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Integrating the Healthcare Enterprise and The National Institute of Standards and Technology Patient Care Devices Domain Test Effort April 2006. Outline. IHE and NIST Use Case Profiles Gateway 11073/HL7 High level diagram Year One Year Two+ NIST Conformance Test Tools Message Maker

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Integrating the Healthcare Enterprise andThe National Institute of Standards and TechnologyPatient Care Devices DomainTest EffortApril 2006


  • IHE and NIST

  • Use Case Profiles

  • Gateway 11073/HL7

  • High level diagram

    • Year One

    • Year Two+

  • NIST Conformance Test Tools

    • Message Maker

      • Input POC (HL7) XML message profiles

      • Data source (physiologic)

      • Output: HL7 test messages

        • Test framework

    • ICSGenerator

      • Implementation Conformance Statements

    • ValidatePDU

      • PDU syntax (and later semantics?)

  • 11073 DIM XSchema

  • Questions

Integrating the healthcare enterprise ihe and nist
Integrating the Healthcare Enterprise IHE and NIST

  • IHE defines a Technical Framework for the implementation of established messaging standards to achieve specific clinical goals.

  • NIST supports IHE fundamental objective:

    • To ensure that in the care of patients all required information for medical decisions is both correct and available to healthcare professionals.

  • NIST contributes to a rigorous testing process for the implementation of the Technical Framework.

    • Conformance claims by products must still be made in direct reference to specific standards.

    • Vendors implementing IHE integration capabilities shall use an IHE Integration Statement to describe the conformance of their product to the specifications in the IHE Technical Framework.

Ihe pcd year 1 use cases
IHE/PCD Year 1 Use Cases

  • The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device.

  • Year One Profiles:

    • Profile 1:The Enterprise Communication of Patient Care Device Data Integration Profile

      Goal: Communicate PCD data to enterprise information systems.

    • Profile 2:The Patient Identification Integration Profile

      Goal:Bind enterprise unique patient identification to the PCD Data which is communicated to the enterprise

Iso ieee 11073 60101 hl7 v2 x ori ieee p1073 6 1 1 application gateway

1073 System









ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1](Application Gateway)













1073-based communications network where 1073 devices interact and

an HL7-based communications network, where HL7-based systems interact.

Problem: A communication gateway is needed between these two worlds!

Solution: ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1]

11073 application gateway ori
11073 Application GatewayORI

  • Can take non-complying data and translate it, permitting owners of legacy devices to transmit data to the enterprise in a consistent way.

  • Major partitions of the ISO/IEEE standards and “architectural” components are mapped:

    • Data types (VITAL vs. HL7)

    • Nomenclature Codes (VITAL vs. LOINC)

    • Information Model (Objects & attributes) to HL7 segments and fields.

    • Encoding Rules (VITAL ASN.1/MDER/XML(?) to HL7 ER, XML(v2.x/v3)

    • Correlate message types (1073 [profiles, GET/SET, CREATE/DELETE, Event Report, etc.] vs. HL7 [interrogatives, Imperatives & declaratives])

How message maker and ics generator could contribute to the ihe pcd year one initiative

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



How Message Maker and ICS-Generator could contribute to the IHE/PCD year one Initiative…




HL7 v2.x


IEEE 1073






(Year 2+ )






IHE/PCD Technical

Framework (Vol. II)



Framework(Year 2+)




HL7 MessageProfile


(e.g., MWB)

*HL7 MessageProfilesXML

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

Conformance test tools
Conformance Test Tools

  • Message Maker

    • Message Maker dynamically constructs HL7 messages based on an HL7 message profile.

    • Data values for the primitive elements (i.e., Field, Component, and Subcomponent) defined in the profile are obtained from a number of data sources.

      • NIST developed database of HL7 primitive data items, HL7 tables, User tables, External tables, local tables, example values from the profiles and default values.

    • Test messages can be valid or invalid and contain variation from message to message.

      • Example of invalid message is a missing data item for a required field.

      • A number of test parameters control the variation in the construction of a message.

        • These may include segment and field cardinality, the usage of certain primitive fields, value sets, data content, and more.

        • Data content variation is achieved by randomly selecting items from the HL7 items database.


Conformance test tools continued based on 11073 dim schema
Conformance Test Tools (continued)(based on 11073 DIM Schema)

  • ICSGenerator

    • Facilitates creation of vendor conformance statements [as well as selection of tests that would be applicable to testing a particular device].

    • Provides Medical device data such as parameters or attributes with value ranges and restrictions. [This data is used as needed by MessageMaker (in addition to testing options, data source(s) and HL2 V2.x profile file) to build the test messages.]


Conformance test tools continued based on 11073 dim schema1
Conformance Test Tools (continued)(based on 11073 DIM Schema)

  • ValidatePDU

    • Provides a basic syntax and structure check for a set of captured messages.


1073 dim xml schema
1073 DIM XML Schema

  • XSchema

    • NIST can capitalize on use of the XSchema by having one schema for both tools (ICSGenerator and ValidatePDU).

      • Since the XSchema is growing substantially in size, NIST needs to verify it's utility before proceeding…

    • The (future) extension of the 1073 DIM model…

      • Verify that XSchema work is useful to capture the relationship among the objects.

    • Use by other efforts (e.g., IHE PCD tooling, IEEE 1073 standard development…)

      • Obtain feedback regarding the utility of the NIST DIM XSchema development work.


  • Is the flow presented in the diagram (slide 7) a valid interpretation of how an IHE Message profile is generated from the IHE Technical Framework (and 1073 representation)?

  • When will the IHE/PCD HL7 v2.x message profiles in XML format be created?

  • In addition to Message Maker source of data, what additional data sources (if any) are available to populate the test messages?

    • What data from ICS-Generator could be used to populate the test messages? Specifically for the year one initiative, if any?

  • The diagram presented represents a one way flow from device (1073) to HL7. Thoughts on flow in the direction from HL7 formatted messages into a 1073 representation?

    Related Longer Term Effort

  • A testing framework is needed to utilize these test messages to examine the behavior of the implementations.