1. Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort ISO/IEEE 11073, IHE-PCD, PHD and NIST Medical Device Communication Test Effort HL7/IEEE WG Meetings (Phoenix, Arizona) 6 May 2008

2. Software Diagnostics and Conformance Testing Division Medical Device Test Effort Medical Device Test Effort NIST Team Members John Garguilo (john.garguilo@nist.gov,john.garguilo@nist.gov 301-975-5248) Sandra Martinez (sandra.martinez@nist.gov,sandra.martinez@nist.gov 301-975-3579) Maria Cherkaoui (maria.cherkaoui@nist.govmaria.cherkaoui@nist.gov Guest Researcher) Richard Theimer (richard.theimer@nist.govrichard.theimer@nist.gov CENTECH Group, Inc., Contractor)

3. Software Diagnostics and Conformance Testing Division Meeting Topics/Discussion Testing focus areas of IHE-PCD –Device to Device (via ISO/IEEE 11073 protocols) –Device to Enterprise (via HL7 protocols) NIST Test Tool Inventory (IHE-PCD) NIST P11073-10202 DIM XSchema (PAR) –PAR Project Plan –X73-10202 Documentation –Feedback to standards IHE-PCD Testing - Next Steps and Future Direction… –Objectives –Technical Framework  Profiles  Carrier  Test Tools –Continue baseline Year 2 and Begin Year 3 Profile development (roadmap) –Develop Use Cases for new profiles as detail added (roadmap) –Establish example data (useful/necessary for described use cases) http://www.nist.gov/medicaldevices

4. Software Diagnostics and Conformance Testing Division Test Focus Areas NIST Test Tools Inventory –Device Communication X73 –ICSGenerator –ValidatePDU –XML Schema ( IEEE P11073-10202 TM D01a) –Enterprise Communication IHE-PCD –Data Mapping from device to “enterprise” (via IHE-PCD Vol II/III Framework Doc) HL7 (general across all IHE domains) –MWB (VA), MessageMaker (NIST) –MESA / Kudu (IHE, Steve Moore) –Web Services (mainly Validation) (NIST) –Gazelle (next generation building on Kudu [and other tools]) –Cypress Effort – just kicked off Cypress wiki: http://collaborate.nist.gov/twiki- cypress/bin/view/Cypress/WebHome

5. Software Diagnostics and Conformance Testing Division IHE-PCD Year 3+ Profile Proposal PCD-Real Time Plug-n-Play X73 APDU Validate APDUs against Standard Determine if APDUs meets device profile (defined using ICSGenerator)

6. Software Diagnostics and Conformance Testing Division What are we doing? Test Tools Test ToolsICSGeneratorValidatePDU What is it?Implementation Conformance Statement Generator, Profile builder X73 Message validation: profile and standard Why?Easy to use interface Based on standard Promote Interoperability Who’s using it?Most major medial device manufactures –IHE-PCD participants (pre-connectathon, connectathon, HIMSS) –PHD participants (smaller devices - Continua effort) A few small manufactures have expressed interest Countries participating: US, Europe, Japan, Korea, Canada How is it being used? As a requirement to standard (ICSs) Early stage interoperability IHE-PCD profile validation Message validation Who are we working with? IHE-Patient Care Domain Personal Health Device WG IEEE 11073 WG

7. Software Diagnostics and Conformance Testing Division CEN 13734 and 13735 DIM XSchema Compare Devices HL7/OBX Mapping (XML) Device UML Diagram ISO/IEEE 11073 DIM Part 10201 Nomenclature Part 10101 ICSGenerator ICSGenerator Tool and XSchema

8. Software Diagnostics and Conformance Testing Division ICSGenerator Capabilities Generates Implementation Conformance Statements (ICSs) –Required in conformance section (10) of DIM x73 document –Ensures common format for ICS generation Builds Device Profile (XML) –Generates an electronic (XML) version of device data model based strictly on the IEEE x73 DIM –Includes private or manufacturer-specific extensions Provides validation against DIM Schema –A device data model generated using this tool can be validated against an updated version of the DIM XSchema Provides high level semantic interoperability –Ensures correct containment relationship and terminology at the object class and related attribute, notification, and behavior level –Compare Device ICSs Device ICSs comparison capability aids in identifying potential interoperability issues Generates HL7 OBX Segments Generates Device UML Diagram

