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 11073 and The National Institute of Standards and Technology Patient Care Devices Domain Test Effort September 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 Agenda Meeting Goals PCD background, IEEE 1073, IHE Involvement in IHE PCD and IEEE 1073 –Year 1, Year 2+ –High Level Diagram –IHE PCD Test Cases NIST Conformance Test Tools –HL7 Test Framework (including Message Maker) Input POC (HL7) XML message profiles Data source (physiologic) Output: HL7 test messages –Test framework –ICSGenerator Implementation Conformance Statements Capabilities and Enhancements (since last WG meeting…) –ValidatePDU PDU syntax NIST 11073 XSchema Issues and Open Discussion…

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/demonstration of development enhancements –Pointer/Links for more detail and contact information NIST XSchema –Provide status update –Discuss/resolve outstanding issues Call for vendor review/use of ICSGenerator Discuss/Resolve any open issues…

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. –Volume I: Integration Profiles –Volume II: Transactions 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. IHE PCD Profile Name: Device Enterprise Communication (DEC) IHE PCD Transactions: PCD-01: Communicate PCD Data PCD-02: Subscribe to PCD Data IHE PCD Actors: Device Observation Consumer, Filter, and Reporter IHE ITI Actor: Time Client - Profile 2: The Patient Identification Integration Profile Goal: Bind enterprise unique patient identification to the PCD Data which is communicated to the enterprise PCD Test Cases

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 11073/HL7 Gateway HL7 System HL7 System 11073-based communications network where 11073 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 Device 11073 Device 11073 Device IEEE 1073 System

7. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 7 n 1073 Standard (DIM) How the NIST Test Framework/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

8. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 8 Conformance Test Tools NIST HL7 Test Framework 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. –Framework to test HL7 implementations is under development http://www.nist.gov/messagemaker Robert Snelick (robert.snelick@nist.gov)

9. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 9 Conformance Test Tools (continued) (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 HL2 V2.x profile file) to build the test messages.] http://www.nist.gov/medicaldevices

10. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 10 IEEE 11073 DIM Nomenclature ICSGeneratorValid XML File XSLT ICS XSchema File ICSGenerator Inputs/Outputs

11. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 11 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.

12. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 12 (since last WG meetings [San Antonio, May 06]) ICSGenerator Enhancements (since last WG meetings [San Antonio, May 06]) 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.

13. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 13 ICSGenerator Enhancements ( Continued…) 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.

14. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 14 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

15. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 15 DIM XSchema Checks common data types Ensures DIM object definition (attributes, behaviors and notifications) Ensures containment association Represents attributes/notification/behavior inheritance Ensures object cardinality Ensures term codes (Managed Objects, attributes, behaviors and notifications) Validates for proper XML structures Checks syntax of XML instances Allows for future extentions of the model

16. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 16 Common data type

17. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 17 Containment/Object Definition This type defines the Simple_MDS object including its containment tree. <xsd:element name="Bedside_Communication_Controller" type="Bedside_Communication_ControllerType" minOccurs="0" …

18. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 18 Attribute Definition …

19. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 19 Attribute Definition (Cont.)

20. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 20 Attribute Groups

21. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 21 Behavior Definition

22. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 22 Notification Definition

23. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 23 Notification Definition (Cont.)

24. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 24 XML INSTANCE FILE Simple_MDS MDC_MOC_VMS_MDS_SIMP 37 clause 7.5.3

25. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 25 XML Instance (cont.) Mds-Status MDC_ATTR_VMS_MDS_STAT MDSStatus 2471 clause 7.5.2.1 C …

26. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 26 Infusion Pump Infusion pump Electronic profile

27. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 27 Containment/Object definition XSchematron rules embedded into the XSchema to solve Xschema constraints of not allowing unordered/unbounded elements. –This constraint was adding the constraint of maintaining the objects in order, which is not a requirement in the DIM.

28. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 28 XSchematron rules OBJECT_NAME must appear one time OBJECT_ID in Simlple_MDS must appear one time TERM_CODE must appear one time Reference must appear one time MOC_RESTRICTIONS must appear one time MOC_APPLICATION_GUIDANCE must appear one time Attribute_Info must appear one time Notification_Info must appear one time Behaviour_Info must appear one time VMD in Simple_MDS should appear at most once( 0 or 1) in Simple_MDS Clock in Simple_MDS should appear at most once( 0 or 1) Patient_Demographics in Simple_MDS should appear at most once( 0 or 1)