1. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 1 Patient Care Devices Domain Test Effort Integrating the Healthcare Enterprise, IEEE 1073 and The National Institute of Standards and Technology Patient Care Devices Domain Test Effort May 2006

2. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 2 Introduction NIST PCD Team John Garguilo (john.garguilo@nist.gov, 301-975-5248)john.garguilo@nist.gov Sandra Martinez (sandra.martinez@nist.gov, 301-975-3579)sandra.martinez@nist.gov Rick Rivello (richard.rivello@nist.gov, 301-975-3519)richard.rivello@nist.gov 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 6 ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1] (Application Gateway) 1073 Network HL7 Network 1073 Device 1073/HL7 Gateway 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] 1073 Device 1073 Device 1073 Device IEEE 1073 System

7. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 7 11073 Application Gateway ORI 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 8 n 1073 Standard (DIM) How Message Maker and ICS-Generator could contribute to the IHE/PCD year one Initiative… (XSLT) Testing Framework (Year 2+) NIST * HL7 v2.x Message Profile: Captures and describes a set of HL7v2.x messages used to solve a Use Case. (Year 2+ ) P1073.6.1.1 ORI (Gateway ) HL7 v2.x Standard IHE/PCD Technical Framework (Vol. II) (Transactions) IEEE 1073 Standard IHE-ITI Patient Administration *HL7 Message Profiles XML IHE Profile (Paper) HL7 Message Profile Builder (e.g., MWB) ICS-Generator ICS XML File -Attribute ID, Term codes, value ranges, qualifiers… -Object Containment Tree

9. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 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. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 14 (IEEE 1073) Issues/Discussion Medical Device Communication Test Suite Issues General –Object name labels – Is there a standard list of labels?