HL7 V2 Implementation Guide Authoring and Management Tool Proposal

1. HL7 V2 Implementation Guide Authoring and Management Tool Proposal Robert Snelick, NIST National Institute of Standards and Technology May 14th 2012 Revised: January 24th, 2013 Contact: rsnelick@nist.gov

2. NIST and Veterans Administration Joint Project • NIST will provide Project Management, Requirements and Design, Existing Tool Components, Tool Integration, and Developers • Peter Rontey, designer and developer of the Messaging Workbench (MWB) will be the Chief Architect and Senior Developer • Key Aspects: • develop Implementation Guide Authoring and Management Tool • component-based Java tool • expands MWB concepts and functionality • integrate with existing NIST tooling • Goals of the Collaboration • Provide tools to be better specify and validate HL7 V2 implementation guides • Tool driven specification development • Leverage VA and NIST expertise • Leverage, expand, and integrate VA and NIST tooling • Messaging Workbench (MWB) • NIST Message Maker, Testing Infrastructure, and Meaningful Use (MU) Tools • Support the Healthcare IT testing and certification efforts (End-to-End) • Initial focus on MU certification but widely applicable

3. Specification to Testing: An End-to-End Approach • Proposed methodology and tools to support the development of HL7 V2 implementation guides and testing of systems that implement the implementation guides • End-to-End Scope • Implementation Guide Authoring and Management • Test Data Authoring and Management • Message Generation and Inspection Document Generation • Test Case Authoring and Management • Testing Infrastructure • Test Engine • Choreography • Validation Engine • Messaging Validation • Functional Validation • Communication Platforms • Leverage and Extend Existing Concepts and Tools • Messaging Workbench (MWB), NIST Message Maker and Testing Infrastructure, OHT MDHT Concepts and components

4. Other Industry Consortia Implementers Certification Body Vendors HITSP NHIN Conceptual View of NIST Testing Infrastructure System Components Specification (IG) Authoring Tools STAKEHOLDERS NIST TEST INFRASTRUCTURE SYSTEM SUT Test System Instance System(s) Under Test Resource Repository User Interface Test Cases, Machine-Readable Test Scripts Templates, Common File Format Specifications Test System Control Test Environments Supported Instance Testing Test Harness Isolated System Testing Workflow Management /Execution Engine Test Analyzer Peer-to-Peer System Testing Test System Development Components Services Test Management Tools and Test Systems Test Agent Proxy Evaluation Agent Test Initiation and Test Identification Management Test Framework Test Framework Test Framework Test Case Creation Generation Test Data Validation Report Remote Services Configuration Settings Management Existing Tool Time Log Analyzer Security Logging User Repository Management Registry/ Repository Aggregated Specialized Other Services External Service Real-Time Monitor

5. What will the tools address? Use Cases Standards Implementation Test Cases Test Data • healthcare use case development • implementation guide development • implementation • specification of test cases • development of test messages • create requirements to guide the standards development • ensure use case requirements are satisfied • create testable assertions criteria • application implements the standard • tests cases should test all requirements specified in the implementation guide • messages support test cases • valid and invalid Test Case Authoring and Management Tool (TCAMT) Message Maker Tool Implementation Guide Authoring and Management Tool (IGAMT) Vendors Test Material Test Scripts Test Execution Results Analysis • artifacts to support testing • processable test cases • execution of the test scripts • juror document or test report • automated or human analysis • XML message profiles • vocabulary • validation context files • methods and tools to transform test cases into machines process-able instructions • test engine interprets test scripts • validate message against test material • create inspection document • provide validation test report • test or certification managers determine pass/fail based on results IGAMT and TCAMT Test Case Authoring and Management Tool (TCAMT) Testing Infrastructure (Test Engine) Testing Infrastructure (Validation) and TCAMT Testing Organizations

