1. Software and Systems Division IHE/PCD Face-to-face meeting April 2012 Semantic Interoperability of Medical Devices Pervasive Computing Program Medical Device Communication Test Project Overview Rosetta Terminology Mapping Management System (RTMMS)

2. Software and Systems Division NIST Contacts and Web Sites John J. Garguilo 301-975-4248 john.garguilo@nist.gov john.garguilo@nist.gov Sandra Martinez 301-975-3579 sandra.martinez@nist.gov sandra.martinez@nist.gov Nicolas Crouzier(Guest Researcher) Project Web site: www.nist.gov/medicaldevices www.nist.gov/medicaldevices RTMMS Web Site: http://hit-testing.nist.gov:13110/rtmms Semantic Interoperability of Medical Devices 2

3. Software and Systems Division Content Topics Connectathon 2012 – Issues Discovered RTMMS deployment status –Test version vs. beta version –User Membership Protocol Rosetta Terminology Mapping Management System (RTMMS) Overview RTMMS demo RTMMS & ICSGenerator - IHE-PCD V&V Testing 3

4. Software and Systems Division 2012 Connectathon Testing issues ACK MSH requirements are not clear in Vol. II –There is not usage requirement for ACK MSH-15 and MSH-16; we set it as optional in our test tool. OBX-6: LEN is now 705, but what about the length of each of the components? The tool will temporarily set it as unlimited. PID-18.4 cardinality [1..1] and usage RE are in conflict. R42 for IPEC is not in an HL7 table 4

5. Software and Systems Division RTMSS - Deployment Status Beta-Test version was made available on 13 January, 2012 –any data/change was not committed (i.e., discarded) Beta version of RTMMS has been available for ~2 months to a select few (~15) individuals of varying roles (e.g., vendor, SDO, Admin) –NIST received feedback on functionality, capability, usability, and interface and subsequently updated the on-line RTMMS NIST continues to work out IEEE membership issues w/ IEEE –Full presentation and proposal made to IEEE by NIST in Dec 2011 –Presentation and Q&A session with IEEE systems people –Kathryn Bennett (IEEE) is to respond with IEEEs position/approval/rejection on the membership reconciliation protocol (procedure) NIST proposed – IEEE had board meeting 2 April 2012 – waiting on feedback 5

6. Software and Systems Division RTMSS - Deployment Plan – Going Forward RTMMS goes live on 1 May 2012 –http://hit-testing.nist.gov:13110/rtmms/http://hit-testing.nist.gov:13110/rtmms/ RTMMS becomes the master version going forward RTMMS will be available to IHE-PCD members (but only if IEEE members) and select others. –If interested in obtaining an RTMMS system id and password Go to Web Applications (URL below) and request and account http://hit-testing.nist.gov:13110/rtmms/ –NIST will perform the appropriate background checks Initially there may be a 1-5 business day turn-around If approved (vetted with IEEE) - NIST will provide a corresponding email with approved account information. 6

7. Software and Systems Division RTMSS - Deployment Plan (continued) NIST will in parallel evaluate ISO/IEEE 11073 SDO Database –Created, owned, and (currently) only used by Jan Wittenber (Philips Healthcare) as IEEE x73 Upper Layer Chair SDO dB used to move x73-10101 to V2 is Spring 2012 –NIST/x73 Co-chairs working on a procedure to integrate RTMMS data with Jan Ws/x73 SDO dB and enable normative additions to the standard vetted through the x73 ballot process. 7

8. Software and Systems Division IHE-PCD Profile: RTM Overview (Rosetta Terminology Mapping) RTM is an IHE-PCD Constrained Value Set that addresses the problem of medical device semantic interoperability by proposing a mapping to a standard nomenclature –Identifies the core set of semantics appropriate for medical devices –Maps vendors terminology to standard terminology –Maps associated information to terminology: e.g., numeric parameters to their associated units-of- measure and enumerated values ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFra meworkforTrialImplementation/IHE_PCD_TF_Suppl ement_Rosetta_Terminology_Mapping_RTM_TI_20 08-08-22.pdf 8

