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Change Expectations > Change Technology > Change Healthcare The Medical Device "Plug-and-Play" (MD PnP) Interoperability Program is promoting innovation in patient safety and clinical care by leading the adoption of secure patient-centric integration of medical devices and IT systems in clinical environments. |
FDA Workshop Slides
| QUICK LINKS > FDA > Continua > CIMIT > MD PnP White Paper > ICE Standard (ASTM 2761) > MD FIRE Document ............................................ CONTACT INFORMATION MD PnP Program 65 Landsdowne St., Suite 200 Cambridge, MA 02139 info@mdpnp.org Julian M. Goldman, MD Program Director jgoldman@mdpnp.org Drayton Freeman Program Assistant dwfreeman@mgh.harvard.edu |
The FDA (CDRH) Workshop on
Medical Device Interoperability: achieving safety and effectiveness
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 25-27, 2010
Workshop Presentations (slides)
(Updated Feb 14, 2010)
Note: Workshop videos are linked to presentations in the 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
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