6. Shortcoming of V2 Implementation Guides • Each guide has their own style, format, terminology, and interpretation of concepts • The only thing that is consistent with implementation guides is that they are inconsistent • Interpretation of the conformance constructs is not universal • Not only across organization but within originations (e.g., IHE and HL7) • IHE varies from standard HL7 V2 constructs (e.g., R2 Usage) • Conformance requirements written in English and often as embedded comments • If written at all, are often not clear • Condition Predicates not well defined (if at all) • Difficult to create machine processable representation of implementation guide • Current process is to create English document and then create conformance profile • Use MWB to create XML conformance profile • Often the conformance profile is not created • HL7 XML Conformance Profile does not capture the complete set of requirements specified in the implementation guide • Ambiguous statements difficult to translate to concrete conformance requirements • Testing approach, plan, and requirements are absent • Implementation Guides do not provide test plan supplements

7. The need for Uniformity: NIST Experience with HL7 V2 IGs • ONC S&I Framework Lab Results Interface (LRI) • MU-2014 (HL7 Balloted) • CDC PHIN Immunization (EHR to Public Health) • MU-2011 and MU-2014 • HL7 Labs to Public Health (EHR to Public Health) • MU-2011 and MU-2014 (HL7 Balloted) • IHE PIX (Patient Identification Cross-referencing) • Integration Profile (Multiple Message Profiles) • Pre-connectathon and Connectathon Testing • IHE PDQ (Patient Demographic Querying) • Integration Profile (Multiple Message Profiles) • Pre-connectathon and Connectathon Testing • IHE PCD (Patient Care Devices) • Integration Profile (Multiple Message Profiles) • Pre-connectathon and Connectathon Testing

8. How can we Address the Increased Demand for Tools? Implementation Guide Authoring Tools (Create more “testable” specifications!) Implementation Guides (Number is increasing rapidly—no testing tools available) IHE HL7 v2 PIX/PDQ Technical Framework HL7 v2 MU Lab Results Interface (LRI) Implementation Guide ELINCS HL7 v2 Lab Orders and Results Implementation Guide IHE HL7 v2 PCD Technical Framework HL7 v2 MU Syndromic Surveillance Implementation Guide HL7 v2 MU Immunization Reporting Implementation Guides HL7 v2 MU incorporate Lab Results & Reportable Lab Results Implementation Guides HL7 v2 Implementation Guides in General (HL7, CDC, PHIN, ISDS, ONC, etc.) IHE HL7 v2 Technical Framework In General 20+ IHE integration profiles using V2! Test Case Management Tool (Let domain experts help write the test cases!) Test Cases and Testing Artifacts Test System (Allow NIST/others to build tools quickly)

9. End-User (Vendor) Testers SDOs “Reusable” Test System Phase 3 HL7 Test Tool Phase 1 Implementation Guide Authoring Tool Test Flow Engine User Interface Test Agent Support HL7 v2 Test Agent Core Test Cases Test Case Management Tool Phase 2 Test Engine Message Generation and Validation Test Agent Support Test Management Test Agent Core Web Application Communication Real- Time Log Vendor System Under Test Test Agent Support Test Agent Core Reports HL7 v3 Special Validation MLLP (v2) or SOAP (v3) NIST Server/Other Server Tool Builder Tasks

10. Proposed Use and Goals Integrated Tooling • Develop tooling to automate process as much as possible • Component integration—one tool output flows into the next • E.g., Conformance profile and conformance statements created during implementation guide development can directly be used by validation engine • Machine processable message profile specification • Used and built upon throughout and the development and testing cycle • Constraints as specified in Implementation Guide Authoring Tool are used directly by validation engine • Goal is to enable domain experts to develop artifacts • Tooling will better enable domain experts to produce quality implementation guide requirements and test criteria • HL7 Balloted Implementation Guides should use the tool to create (template) • Ensure consistent definition and use of HL7 V2 Conformance Concepts • Ensure conformance constructs specified correctly and completely • Ensure compatibility with the standard or document variances • Implementation Guides should have companion test plans complete with example/test messages • A quality level for implementation guides can be establish • Test plans can be balloted by HL7 • Developing test plans in coordination with the implementation guide development promotes better understanding of the requirements and force clear conformance requirements • Establish Implementation Guide Best Practices—Enforce with tooling • With HL7 CGIT WG participation the ONC S&I Framework Lab Results Interface (LRI) Implementation Guide and NIST’s development of the LRI Test Plans and Test Tool is an example that is heading in the right direction

