1. August 11, 2006 Washington DC HITSP Project Interoperability Specification Inspection Test Contract HHSP23320054103EC

2. 1 The purpose of this presentation is to orient HITSP IS Testers by providing...  Information about the formation of HITSP  An overview of the HITSP Harmonization Process  IS Testing Material Overview and Schedule

3. 2 Evaluation of Standards Harmonization Process for HIT In 2005, HHS awarded contracts to seed a public-private effort to build a national health information network

4. 3 Evaluation of Standards Harmonization Process for HIT A public-private “Community” was then established to serve as the focal point for America’s health information concerns and drive opportunities for increasing interoperability Health Information Technology Standards Panel (HITSP) National Health Information Network (NHIN) Architecture Projects The Health Information Security and Privacy Collaboration (HISPC) The Certification Commission for Health 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 206 different member organizations and is administered by a Board of Directors 17 SDOs (8%) 161 Non-SDOs (79%) 18 Govt. bodies (8%) 10 Consumer groups (5%) HITSP includes 206 different member organizations and is administered by a Board of Directors 17 SDOs (8%) 161 Non-SDOs (79%) 18 Govt. bodies (8%) 10 Consumer groups (5%)

5. 4 Evaluation of Standards Harmonization Process for HIT The Community formed workgroups to focus on four breakthrough areas  Biosurveillance -- Transmit essential ambulatory care and emergency department visit, utilization, and lab result data from electronically enabled health care delivery and public health systems in standardized and anonymized format to authorized public health agencies with less than one day lag time.  Consumer Empowerment -- 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.  Electronic Health Record Exchange -- Deploy standardized, widely available, secure solutions for accessing laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties.  Chronic Care – Ensure that widespread use of secure messaging, as appropriate, is fostered as a means of communication between clinicians and patients about care delivery HITSP Focus

6. 5 Evaluation of Standards Harmonization Process for HIT The HITSP team was charged with completing eleven different tasks, with current efforts focused on the harmonization process 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, C Fantaskey, Booz Allen Project Management Team Executive in Charge, F. Schrotter, ANSI Program Manager, L. Jones GSI Deputy PM, J Corley, ATI Project Manager, C Fantaskey, Booz Allen Harmonization Process Delivery Technical Manager Joyce Sensmeier, HIMSS Harmonization Process Delivery Technical Manager Joyce Sensmeier, HIMSS Harmonization Process Definition Technical Manager Michelle Deane, ANSI Harmonization Process Definition Technical Manager 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 the 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 – ongoing efforts 11.Assist with communications – ongoing efforts

7. 6 The purpose of this presentation is to orient HITSP IS Testers by providing...  Information about the formation of HITSP  An overview of the HITSP Harmonization Process  IS Testing Material Overview and Schedule

8. 7 Evaluation of Standards Harmonization Process for HIT I Harmonization Request Harmonization Process Steps 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 The actual harmonization process is a series of steps taken by industry stakeholders within the context of HITSP

9. 8 Evaluation of Standards Harmonization Process for HIT HITSP Framework Basis for Interoperability Specification Template  HITSP receives Use Cases and Harmonization Requests from external sources, such as AHIC and ONC.  The Use Case or Request defines scenarios, business actors, and business and functional/interoperability requirements.  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.  Each HITSP construct, i.e., transaction package, transaction or component, may constrain the construct or standard below it. Constraints follow a strict hierarchy and are only imposed by the next higher construct.  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. The first objective for September is meeting Use Case functional/interoperability requirements.  HITSP constructs are version controlled and, if reused, will be uniquely identified.  The HITSP constructs are a refinement of the “building block” concepts – “building block” is no longer a HITSP construct. Our current set of building blocks is a library of candidates that might be used to construct a transaction package, transaction or component. Building blocks are instances of composite standards.

