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) Focus areas of IEEE PHD WG –Standards development (X73-20601 and 104xx) –Device to Device (via ISO/IEEE 11073 protocols) NIST Test Tool Inventory and Update –Patient Care Device focus (mainly IHE-PCD) –Adaptation to Personal Health Device NIST P11073-10202 DIM XSchema (PAR) –PAR Project Plan –X73-10202 Documentation Discussion –Feedback to standards http://www.nist.gov/medicaldevices

4. Software Diagnostics and Conformance Testing Division Test Focus Areas NIST Test Tools Inventory –Device Communication ISO/IEEE 11073 –ICSGenerator –ValidatePDU –XML Schema ( ISO/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 and Erik Poiseau) –Web Services (mainly Validation) (NIST) –Gazelle (next generation building on Kudu [and other tools]) –Cypress Collaborative – 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 Whos 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 Validate Standard IHE-PCD profile validation Message validation Validate Standard 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 Parts 10201/ 20601 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 ICSGenerator Enhancements Whats new since our last meeting… Added PHD Profile –Agent ICSGenerator has been enhanced to allow the generation of X73-PHD 104xx XML configuration files in compliance with the IEEE P11073 20601. –The tool prohibits users from developing non-compliant IEEE P11073 20601 configuration files. –(e.g., restricting a user from abstractly defining a conditional attribute (which is mandatory in the standard). –Currently we have developed configuration files for: 10415 Weighing Scale 10404 Pulse Oximeter 10441 Cardiovascular fitness and activity monitor 10442 Strength fitness equipment ICSGenerator also generates ICSs tables as required by IEEE P11073 20601.

10. 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)

11. 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

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 ValidatePDU Capabilities (Detailed) 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)

14. Software Diagnostics and Conformance Testing Division ValidatePDU Enhancements Whats new since our last meeting… No new enhancements See coming slides for next steps…

15. 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 NISTs 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…

16. Software Diagnostics and Conformance Testing Division

17. 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

18. 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

19. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Topics of Discussion Purpose Status Strategy for Review Content of Document Next Steps…

20. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Purpose What the XSchema is… –To enable conformance to standard (specifically Domain Information Model and Nomenclature) Needed for conformance testing Needed by tooling for automation/consistent approach –Otherwise one must do this by hand, which usually leads to errors propagated into standard(s) –Attempt to document how DIM (ASN.1) Data Types map to XML What the XSchema is not… –Not intended to replace ASN.1 defined in DIM Exercise of formalizing DIM in a normalized way –Verification What does it mean to verify the XSchema Classic – more definition, resource issue? PHD – less definition, more resources (across more devices) –Validation Using tools to express device Expressing the device according to the standard (Schema tie) –All of XSchema content (XSD) will go into document

21. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Status To date we have been presenting our work and test tools based on the classic DIM –ICSGenerator Generates ICSs Device specializations (abstract representation compliant to DIM) –ValidatePDU Validates syntax of APDU Validates low level semantics of APDU against profile (from ICSGenerator DIM XML Schema Java Class libraries –ASN.1 data types in Java (including MDER)

22. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Strategy for Review Strategy for review/discussion of x73-10202 Document –First Exposure Description of how documentation maps to the problem –E.g., Object Definition and relationships –Second Exposure Eye-ball each section (text, example, MOC Attributes) –Third (Detailed) Exposure Editorial – go through line by line for emissions, redundancy, etc. leading to a design review Some level of traceability to do conformance testing

23. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Document Content Overview, Normative References, Definitions, Abbreviations and Acronyms, Guiding principles XSchema Design Approach XSchema Architecture XSchema Object Definitions –Data Types Common Data Types Attribute Data Types –Object Definitions Containment relationships Object Inheritance –Attribute Definition –Behaviour Definition –Notification Definition –Private Extensions Annexes –DIM Traceability (Normative) – how to trace back to DIM –Automated Conformance Toolkit Architecture (Informative) –Bibliography (Informative)

24. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Document Content - Design Based on Object-oriented approach from DIM The DIM is an object-oriented model that consists of objects, the object attributes, and methods which are abstractions of real-world entities in the domain of medical devices. UML Diagram (packages in the form of object diagrams)

25. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Document Content – Design (Cont.) The following UML components are addressed: Containment Relationship Inheritance Encapsulation Multiplicity The following textual elements of the IEEE 11073 DIM are also addressed: Managed Object Classes (MOC) Definitions Attribute Definition Attribute Groups Behavior Definition Notification Definition Attribute groups Private extensions Common Data Type Terminology Service Model ICS tables

26. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Document Content - Architecture DIM XML Schema GeneralICS.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

27. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Document Content - Architecture DIM XML Schema Diagram

28. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Document Content – Object Definitions Example Common Data Type Example –8-bit unsigned integer INT-U8 ASN.1 type mapped into XSD INT-U8::=INTEGER(0..255) XSD Representation using ASN2XSD tool:

29. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema XSchema:DIM Traceability (Normative) XSchema Component DIM Clause(s)Comments DIM_Data_Types.xsd7.1.2, 7.3.2.1, 7.3.3.1, 7.3.4.1, 7.3.5.1, 7.3.6.1, 7.3.8.1, 7.3.9.1, 7.3.10.1, 7.3.11.1, 7.3.12.1, 7.3.13.1, 7.3.13.2, 7.4.1.1, 7.4.2.1, 7.4.3.1, 7.5.1.1, 7.5.2.1, 7.5.2.2, 7.5.2.3, 7.5.7.2, 7.5.8.1, 7.5.8.2, 7.5.9.1, 7.5.10.1, 7.5.10.2, 7.5.10.3, 7.6.1.1, 7.6.1.2, 7.6.1.3, 7.6.2.1, 7.6.3.1, 7.6.4.1, 7.6.5.1, 7.6.6.1, 7.6.8.1, 7.6.9.1, 7.7.1.2, 7.7.1.3, 7.7.2.1, 7.7.4.1, 7.7.5.3, 7.7.7.1, 7.7.7.3, 7.7.9.3, 7.8.1.2, 7.8.1.3, 7.8.6.1, 7.8.7.1, 7.9.2.1, 7.9.4.1, 7.10.1.1, 7.10.1.2, Represents common data types and all type definitions in the DIM. DIM_Values.xsd 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 7.10 Associates general information such as reference clause, qualifier; object, attribute, behavior and notification term codes; object, attribute, behavior and notification name; attribute_Id, behaviour_Id, notification_Id; behavior action parameter type, behavior action result type and notification event parameter type MOC_Attr_Bahav_Notif. xsd 7.2, 7.3, Associate values defined in DIM_values.xsd to specific attributes, behavior or notification.

30. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Document Content Overview, Normative References, Definitions, Abbreviations and Acronyms, Guiding principles XSchema Design Approach XSchema Architecture XSchema Object Definitions –Data Types Common Data Types Attribute Data Types –Object Definitions Containment relationships Object Inheritance –Attribute Definition –Behaviour Definition –Notification Definition –Private Extensions Annexes –DIM Traceability (Normative) – how to trace back to DIM –Automated Conformance Toolkit Architecture (Informative) –Bibliography (Informative)

31. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Next Steps (near term goals) Take a detailed pass to see if the document is on target. Determine, through use: Can the XSchema/Tooling be used to express manufacturers devices? Help calibrate whats in conformance tools… …and tie tools back into the standard Feedback back into the standard (through issues) Lead to another document for PHD DIM XSchema (20601) Driven by Users: –What will users do with this document? –Will tooling be enough (for the validation part) –Feedback from use of tools should drive document (and standard)

32. Software Diagnostics and Conformance Testing Division IEEE P11073-10202 TM /D01a XML Schema Questions and Further Discussion… Actions/Take-aways Thanks for your input and attention

33. Software Diagnostics and Conformance Testing Division Begin Sandras PHD Slides Sandras slides

34. Software Diagnostics and Conformance Testing Division PHD Project IEEE P11073-20601 IEEE P11073-20601 makes use of information objects that are defined in ISO/IEEE Std 11073-10201, adapting these information objects to the domain of Personal Health Device communication. The information objects are specialized and therefore modified in the following ways: –The definition of attributes that are mandatory, optional, or conditional may be different * –Additional Object Services may be defined –Additional Attributes may be defined –Some features of the original model might not be used If there is a discrepancy between standards, the IEEE P11073-20601 standard takes priority. IEEE P11073-20601 replicates relevant portions of ISO/IEEE Std 11073-10101 and incorporates new nomenclature codes.

35. Software Diagnostics and Conformance Testing Division Leveraging NIST Tools to 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 ICSs

36. Software Diagnostics and Conformance Testing 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 will be included and redefined, when appropriate.

37. Software Diagnostics and Conformance Testing Division Classic X73 DIM XSchema GeneralICS.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

38. Software Diagnostics and Conformance Testing 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

39. Software Diagnostics and Conformance Testing Division ICSGenerator, DIM XSchema and PHD-DIM ICSGenerator ICSGenerator generates X73 Classic device specializations using IEEE X73 baseline and polling application profiles. –For PHD, ICSGenerator will use an XML IEEE P11073-104XXX device specialization configuration file to define implementation of a device specialization. ICSGenerator has been enhanced to allow the generation of X73-PHD 104xx XML configuration files in compliance with the IEEE P11073 20601. –The tool will not allow to develop a configuration file that is not in compliance to IEEE P11073 20601. (ex. Trying to support an attribute as conditional or optional when the IEEE P11073 20601 states that it must be mandatory. –Currently we have developed configuration files for: 10415 Weighing Scale 10404 Pulse Oximeter 10441 Cardiovascular fitness and activity monitor 10442 Strength fitness equipment ICSGenerator also generates ICSs tables as required by IEEE P11073 20601. The tool must be enhanced to generate X73-PHD 104xx device specializations –XSchematron rules must be applied to achieve compliance to the IEEE P11073-104XXX specification.

40. Software Diagnostics and Conformance Testing Division ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

41. Software Diagnostics and Conformance Testing Division ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

42. Software Diagnostics and Conformance Testing Division ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

43. Software Diagnostics and Conformance Testing Division ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

44. Software Diagnostics and Conformance Testing Division ICSGenerator, DIM XSchema and PHD-DIM X73-10404 (Pulse Oximeter)

45. Software Diagnostics and Conformance Testing Division ICSGenerator, DIM XSchema and PHD-DIM X73-10415 (Weighing Scale)

46. Software Diagnostics and Conformance Testing Division ValidatePDU 2.0 and PHD-DIM Current version of ValidatePDU 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.

47. Software Diagnostics and Conformance Testing Division Next Steps Enhance ICSGenerator to add the capability to generate implementations of IEEE-11073 PHD 104xx device specializations in XML including the ICS tables. –Incorporate XSchematron validation Enhance ValidatePDU to validate PHD type messages.