9. Software and Systems Division RTMMS Overview (RTM Management System) A web application* that allows vendors and reviewers access, retrieval, and reporting of Rosetta Tables over the internet in conformance to IHE-PCD RTM Profile An electronic resource/tool providing the capability of saving data in xml format (as defined by RTM Profile) Aids the harmonization process by: –Identifying missing terms –Automatic generation of the Harmonized Rosetta Table –Providing latest up-to-date view of hRTM table Facilitates the proposal of New Terms to IEEE 11073 Nomenclature standard Facilitates Conformance Tooling –Message verification and conformance (syntax and semantics) –Leading to interoperability… *developed by and currently hosted at NIST 9

10. Software and Systems Division Rosetta Terminology Mapping Data Base Rosetta Table –Maps vendor supported observations, units and enumerations to ISO/IEEE x73 nomenclature Units Table –Defines allowed units-of-measure –Defines groups of related units-of-measure Enumerations Table –Defines groups of enumerated values hRTM Table –Generated from the original Rosetta X73 Nomenclature DB Security DB - Stores users information RTMMS Key Tables

11. Software and Systems Division Access to NIST IEEE 11073 Nomenclature database –Appendix A terms (from ISO/IEEE 11073 10101: Nomenclature) –Appendix B terms (from ISO/IEEE 11073 10101: Nomenclature) –IDCO terms (ISO/IEEE 11073-10301 – implantable device cardiac) –aECG (annotated Electrocardiography) –PHD terms (personal health domain) Access to RTM database Ability to proposed terms in Rosetta hRTM, units and enumeration download-able in XML format User registration –Email confirmation, approval process… controlled through admin Filtering based on regular expressions Rosetta validation against hRTM Management capabilities for SDO users RTMMS Features

12. Software and Systems Division RTMMS Users General user –Views Rosetta Tables Reviewer –Participates in discussions Vendor –Vendor sandbox –Modifies Vendor Rosetta Table –Suggests new terms –Modifies Units and Enumerations Table –User type also used for working groups SDO (Standard Development Organization) –Modifies Units and Enumerations Table –Register new terms Admin –Manages User Accounts

13. Software and Systems Division Issues / Key Work Items Synching membership from IEEE to NIST Long-term – who owns and maintains RTMMS IEEE copyright issues –Against NIST Policy to maintain proprietary data –Displaying of copyrighted information… Maintenance issues… Hosting/Server issues… Access control issues… Integration of SNOMED-CT Terms –Expertise needed – mappings provide equivalence between SNOMED CT/x73 (e.g., Norman Jones IHTSDO) Integration of LOINC Terms –Mapping must be provided by exerts (e.g., Clem McDonald – NLM)

14. Software and Systems Division RTMMS Updates Vendors can now propose units and enumerations Fixed interface glitches found during testing period Rosetta terms can now have multiple groups Mouse-over help on table headers Improved PDF reports for x73 Wrapped text in x73 tables Global search in x73 tab SDOs can now create/propose a Rosetta term Improved new account request process RTMMS is now compatible with IE7, although it works best with Firefox, Chrome or Safari Updated users guide

15. Software and Systems Division RTMMS Functionality Demo Viewing the RTM Tables (all user types) Mapping X73 and UCUM units (SDO) Mapping a Term (Vendor and SDO) Proposing new terms (Vendor and SDO) Term Review (SDO, Vendors and Reviewers) Term approval (SDO) http://www.youtube.com/watch?v=rP_Tsb6wl F8&hd=1

