies how to use one or more HITSP constructs to meet use- case requirements  HITSP EHR Interoperability Specification  Uses UML diagram to identify technical actors and actions  Sets context  Testable functional requirements  Ids transactions or transaction packages Definitions and Rules

26. 25 Evaluation of Standards Harmonization Process for HIT Definitions and Rules (continued) LevelDefinitionExampleRules Transaction Package  Defines how two or more transactions are used to support a stand-alone information interchange within a defined context between two or more systems  Record Locator Service  Entity Identification Service  Thin context and interoperability requirements  Testable  Based on analysis of like technical actors, context and content harmonized across transactions  May be fulfilled by one or more transactions or composite standard  Expresses constraints on transactions or composite standard Transaction  Logical grouping of actions, including necessary content and context, that must all succeed or fail as a group.  Query lab result  Send lab result  Fulfills all actions between two or more systems needed to meet one or more interoperability requirements  Testable  May be fulfilled by components or composite standard  Expresses constraints on components or composite standard

27. 26 Evaluation of Standards Harmonization Process for HIT Definitions and Rules (continued) LevelDefinitionExampleRules Component  An atomic construct used to support an information interchange or to meet an infrastructure requirement (e.g., security, logging/audit)  Lab result message  Lab result context  Typically will use one “primary” standard and may have other “secondary” standards  Expresses constraints on base or composite standards

28. 27 Evaluation of Standards Harmonization Process for HIT Definitions and Rules (continued) LevelDefinitionExampleRules Base Standard  A standard capable of fulfilling a discrete function within a single category produced and maintained by a single standards organization.  Messaging standard  Security standard  Code set. Per HITSP definition the term “standard” refers, but is not limited to: –Specifications –Implementation Guides –Code Sets –Terminologies –Integration Profiles Composite Standard  Grouping of coordinated base standards, often from multiple standards organizations, maintained by a single organization. In HITSP, it can serve as a component, transaction or transaction package functional requirements.  Integration profiles  Implementation guides  Health transaction services Per Definition above

29. 28 Evaluation of Standards Harmonization Process for HIT Design and Standards Selection  Once requirements have been defined, HITSP scopes the set of constructs to address them  HITSP designs the constructs based on Technical Actors and Transactions –New constructs –Existing constructs to be reused  HITSP identifies the pool of candidate standards  HITSP evaluates the candidate standards against Tier 1 and Tier 2 criteria to define the selected standards  The Requirements, Design, and Standards Selection (RDSS) document is published for a four week comment period

30. 29 Evaluation of Standards Harmonization Process for HIT  The standards required to support each major Use Case event were organized within an agreed upon standards taxonomy  The standards selected for inclusion in the pool were examined using ‘HITSP approved’ Tier 1 and Tier 2 Harmonization Readiness Criteria Tier 1 Standards Readiness Criteria

31. 30 Evaluation of Standards Harmonization Process for HIT Tier 2 Standards Readiness Criteria  Suitability –The standard is named at a proper level of specificity and meets technical and business criteria of use case  Compatibility –The standard shares common context, information exchange structures, content or data elements, security and processes with other HITSP harmonized standards or adopted frameworks as appropriate  Preferred Standards Characteristics –Approved standards, widely used, readily available, technology neutral, supporting uniformity, demonstrating flexibility and international usage are preferred  Standards Development Organization and Process –Meet selected criteria including balance, transparency, developer due process, stewardship and others  Total Costs and Ease of Implementation –Deferred to future work

32. 31 Evaluation of Standards Harmonization Process for HIT Interoperability Specification Development, Inspection Testing and Public Comment  Once the RDSS is published, HITSP begins to define and document the Interoperability Specification constructs  Comments on the RDSS are feed into the Interoperability Specification development process – the RDSS is not republished  The Interoperability Specification constructs are published for a 4- week period of public comment and inspection testing  Inspection Testing is a focused desktop review of the constructs –Inspection Testers are recruited from the HITSP membership and other interested stakeholders –Inspection Testers are given a set of specific criteria to be used to evaluate the Interoperability Specification construct

