1. 1 Testing for Medical Devices Communications Lynne Rosenthal National Institute of Standards and Technology Information Technology Laboratory Lynne.rosenthal@nist.gov 301-975-3353 http://www.nist.gov/ehealth

2. 2 Today’s topics Who is NIST (background) IHE and NIST What is Conformance and So What! Testing for the Medical Device Communications IHE and Medical Devices

3. 3 NIST Collaborates with the HC Industry Part of the US Dept of Commerce NIST works with industry to develop standards and tests to improve the quality of software and achieve interoperable solutions HC Collaborations focus in three areas  Measurable standards leading to interoperability  Integration of emerging technologies  Prototyping and test bed development for industry

4. 4 NIST Participation with Industry ANSI HISB - Healthcare Informatics Standards Board ASTM – ASTM International ATA – American Telemedicine Association IEEE 1073 Medical Device Communications HIMSS/IHE - Healthcare Information and Management Systems Society / Integrating the Healthcare Enterprise HL7 – Health Level Seven OASIS – Organization for the Advancement of Structured Information Standards URAC – (not an acronym) Wedi – Workgroup for Electronic Data Interchange NIST participation:  Organizational members usually with technical/conformance lead role HL7 Conformance SIG Co-Chair, IHE IT Infrastructure Committee Co-chair  Technical level collaboration with private-industry member organizations IHE Open Source effort, IEEE 1073 Medical Device testing effort  Co-sponsor awareness activities Co-sponsor of HIMSS Summer Summit, New York City, June 2005 Participant IHE Connect-a-thons and Annual HIMSS Conference and Expo

5. 5 NIST and IHE NIST co-chairs IHE IT Infrastructure Group Defines, tests, and implements integration profiles  Co-authored IHE Cross Enterprise Document Sharing Profile (XDS)  Developed XDS reference implementation and test tool  Participate in Connect-a-thons and HIMSS Annual Conference Showcases

6. 6 Testing Why bother? What types of testing?

7. 7 Standards are not enough Standards not enough to ensure interoperability  Standards only meaningful if implemented in a consistent way Need to ensure that implementations adhere to the standard  What is expected of implementations in order to claim conformance – i.e., what are the requirements?  How will we know if an implementation conforms? test suites, test tools Conformance is necessary but not sufficient for interoperability Interoperability does not imply conformance

8. 8 Terminology CONFORMANCE – the fulfillment of a product, process or service of specified requirements. CONFORMANCE CLAUSE - a section of a specification that defines at a high level, the requirements, criteria, or conditions to be satisfied in order to claim conformance. Conformance REQUIREMENTS – requirements indicating the behavior, action, capability that constitutes implementation of the function. CONFORMANCE TESTING – a way to determine directly or indirectly that relevant requirements are fulfilled. INTEROPERABILITY TESTING – a way to determine that 2 or more systems or components can exchange information and use the information that has been exchanged.

9. 9 Conformance Testing Serves as a communication between buyer and sellers  Buyers increased confidence  Sellers substantiate claims Bound in scope by the specification  Tests capture the technical requirements within the specification  Internal structure of product-under-test not accessible (black box testing) Note: referred to as conformity assessment in ISO Guide 2

10. 10 Conformance Tests Requirements 100% non conforming ???? conforming Test programs Specification Implementation

11. 11 Medical Device Communications Standard Complex High degree of flexibility in how standard is applied  Information model of a specific device  Use of attributes, value ranges and access  Use of extended (communication services (scanners) scan periods and scanner configurability Implementation Conformance Statement (ICS)  Form of data sheet that discloses details of a specific implementation and specifies which features are provided.  Supplied by the implementor/vendor

12. 12 What is NIST doing for IEEE 1073 Collaboration with IEEE 1073 committee  Developing conformance tests and tools  Developed XML Schema file from ASN.1 definitions  Feedback loop to standard Conformance tests and tools  ValidatePDU – checks messages for syntax, structure and correct data  Library of test files (eventually)  ICS Tool – web-based Facilitates completion, consistency, minimize errors Facilitates manipulation of the information (creates ICS report) Facilitates identifying set of applicable tests

13. 13 Medical Device Tests Medical Device Tests Device Test Suites Device Test Suites ICS Report s ICS Report s Medical Device Testing (Check messages syntax, structure, correct Data) ValidatePDU Tool Vendo r ICS input Vendo r ICS input IEEEMedicalDevices Specs. (DIM-ASN.1)(Schema) ICS Tool XML 05081301001601025689921022000212

14. 14 IHE Medical Devices Project Goal = Interoperability  Use case driven selection of standards with tied-down options  Identify subset(s) being implemented – create profile  Tests and tools to ensure correct implementation IHE includes testing aspect for its projects Potential tools and testing (for profile)  ICS tool to identify the subset of the profile  Test messages, validation tool, ???  Conformance tests (a full test suite is not necessary)  Interoperability tests  Prototypes? Web-based ICS Tool Validate PDU Tool Test messages

15. 15 Contact information Rick Rivello (richard.rivello@nist.gov)richard.rivello@nist.gov 301-975-3519 Sandra Martinez (sandra.martinez@nist.gov) 301-975-3579 Discussion, Questions?

16. 16 ICSMaker

17. 17 0601025689921022000212 Medical Device Testing ValidatePDU Tool Check messages for: - Syntax - Structure - Correct Data IEEE Medical Device Specifications Schema Definitions PDU – Structure DIM – Medical Data ICS Tool - Device specific data - DIMl ICS REPORTS ICS REPORTS Medical Device Tests Medical Device Tests Device Test Suites Device Test Suites XML

18. 18 Enterprise Imaging Center Hospital B Hospital A Emergency Room Physician Patient Admin Repository Cross- Enterprise Document Registry (XDS) Cross- Enterprise Document Registry (XDS) Cross-Enterprise Document Sharing