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Medical Device Test Effort NIST Team Members

ISO/IEEE 11073, IHE-PCD, PHD and NIST Medical Device Communication Test Effort HL7/IEEE WG Meetings (Phoenix, Arizona) 6 May 2008. Medical Device Test Effort NIST Team Members. John Garguilo ( john.garguilo@nist.gov , 301-975-5248) Sandra Martinez ( sandra.martinez@nist.gov ,

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Medical Device Test Effort NIST Team Members

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  1. ISO/IEEE 11073, IHE-PCD, PHD andNISTMedical Device CommunicationTest EffortHL7/IEEE WG Meetings (Phoenix, Arizona)6 May 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)

  3. 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. Test Focus Areas • NIST Test Tools Inventory • Device Communication • ISO/IEEE 11073 • ICSGenerator • ValidatePDU • XML Schema (ISO/IEEE P11073-10202TMD01a) • 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. X73 APDU IHE-PCD Year 3+ Profile ProposalPCD-Real Time Plug-n-Play • Validate APDUs against Standard • Determine if APDUs meets device profile (defined using ICSGenerator)

  6. What are we doing? Test Tools

  7. CEN 13734 and 13735 Compare Devices HL7/OBXMapping(XML) Device UML Diagram ICSGenerator Tool and XSchema ISO/IEEE 11073 Nomenclature Part 10101 DIM Parts 10201/ 20601 DIMXSchema ICSGenerator

  8. 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. ICSGenerator Enhancements What’s 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 ICS’s tables as required by IEEE P11073 20601.

  10. (From ICSGenerator) Device Profile (xml) ValidatePDU ROSEapdu (MDER) Validation Report (MDER + XER CoderEncode/Decode) (APDU Syntax and Semantic Validation) ValidatePDU Tool • ValidatePDU: Performs APDU syntax/structure and semantic validation using a MDER Coder. Device Profile (xml) Device Profile (xml) ValidatePDU ValidatePDU ROSEapdu (MDER) ROSEapdu (MDER) Validation Report Validation Report (MDER + XER Coder) (MDER + XER Coder) (APDU Syntax and Semantic Validation) (APDU Syntax and Semantic Validation) APDU (XER)

  11. 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)

  12. 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)

  13. ValidatePDU Enhancements What’s new since our last meeting… • No new enhancements • See coming slides for next steps…

  14. IEEE P11073-10202TM/D01a XML Schema Topics of Discussion • Purpose • Status • Strategy for Review • Content of Document • Next Steps…

  15. IEEE P11073-10202TM/D01a XML SchemaPurpose • 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

  16. IEEE P11073-10202TM/D01a XML SchemaStatus • 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)

  17. IEEE P11073-10202TM/D01a XML SchemaStrategy 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

  18. IEEE P11073-10202TM/D01a XML SchemaDocument 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)

  19. IEEE P11073-10202TM/D01a XML SchemaDocument 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)

  20. IEEE P11073-10202TM/D01a XML SchemaDocument 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

  21. DIM.xsd GeneralICS.xsd serviceICS.xsd PollingMode.xsd MOC_Defs.xsd Baseline-Manager.xsd MOC_Attr_Behav_Notif.xsd Rose.xsd DIM_Values.xsd DIM_Data_Types.xsd Transport.xsd (http://www.nist.gov/x73DIM) osxdlib.xsd DIM XSchema Document Structure (http://www.obj.sys.com/v1.0/XMLSchema) include import IEEE P11073-10202TM/D01a XML SchemaDocument Content - Architecture • DIM XML Schema

  22. IEEE P11073-10202TM/D01a XML SchemaDocument Content - Architecture • DIM XML Schema Diagram

  23. IEEE P11073-10202TM/D01a XML SchemaDocument 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: <xsd:element name="INT-U8" type="iNT-U8"/> <xsd:simpleType name="iNT-U8"> <xsd:restriction base="xsd:unsignedByte"/> </xsd:simpleType>

  24. IEEE P11073-10202TM/D01a XML SchemaXSchema:DIM Traceability (Normative)

  25. IEEE P11073-10202TM/D01a XML SchemaDocument 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)

  26. IEEE P11073-10202TM/D01a XML SchemaNext 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 manufacturer’s devices? • Help calibrate what’s 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)

  27. IEEE P11073-10202TM/D01a XML Schema • Questions and Further Discussion… • Actions/Take-aways • Thanks for your input and attention 

  28. Begin Sandra’s PHD Slides • Sandra’s slides

  29. PHD ProjectIEEE 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.

  30. X73-104xx XMl config. DIM XSchema PHD XSchema. DIM XML config. PHD XML config. ICS’s X73-104xx XMl config. ICS’s X73-104xx XSchematron. Device Specializations Device Specializations Device Specializations ICS’s X73-104xxXML config. PHD-DIM (IEEE-11073-104xx) PHD-DIM (IEEE-11073-20601) X73 DIM (IEEE 11073-10201) Leveraging NIST Tools to PHD ICSGenerator ValidatePDU

  31. 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.

  32. DIM.xsd GeneralICS.xsd serviceICS.xsd PollingMode.xsd MOC_Defs.xsd Baseline-Manager.xsd MOC_Attr_Behav_Notif.xsd Rose.xsd DIM_Values.xsd DIM_Data_Types.xsd Transport.xsd (http://www.nist.gov/x73DIM) osxdlib.xsd DIM XSchema Document Structure (http://www.obj.sys.com/v1.0/XMLSchema) include import “Classic” X73 DIM XSchema

  33. asn1.xsd (http://www.obj.sys.com/v1.0/XMLSchema) PHD_DIM XSchema PHD_DIM.xsd PHD_MOC_Defs.xsd PHD_MOC_Attr_Behav_Notif.xsd Qual_Bases.xsd PHD_Data_Types.xsd PHD_Import.xsd DIM_Data_Types.xsd (http://www.nist.gov/x73DIM) Enumerations_Bases.xsd include import redefine

  34. 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 ICS’s 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.

  35. ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

  36. ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

  37. ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

  38. ICSGenerator, DIM XSchema and PHD-DIM X73-10441 (Cardiovascular fitness and activity monitor)

  39. ICSGenerator, DIM XSchema and PHD-DIM X73-10404 (Pulse Oximeter)

  40. ICSGenerator, DIM XSchema and PHD-DIM X73-10415 (Weighing Scale)

  41. ValidatePDU 2.0and 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.

  42. 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.

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