Medical Device Test Effort NIST Team Members

1. IHE-PCD F2F WG MeetingsMedical Device CommunicationTest EffortIHE-PCD WG Meetings (Boston/Holliston, Massachusetts)21-23 October 2008

2. Medical Device Test EffortNIST Team Members • John Garguilo (john.garguilo@nist.gov, 301-975-5248) • Sandra Martinez (sandra.martinez@nist.gov, 301-975-3579) • Maria Cherkaoui (maria.cherkaoui@nist.gov Guest Researcher) • Richard Theimer (richard.theimer@nist.gov CENTECH Group, Inc., Contractor) www.nist.gov/medicaldevices http://hl7v2tools.nist.gov/

3. Meeting Topics/Discussion • NIST Tooling • IHE-PCD Profile/Message Validation • NIST V2 Validation Tools • ICSGenerator • Supporting IHE-PCD • Enhancements for X73-20601 and 104xx • ValidatePDU • Validates APDU syntax against X73 DIM specifications and the X73 Application Profiles – Base Standard and • Validates APDU semantic/content against device profile. • RTM Management Service • Use Case • UML System Model, and Package diagram • Standards development • NIST P11073-10202 DIM XSchema (PAR) • X73-10202 Documentation • Needs • Validation and Verification (currently only through tooling) • http://www.nist.gov/medicaldevices

4. NIST Tooling IHE-PCD Profile/Message Validation • NIST V2 Testing Tools • Validate HL7 V2 profiles (Msg_type^Event_type^ e.g., ORU^R01^…) • Validate HL7 V2 messages (e.g., PCD-01) Message structure (e.g., MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,…}) • Generate HL7 V2.x messages • ICSGeneratorTool • Model Device according to x73 (DIM and Nomenclature) • Generate device profiles (device specialization in XML format) • Device profile becomes part of a“Medical Device Semantic Database” • Used for semantic/content validating and system configuration. • Proposed RTM “Management Service” • A web application/service to facilitate RTM terminology authoring, review, and reporting • The “Harmonized” Rosetta table will become part of a “Medical Device Semantic Database” for purposes of semantic testing. • Medical Device Semantic Database (Yet to come…) • To include semantic related information such as: • Terminology based on Rosetta Terminology Mapping (RTM) – The “Harmonized” Rosetta Table. • ISO/IEEE 11073-10101 Nomenclature • Device specializations (IHE-PCD Vol. 3 Content Profiles),PHD 104xx specializations – • Will include terminology from RTM and from ISO/IEEE 11073-10101 Nomenclature entered by the user via ICSGenerator.

5. NIST V2 Testing Tools IHE-PCD: PCD-01 PCD-01 HL7 V2 msg. MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,… HL7 Profile (XML) NIST V2 Testing tools (MessageValidator) Validation Report PCD-01 HL7 V2 Assertions (XML) (validation context) V2Test Scenario + NIST Medical Dev Semantic DB NIST ICSGenerator

6. NIST Testing Tools Validating IHE-PCD Transactions (messages)What’s Needed? • HL7 Profile (typically from MWB) • MWB profile: .mwb file • MWB table: .mwt file(s) • A Validation Context (for NIST V2 Validation Tools) • Context must be provided where the user specifies the elements of the message to be validated. • Referred to as “failure types”: User-provided (XML) ‘validation context’ file in a specific format. • User provided tables or databases • E.g., Medical Device Semantic Database or • By providing the values in the ‘validation context’ file… • Test Scenarios for each profile (e.g., IHE-PCD ACM, PIV Profiles) • Tied to Framework Docs (supplements)

7. IHE-PCD MWB: HL7 V2.5 PCD-01 Profile

8. NIST Testing Tools Validating IHE-PCD Transactions (messages)What is and is NOT validated? • Validation performed at the HL7 profile level • NIST V2 Tooling does not provide the capability of conditional validation (e.g., validating that a REF_ID has the proper unit associated to it.) • Semantic validation at Element Level • Based on the “Medical Device Semantic Database” • Includes: • * observation identifier (REF_ID) • CF_CODE10 • CODE10 • Units • Enum_Values • ContainedBy

9. NIST V2 Testing Tools: PCD-01 and Rosetta relationship(RTM Validation at the Device/Gateway Message Level) NIST Testing Tool provides validation in the following areas (failure types): • VERSION*: The version in the message and in the profile should match. • MESSAGE_STRUCTURE_ID*: The message type (MSH.9 element) in the profile and in the message should match. • MESSAGE_STRUCTURE: The message should have a valid message structure (correct usage, correct cardinality, and correct element name). • USAGE: R elements should be present; X elements should not be present in the message. • CARDINALITY: Elements should be present at least the minimum times and at most the maximum times specified in the profile. It should also take into account the usage of the element (X element with a minimum of 4 should not be present in the message). • LENGTH: The value of the element should have a length equal or less than the value specified in the profile. • DATATYPE: For the datatype NM, DT, DTM, SI and TM, the value of the element should match the regular expression defined in the standard. • DATA: The value of the element should match a constant specified in the profile, a value set specified in a table, a value or a regular expression specified in the message validation context. • MESSAGE_VALIDATION_CONTEXT*: This is a user input error when the location specified in the message validation context can't be found in the message. • TABLE_NOT_FOUND*: This is a user input when a table can't be found in the table files (TableProfileDocument). • AMBIGUOUS_PROFILE*: The profile should not be ambiguous.

