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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 ( [email protected] , 301-975-5248) Sandra Martinez ( [email protected] ,

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Medical Device Test Effort NIST Team Members

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Medical device test effort nist team members

ISO/IEEE 11073, IHE-PCD, PHD andNISTMedical Device CommunicationTest EffortHL7/IEEE WG Meetings (Phoenix, Arizona)6 May 2008


Medical device test effort nist team members

Medical Device Test EffortNIST Team Members

  • John Garguilo ([email protected],

    301-975-5248)

  • Sandra Martinez ([email protected],

    301-975-3579)

  • Maria Cherkaoui ([email protected]

    Guest Researcher)

  • Richard Theimer ([email protected]

    CENTECH Group, Inc., Contractor)


Meeting topics discussion

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


Test focus areas

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


Ihe pcd year 3 profile proposal pcd real time plug n play

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)


What are we doing test tools

What are we doing? Test Tools


Medical device test effort nist team members

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


Icsgenerator capabilities

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


Icsgenerator enhancements

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.


Validatepdu tool

(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)


Validatepdu capabilities

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)


Validatepdu capabilities detailed

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)


  • Validatepdu enhancements

    ValidatePDU Enhancements

    What’s new since our last meeting…

    • No new enhancements

    • See coming slides for next steps…


    Ieee p11073 10202 tm d01a xml schema topics of discussion

    IEEE P11073-10202TM/D01a XML Schema Topics of Discussion

    • Purpose

    • Status

    • Strategy for Review

    • Content of Document

    • Next Steps…


    Ieee p11073 10202 tm d01a xml schema purpose

    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


    Ieee p11073 10202 tm d01a xml schema status

    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)


    Ieee p11073 10202 tm d01a xml schema strategy for review

    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


    Ieee p11073 10202 tm d01a xml schema document content

    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)


    Ieee p11073 10202 tm d01a xml schema document content design

    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)


    Ieee p11073 10202 tm d01a xml schema document content design cont

    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


    Ieee p11073 10202 tm d01a xml schema document content architecture

    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


    Ieee p11073 10202 tm d01a xml schema document content architecture1

    IEEE P11073-10202TM/D01a XML SchemaDocument Content - Architecture

    • DIM XML Schema Diagram


    Ieee p11073 10202 tm d01a xml schema document content object definitions

    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>


    Ieee p11073 10202 tm d01a xml schema xschema dim traceability normative

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


    Ieee p11073 10202 tm d01a xml schema document content1

    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)


    Ieee p11073 10202 tm d01a xml schema next steps near term goals

    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)


    Ieee p11073 10202 tm d01a xml schema

    IEEE P11073-10202TM/D01a XML Schema

    • Questions and Further Discussion…

    • Actions/Take-aways

    • Thanks for your input and attention 


    Begin sandra s phd slides

    Begin Sandra’s PHD Slides

    • Sandra’s slides


    Phd project ieee p11073 20601

    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.


    Leveraging nist tools to phd

    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


    Icsgenerator dim xschema and phd dim

    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.


    Classic x73 dim xschema

    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


    Phd dim xschema

    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


    Icsgenerator dim xschema and phd dim1

    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.


    Icsgenerator dim xschema and phd dim2

    ICSGenerator, DIM XSchema and PHD-DIM

    X73-10441 (Cardiovascular fitness and activity monitor)


    Icsgenerator dim xschema and phd dim3

    ICSGenerator, DIM XSchema and PHD-DIM

    X73-10441 (Cardiovascular fitness and activity monitor)


    Icsgenerator dim xschema and phd dim4

    ICSGenerator, DIM XSchema and PHD-DIM

    X73-10441 (Cardiovascular fitness and activity monitor)


    Icsgenerator dim xschema and phd dim5

    ICSGenerator, DIM XSchema and PHD-DIM

    X73-10441 (Cardiovascular fitness and activity monitor)


    Icsgenerator dim xschema and phd dim6

    ICSGenerator, DIM XSchema and PHD-DIM

    X73-10404 (Pulse Oximeter)


    Icsgenerator dim xschema and phd dim7

    ICSGenerator, DIM XSchema and PHD-DIM

    X73-10415 (Weighing Scale)


    Validatepdu 2 0 and phd dim

    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.


    Next steps

    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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