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Integrating the Healthcare Enterprise, IEEE 11073 and The National Institute of Standards and Technology Patient Care Medical Devices Test Effort January 2007. Introduction. Presenter Jan Wittenber (for NIST Team) NIST PCD Team John Garguilo ( , 301-975-5248)

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Integrating the Healthcare Enterprise, IEEE 11073andThe National Institute of Standards and TechnologyPatient Care Medical Devices Test EffortJanuary 2007



  • Jan Wittenber (for NIST Team)


  • John Garguilo (, 301-975-5248)
  • Sandra Martinez (, 301-975-3579)
  • Rick Rivello (, 301-975-3519)


  • Meeting Goals
  • NIST 11073 XSchema
  • NIST Conformance Test Tools
    • HL7 Test Framework (including Message Maker)
    • ICSGenerator
      • Implementation Conformance Statements
      • Capabilities and Enhancements (since last WG meeting…)
    • ValidatePDU
  • Next Steps…
  • Call for Help…
meeting goals
Meeting Goals
  • Describe high-level IEEE/IHE PCD test focus areas
  • NIST XSchema
    • Provide status update
  • Provide Tool Inventory/update:


    • Brief description of development capabilities and enhancements


  • Next Steps
  • Gather Feedback…
    • Call for vendor/clinical engineers and WG members to review/use the NIST XSchema and ICSGenerator

HL7 v2.x


IEEE 11073





-Attribute ID, Term codes, value ranges, qualifiers…-Object Containment Tree






IHE/PCD Technical

Framework (Vol. II)





HL7 MessageProfile


(e.g., MWB)

*HL7 MessageProfilesXML

How the NIST Test Framework/Message Maker and ICSGeneratorcould contribute to the IHE/PCD Initiative…




NIST XSchema

11073 Standard

(DIM + Nomenclature)


(Year 2+ )



NIST IHE Test Framework

*HL7 v2.x Message Profile: Captures and describes a set of HL7v2.x messages used to solve a Use Case.

icsgenerator inputs outputs
ICSGenerator Inputs/Outputs


IEEE 11073



Device Profile(Valid XMLFile)



dim xschema status
DIM XSchema Status
  • XSchema modifications:
    • Added capability to associate values with data types
    • Created DIM_Values.xsd library containing textual object information such as reference, object id, object name, etc.
      • Reason:
        • Facilitates access and manipulation of this type of information.
        • Reduces size of DIM.xsd.
        • Facilitates upgrades to DIM.xsd.
    • Created separate schema library for DIM data types
      • Reason:
        • Facilitates access and manipulation of data types.
        • Makes data types reusable by other application.
        • Facilitates upgrades to DIM.xsd
        • Reduces size of DIM.xsd
    • Optimized XSchematron rules in DIM.xsd.
    • Applied XML Schema best practices for optimization purposes in different areas of the DIM.xsd.
  • Developing draft IEEE 11073 DIM XML Schema document
    • Used IEEE 11073.1.1.2 aECG Nomenclature template as example.
conformance test tools based on 11073 dim schema
Conformance Test Tools(based on 11073 DIM Schema)
  • ICSGenerator
    • Facilitates creation of vendor conformance statements.
    • Provides Medical device data such as parameters or attributes with value ranges and restrictions. [This data can be used as needed by Message Maker (in addition to testing options, data source(s) and HL7 V2.x profile file) to build the test messages.]
icsgenerator capabilities
ICSGenerator Capabilities
  • Generates ICS’s as required in DIM document.
  • Ensures common format for ICS generation.
  • Generates an electronic (XML) version of device data model based strictly on the IEEE 11073 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
    • Ensuring correct containment relationship and terminology at the object class and related attribute, notification and behavior level.
    • Device ICS’s comparison capability aids in identifying potential interoperability issues.
icsgenerator capabilities cont
ICSGenerator Capabilities (cont.)
  • Dynamic tree generation
  • Ability to generate UML diagrams
  • Device data model comparison reports.
    • Exported to HTML or PDF document format.
  • General and Service Support ICS captured in XML
  • Transport ICS for IRDA Cable Connected profile.
  • Ability to handle private or manufacturer-specific extensions.
  • DIM MOC, Attribute, Notification and Behavior ICS tables generated into HTML.
icsgenerator capabilities cont1
ICSGenerator Capabilities(cont.)
  • Ability to add an Application Guidance Statement for the MOC
  • CREATE/DELETE Service Support for MOC's
  • Ability to Add Attribute Access for an attribute. (e.g., GET, SET, SCAN...)
  • Enhanced ability to Add/Remove Attributes, Behaviors and Notifications.
  • Code added to ICSGenerator that enables users to add/delete Composite MDS to the containment tree
icsgenerator enhancements since last wg meetings boca raton sept 06
ICSGenerator Enhancements(since last WG meetings [Boca Raton, Sept 06])
  • Interface upgrades
    • Added menu bar to re-start application
    • Added PDF report generation for ICS Tables.
    • Added pop-up menu to MOC in JTree to manipulate the objects.
    • Improved JTree collapsing behavior when manipulating the objects.
  • Created an installer to automatically install ICSGenerator.
icsgenerator work in progress
ICSGenerator Work-in-Progress
  • Value/Data type association
    • Creating a DIM data type library
  • Adding value input dialog
  • Mapping observation values to HL7 OBX segments
    • OBX-2, OBX-3, OBX-4, OBX-5, OBX-6 and OBX-7
  • Updating ICSGenerator code to compile and run under Java 1.5
  • Updating Users Guide to include latest ICSGenerator changes
conformance test tools continued based on 11073 dim schema
Conformance Test Tools (continued)(based on 11073 DIM Schema)
  • ValidatePDU
    • Provides a basic syntax and structure check for a set of captured messages.
  • Future Enhancements
    • Translating BER/MDER XML
      • Needed for 11073 syntax/structure/semantic testing
next steps
Next Steps
  • NIST 11073 DIM XSchema
    • Document IEEE 11073 Normative Standard
      • PAR approved 9/15/06?
      • Project Plan under development
      • Maintenance issue of electronic file (versus paper documentation) in Standard
  • ICSGenerator
    • Add Remaining Transport Profiles
    • Continue Enhancing Interface and Usability; Documentation
    • Work w/ IHE PCD Team and Medical Device Vendors
    • Unit of Measurement (e.g., convert IEEE units of measurement to UCUM, if adopted)
    • Mapping IEEE x73-10101 (Nomenclature) ‘Unit Codes’ to Reference Identifiers
  • Look into issue of Unit Attribution Semantics (long range)
next steps continued
Next Steps (continued…)
  • IHE PCD Test Case Development (Year 2)
    • Support HL7 Profile Development (using MWB and Message Maker)
      • Output test messages
    • Obtain data values
      • To be used w/ Message Maker test generation
    • Research potential link of IEEE X73-basedICS files (XML) into MWB and Message Maker
call for help
Call for Help…
  • IEEE X73/IHE WGs, Vendors/Clinical Engineers
    • Validate NIST XSchema
    • Install and evaluate ICSGenerator
      • Provide feedback on utility and functionality
    • Recommendations for enhancements

NIST Contacts: John Garguilo ( Martinez ( Rivello (