1. Software Diagnostics and Conformance Testing Division Medical Device Communication Test Effort Integrating the Healthcare Enterprise, IEEE 11073 and NIST Medical Device Communication Test Effort September 2007

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 I. 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 Goals NIST Test Tools Update –ICSGenerator –ValidatePDU NIST 11073 DIM XSchema (PAR) –PAR Project Plan –Status, Enhancements –Next Steps… DIM Open Issues and Status http://www.nist.gov/medicaldevices

4. Software Diagnostics and Conformance Testing Division DIM XSchema Compare Devices HL7/OBX Mapping (XML) Device UML Diagram ISO/IEEE 11073 DIM Part 20101 Nomenclature Part 10101 ICSGenerator NIST’s ICSGenerator and XSchema

5. Software Diagnostics and Conformance Testing Division (since last WG meetings [Cologne, April 07]) ICSGenerator Enhancements (since last WG meetings [Cologne, April 07]) Added capability to capture a “Top Level”, “General Interoperability, Baseline Profile, Polling Mode” ICSs. Added capability to select the type of device specialization (Manager/Agent). Added capability to id attribute fields as static, fixed or dynamic.

6. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 (ValidatePDU 1.0 Re-designed) ValidatePDU 1.0: Performs APDU syntax/structure validation using XML. ValidatePDU 2.0: Performs APDU syntax/structure and semantic using a MDER Coder. ValidatePDU (APDU Syntax and low level Semantic Validation) Validation Report APDU (XER) (DIM-DataTypes.xsd) ValidatePDU (APDU Syntax and Semantic Validation) Device Profile (xml) Validation Report ROSEapdu (MDER) APDU (XER) (MDER + XER Coder)

7. Software Diagnostics and Conformance Testing Division APDU 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

8. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 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) if a MOC, attribute, behavior and notifications identified in a message is implemented by the device profile. if attributes identified in a message are implemented as part of a MOC in the device profile. if the message contains the attribute as required by the device profile (missing or unrecognized attributes). if the message contains valid MOC information, such as handle and context-id according to the device profile. if the message contains valid attribute information, such as fixed values and value ranges according to the device profile. if a behavior identified in a message is supported by the device profile. if MOC objects hierarchy complies with device profile specifications. if the message contains the MOCs as required by the device profile (missing MOC or unrecognized MOCs)

9. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 Capabilities Decodes MDER PDUs and build 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 2.0 functionalities are captured in a ValidatePDU Software Requirements Specification document. (Reviewed by some members of the WG)

10. Software Diagnostics and Conformance Testing Division Assertions Message must be confirmed Message type checked MDS-create-notification must be confirmed MOC must be either Simple MDS, Hydra MDS, Composite Single MDS or Composite multi Beds MDS MOC checked MOC is invalid, it should be MDS, Simple MDS, Hydra MDS, Composite Single Bed MDS or Composite multi Beds MDS …

11. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 Restrictions  ValidatePDU performs message structure validation on all agents and manager APDU’s message type, but it only applies full validation (semantic and syntax) to the following message types (later versions may incorporate more messages) : –MDS messages MDS::Mds-Create-Notification Event Report MDS::Mds-Create-Notification Event Report Result MDS::Mds-Attribute-Update Event Report MDS::Mds-Attribute-Update Event Result –Context Scanner Messages CREATE Context Scanner Invoke CREATE Context Scanner Result Context Scanner Object Create Notification Event Reports Context Scanner Object Create Notification Event Report Confirmation –Episodic Configurable Scanner Messages Episodic Scanner Unbuffered Scan Event Report Episodic Scanner Unbuffered Event Report Confirmation –Periodic Scanner Messages Periodic Scanner SET Operational-State Periodic Scanner SET Operational-State Confirm Periodic Scanner Buffered Scan Event Report Periodic Scanner Buffered Event Report Confirmation –Alert Scanner Messages GET Messages SET Messages

12. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 Restrictions (cont.)  Performs semantic validation at the device profile level (as constrained by the user) only.  Device profile must be an instance of the NIST DIM Schema. Processes only ROSE apdu ASN.1 type encoded in MDER. –This restriction excludes BER encoded ACSE messages.

13. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0

14. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 (XER view)

15. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 Future Enhancements  Add support for FastBufScanReport PDUs for waveform reporting  Add support for behavior type messages.  Add support for Rose RORJapdu – Remote Operation Error  Add support for Rose RORLIVapdu – Linked Invoke  Add semantic validation against polling mode agent/manager device profile.  Update the Message Information display to include event type and action type.

