Medical Device Test Effort NIST Team Members

1. ISO/IEEE 11073, IHE-PCD, PHD andNISTMedical Device CommunicationTest EffortHL7/IEEE WG Meetings (Orlando, Florida)12-16 January 2009

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) • www.nist.gov/medicaldevices

3. Meeting Topics/Discussion • MDC Testing Project - Status Update… • NIST Tooling • ICSGenerator • Enhancements supporting private profile templates • IHE-PCD Profile/Message Validation • NIST V2 Validation Tools • RTM Management Service • Use Case • Prototype • Demonstration / Example • Next Steps • Medical Device Semantic Database • Standards development • NIST P11073-10202 DIM XSchema (PAR) • Needs • Validation and Verification (currently only through tooling) • PAR Project Plan Update http://www.nist.gov/medicaldevices

4. Project Update • Richard Theimer’s contract ended… • Java class library (for ASN.1 types) on hold… • Affects ASN.1 encoding (coder/decoder) • Java Class library pending… • Effects next version of ValidatePDU • Critical Validation for x73 implementation (as defined in x73 Standard) • Continue incremental Verification & Validation of x73 DIM XML Schema • Status uncertain for attending Kyoto WG meetings…

5. Tool Review • Device Communication Test Tooling • XML Schema of the ISO/IEEE 11073 Domain Information Model (x73-10202) • ICSGenerator Tool • Produces standard-compliant device profiles and specializations • Generates Implementation Conformance Statements • ValidatePDU Tool • Provides message syntax and semantic validation • Java Class Library (of standard’s syntax notation) • Implementable-code of abstract types defined in standard • Coder (encodes and decodes APDUs) • Critical Validation for x73 implementation (as defined in x73 Standard) • RTM Management Service

6. ICSGenerator Enhancements New ICSGenerator version released (v3.2.4) Installer and associated ‘User Guide’ posted to project web site (http://www.nist.gov/medicaldevices/tools) Private profile template feature now available Added option to manage private profile templates. Allows vendors/users to generate device profiles based on a private profile template built using ICSGenerator. Profile Template Use Once a profile template is created and saved, the user can import the template and use it to quickly generate device specializations. Templates created according to standard Ties into V & V of DIM XML Schema Specific feedback of vendors w/out subjecting disclosure Vendors more likely to build profile(s) using tooling as device capabilities and features can be described (down to proprietary level and stored as “in-house” templates)

7. ICSGenerator Enhancements(Continued) Private Extensions created by user (extending or altering from the standard) are NOT validated against the DIM standard PHD Specializations: ten now modeled in tool… Continuing to add PHD specializations as approved… PHD members modeling specializations in ICSGenerator as an initial validation tool (against 20601)

8. NIST V2 Testing Tools: Integrating IHE-PCD Components of IHE-PCD profile/message validation using the NIST V2.x Tools PCD-01 HL7 V2 msg. MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,… HL7 Profile (XML) http://hl7v2tools.nist.gov NIST V2 Testing tools (Message/profile Validator) Validation Report PCD-01 HL7 V2 Assertions (XML) (validation context) Repository …others asdeveloped RTM DB ......

9. NIST V2 Testing Tools: IHE-PCDTypes of Testing Validation of IHE-PCD message(s) and corresponding HL7 Profile(s) Validation of message syntax and semantic content Against HL7 V2 message (e.g., PCD-01) Message structure (e.g., MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,…}) Against HL7 profile (Msg_type^Event_type^ e.g., ORU^R01^…) Against HL7 and/or user provided tables Example of user provided table is RTM for units, ref_ids, etc. Against ‘validation context’, including specific values Defined in XML (more to come…)

10. NIST V2 Testing Tools: Types of TestingContinued Validation against ‘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.

11. NIST V2 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… • HL7 Transactions (Messages))

12. NIST HL7 V2 Tools – RTM/PCD-01 Message Validation – Example Test case description: For an OBX conveying a <METRIC> 'dot-level-4' observation that references MDC nomenclature, the REF_ID in OBX-3.2 shall match a row in the harmonized Rosetta table. Test case description: For an OBX conveying a <METRIC> 'dot-level-4' observation, UoM in OBX-6.2 shall match a row in the harmonized Rosetta table. Sample message (IHE-PCD TF-Vol2: Simple device – minimal context): MSH|^~\&|ORIGatewayInc^ACDE48234567ABCD^EUI64||||20060713095730-0400||ORU^R01^ORU_R01|MSGID1233456789|P|2.5|2||NE|AL|||||IHE PCD ORU-R01 2006^HL7^2.16.840.1.113883.9.n.m^HL7 PID|||12345^^^^PI^DowntownCampus||Doe^John^Joseph^JR^^^L^A|||M OBR|1|AB12345^ORIGatewayInc ICU-04^ACDE48234567ABCD^EUI-64|CD12345^ORIGatewayInc ICU-04^ACDE48234567ABCD^EUI-64|149538^MDC_PLETH_PULS_RATE^MDC|||20060713095715-0400 OBX|1|NM|149538^MDC_PLETH_PULS_RATE^MDC|1.1.1.1|83|264896^MDC_DIM_PULS_PER_MIN^MDC|||||R|||20060713095715-0400|||264896^MDC_UPEXT_FINGER^MDC

