1. IHE Patient Care Device Domain Connectathon/Showcase WG Kick Off Meeting July 30, 2009 © 2009 ACCE, HIMSS, IHE Version 1.2 20090723

2. WG Introduction Introductions –Excel participation spreadsheet –Companies must be IHE members Review of WG purpose - collaboration, cooperation, facilitation WG documentation - Wiki page(s) for minutes, action items, Scenario –http://wiki.ihe.net/index.php?title=PCD_Connec tathon%26Showcase_WG_2009-10

3. Structure Main WG page with links to individual meetings, testing overviews, showcase preparation –Master Action Item list Summary of preparation process –Select profiles to implement –Test –Demonstrate Development of a calendar –IHE Webinars instead of F2F

4. Testing Connectathon –Required for entry to a Showcase Showcase is optional Pre-Connectathon, Virtual Connectathon, Connectathon testing Brief description of the MWB, NIST Validation Tools and uses

5. VA’s MWB Messaging Workbench is developed by Peter Rontey. Useful as a development tool as well as test tool. PCD Pre-Connectathon testing relies upon the MWB. –Sample messages available. –May be used in Virtual Connectathon testing.

6. Validation Tools NIST’s Involvement… Collaborations –Integrating Health Enterprise - Patient Care Devices (IHE-PCD) –IEEE 11073 Personal Health Devices (PHD) Working Group (WG) –ISO/IEEE 11073 WG (Healthcare Devices SIG) MDC Standards development –ISO/IEEE 11073 (X73) Point-of-care Medical Device Communication (MDC) –NIST developed X73 electronic information model –Work with SDOs (testing perspective), clinicians, clinical engineers Device Communication Test ToolingDevice Communication Test Tooling –Rosetta Terminology Mapping (RTM) Management System –XML Schema of the ISO/IEEE 11073 Domain Information Model –ICSGenerator Tool Produces standard-compliant device profiles and specializationsProduces standard-compliant device profiles and specializations Generates Implementation Conformance StatementsGenerates Implementation Conformance Statements –ValidatePDU Tool Provides X73 message syntax and semantic validationProvides X73 message syntax and semantic validation –Java Class Library (of standard’s syntax notation) Implementable-code of abstract types defined in standardImplementable-code of abstract types defined in standard Coder (encodes and decodes APDUs)Coder (encodes and decodes APDUs) –HL7 V2 Validation Tools - http://hl7v2tools.nist.gov http://www.nist.gov/medicaldeviceshttp://www.nist.gov/medicaldevices, http://www.nist.gov/medicaldevices IHE has an MOU with Continua.

7. NIST’s Validation Tools Types of Testing Instance System Testing (‘09-’10 cycle) –Virtual- and Pre-connectathon type –(Message Validation) – Validating message compliance to HL7 –(RTM Testing) – HL7 message compliance to RTM/Terminology and Semantics Isolated System Testing (‘09-’10 cycle) –Virtual- and Pre-connectathon type –Application functional behavior HL7 Message Syntax Validation RTM/Terminology (including co-constraints) Functional behavior testing Peer-to-peer Testing ( ‘10-’11 cycle) –Connectathon type

8. Resources Availability of last year's tests, samples and MWB efforts –ftp://ftp.ihe.net/Patient_Care_Devices/ConnectathonsIncl udingProcessAndTesting/Yr3-2009/ Technical Framework and Other Trial Implementation Versions (last year’s) –ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFramewo rkforTrialImplementation/ Supplements (for New Directions) –TBD

9. Profile – CT – Consistent Time ITI-01 Required

10. Profile – RTM – Rosetta Terminology Mapping RTM compliance –Required for physical observations whose REFID identifier (OBX-3) matches a Rosetta row: the units-of-measure (OBX-6, if used), enumerated values (OBX-5, if used) and/or external measurement sites (OBX-20, if used) must match those specified for the same row. –If a REFID in OBX-3 is not in the Rosetta, then a warning will be noted. This allows vendors to use unofficial MDC REFIDs on an interim basis. Testing with NIST Validation Test Tools

