1. Tools Supporting ISO TC215 – ISO 19669 Re-Usable Component Strategy for Use Case Development Presented to HSPC DC Meeting, 17-19 June 2015 Presented by Gary.Dickinson@ehr-standards.com June 17, 2015

2. Tools Supporting ISO 19669 Vision Goals – Interoperable Health IT systems – Maintaining health record authenticity and accountability Objectives – Semantic Interoperability – full development lifecycle support – Traceability among Requirements, Design, Test and certification artifacts using tooling – Model Driven Architecture, design and testing support 17 June 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 2

3. Tools Supporting ISO 19669 Key Collaborators – Use Case Developers: Office of National Coordinator (ONC), Standards and Interoperability (S&) Framework, S&I Simplification Work Group; Canada Health Infoway (tentative); Health Services Platform Consortia (in discussion), Defense Health Agency, Veterans Administration – Expertise and Guidance: National Institute for Standards and Technology (NIST) – Use Case Repository: Agency for Health Research and Quality (AHRQ)/US Health Information Knowledgebase (USHIK) – Information Model: US Federal Health Information Model (FHIM), part of US Federal Health Architecture (FHA) – Standards Developers: Health Level Seven (HL7) Electronic Health Record (EHR) Work Group; ISO TC215 (Health Informatics) WG1 (Architecture, Frameworks and Models) – Tool Developers: Prometheus Computing (Beacon); SPARX Systems (Enterprise Architect) 17 June 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 3

4. Tools Supporting ISO 19669 Source Information (Traceability) – HITSP Use Cases and S&I Framework Use Cases – ISO 19669 Methodology (Technical Report) – ISO/HL7 10781 EHR System Functional Model R2 – ISO/HL7 16527 PHR System Functional Model R1 – FHA FHIM – captures data requirements and maps to implementable HL7 V2, HL7 CDA, CCDA, HL7 FHIR HIPAA X12 Transaction Set NCPDP (Pharmacy) SNOMED, LOINC, RXnorm vocabularies and code sets – NIST Health IT Test and certification Framework Tools for Implementation Guide Authoring and Management Tool (IGAMT) Test Case Authoring and Management Tool (TCAMT) – AHRQ USHIK-based repository: HITSP and S&I Use Cases 17 June 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 4

5. Tools Supporting ISO 19669 Benefits – agile aligned interoperable systems – Patient Privacy and Security Authentication/Authorization/Audit/Accountability support within ACA compliance Rules – Record Management Lifecycle & Provenance support – higher effectiveness and efficiency – Specification, Test Certification Framework for EHRs – Integrated Framework for End User Requirements traceability to Health IT certification and implementations 17 June 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 5

6. ISO TC215 – ISO 19669 Re-Usable Component Strategy for Use Case Development Report to ISO TC215 WG1 21 April 2015 San Francisco, California, USA

7. ISO 19669 Fundamentals Based on US Standards and Interoperability (S&I) Framework –Sponsored by the US Office of National Coordinator for Health Information Technology (ONC) –Based on S&I Simplification Work Group analysis (2011 on) In Close Collaboration with –US National Institute for Standards and Technology (NIST) –US Agency for Health Quality and Research (AHRQ) Now: ISO 19669 –Approved as New ISO Work Item - April 2014 –Added to ISO TC215 WG1 Work Program –Draft in Development 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 7

8. In General Use Cases A Use Case has –One or more Scenario(s) with –One or more Event(s) with –One or more Action(s). Use Case Scenarios describe (resolve to): –A set and sequence of Actors taking Actions; –A progression of steps. Actors may be –Individuals, organizations or systems. 21 April 20158 ISO 19669 - Re-Usable Component Strategy for Use Case Development

9. In General Use Cases Convey Uniform and Integrated Patterns of: –Patient Flow – with Patient as Actor –Provider (Work/Process) Flow – with Provider as Actor –Information Flow – including System as an Actor And Show: –Event Steps with Actions taken – by Actors in Roles – to support individual health and provide healthcare –Often including health record entries resulting from Actions taken With Commonalties, Patterns of Repetition/Re-Use –Both Current and Potential 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 9

10. US Standards and Interoperability (S&I) Framework S&I Simplification WG Reviewed S&I Initiative Use Cases Identified Commonalties, Patterns of Repetition/Re-Use –Both Current and Potential Compiled and Distilled Components from S&I Initiatives Current Analysis: 20 Use Cases with 44 Multi-Step Scenarios 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 10

11. 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 11

12. S&I Framework – Cross Initiative – S&I Simplification Key Objectives To identify a set of Core Components broadly applicable to, and re-usable in subsequent specification of, Use Cases –Core Components are Requirements, Events, Actions, Actors, Roles and Data Objects and Elements, that we: Find in common across Use Cases, Scenarios and Events; Might re-use in a new Use Case Scenario. To establish/maintain a Core Component Registry To allow each Use Case Initiative to –Select (re-use) Core Components applicable to their needs –Create anew: identify new Core Component candidates To identify Implementable Data and Software Constructs fulfilling Core Component requirements 21 April 201512 ISO 19669 - Re-Usable Component Strategy for Use Case Development

13. S&I Framework – Cross Initiative – S&I Simplification Key Objectives, con’t To lay the foundation for a consistent infrastructure and build-out To lead to uniformity in requirement specification, standards and implementation guidance, software development, testing and certification, implementation To ensure requirements traceability, at each progression step, and end-to-end (use case to implementation) [NIST] To apply cross-industry: beyond S&I Framework, beyond the domain of health and healthcare –A generic approach 21 April 201513 ISO 19669 - Re-Usable Component Strategy for Use Case Development