11. Tool Component Overview • Implementation Guide Authoring and Management • Messaging Profiling and IG Document Generation • Test Data Authoring and Management • Test Data Organization, Library Creation, and Management • Message Generation and Inspection Document Generation • Assembly of Test Data, Message Generation, and Juror Inspection Documents • Test Case Authoring and Management • Support complete Test Plan Life Cycle • Incorporates Conformance Profiles, Test Messages, Inspection Documents • Support Scenario and Application Functional Behavior Testing (Actor based) • Testing Infrastructure • Test Engine • Choreograph a sequence of transactions • Validation Engine • Messaging Validation • Functional Validation • Communication

12. The Big Picture: HL7 V2 End-to-end Testing Support Implementation Guide Authoring & Management Tool Test Case Management and Authoring Tool Testing Infrastructure Testing Tools HL7 V2 Impl. Guide Template Test Plan Template Conformance Profiles (XML) IG Template Wizard Test Plan Development Testing Environments Capabilities Web Applications Use Case Development Test Case Development Domain Specific Tools Conformance Profile (XML) Vocabulary Libraries (XML) Use Cases Test Agents Message Profiling Constraint Generator Test Case Specific Context Files (XML) Testing Infrastructure Components HL7 v2 Standard Message Definition Vocabulary Library (XML) Execution Engine Vocabulary Profiling Test Script Generator Resource Bundle Validation Engine Specification Validation Context File (XML) Resource Bundle Management General Transaction Constraints (e.g., IG , TF, or user input)¹ Disposition Traceability Data Sheet and Juror Document Generator Data Sheets Message Generation Engine Juror Documents Test Plan Execution Script (XML) Utilities Document Generator Test Plan Integration Test Case Requirements Test Plan Execution Script (XML) HL7 v2 Standard Value Sets DITA XML MessageMaker Report Generation Validation Data Management Impl. Guide English Document Utilities Document Generator Message Generation Test Plan English Document Communication Import Value Sets Communication Artifact Repository Documentation Domain Experts and Test Case Developers Domain Experts Software Engineers Tool Developers User Input Tool Generated ¹ Support existing specifications R. Snelick May 8th, 2012

13. Implementation Guide Authoring Tool Overview • Provides support to create a consistent (“standardized”) HL7 V2 Implementation Guide • The HL7 V2 conformance principles and profile is the foundation • Explicitly define conformance requirements that can be processed automatically • HL7 V2 conformance profile constraints • Value Set constraints • Conditional constraints • Explicit conformance statements • Other constraints • Authoring tool maintains internal representation of message definition and constraints • Constraints/Conformance Requirements must be specified in such a manner that they can be processed/tested automatically • Publishes English version implementation guide • Work the other way around; define constraint in tool  publish IG • Modifications made in tool and republished • Pre-defined Implementation Guide Skeleton • Think of it as a “Super MWB” • Will include many of the concepts and functionality of the MWB • Expand scope to document generator and support additional conformance constructs • Build modular/reusable components—Java Platform • Leverage and integrate existing NIST testing Infrastructure components • Deploy as Web Applications

14. Current IG Authoring and NIST Testing Process² Validation Tool Conformance Profile (XML)¹ Create Implementation Guide English Document Manually Value Sets (XML) MWB Specification Validation Context File (XML) Implementation Guide English Document Constraint Generator Table Library (XML) Test Case Specific Validation Context File (XML)³ Constraint Generator Table Library (XML) ¹ Often not created; NIST creates default conformance profile automatically and adds use case specific constraints in validation context. Current NIST testing for meaningful use certification is an example. ² This is the current NIST approach. This may differ in other organizations. ³ Testing for conditional requirements are implemented with data sets and a dynamic “profile”—captured in a spreadsheet and rendered as a validation context