11. Profile – DEC – Device Enterprise Communication A fundamental PCD profile PCD-01 –Device Observation Reporter (DOR) to –Device Observation Consumer (DOC) PCD-02 Subscribe to Patient Data (SPD) Option –DOC to Device Observation Filter (DOF) Patient Identification Binding

12. Profile – ACM – Alarm Communication Management Alarm Communication Management enables the remote communication of point-of-care medical device alarm conditions ensuring the right alarm with the right priority to the right individuals with the right content (e.g., evidentiary data). Alarms/alerts for physiologic and non- physiologic (device) data. Actors: AR, AM, AC, AA

13. Profile – PIV – Point of Care Infusion Verification Supports the electronic transfer of infusion parameters from a Bedside Computer-assisted Medication Administration (BCMA) system to a general-purpose infusion pump. This capability will reduce errors by eliminating keystroke errors and by increasing the use of automatic dosage checking facilitated by the onboard drug libraries in “smart pump” systems. In addition to the reduction of medication administration errors, this integration may also increase caregiver productivity and provide more contextual information regarding infusion data. Uses PCD-03 (Communicate Infusion Order) transaction. Updated Trial Implementation version (v2.0) will be available for public comment in early August and published in early September. Full clinical workflow for BCMA should also support PCD- 01 in order to obtain pump status once the pump is started.

14. Profile – IDCO – Implantable Device Cardiac Observation Specifies the creation, transmission, and processing of discrete data elements and report attachments associated with cardiac device interrogations (observations) or messages. Actors: DOR, DOC

15. Profile – MEM – Medical Equipment Management Current year: White Paper –For public comment in July –Use cases and scenarios –Examines the data elements required and current standards –Roadmap Next year: –Battery Management –Configuration Management –Location Boundary Alarm HIMSS 2010 Showcase: –New Directions for Battery Management, Configuration Management and Location Boundary Alarm

16. Profile – WCM – Waveform Communication Management Will extend the DEC profile to provide a method for passing near real-time waveform data using HL7 v2 observation messages. TI version will be available in 2010. New Directions may be demonstrated at HIMSS10.

17. Profile – DPI – Device Point-of- Care Integration Brings focus on device connectivity around a patient-centric point-of-care, including "first link" interfaces between devices or a device manager / supervisor system. This activity includes initial development of a white paper, followed by a number of proposed profiles such as: discovery and association, data reporting, symmetric (bi-directional) communication, and external control.

18. Showcase Intro to Showcase Process –Connectathon tests for admission –Development of a Clinical Scenario(s) –Allocation of functions among companies, systems –Potential integration with other domains –Design of structure –Rehearse, provide demonstration

19. 2009 Showcase

20. Showcase Likelihood that PCD will have multiple tours – more participants Developing Scenario(s) Last year's experience, lessons learned Coordination between technical and marketing folk

21. To Do Orientation, mentoring of those new to the process Orientations to –RTM –MWB –NIST Validation Tools Coordination between technical and marketing folk Develop regular meeting dates Recruit vendors

22. IHE PCD Contacts Profiles ACM Monroe Pattillo monroe.pattillo@philips.com ACM John Rhoads john.rhoads@philips.com DEC Todd Cooper t.cooper@ieee.org DPI Todd Cooper t.cooper@ieee.org IDCO Tom Schultz thomas.w.schultz@medtronic.com IDCO Nick Steblay nicholas.steblay@bsci.com MEM Steve Merritt steve.merritt@bhs.org PIV Jeff Rinda Jeffrey.Rinda@hospira.com RTM Paul Schluter Paul.Schluter@med.ge.com WCM Ken Fuchs ken.fuchs@draeger.com PCD Technical Project Manager Manny Furstefurst@imp-tech.com Manny Furstefurst@imp-tech.com