33. 32 Evaluation of Standards Harmonization Process for HIT Inspection Testing Objectives Objective To validate that the IS…. Process Meets Use Case Requirements  Validate that the IS when implemented will meet the specific requirements as defined in the use case and contains accurate references and data Is Technically Valid  Check the specification to determine the existence of the following: ―Ambiguities/ lack of specificity ―Inconsistencies ―Gaps and overlaps ―Testability ―Completeness ―Internal consistency ―Ability to implement

34. 33 Evaluation of Standards Harmonization Process for HIT Resolution and Publication  The public comments and the results of the Inspection Testing are reviewed and dispositioned by the HITSP Technical Committees –Content changes are: Accepted, Accepted with modification, Rejected (non-persuasive) –Process-related changes are referred to Process Review Committee –Project-related changes are referred to the Project Team  The Interoperability Specification constructs are republished and presented to the Panel for approval  Upon approval by the Panel, the Interoperability Specifications are advanced to AHIC, ultimately to be accepted and then recognized (one year later) by the HHS Secretary

35. 34 Evaluation of Standards Harmonization Process for HIT Implementation Testing  Once the specifications are released HITSP enlists partners to: –develop test plans, data and suites to test the implementation –support a program for progressive testing, feedback and deployment of implementations  Feedback from test implementers is used by the Technical Committees to revise and republish the Interoperability Specifications  The HITSP implementation support and testing process does NOT involve any kind of determination of a products “conformance”  HITSP is currently working with NIST, CCHIT, and ONC to define an overall integrated interoperability testing strategy –As a first step, HITSP has worked with NIST to establish an Implementation Testing and Support website, which provides links to existing test resources

36. 35 Evaluation of Standards Harmonization Process for HIT HIT Implementation Testing Web Site Preview

37. 36 Evaluation of Standards Harmonization Process for HIT Maintenance Process  HITSP documents are maintained through a structured release and publication process; with on-going “major” or “minor” releases  Major - Any change that introduces a requirement where a modification to an implementation MUST occur in order to remain conformant to the Interoperability Specification, or a component thereof, is to be considered a major change –Major releases go through inspection testing, public comment, and Panel approval –Major releases are versioned as (1.0, 2.0, 3.0 etc)  Minor - Any change that loosens restrictions, clarifies use or intent but does not require any action for an implementation to remain conformant is considered a minor change –Minor releases are issued by consensus at the Technical Committee Level –Minor releases are versioned as 2.1, 2.2, 2.3, etc

38. 37 Topics  HITSP Mission within ONC Interoperability Initiatives  HITSP Organization  HITSP Process  Introduction to Current Interoperability Specifications  HITSP 2007/2008 Work Plan

39. 38 Evaluation of Standards Harmonization Process for HIT Consumer Empowerment Registration and Medication History  Scope –Deploy to targeted populations a pre-populated, consumer-directed and secure electronic registration summary. Deploy a widely available pre- populated medication history linked to the registration summary  Addresses core consumer empowerment enabling “connected PHRs”  Now recognized to be also applicable to EHR-to-EHR information exchange for interoperable patient charts with meds, allergies, problems, registration info.  A successful collaboration between HITSP and several HITSP member organizations developing base standards and implementation guides/profiles: ASTM, CAQH, CDC, FMT, HL7, IHE, NCPDP, X12, SNOMED

40. 39 Evaluation of Standards Harmonization Process for HIT Consumer Empowerment Registration and Medication History

41. 40 Evaluation of Standards Harmonization Process for HIT Biosurveillance  Scope –Transmit essential ambulatory care and emergency department visit, utilization, and lab result data from electronically enabled health care delivery and public health systems in a standardized and anonymized format to authorized public health agencies with less than one day lag time  IS maximizes data sources and provides stringent data management to ensure proper routing, security, privacy, and timely reporting –IS provides support for any variant of architectural environments –IS includes full options of standards to maximize data and information exchange  Addressing gaps with referrals to SDOs through the Foundations Committee  Actively aligning with other public health industry initiatives

42. 41 Evaluation of Standards Harmonization Process for HIT Biosurveillance

43. 42 Evaluation of Standards Harmonization Process for HIT Electronic Health Record (EHR) Laboratory Results Reporting  Scope –Deploy standardized, widely available, secure solutions for accessing laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties  IS addresses lack of harmonization among data interoperability standards including vocabulary and laboratory and other messaging standards –IS accommodates both laboratory message transaction and document sharing paradigms –IS selects standards with wide coverage to address gaps and provide mapping between standards to address overlaps  HL7 and HITSP Lab WG are coordinating activities to complete a lab message implementation guide to meet the use case requirements

