1. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 1 Patient Care Medical Devices Test Effort Integrating the Healthcare Enterprise, IEEE 11073 and The National Institute of Standards and Technology Patient Care Medical Devices Test Effort January 2007

2. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 2 Introduction Presenter Jan Wittenber (for NIST Team) 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 Outline Meeting Goals NIST 11073 XSchema NIST Conformance Test Tools –HL7 Test Framework (including Message Maker) –ICSGenerator Implementation Conformance Statements Capabilities and Enhancements (since last WG meeting…) –ValidatePDU Next Steps… Call for Help…

3. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 3 Meeting Goals Describe high-level IEEE/IHE PCD test focus areas NIST XSchema –Provide status update Provide Tool Inventory/update: ICSGenerator –Brief description of development capabilities and enhancements ValidatePDU Next Steps Gather Feedback… –Call for vendor/clinical engineers and WG members to review/use the NIST XSchema and ICSGenerator

4. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 4 n 1073 Standard (DIM) How the NIST Test Framework/Message Maker and ICSGenerator could contribute to the IHE/PCD Initiative… (XSLT) 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 11073 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 NIST IHE Test Framework NIST XSchema 11073 Standard (DIM + Nomenclature)

5. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 5 IEEE 11073 DIM Nomenclature ICSGeneratorDevice Profile (Valid XML File) ICS XSchema File ICSGenerator Inputs/Outputs

6. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 6 DIM XSchema Status XSchema modifications: –Added capability to associate values with data types –Created DIM_Values.xsd library containing textual object information such as reference, object id, object name, etc. Reason: –Facilitates access and manipulation of this type of information. –Reduces size of DIM.xsd. –Facilitates upgrades to DIM.xsd. –Created separate schema library for DIM data types Reason: –Facilitates access and manipulation of data types. –Makes data types reusable by other application. –Facilitates upgrades to DIM.xsd –Reduces size of DIM.xsd –Optimized XSchematron rules in DIM.xsd. –Applied XML Schema best practices for optimization purposes in different areas of the DIM.xsd. Developing draft IEEE 11073 DIM XML Schema document –Used IEEE 11073.1.1.2 aECG Nomenclature template as example.

7. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 7 Conformance Test Tools (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 HL7 V2.x profile file) to build the test messages.] http://www.nist.gov/medicaldevices

8. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 8 ICSGenerator Capabilities Generates ICSs 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 ICSs comparison capability aids in identifying potential interoperability issues.

9. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 9 ICSGenerator Capabilities (cont.) 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.

10. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 10 ICSGenerator Capabilities (cont.) 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. Code added to ICSGenerator that enables users to add/delete Composite MDS to the containment tree

11. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 11 (since last WG meetings [Boca Raton, Sept 06]) ICSGenerator Enhancements (since last WG meetings [Boca Raton, Sept 06]) Interface upgrades –Added menu bar to re-start application –Added PDF report generation for ICS Tables. –Added pop-up menu to MOC in JTree to manipulate the objects. –Improved JTree collapsing behavior when manipulating the objects. Created an installer to automatically install ICSGenerator.

12. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 12 ICSGenerator Work-in-Progress Value/Data type association –Creating a DIM data type library Adding value input dialog Mapping observation values to HL7 OBX segments –OBX-2, OBX-3, OBX-4, OBX-5, OBX-6 and OBX-7 Updating ICSGenerator code to compile and run under Java 1.5 Updating Users Guide to include latest ICSGenerator changes

13. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 13 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 11073 syntax/structure/semantic testing http://www.nist.gov/medicaldevices

14. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 14 Next Steps NIST 11073 DIM XSchema –Document IEEE 11073 Normative Standard PAR approved 9/15/06? Project Plan under development Maintenance issue of electronic file (versus paper documentation) in Standard ICSGenerator –Add Remaining Transport Profiles –Continue Enhancing Interface and Usability; Documentation –Work w/ IHE PCD Team and Medical Device Vendors –Unit of Measurement (e.g., convert IEEE units of measurement to UCUM, if adopted) –Mapping IEEE x73-10101 (Nomenclature) Unit Codes to Reference Identifiers Look into issue of Unit Attribution Semantics (long range)

15. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 15 Next Steps (continued…) IHE PCD Test Case Development (Year 2) –Support HL7 Profile Development (using MWB and Message Maker) Output test messages –Obtain data values To be used w/ Message Maker test generation –Research potential link of IEEE X73-based ICS files (XML) into MWB and Message Maker

16. National Institute of Standards and Technology Technology Administration U.S. Department of Commerce 16 Call for Help… IEEE X73/IHE WGs, Vendors/Clinical Engineers –Validate NIST XSchema –Install and evaluate ICSGenerator Provide feedback on utility and functionality –Recommendations for enhancements NIST Contacts: John Garguilo (john.garguilo@nist.gov) Sandra Martinez (sandra.martinez@nist.gov) Richard Rivello (richard.rivello@nist.gov)john.garguilo@nist.govsandra.martinez@nist.gov