1. Software and Systems Division Medical Device Communication Test Effort ISO/IEEE 11073, IHE-PCD, PHD and NIST Medical Device Communication Test Effort HL7/IEEE WG Meetings (Vancouver, British Columbia, Canada) 17-18 September 2008

2. Software and Systems 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) www.nist.gov/medicaldevices

3. Software and Systems Division Meeting Topics/Discussion NIST Tooling –IHE-PCD Profile/Message Validation –NIST V2 Validation Tools –ICSGenerator Supporting IHE-PCD Enhancements for X73-20601 and 104xx RTM Management Service –Use Case –UML System Model, and Package diagram Standards development –NIST P11073-10202 DIM XSchema (PAR) –PAR Project Plan Update –X73-10202 Documentation –Needs Validation and Verification (currently only through tooling) http://www.nist.gov/medicaldevices

4. Software and Systems Division 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 ICSGenerator Tool -Model Device according to x73 -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. Software and Systems Division NIST V2 Testing Tools IHE-PCD: PCD-01 NIST V2 Testing tools (MessageValidator) PCD-01 HL7 V2 msg. Validation Report PCD-01 HL7 V2 Assertions (XML) (validation context) HL7 Profile (XML) MSH,PID,PV1,OBR,NTE,{ OBX},OBX,OBX,OBX,… Medical Dev Semantic DB Medical Dev Semantic DB

6. Software and Systems Division 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… NIST Testing Tools Validating IHE-PCD Transactions (messages) What’s Needed?

7. Software and Systems Division IHE-PCD MWB: HL7 V2.5 PCD-01 Profile

8. Software and Systems Division Validation performed at the HL7 profile level Semantic validation at Element Level –Based on the “Medical Device Semantic Database” –Includes: * observation identifier (REF_ID) CF_CODE10 CODE10 Units Enum_Values ContainedBy 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.) NIST Testing Tools Validating IHE-PCD Transactions (messages) What is and is NOT validated?

9. Software and Systems Division 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. NIST V2 Testing Tools: PCD-01 and Rosetta relationship (RTM Validation at the Device/Gateway Message Level)

10. Software and Systems Division RTM Validation Sample Validation Context

11. Software and Systems Division RTM Validation Sample Validation Context (Continued)

12. Software and Systems Division ICSGenerator Supporting IHE-PCD; PCD-01 ( ) X73 GENERAL DEFINITION (Vol. II) ICSGenerator PCD-01 Vol II MDS VMD CHAN NUM NUM ENUM NUM (SPECIALIZED DEVICE) Vol III, static document Medical Dev Semantic DB Device XML Profile + ICSs

13. Software and Systems Division NIST Tooling Medical 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 Medical Dev Semantic DB Device XML Profile + ICSs RTM Harmonized (Terminology, UoM) X73 Nomenclature (11073-10101)

14. Software and Systems Division Meeting Topics/Discussion XML Schema: Normative Addition to x73-DIM Standards development –NIST P11073-10202 DIM XML Schema (PAR) –PAR Project Plan UpdatePAR Project Plan Update “ x73.10202_9_12_08.mpp ” –X73-10202 Documentation No update since last 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])

15. Software and Systems Division Thank You! Questions/Discussion Thank you! www.nist.gov/medicaldevices

16. Software and Systems Division Meeting Topic/Discussion RTM “Management Service” –Proposed Service –Proposed Steps to implement –Use Case –UML System Model –Package Diagram –Entity Relationship Diagram

17. Software and Systems Division 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”.

18. Software and Systems Division “RTM Management Service” Proposed Steps Database/XML Service initially prototyped and located at NIST Once there’s a road: Migrate ‘protoype’ to ‘pilot’ Down the road: Migrate ‘pilot’ the 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

19. Software and Systems Division RTM Management System Use Case Use Case

20. Software and Systems Division RTM UML Model

21. Software and Systems Division RTM Packages

22. Software and Systems Division RTM Database Entity Relationship Diagram

23. Software and Systems Division Thank You! Questions/Discussion Thank you! www.nist.gov/medicaldevices

24. Software and Systems Division Medical Device Communication Test Effort ISO/IEEE 11073, PHD WG and NIST Medical Device Communication Test Effort September 18 2008

25. Software and Systems Division Leveraging NIST Tools For PHD X73 DIM (IEEE 11073-10201) ICSGenerator DIM XSchema PHD-DIM (IEEE-11073-20601) PHD XSchema. DIM XML config. PHD XML config. ValidatePDU X73-104xx XMl config. X73-104xx XMl config. X73-104xx XML config. X73-104xx XSchematron. PHD-DIM (IEEE-11073-104xx) Device Specializations ICS’s

26. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM PHD XSchema A PHD-DIM XSchema has been developed to represent the IEEE P11073 20601 standard. The PHD XSchema adopts the DIM XSchema architecture and reuses some of it components, when applicable. –DIM_Data_Type.xsd containing classic x73 ASN.1 definition included and redefined, when appropriate.

27. Software and Systems Division PHD_DIM XSchema PHD_MOC_Defs.xsd PHD_MOC_Attr_Behav_Notif.xsd PHD_Data_Types.xsd (http://www.obj.sys.com/v1.0/XMLSchema) asn1.xsd (http://www.nist.gov/x73DIM) PHD_DIM.xsd includeimport DIM_Data_Types.xsd PHD_Import.xsd Enumerations_Bases.xsd redefine Qual_Bases.xsd

28. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM ICSGenerator Enhancements Ability to model X73-PHD 104xx device specializations. Added interface for dynamic ICS update. New validation tab to show validation errors and ability to update the validation reports at any time. Ability to import a default configuration file from the context menu of the tree. Improved comparison capability to support agent to manager and device to device comparison types. –Agent -> Manager : compares the data model objects for interoperability purposes. –Device -> Device : compares supported features.

29. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM Validating 104xx Specializations A 104xx device specialization configuration file is created using the IEEE P11073-104xx specialization document. –XMLSPY is used to capture attribute, behavior and notification information in an xml file (partial configuration file). –Merges the xml “partial configuration” file with the IEEE P11073- 20601 configuration file using an in-house program to get the final configuration file for 104xx specialization. The merge adds missing information such as datatypes, term codes, object, attribute, behavior and notification ids. The newly created P11073-104xx specialization file is validated when the file is loaded into the ICSGenerator tool. –Validation is performed against the IEEE P11073-20601 XSchema and will identify any inconsistencies mostly related to objects, attribute, behavior and notification information.

30. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM Specialization Profiles

31. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

32. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

33. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

34. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM X73-10404 (Pulse Oximeter)

35. Software and Systems Division ICSGenerator, DIM XSchema and PHD-DIM X73-10415 (Weighing Scale)

36. Software and Systems Division ValidatePDU 2.0 and PHD-DIM Current version of ValidatePDU validation –Validates APDU syntax against X73 DIM specifications and the X73 Application Profiles – Base Standard and –Validates APDU semantic/content against device profile. ValidatePDU must be enhanced to support IEEE P11073-20601 specification: –Incorporate new and modified PHD data types. –Extract assertions from the PHD specifications. –Develop code to properly validate and parse PHD messages.

37. Software and Systems Division Next Steps Work with Vendors/WGs to validate and verify ICSGenerator Tool and XSchema Enhance ValidatePDU to validate PHD type messages. Obtain X73 APDUs (from Doug’s simulation tool?) to validate coding (encoding/decoding) of the NIST tool

38. Software and Systems Division Thank You! Questions/Discussion Thank you! www.nist.gov/medicaldevices