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Introduction

Integrating the Healthcare Enterprise, IEEE 1073 and The National Institute of Standards and Technology Patient Care Devices Domain Test Effort May 2006. Introduction. NIST PCD Team John Garguilo ( john.garguilo@nist.gov , 301-975-5248)

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Introduction

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  1. Integrating the Healthcare Enterprise, IEEE 1073andThe National Institute of Standards and TechnologyPatient Care Devices DomainTest EffortMay 2006

  2. Introduction NIST PCD Team • John Garguilo (john.garguilo@nist.gov, 301-975-5248) • Sandra Martinez (sandra.martinez@nist.gov, 301-975-3579) • Rick Rivello (richard.rivello@nist.gov, 301-975-3519) Agenda • Involvement in IHE PCD and IEEE 1073 • Year 1, Year 2+ • High Level Diagram • 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?) • NIST 1073 XSchema

  3. Goals • Describe high-level test focus areas • Provide Tool Inventory/update • Brief description • Pointer/Links for more detail and contact information • Feedback on tool enhancements • Reconcile Outstanding Issues • Provide update on NIST XSchema • Reconcile differences between 1073 DIM and Nomenclature Documents • Discovered through tool/XSchema development

  4. 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.

  5. 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

  6. 1073/HL7 Gateway 1073 Device 1073 Network HL7 Network HL7 System IEEE 1073 System 1073 Device 1073 Device 1073 Device HL7 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]

  7. 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])

  8. HL7 v2.x Standard IEEE 1073 Standard IHE-ITI Patient Administration -Attribute ID, Term codes, value ranges, qualifiers…-Object Containment Tree ICS-Generator ICS XML File P1073.6.1.1 ORI (Gateway) IHE/PCD Technical Framework (Vol. II) (Transactions) IHE Profile (Paper) HL7 MessageProfile Builder (e.g., MWB) *HL7 MessageProfilesXML How Message Maker and ICS-Generator could contribute to the IHE/PCD year one Initiative… 1073 Standard (DIM) n (Year 2+ ) NIST (XSLT) Testing Framework(Year 2+) *HL7 v2.x Message Profile: Captures and describes a set of HL7v2.x messages used to solve a Use Case.

  9. 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 • Robert Snelick (robert.snelick@nist.gov)

  10. Conformance Test Tools (continued)(based on 11073 DIM Schema) • ICSGenerator • Facilitates creation of vendor conformance statements [as well as potential selection of tests applicable to testing a particular device]. • Provides Medical device data such as parameters or attributes with value ranges and restrictions. [This data can be 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

  11. Conformance Test Tools (continued)(based on 11073 DIM Schema) • ICSGenerator • Capability of reloading an existing ICS • Added term codes • Future Enhancements • Add capability to dynamic build containment tree • Add Service Support ICS

  12. 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 1073 syntax/structure/semantic testing • http://www.nist.gov/medicaldevices

  13. 1073 XML Schema • NIST 1073 XSchema represents: • X73 DIM including: • Common Data type definitions • Managed Object Class definitions • attributes, behaviors and notifications definitions • Attribute groups (not included yet) • Base classes (not included yet) • Containment tree • ICS Model • Service Model • Term codes for Managed Objects, attributes, behaviors and notifications • ASN.1 included in other X73 documents • Used by NIST conformance tools • ICSGenerator : A device profile developed using this tool could potentially “claim” conformance to the X73 DIM standard. • ValidatePDU: X73 message validator for syntax and structure • Possible use by other efforts (e.g., IHE PCD tooling, IEEE 1073 standard development

  14. (IEEE 1073) Issues/Discussion • Medical Device Communication Test Suite Issues • General • Object name labels – Is there a standard list of labels?

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