MD PnP: Getting connected for patient safety (TM)


                                      

FDA Workshop on Medical Device Interoperability
January 25-26-27, 2010
FDA Interop WorkshopContinuaFDACIMIT
The FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
Workshop on Medical Device Interoperability
Co-Sponsored by:
THE CONTINUA HEALTH ALLIANCE
and
THE CENTER FOR INTEGRATION OF MEDICINE & INNOVATIVE TECHNOLOGY (CIMIT)
Medical Device "Plug-and-Play" Interoperability Program (MD PnP)
January 25-26-27, 2010


 Workshop Presentations (slides)
(updated Feb 14, 2010)

   Note - Workshop videos are linked to presentations in final workshop agenda 
   Day 1 - January 25, 2010
  Donna-Bea Tillman, PhD - Director, ODE, FDA/CDRH
Welcome

  Charles Friedman, PhD - ONC for HIT
Device Interoperability and the National HIT Agenda

  Jeff Shuren, MD, JD - Director FDA/CDRH
Safety and Effectiveness Challenges in Interoperability

  Doug Rosendale, DO, FACOS - VHA
Setting the Stage: Device, Local, Regional, and National Perspectives on Medical Device Interoperability


Julian M. Goldman, MD - Partners/CIMIT/MGH
Clinical Perspective on Interoperable Medical Device Systems

  Dave deBronkart
Consumer and Patient Perspective on Innovation and Interoperability in Healthcare

       Session 1: Lessons Learned from Existing Regulatory Practices
  Brad Thompson - Moderator
  Maureen Baker - NHS
  Yi Zhang - FDA (CDRH/OSEL/DESE)
  Mary Brady - FDA (CDRH/OSB)

       Session 2: Enterprise Issues
  Michael Robkin - Moderator - Anakena Solutions
  Douglas Grey, Tom Judd, Tom MacGrane -  Digital Operating Room  - Kaiser

   Tim Gee- Converged Medical Device and Enterprise Network - Medical Connectivity Consulting

   Session 3: Systems-of-Systems Issues
   Julian M. Goldman, MD - moderator
   Frank E. Block, Jr., MD -  Systems of Systems Issues -  - VCU
   Dick Moberg - Using Standard Communications Protocols to Implement Medical Device Plug-and-Play -- Moberg Research Inc.

   George Samaras, PhD -  Wrangling the human element of interoperability - Samaras & Associates, Inc.

       Session 4: Mass Interoperability
  Brad Thompson - Moderator
   Jain Praduman - Mobile Health -- Vignet Inc.
   Brigette Pinewski, MD -  “Tooling” Communities to advance Community Resilience - Peace health Labs
   Mike Paradis - The Do’s and Don’ts of creating an ULP Wireless Network - Dynastream Innovations Inc.

       Session 5: System Level Risk Analysis
   Brian Fitzgerald - Moderator - FDA/CDRH/DESE
   John Zaleski PhD - Multi-parameter data integration to support clinical decision making - Philips Research NA
   Dale Wiggins - FiO2 Control in pre-term infants: a case for device interoperability - Philips Healthcare
   Tracy Rausch - The building blocks of clinical systems - DocBox Inc.
   Peter Kelley - Managing Risk in Systems of Systems - Capsule Technology Inc.
   
   Day 2 - January 26, 2010
   Michael Robkin - President, Anakena Solutions
A Short history of interoperability

   Sandy Weininger, PhD - FDA/CDRH/OSEL
Pieces of the puzzle: Actors in interoperability

   Scott Thiel, MBA, MT, RAC - Roche Diagnostcs
Making it happen: Manufacturers perspectives on interoperability

        Session 6 - Software Issues
   John Denning - Safety and effectiveness issues in electronic medical records
   Luis Melendez - Medical device data patient context challenges - Partners HealthCare

        Session 7 - Integration and Interoperability Issues in a Regulated Environment
   Scott Thiel - moderator
   Renate MacLaren - Interoperability through integration - IMS
   Alasdair MacDonald - Universal interface between medical devices and IT/communication systems - Telemedic Systems
   Dave Arney - Toward a plug-and-play system for medical devices: lessons from case studies - Univ. Penn

        Session 8 - Standards, Interfaces, and Interoperability Issues
   Dave Osborn - Moderator - Philips Medical Systems
   Todd Cooper - Impact of ARRA/HITECH on Device Connectivity: Safe? Effective? Say what?! - Breakthrough Solutions Foundry, Inc.
   Ken Fuchs - Connectivity? Integration? Plug and Play? What is the Interoperability end game? - Draeger Medical Systems, Inc.
   Paul Schluter, PhD -  Semantic Interoperability for Medical Device Data Interchange- GE Healthcare
   John Garguillo - Helping the Cause of Medical Device Interoperability Through Standards-based Test Tools - NIST
   Tracy Rausch - ICE-PAC Approach to Understanding Clinical Requirements - DocBox, Inc.
   
   Breakout Working Session #1, Report back
   Breakout Working Session #2, Report back
   Brad Thompson - low-acuity group issues report back - Epstein, Becker, Green
   
   Wednesday January 27, 2010
   FDA report back
   Terrie Reed - Unique Device Identification (UDI) for interoperability - FDA
   Next steps