10. 9 Evaluation of Standards Harmonization Process for HIT HITSP Framework

11. 10 Evaluation of Standards Harmonization Process for HIT LevelDefinitionExampleRules Use Case or Harmonization Request  Defines business/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  Based on UML diagram to identify technical actors and actions  Sets context  Testable functional requirements  Ids transactions or transaction packages 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 the 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 Definitions and Rules

12. 11 Evaluation of Standards Harmonization Process for HIT Definitions and Rules (cont.) 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 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

13. 12 Evaluation of Standards Harmonization Process for HIT The Harmonization Process – Inspection Testing I Harmonization Request Harmonization Process Steps 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 You are here

14. 13 Evaluation of Standards Harmonization Process for HIT The Inspection Test is just one in a series of tests that will be performed to validate the utility of the specification  The HITSP harmonization process results in an interoperability specification that will be widely disseminated  A series of tests is required to validate the quality and usability of the specification  The first test in the series of tests is the Inspection Test  The objective of the Inspection Test is to ensure that the IS meets the requirements of the Use Case and can be used to implement the requirements TitleDue to HHSStakeholders Inspection TestSept 29, 06HITSP, EHRVA, IHE, Gov’t, others Plan for interoperability testing Sept 29, 06HITSP, NIST, NLM, others Third party testing2007HITSP, NIST, CCHIT Orchestration and implementation test 2007HITSP, IHE, FHA, EHRVA, NHIN

15. 14 Evaluation of Standards Harmonization Process for HIT The purpose of the inspection test is to ensure the Interoperability Specifications meet the following objectives Conforms to Style and Editorial Guidelines (Note that this will primarily be the responsibility of the HITSP project team and not the testers)  Ensure the integrity of document pieces – that all the cascading documents are present  Validate grammar, spelling, and consistency of terminology  Validate that it follows the style guide for text and graphics Contains Accurate References and Data  Validate the references to other documents and data sources are valid and that data in tables is accurate. Meets Use Case Requirements  Validate that the IS when implemented will meet the specific requirements as defined in the use case 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

16. 15 Evaluation of Standards Harmonization Process for HIT There are 8 major steps that HITSP must follow to complete the Interoperability Specification (IS) inspection test process 1.Identify and engage key volunteer test resources 2.Develop the tools and procedures for gathering and responding to test findings 3.Assign testers to IS documents 4.Distribute Interoperability Specifications to the assigned testers 5.Conduct the test and hold test monitoring sessions– including a test kickoff, mid-point test monitoring session, IS specific walkthrough sessions, and final test debrief 6.Consolidate and document test results 7.Writers analyze and disposition test defects, updating IS documents as appropriate 8.Wrap up testing and prepare for posting to HITSP.org for public comment

17. 16 The purpose of this presentation is to orient HITSP IS Testers by providing...  Information about the formation of HITSP  An overview of the HITSP Harmonization Process  IS Testing Material Overview and Schedule

18. 17 Evaluation of Standards Harmonization Process for HIT Inspection testers will sign up for one or more Interoperability Specifications and receive documents and test worksheets Testing Material PacketDescriptionAction Interoperability Specifications:  Biosurveillance  Electronic Health Records Exchange  Consumer Empowerment  Review each IS and supporting documents utilizing the materials provided to you in the material packet Technical Validity Worksheet – series of general criteria  The worksheets will correspond to the type and number of construct documents  Primary testing tool  Complete a worksheet per document  Add a reference point in the document and comment for any criteria we fail IS-level Requirements Worksheets  Validated and simplified worksheet  Listing of event action codes from the harmonized use cases  Note where the IS fails to meet a requirement (include comment) Data Element Worksheet – IS level requirements only  Listing of data elements derived from IS requirements worksheet  Note where the IS fails to meet a requirement (include comment) General and Editorial Worksheet  Lowest priority worksheet  (Note that this will primarily be the responsibility of the HITSP project team and not the testers)  Validate grammar, spelling, and consistency of terminology  Validate that it follows the style guide for text and graphics

19. 18 Evaluation of Standards Harmonization Process for HIT The testing process will occur over a two-weeks period with updates scheduled throughout Activities August 182122232425262728293031 Phase 2 Receive Testing Package Testing Period Testing Period Kick-off Mid-Point Telecon EHR IS Walkthrough Telecon BIO IS Walkthrough Telecon CE IS Walkthrough Telecon End-Point Telecon Key Deliverable Key Meeting