10. RTM Validation Sample Validation Context

11. RTM Validation Sample Validation Context (Continued)

12. NIST ToolingMedical Device Semantics • Medical Device Semantic Database (Yet to come…) • To include semantic related information such as: • Terminology based on Rosetta Terminology Mapping (RTM) – The “Harmonized” Rosetta Table. • ISO/IEEE 11073-10101 Nomenclature • Device specializations (IHE-PCD Vol. 3 Content Profiles), PHD 104xx specializations – • Will include terminology from RTM and from ISO/IEEE 11073-10101 Nomenclature entered by the user via ICSGenerator. Medical Dev Semantic DB NIST V2Test Scenario + RTM Harmonized (Terminology, UoM) Device XML Profile + ICSs X73Nomenclature (11073-10101)

13. Meeting Topics/DiscussionXML Schema: Normative Addition to x73-DIM • Standards development • NIST P11073-10202 DIM XML Schema (PAR) • X73-10202 Documentation • No update since last IEEE/HL7 WG meeting • “ieee-11073-10202-d01a-2008-04-30-clean-jjg.doc” • “ieee-11073-10202-d01a-2008-04-30-deltas-jjg.doc” • Call for reviewers and help with documentation • Needs • Validation and Verification of XML Schema(currently only through tooling) • V & V is ongoing • As ICSGenerator is further enhanced and developed • As RTM work comes to fruition and is incorporated into tooling • As IHE-PCD model device specializations (content profiles – in Technical Framework Volume III) • As PHD WG approves PHD devices and models (validating -20601 and 104xx [as tied to Nomenclature – 10101 and DIM – 10201])

14. Thank You! • Questions/Discussion • Thank you! • www.nist.gov/medicaldevices • http://hl7v2tools.nist.gov/

15. Rosetta Terminology ServiceF2F Agenda Item • RTM “Management Service” • Proposed Service • Proposed Steps to implement • Use Case • UML System Model • Package Diagram • Entity Relationship Diagram • Task List and Proposed Project Plan

16. NIST Tooling To Support RTM Process Proposed “RTM Management Service” • The tool will be a web application to allow vendors and reviewers access, retrieval, and reporting of Rosetta Tables over the internet in conformance to RTM. • Addresses RTM requirement : “Any corrections or additions will be reflected back in the vendor’s table and a new version of the merged table (and XML files) will be created. • The tool will provide the capability of saving information in XML format as defined by RTM proposal • The tool will provide the capability to apply XSLT transformations specified by the RTM proposal to harmonize the tables • Merge individual vendor table(s) into a single table. • Provide a report identifying differences • RTM example: “Create a list of the MDC reference identifiers and the vendors that select it, and MDC identifiers that were selected by only a single vendor --would be examined and compared with similar terms”. • Provide a report identifying missing or new terms (no mapping). • RTM requirement: “Any missing or new MDC reference identifiers will be submitted to the appropriate standards group to create and add the new terms to the relevant standard”.

17. “RTM Management Service” Proposed Steps • Database/XML Service initially prototyped and located at NIST • Once there’s a road: Migrate ‘protoype’ to ‘pilot’ application • Down the road: Migrate ‘pilot’ tool into a web service. • Further down the road: vetted ‘pilot’ system/functionality is moved to SDO which becomes “owner” and “maintainer” • A set of assertions extracted from RTM will be used to make sure we take into consideration all normative requirements and to facilitate the tool development process. NOTE: The final merged table will be used as basis for testing  ICSGenerator, ValidatePDU and NIST V2 Testing Tool

18. RTM Management SystemUse Case

19. RTM UML Model

20. RTM Packages

21. RTM Database Entity Relationship Diagram

22. RTM Management SystemProposed Project Plan: ~2.5 months • Create and populate database • Get data from “Rosetta” excel document • Extract data for each vendor • Populate all tables • View vendors, “Rosetta” or “Harmonized-Rosetta” tables • Edit/add vendor data • Display possible group values • Display possible reference ids • Display possible units • Verify mandatory information has been supplied • Add comments to “Rosetta” by reviewers • Display time of comment and name of the user • Update vendor table • Save data • Vendor data and update “Rosetta” • Save “Rosetta” and update vendor data • Download XML “Rosetta” and xml Harmonized-”Rosetta” • Generate XML form database • Generate harmonized “Rosetta” • Highlight conflicts in “Rosetta” (verify that a reference id is always associated to one term code, verify that mandatory fields are filled, etc...) • If no conflicts detected generate harmonized “Rosetta”

23. Thank You! • Questions/Discussion • Thank you! • www.nist.gov/medicaldevices