Introduction

1. Integrating the Healthcare Enterprise, IEEE 11073andThe National Institute of Standards and TechnologyPatient Care Medical Devices Test EffortJanuary 2007

2. Introduction Presenter • Jan Wittenber (for NIST Team) 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) 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. 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. HL7 v2.x Standard IEEE 11073 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 the NIST Test Framework/Message Maker and ICSGeneratorcould contribute to the IHE/PCD Initiative… 1073 Standard (DIM) NIST XSchema 11073 Standard (DIM + Nomenclature) n (Year 2+ ) NIST (XSLT) NIST IHE Test Framework *HL7 v2.x Message Profile: Captures and describes a set of HL7v2.x messages used to solve a Use Case.

5. ICSGenerator Inputs/Outputs XSchemaFile IEEE 11073 Nomenclature ICSGenerator Device Profile(Valid XMLFile) DIM ICS

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. 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. 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.

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. 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. 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. 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. 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. 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. 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-basedICS files (XML) into MWB and Message Maker

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)