9. Software Diagnostics and Conformance Testing Division ValidatePDU Tool ValidatePDU: Performs APDU syntax/structure and semantic validation using a MDER Coder. APDU (XER) ValidatePDU (APDU Syntax and Semantic Validation) Device Profile (xml) Validation Report ROSEapdu (MDER) (MDER + XER Coder) ValidatePDU (APDU Syntax and Semantic Validation) Device Profile (xml) Validation Report ROSEapdu (MDER) (MDER + XER Coder) ValidatePDU (APDU Syntax and Semantic Validation) Device Profile (xml) Validation Report ROSEapdu (MDER) (MDER + XER Coder Encode/Decode) (From ICSGenerator)

10. Software Diagnostics and Conformance Testing Division APDU Structure MDS System-Type AttrSystem-Model Attr MDSCreateInfo System-TypeSystem-Model EventReport MDSCreateInfo Operation invoke EventReport CMDISE ROSE Medical Device System Common Medical Device Information Service Element Remote Operation Service Element

11. Software Diagnostics and Conformance Testing Division ValidatePDU Capabilities Validates APDU syntax against X73 DIM specifications and the X73 Application Profiles – Base Standard ASN.1 data types syntax. Object hierarchy, cardinality, acceptable behaviors, notifications and attributes in compliance with X73 Standards. Relationship between ROSE and CMIP data types. Validate APDU semantic/content against device profile (object, attribute, behavior, notification and services implementation) –Tool determines if: a MOC, attribute, behavior and notifications identified in a message is implemented by the device profile. attributes identified in a message are implemented as part of a MOC in the device profile. the message contains the attribute as required by the device profile (missing or unrecognized attributes). the message contains valid MOC information, such as handle and context-id according to the device profile. the message contains valid attribute information, such as fixed values and value ranges according to the device profile. a behavior identified in a message is supported by the device profile. MOC objects hierarchy complies with device profile specifications. the message contains the MOCs as required by the device profile (missing MOC or unrecognized MOCs)

12. Software Diagnostics and Conformance Testing Division ValidatePDU Capabilities Decodes MDER PDUs and builds ASN.1 object instances. Provides an interface to display a parsed message in the following formats: –XER (in compliance with the standard XER where applicable). –MDER binary –Enhanced view (JTree representation) Generates Validation Reports. Highlight incorrect fields in enhanced view. Associates report messages with Test Assertions. Note: ValidatePDU functionalities are captured in a ValidatePDU Software Requirements Specification document. (Reviewed by members of the WG)

13. Software Diagnostics and Conformance Testing Division DIM XSchema Objectives/Goals and Intent Objectives: 1.Translate DIM (into XML) to develop conformance related automation (tooling) [one of NIST’s original objectives], 2.Serve as feedback/loop mechanism to DIM standard, 3.Enable standard-based implementation, 4.Gain understanding of standard. Intent: Not intended to replace DIM, but enable implementation of it…

14. Software Diagnostics and Conformance Testing Division DIM XSchema Status/Update Quick XSchema Component Review PAR Approval DIM XSchema –Approval Date: 05-December-2007 –IEEE P11073-10202 TM D01a Draft Standard for Health Informatics – Medical Device Communication – Domain Information Model – XML Schema Format Project Plan Next Steps Future Directions? Issues (next: May ‘08 IEEE/HL7 WG mtgs)

15. Software Diagnostics and Conformance Testing Division Next Steps for X73-10202… Call for help w/ P10202 document content, issues, and review Need (Industry involvement with) V & V –Verification of translation: DIM  XML Schema Is it a faithful translation? –Validation of tools by modeling devices E.g., Monitor, Ventilator, Infusor (PHD devices?) Do users find the XSchema correct? Usable? How do we support it? 10202 Document and Standardization Process –Usability issues and content E.g., mapping of XML to/from paper DIM, nomenclature, etc. –Who is the audience? Could be the main users of the doc/project are conformance folks? –Is the draft a reasonable starting place? Still need 1 or more iterations to get things organized? –Tracking Issues: e.g., Informative vs. Normative, how do we handle copyright and IP issues, etc… –Establish review process for DIM XSchema Establish core review group

