1. Helping the Cause of Medical Device Interoperability Through Standards- based Test Tools DoC/NIST John J. Garguilo (john.garguilo@nist.gov) January 25, 2010

2. 2 Medical Device Communication NIST Test Effort Medical Device Standards Work –Device and Enterprise-level Integrating Health Enterprise - Patient Care Devices (IHE-PCD) –Enterprise-level Personal Health Devices –Personal Tele-health-level Facilitate the efficient exchange of medical device and vital signs data throughout the HC enterprise –Test Research Methods –Conformance  Interoperability (based on Standards) –Ultimately: Real-time plug-and-play interoperability

3. 3 Conformance Testing: Using ‘Profiles’ to Advance Rigorous Testing Specification Constraints User / Device Message E.g., HL7 V2 Terminology/ Nomenclature Standards Profile Domain Framework Test Case/ Value(s) Test Case/ Value(s) Validation Test Management Test Services Test System Development Components Test Harness Test Resources Based on Use Case(s) Report Test System Instance

4. 4 Validation Operational Process: Origin of Test Assertions HL7 v2 Standard Message Definition IHE TF Message Transaction Constraints HL7 v2 Standard Value Sets IHE TF Message Transaction Value Set Constraints Harmonized Rosetta Terminology Mapping Constraints ISO/IEEE 11073 Nomenclature Assertions Validation Context File (XML) Table Library (XML) Conformance Profile (XML) Validation Engine Test Case Specific Test Assertions IHE-PCD TF Message Transaction Test Assertions Validation Context File (XML)

5. 5 Test Environments Instance Testing –Conformance (e.g., against HL7 V2.x or CDA) Implementation conforms to Spec. on which it is based Isolated System Testing –Includes Instance Testing Activities –Protocol Conformance –Functional Behavior Conformance Features and Operational behavior correspond to Specs. Peer-to-Peer System Testing –Includes Isolated System Testing Activities –Interoperability Testing Testing complete application environment May include interacting w/ Database, using Network Communications, or interacting w/ other hardware, apps, or systems if appropriate

6. 6 Instance Test Environment E.g., Conformance Testing of an HL7 V2 Message Report Test Artifacts Conformance Profile HL7 Tables ‘Device’ Test Agents ISO/IEEE 11073/Rosetta Terminology Test Artifacts Conformance Profile HL7 Tables ‘Device’ Test Agents ISO/IEEE 11073/Rosetta Terminology HL7 V2 Message Validation HL7 V2 Message Validation ServicesTest Management HL7 V2 Message Validation Test Case HL7 V2 Message Validation Test Case Results HL7 V2 Message Validation Report Results HL7 V2 Message Validation Report Test Harness (Java Code) Test Harness (Java Code) Test Execution User Web Application Client HL7 V2 Message HL7 V2 Message Registry/ Repository

7. 7 Isolated System Test Environment E.g., IHE-PCD Testing using a Web Application Client Report IHE-PCD DOR Test Agent IHE-PCD DOR Test Agent HL7 V2 Message Generation HL7 V2 Message Generation IHE-PCD DOC Test Agent IHE-PCD DOC Test Agent HL7 V2 Message Validation HL7 V2 Message Validation ServicesTest Management Router/Logger/Proxy Vendor System Under Test Test Artifacts Conformance Profiles HL7 Tables Validation Context Files Generation Context Files Test Artifacts Conformance Profiles HL7 Tables Validation Context Files Generation Context Files IHE-PCD Client Test Scenario IHE-PCD Client Test Scenario Results HL7 V2 Message Validation Reports Results HL7 V2 Message Validation Reports Test Harness (Java Code) Test Harness (Java Code) Test Execution Web Application Client

8. 8 NIST HIT Testing Infrastructure Design A Framework for Building Test Systems—an SOA Approach Test Data ServicesTest Management Test Description Test Description Results Test Harness Test Harness Test Execution Router/Logger/Proxy User Facilitator Monitor System Under Test Validation Generation Test Agent Evaluation Agent Aggregated Services Test Artifacts Time Report Security Logging Proxy Log Analyzer Specialized Validation Specialized Validation Other Services Test Analyzer Test Analyzer

9. 9 Thank YOU! Discussion/Questions/Comments Visit us at the NIST Tool Sites:  MDC Testing Web site: www.nist.gov/medicaldevices www.nist.gov/medicaldevices  IHE-PCD Pre-Connectathon Web site: http://xreg2.nist.gov:8080/PCD-HL7Web/  IHE-PCD Connectathon Web site: http://xreg2.nist.gov:8080/PCD- HL7WebCon/