15. HL7 V2 Implementation Guide Authoring Tool • Graphical User Interface tool • Provides “template” Implementation Guide • Conformance terminology and meaning section • Use Case(s) • Dynamic model (message interactions) • Static model (message layout and constraints) • Value Set Definitions • Expanded Conformance Profile Attributes • Text and Machine processable conformance statements • Text and Machine processable conditional predicates • Standard constraint model infrastructure • Exports message profile and table library • Utilities (profile comparison, profile compatibility checker, etc.) • Implementation Guide Management • including disposition history

16. Skeleton Implementation Guide Structure and Format HL7 V2 Implementation Guide Title • Introduction and Overview • Define template sub-sections Example Messages (Incorporate/Use Message Maker Tool) • Use Case Description • Develop format to process automatically • Extracted List of Conformance Requirements • Processable by tooling • Dynamic Behavior Description • Develop format to process automatically • Associated Files • XML Conformance Profile • XML Table Library • XML Conditional Constraint Definitions • XML Static Constraint Definitions (formats, etc) • Static Message Definition Layout • Created with XML conformance profile or internal message definition representation • Column for assertion description and tagged format sufficient for automated processing • Conformance Construct Definitions and Validation Interpretations • Including an explanation of how conformance constructs are tested • Adapted from HL7 Conformance Profile • Could be a standardized Appendix or Supplement Value Set Definitions

17. Implementation Guide Authoring and Management Tool Proposed Design ?? • Java Library • Parser • Validation Implementation Guide Authoring & Management Tool HL7 V2 Impl. Guide Template IG Template Wizard Code Generator Use Case Development Conformance Profile (XML) Use Cases MessageMaker Data Management Message Profiling Message Generation HL7 v2 Standard Message Definition Vocabulary Library (XML) Vocabulary Profiling Specification Validation Context File (XML) General Transaction Constraints (e.g., IG , TF, or user input)¹ Disposition Traceability Provides list of conformance constraints not captured in conformance profile Utilities Example Messages HL7 v2 Standard Value Sets DITA XML Impl. Guide English Document Document Generator Import Value Sets Domain Experts ¹ Support existing specifications; ideally we would want to start writing an IG with the tool but many guides currently exist. User Input Tool Generated

18. Messaging Profiling • Define Message Constraints (Abstract Level) • Conformance Constructs • Message Structure (Support Libraries and Variances) • Message Level • Segment Level • Data Type Level • Usage • Conditional (Condition Predicates) • Cardinality • Length • Constant Values • Vocabulary • Truncation • Conformance Statements • Captures messaging, syntax, and limited semantic (content) constraints

19. Key Component

20. Support Spectrum of Conformance Statements • Single-message Value Correlation • Defines a relationship between 2 or element values • E.g., For observations related to the testing of a specimen OBX.14 shall contain specimen collection time and will be value the same as OBR.7 and SPM.17.1 • Data Type Value Placement • Define the possible location of values • CE 1st/2nd triplet • Conditional Element Present • Either OBR.16 or ORC.21, ORC.22, and ORC.23 must be present • Conditional Data Content • If OBR.16 is populated then ORC.12 shall contain the same data content if populated

21. Team • Rob – Project and Design Lead • Salifou – Technical Lead • Rizwan – HITTI PM and Technical Lead ?? • Pete – HITTI PM ?? • Woo – Developer-Integrator • HITTI – Developer(s) ?? • Sandra – User/Tester • Mike – Interested Party, Developer??

22. Timeline • March 22 – basic profile capability • April 12th – Prototype for review • May 3rd - 1st official prototype to be presented at HL7 • August 9th – 1st release for review • September 6th – 1st official release to be presented at HL7 and made publically available • Add additional functionality and support for test data creation • Timeline to be refined as needed and intermediate milestones will be established • Message Maker/TCAMT will need to be considered