14. S&I Framework – Cross Initiative – S&I Simplification Considering… Which Components of a Use Case are: –Potentially computable? As implementable software and/or data objects? –Uniquely identifiable? Catalogue-able? In an established repository? –Candidates for re-use? In another Use Case scenario? 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 14

15. Components selected from S&I Initiative Use Cases Is it…Potentially Computable for… In Common? Re-Usable? Computable? Identity Accountability Permission, Consent Access, Data Use Performance/ Fulfillment Capture, Provenance Content: Struct/Unstruct Coding, Classification Completeness Signature Audit RequirementsYYY Actors, RolesYYY Scenarios, Events, Actions YYY  As standards-based software services Data Objects, Elements YYY  As standards-based data objects, messages, documents… S&I Framework – Cross Initiative – S&I Simplification Component Candidates 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 15

16. S&I Framework – Cross Initiative – S&I Simplification Analysis Focus Requirements Actors and Roles –Individuals, Organizations, Systems Scenarios Events and Actions Data Objects and Elements 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 16

17. S&I Simplification Work Group has: –Analyzed 20 S&I Use Cases with 44 Scenarios –Specified Actions (examples) for each Scenario and Event Step Next Slide –Shows Repetition Counts for Action Examples 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 17 S&I Simplification Analysis

18. 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 18 S&I Simplification Analysis Examples Potential Re-Use – Actions Repetition Count 

19. 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 19 Source: Rob Snelick, NIST

20. 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 20 Traceability – Anchored by Use Case Authoring Tool (UCAT) From Sketch to Implementation Use CaseSoftware Requirements Specification HarmonizationDevelopmentTesting/Cert Implementation  Traceability  WHO Non-IT Business/ Clinical Expert  Expert User  Developer/ Vendor  Testing Body  Business/ Clinical User  HOW Sketches  Maps to  Selects from  Develops using  Tests  Implements using  WHAT Use Case Scenarios, Events Actions, System Functions Implementable Standards-Based Software Modules/Services Use Case Data Req’ts FHIM Data Objects Implementable Standards-Based Data Artifacts (e.g., HL7 FHIR resources, messages, documents) Tool Use Case Authoring Tool (UCAT) UCAT [Vendor] NIST TCAMT [Enterprise] NIST IGAMT Feedback at each Stage

21. S&I Simplification Leveraging Opportunities S&I Use Cases – Buildout ISO and CEN National Members (via ISO 19669) –Often tied to National HIT Programs Federal Health Architecture –DoD, VA, IHS, FDA, CMS, HHS, ONC, also CDC, NLM, NIH NIST: Cross Industry Canada Health Infoway West Health Institute Health Services Platform Consortium (HSPC) Model Driven Health Tools (MDHT) 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 21

22. S&I Simplification Use Case Template Examples Seeking –Blank Use Case Requirements Template –Template with example Use Case filled in –For comparison with S&I Use Case Requirements Template 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 22

23. SeekingRequests to Status Blank Use Case Requirements Template Template with one or more example Use Case(s) filled in Nancy Orvis, US DOD MHS Requested David Bass, US VHA Received Other US FHA Agencies, via FHA HIM Requested ISO TC215 National Member Bodies - Beatriz Leao (Brazil) Received CEN TC215 WG1 – Stephen Kay (UK) Anticipated Canada Health Infoway – Ron Parker Requested Health Services Platform Consortia (HSPC) - Craig Parker, MD, Laura Heerman Discussed West Health Institute – Todd Cooper Discussed 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 23 S&I Simplification Use Case Template Examples

24. S&I Framework – Cross Initiative – S&I Simplification UCAT Tool Developers Prometheus Use Case Editor –Art Griesser, Lead –a.griesser@prometheuscomputing.coma.griesser@prometheuscomputing.com –https://prometheuscomputing.com/beaconhttps://prometheuscomputing.com/beacon Sparx Enterprise Architect Extensions –J.D. Baker, Lead –jbaker@sparxsystems.comjbaker@sparxsystems.com –http://www.sparxsystems.comhttp://www.sparxsystems.com 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 24

25. S&I Framework – Cross Initiative – S&I Simplification Links US Office of National Coordinator (ONC) Standards and Interoperability (S&I) Framework Wiki –http://wiki.siframework.orghttp://wiki.siframework.org S&I Simplification Wiki –http://wiki.siframework.org/Cross+Initiative+-+S%26I+Simplification+WGhttp://wiki.siframework.org/Cross+Initiative+-+S%26I+Simplification+WG –http://wiki.siframework.org/Use+Case+Simplification+Reference+Materialshttp://wiki.siframework.org/Use+Case+Simplification+Reference+Materials Federal Health Information Model (FHIM) –http://www.fhims.orghttp://www.fhims.org AHRQ/USHIK S&I Pilot Site –http://ushik- stg.dcgroupinc.com/mdr/portals/si?system=si&enableAsynchronousLoading=truehttp://ushik- stg.dcgroupinc.com/mdr/portals/si?system=si&enableAsynchronousLoading=true HL7 EHR Interoperability Wiki –http://wiki.hl7.org/index.php?title=EHR_Interoperability_WGhttp://wiki.hl7.org/index.php?title=EHR_Interoperability_WG 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 25

26. ISO 19669 Contact Gary L. Dickinson –Director, Healthcare Standards, CentriHealth –Lead, S&I Framework, S&I Simplification Work Group –Co-Chair, HL7 EHR Work Group –+1-951-536-7010 –gary.dickinson@ehr-standards.comgary.dickinson@ehr-standards.com 21 April 2015 ISO 19669 - Re-Usable Component Strategy for Use Case Development 26