National Institute of Standards and Technology Technology Administration

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

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce 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 – HL 7 Test Framework (including Message Maker) – ICSGenerator • Implementation Conformance Statements • Capabilities and Enhancements (since last WG meeting…) – Validate. PDU • • Next Steps… Call for Help… 2

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce 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 Validate. PDU • Next Steps • Gather Feedback… – Call for vendor/clinical engineers and WG members to review/use the NIST XSchema and ICSGenerator 3

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce How the NIST Test Framework/Message Maker and ICSGenerator could contribute to the IHE/PCD Initiative… 1073 NIST Standard XSchema (DIM) HL 7 v 2. x Standard IEEE 11073 Standard IHE-ITI Patient Administration HL 7 Message Profile Builder (e. g. , MWB) -Attribute ID, Term codes, value ranges, qualifiers… -Object Containment Tree ICS XML File NIST (XSLT) IHE/PCD Technical Framework (Vol. II) (Transactions) IHE Profile (Paper) (Year 2+ ) ICS-Generator P 1073. 6. 1. 1 ORI (Gateway) 11073 Standard (DIM + Nomenclature) n NIST IHE Test Framework *HL 7 Message Profiles XML *HL 7 v 2. x Message Profile: Captures and describes a set of HL 7 v 2. x messages used to solve a Use Case. 4

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

National Institute of Standards and Technology • • XSchema modifications: Technology Administration • U. S. Department of Commerce DIM XSchema Status – 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 6 – Used IEEE 11073. 1. 1. 2 a. ECG Nomenclature template as example.

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce 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 HL 7 V 2. x profile) to build the test messages. ] • http: //www. nist. gov/medicaldevices 7

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce 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. 8

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce 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. 9

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce 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, 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 10

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

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce ICSGenerator Work-in-Progress • Value/Data type association – Creating a DIM data type library • Adding value input dialog • Mapping observation values to HL 7 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 12

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce Conformance Test Tools (continued) (based on 11073 DIM Schema) • Validate. PDU – 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 13

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce 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 x 73 -10101 (Nomenclature) ‘Unit Codes’ to Reference Identifiers • Look into issue of Unit Attribution Semantics (long range) 14

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce Next Steps (continued…) • IHE PCD Test Case Development (Year 2) – Support HL 7 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 X 73 -based ICS files (XML) into MWB and Message Maker 15

National Institute of Standards and Technology • Technology Administration • U. S. Department of Commerce Call for Help… • IEEE X 73/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) 16