16. Software Diagnostics and Conformance Testing Division Potential Future Direction… Future Direction (of NIST’s X73 Test Tools)? –RT PnP Profile –Leveraging NIST Conformance Tooling to PHD work PHD Application Profile (optimized exchange protocol) 11073-20601 As ‘Specializations’ balloted (11073-104xx) –Further down the road… Simulators?? Manager/Agent??? X73 APDU Message Generation???

17. Software Diagnostics and Conformance Testing Division IHE-PCD Year 3+ Profile Proposal PCD-Real Time Plug-n-Play X73 APDU Validate APDUs against Standard Determine if APDUs meets device profile (defined using ICSGenerator)

18. Software Diagnostics and Conformance Testing Division

19. IHE-PCD Testing IHE PCD Testing – Key Objectives –Increase test comprehensiveness & quality –Support both conformance & interoperability testing –Coordinate with IHE Gazelle Project –Establish single framework for PCD covering increasing complexity and technologies over next 5 years –Support for pre- & virtual connectathons, actual connectathon & enable year round testing –Generate work products that companies can use in their regulatory submissions –Remain in alignment with IHE-PCD profile development road map

20. Software Diagnostics and Conformance Testing Division IHE-PCD Testing IHE PCD Testing – See Visio Diagrams –PCD Technical Framwork Documents (Transactions and Content) –IHE-PCD Profiles ACMAlarm Comm. Management DDTDevice Document Template DECDevice Enterprise Comm. DS-Device Specializations PIVPoint-of-care Infusion Verification MEMMedical Equipment Mgmt. PIBPatient ID Binding PNPPlug-and-Play RTMRosetta Term Mapping SPDSubscribe to Patient Data RMRemote Monitoring

21. Software Diagnostics and Conformance Testing Division Gazelle moving forward (from Steve Moore’s slide set) Healthcare Enterprise Testing discussed –Monitored Single and Collaborative Connection Testing –Monitored Single and Collaborative Pre-Connectathon –Self-graded, singular –Integration testing via Internet Virtual Connectathon –Supplement w/ monitor –Monitored single –Collaborative via Internet Company Internal –Unmonitored, Single –Self-graded Single –Unmonitored Collaborative –Internet Collaborative Certification Testing –Not an IHE category –Extension of monitored testing with appropriate rigor Building a Gazelle Openness, transparency, free distribution

22. Software Diagnostics and Conformance Testing Division Gazelle Process… (from Steve Moore’s slide set) Control System –One of Several Connection Testing Private Vendor Testing Internet Testing Test Engine –Base Test Engine Test Engine by Profile Test Engine by Kind of Testing –Connectathon, Singular Data Store/Data Base Simulators – Actors Validation Services –Pick Validation Service(s) based on region Test Scenarios Demographic Services –IHE Japan may need particular encoding for Japanese Language –Based on region –Seed tests with different data Proxy – to/from- System Under Test

23. Software Diagnostics and Conformance Testing Division Gazelle Process (cont.)… (from Steve Moore’s slide set) Run Gazelle… –Users register systems/actors/profiles Handoff from Controller to Test Engine Determining Points of Intersection- collaboration areas? Data Structures/Files in Gazelle Gazelle Common Interfaces –Controller/test engine –Test Engine/Simulator, etc… Simulators Other Gazelle Needs –Authoring Tools

24. Software Diagnostics and Conformance Testing Division Potential Future Direction… Gazelle Detailed DEC Test Scenario –Test Scenario Actors / Evaluation Items Notes and Questions Message Profile and Data –Transactions [1..x] e.g., communicate data, query data… »Segment Spec and Data (e.g., MSH, OBX, etc.) *Validation Criteria –Transactions [1..x] e.g., communicate data, query data… »Message Profile »Table Definitions »Test Case Specific Validation Criteria *Validation Criteria Specified for the purpose of determining whether or not the implementations successfully completed the tests