16. Software and Systems Division Viewing the RTM Tables/ Rosetta Table

17. Software and Systems Division Viewing the RTM Tables/ Units Table

18. Software and Systems Division Viewing the RTM Tables/ Enumeration Table

19. Software and Systems Division Mapping X73 and UCUM units (Vendor and SDO)

20. Software and Systems Division Mapping X73 and UCUM units (Vendor and SDO)

21. Software and Systems Division Mapping X73 and UCUM units Creating a new UOM MDC

22. Software and Systems Division Mapping X73 and UCUM units Searching for existent UOM MDC

23. Software and Systems Division Mapping X73 and UCUM units (Vendor and SDO)

24. Software and Systems Division Mapping a Term (Vendor and SDO)

25. Software and Systems Division Mapping a Term (Vendor and SDO) Drug Delivery Rate mapping

26. Software and Systems Division Mapping a Term (Vendor and SDO) Drug Delivery Rate mapping

27. Software and Systems Division Mapping a Term (Vendor and SDO) Drug Delivery Rate mapping

28. Software and Systems Division Mapping a Term (Vendor and SDO) Drug Delivery Rate mapping

29. Software and Systems Division Mapping a Term (Vendor and SDO) Drug Delivery Rate mapping

30. Software and Systems Division Mapping a Term (Vendor and SDO) Drug Delivery Rate mapping

31. Software and Systems Division Mapping a Term (Vendor and SDO) Drug Delivery Rate mapping

32. Software and Systems Division Proposing new terms (Vendor and SDO) MDCX_RESP_RATE_SPNT

33. Software and Systems Division Proposing new terms (Vendor and SDO) MDCX_RESP_RATE_SPNT

34. Software and Systems Division Term Review (SDO, Vendors and Reviewers)

35. Software and Systems Division Term Review (SDO, Vendors and Reviewers) General Discussion

36. Software and Systems Division Term Review (SDO, Vendors and Reviewers) Filtering/searching

37. Software and Systems Division Term Approval process (SDO) Approving new proposed terms

38. Software and Systems Division Term Approval process (SDO)Approving new proposed terms

39. Software and Systems Division Term Approval process (SDO) Registering a new proposed terms

40. Software and Systems Division Term Approval process (SDO) Approving mapped terms

41. Software and Systems Division Term Approval process (SDO) Approving mapped terms

42. Software and Systems Division Term Approval process (SDO) Approving mapped terms

43. Software and Systems Division ICSGenerator Overview Model Devices in compliance with the X73 DIM, capturing; –object relationship (containment) –object attributes, behavior and notifications –Objects and parameters term codes from hRTM and X73 Nomenclature –Device profile generated in XML in compliance to the DIM schema Generates Implementation Conformance Statements (device supported features) in a tabular and XML format. –General ICS –Service Support ICS –Transport ICS –DIM MOC ICS –MOC Attribute ICS –MOC Behavior ICS –MOC Notification ICS Uses an embedded DIM database originated from the DIM Schema Provides access to IEEE 11073 nomenclature, hRTM and Rosetta (proposed terms) Generates a PDF file that includes only object containment and parameters. Generates simplied vesion of the device profile (xml)

44. Software and Systems Division ICSGenerator Status Object cardinality support Access to RTMMS Rosetta proposed terms –Connecting to NIST RTMMS web service Automatic generation of device profile in PDF format. compound numeric support. Dbase lookup (X73 nomenclature, DIM and hRTM)

45. Software and Systems Division RTMMS & ICSGenerator - IHE-PCD V&V Testing

46. Software and Systems Division PCD-01 Infusion Pump - Vol2 (Annex D) Access to MDDbase(x73, hRTM and Rosetta)

47. Software and Systems Division ICSGenerator XML Profile content ICSGenerator XML PCD-01 Infusion Pump Profile The ICSGenerator profile contains: –All the objects involved –object attributes –Behavior and Notifications –Object term codes –Containment – Units and enumerations

48. Software and Systems Division PDF generated from the Infusion Pump Device profile

49. Software and Systems Division MD Semantic Dbase Look-up

50. Software and Systems Division Physiological Monitor – Compound Numeric MDC_DIM_CM_H2O, unit used in Vol3 is not in hRTM