13. NIST HL7 V2 Tools – RTM/PCD-01 Message Validation – Example Validation context:

14. NIST HL7 V2 Tools – RTM/PCD-01 Message Validation

15. NIST HL7 V2 Tools – RTM/PCD-01 Message Validation

16. NIST HL7 V2 Tools – RTM/PCD-01 Message Next Steps • Enable conditional testing (via context validation??) • Continue to work with IHE-PCD domain over ’09 virtual, pre- and connectathon cycle to improve process and capabilities • Provide tutorial of NIST V2 tools to IHE-PCD (and others interested) • Define/Design context specification service • To work with NIST tools (and MWB?)

17. Meeting Topics/Discussion • RTM Management Service • Service defined • Use Case • Prototype • Demonstration / Example • Next Steps

18. NIST Tooling To Support RTM Process “RTM Management Service” A web application that allows vendors and reviewers access, retrieval, and reporting of Rosetta Tables over the internet in conformance to RTM. The tool will provide the capability of saving the data in the xml format as defined by RTM. Aid in The harmonization process by: Identifying missing terms Facilitate the proposal of new terms. Automatic generation of the “Harmonized Rosetta Table”

19. “RTM Management Service” Continued Database/XML Server initially prototyped and located at NIST. In the future the tool could become a web service. A set of assertions extracted from RTM were 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

20. RTM Management Service Use case

21. RTM Management Service Status An RTM Management Service prototype is now available. Prototype features include: Interface to display units and enumerations (Values + Groups). Interface to display Rosetta entries: Grid with details panel to show information of selected row. Interface to add/edit an entry: User may choose a Ref_ID from a set of Ref_IDs, term code and context free term code are automatically filled User may choose a Group from a set of Groups. User may select units or enumerations from a user friendly interface. User may enter his comments (name of user + date of comment are captured) Required fields are highlighted A review window displays values to be saved so the user may confirm or cancel. Ability to download Rosetta tables in XML format. Ability to automatically generate a basic version of the “Harmonized Rosetta Table”

22. RTM Management Service Units Table

23. RTM Management Service Enumerations Table

24. RTM Management Service Vendors Table

25. RTM Management Service Edit Entry Table

26. RTM Management Service Add Comment

27. RTM Management Service “Next Steps” Functional Save data into the RTM database. Improve the automatic generation of the Harmonized Rosetta. Need additional requirements. Implement user (roles) privileges. Identify and highlight inconsistencies in Rosetta. New terms, conflicting data, missing mandatory data Incorporate “Units” and “Enumerations” management capabilities. Adding “containedBy”, “contains” and “External_Sites” to the interface. Logical Provide RTM MS to Paul Schluter for trial and vetting Provide to others interested for trial use period Address issues and enhance as needed Establish approval process (e.g., new terms) Feed into ISO/IEEE process Establish repository at NIST site Later would be taken over by SDO(?)

28. Medical Device Semantic Database Medical Device Semantic Database (not available yet) 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 104x specializations – will include terminology from RTM and from ISO/IEEE 11073-10101 Nomenclature entered by the user via ICSGenerator. PCD-01 HL7 V2 msg. MSH,PID,PV1,OBR,NTE,{OBX},OBX,OBX,OBX,… HL7 Profile (XML) Validation Context (XML) NIST V2 Testing tools (MessageValidator) Validation Report ICSGenerator MD Semantic DB

29. Meeting Topics/DiscussionXML Schema: Normative Addition to x73-DIM • Standards development • NIST P11073-10202 DIM XML Schema (PAR) • PAR Project Plan Update • “x73.10202_1_14_09.mpp” • X73-10202 Documentation • No update since last WG meeting • 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])

30. Thank You! • Questions/Discussion • Thank you! • Our project websites: • http://www.nist.gov/medicaldevices • http://hl7v2tools.nist.gov