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

  2. Outline • 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

  3. 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.

  4. 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

  5. 1073 System 1073 System 1073 Device 1073 Device 1073 Device ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1](Application Gateway) 1073/HL7 Gateway 1073 Device 1073 Network HL7 Network HL7 System HL7 System 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]

  6. 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])

  7. -Attribute ID, Term codes, value ranges, qualifiers…-Object Containment Tree ICS-Generator ICS XML File How Message Maker and ICS-Generator could contribute to the IHE/PCD year one Initiative… 1073 Standard (DIM) HL7 v2.x Standard IEEE 1073 Standard IHE-ITI Patient Administration n (Year 2+ ) NIST P1073.6.1.1 ORI (Gateway) (XSLT) IHE/PCD Technical Framework (Vol. II) (Transactions) Testing Framework(Year 2+) IHE Profile (Paper) HL7 MessageProfile Builder (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.

  8. 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. • http://www.nist.gov/messagemaker

  9. 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.] • http://www.nist.gov/medicaldevices

  10. Conformance Test Tools (continued)(based on 11073 DIM Schema) • ValidatePDU • Provides a basic syntax and structure check for a set of captured messages. • http://www.nist.gov/medicaldevices

  11. 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.

  12. Questions • 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.

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