16. Software Diagnostics and Conformance Testing Division Plug-n-Play Real Time Profile Test Tool Validation NIST ICSGenerator PnP MD Agent Simulator PnP MD Manager Simulator PnP PoC RT 11073-3020011073-30300(G)11073-2010111073-2020x NIST ValidatePDU Device Profile (XML) X73 APDU (MDER) X73 PDUs Validation Report WIRESHARK MDER Extraction Tool “libpcap”file (Non-RT)

17. Software Diagnostics and Conformance Testing Division DIM XSchema Discussion Points Quick XSchema Component Review Characteristics Update Object Inheritance Project Plan

18. Software Diagnostics and Conformance Testing Division DIM XML Schema GeneralICS.xsdGeneralServices.xsdserviceICS.xsd DIM_Values.xsd PollingMode.xsd MOC_Defs.xsd MOC_Attr_Behav_Notif.xsd DIM_Data_Types.xsd (http://www.obj.sys.com/v1.0/XMLSchema) osxdlib.xsd (http://www.nist.gov/x73DIM) DIM.xsd includeimport DIM XSchema Document Structure Rose.xsd Transport.xsd Baseline-Manager.xsd

19. Software Diagnostics and Conformance Testing Division DIM XSchema Characteristics Component Definition General Approach Namespaces: All DIM Schemas share same targetNamespace Versioning: Version attribute in schema element Expressing Constraints: Schematron Rules added to: –Solve co-occurrence constraints (cardinality) on MOC elements –Solve the ASN2XSD mapping of ASN.1 “ANY DEFINED BY

20. Software Diagnostics and Conformance Testing Division DIM XSchema Update Implemented new approach for representing object inheritance. –Previous approach: Re-defines inherited attributes in object definitions. –Alternatives: “Derivation by extension” – consists of a complex type extending another complex type using the element –To implement, we must use the compositor which imposes an order in the elements  not a requirement in the standard  difficult to maintain by an application such ICSGenerator Using “group models” for grouping elements with: –“ compositor” which imposes an order OR –“ unbounded compositor” which disables the uniqueness property of each element –Selected approach: “group model” approach to represent object inheritance. using the “group model” grouping elements with the unbounded compositor and applying Schematron to recover the uniqueness property of the elements (DIM attributes)

21. Software Diagnostics and Conformance Testing Division DIM XSchema DIM Object inheritance Previous Approach: Re-defines inherited attributes in object definitions. This complex type defines attribute information VMD

22. Software Diagnostics and Conformance Testing Division DIM XSchema DIM Object Inheritance (cont.) New Approach: “Group Model” used for grouping elements with the unbounded compositor (from above) + Schematron to recover the uniqueness property of the elements (attributes) This complex type defines attribute information for Alert Schematron: Element Alert-Condition should be mandatory Element Limit-Specification should be optional Element Vmo-Reference should be optional Element Type should be mandatory Element Handle should be mandatory Element Label-String should be optional

23. Software Diagnostics and Conformance Testing Division DIM XSchema Project Plan

24. Software Diagnostics and Conformance Testing Division DIM X73-10202 XSchema Project Plan Completed (on-plan) Tasks –PAR Project Plan Minor Revision to plan (post Cologne, pre Atlanta) Requirements Gathering Identify Schema Best Practices and Approach for Implementation Identify Approach for Object Inheritance Identify Approach for Content Model Extensibility Map Requirements to Schema Develop Textual Definitions  ASN.1 Common Data Types Map ASN.1 to Schema using ASN2XSD Tool Service Model ICS Tables Implementation, Validation, and Testing

25. Software Diagnostics and Conformance Testing Division DIM X73-10202 XSchema Project Plan (cont) Completed (on-plan) Tasks (cont)  Maintenance Comments and issues to IEEE Standards Body DIM and Nomenclature Updates to XSchema Libraries based on review comment Update XSchema documentation to be consistent Design and Code revision and documentation Synchronize XSchema with Paper DIM

26. Software Diagnostics and Conformance Testing Division DIM X73-10202 XSchema Project Plan  Outstanding and Near-term Tasks  Development of X73-10202 document Compose Outline (based on DIM, X73-10201)  Compose first draft, review and produce version 1.0 Ongoing Tasks  Present, Review, Update Plan (Atlanta Sept 07 mtg)  Develop X73-10202 Document (version 1.0)  Maintenance  Comments to Standards Body (DIM and Nomenclature)  Updates to XSchema Libraries based on review  Update XSchema documentation to be consistent  Determine Future Needs  Extensibility and Expandability

27. Software Diagnostics and Conformance Testing Division DIM X73-10202 XSchema Project Plan (cont) X73-10202 Standardization Process Issues –Establish review process for DIM XSchema Establish core review group –Get help with administrative process for IEEE submittal and acceptance (Todd and Jan?) –Develop initial document draft Identify document guidance and format

28. Software Diagnostics and Conformance Testing Division DIM Issues Attribute inheritance –NIST assumption: inheritance is captured in the attribute groups. –Inconsistencies: Demo document (attribute table for infusion pump Hydra MDS): MDS inherits the “handle” attribute from VMS DIM : Handle is not part of any attribute groups inherit by MDS