44. 43 Evaluation of Standards Harmonization Process for HIT Electronic Health Record (EHR) Laboratory Results Reporting

45. 44 Evaluation of Standards Harmonization Process for HIT  A HITSP IS addresses the communication of health information among a number of Business Actors within the context of a specific Use Case.  There are two dimensions to the use/implementation of a HITSP IS by a set of “real world systems”. Each system may chose to support: –One or more of the Use Case Subsets, if any are defined –One or more Business Actors and options, if any are defined. Use of HITSP’s Interoperability Specifications

46. 45 Evaluation of Standards Harmonization Process for HIT Use of HITSP’s Interoperability Specifications  A “real world system” may chose to support: –One or more of the Use Case Subsets –One or more Business Actors and options, if any  Choice of a Use Case Subset (if defined by the IS) implies support of: – A Subset of Business and/or Technical Actors – A Subset of transactions and/or components  Choice of a Business Actor implies support of: –All Technical Actors defined as required to support the selected Business Actor. –All Transactions or Components (Document Content, Terminology Value Sets, etc.) specified as required originating or terminating with each Technical Actor –If any specified, the options associated with each technical actor.

47. 46 Evaluation of Standards Harmonization Process for HIT Example: Use of the EHR-Lab Results IS  The HITSP EHR-Lab IS addresses two use case “subsets”: –Returning Lab results to the ordering provider –Sharing and accessing historical lab results Laboratory EHR Lab Result Msg Option: Copy to Lab Result Msg Laboratory EHR Lab Result Doc Repository & Locator Option: Notification of Availability Lab Result Doc Patient Id Query Patient Id Service Patient Id Service Pt Id Query Option: Copy to Lab Result incl Pt Id Service (Lab, EHR, Pt Id) Option: Notification of Results Availability (Lab, EHR) Business Actor Technical Actor

48. 47 Evaluation of Standards Harmonization Process for HIT Example: Use of the CE-Reg/Med IS  The HITSP CE-Reg/Med IS has no use case “subsets”: PHR Reg/Med Doc Registry Patient Id Service Pt Id Query Option: Registration Info (PHR, Health Plan, EHR) EHR PBM/ Pharmacy Health Plan Repository Register Doc Option: Med & Allergies Info (EHR,PHR, PBM/Pharmacy) Business Actor Technical Actor

49. 48 Topics  HITSP Mission within ONC Interoperability Initiatives  HITSP Organization  HITSP Process  Introduction to Current Interoperability Specifications  HITSP 2007/2008 Work Plan

50. 49 Evaluation of Standards Harmonization Process for HIT JANFEBMARAPRMAYJUNJULAUGSEPOCTNOVDEC HITSP 2007 Timeline (as of June 2007) 02/05/07 HITSP Board 04/23/07 HITSP Board 07/09/07 HITSP Board 10/09/07 HITSP Board 03/19/07 HITSP Panel 05/11/07 HITSP Panel 09/07/07 HITSP Panel 03/06 – 03/08 TC Face to Face Chicago IL 5/08 – 5/10 TC Face to Face Arlington VA 6/18 – 6/20 TC Face to Face San Diego CA 09/04 – 09/06 TC Face to Face Arlington VA Public Comment Inspect Test and Public Comment Implementation Support and Testing (with annual updates as required) Comment Resolution and Panel Approval 02/15 – 05/16 04/13 – 05/16 IS Construct Development 05/17 – 07/19 07/20 – 08/1608/17 – 10/15 Implementation Support and Testing (includes minor document updates) EHR, CE and BIO v 2.0 Activity 1 – Version 2.0 of Existing EHR, CE, BIO ISs Activity 2 – Security and Privacy for All Use Cases Activity 3 – New Emergency Responder EHR Use Case On-going Support 10/15/07 HITSP Panel 07/16/07 HITSP Panel 02/12/07 HITSP Panel Activity 4 –New Use Cases from AHIC Detail Schedule to be Established Upon Review of the Use Cases S&P and EHR-ER v 1.0 Requirements, Design, Standards Selection Public Input on S&P 05/17 – 06/14