Continua/ FDA/ CMIT workshop on medical device interoperability
14 January 2010
The US Food and Drug Administration (FDA), Center for Devices
and Radiological Health, in co-sponsorship with Continua Health Alliance
and the Center for Integration of Medicine & Innovative Technology
(CIMIT) is organising a public workshop entitled Workshop on Medical
Device Interoperability: Achieving Safety and Effectiveness on
25-26 January 2010.
The workshop will be held at the FDA White Oak Campus, 10903 New
Hampshire Ave., Silver Spring, MD 20993, USA.
The purpose of the workshop is to facilitate discussion among FDA,
industry, academia, professional societies, clinical investigators and
other interested parties on issues related to safe and effective
interoperable medical devices.
- Charles P. Friedman, PhD., Deputy National Coordinator for
Health Information Technology, Office of the Secretary for Health
and Human Services
- Jeffrey Shuren, MD, JD, Acting Director, FDA/CDRH
- Donna-Bea Tillman, PhD, Director, Office of Device Evaluation,
- Doug Rosendale, D.O. F.A.C.O.S, Veterans Health Administration,
Office of Health Information, Joint Interoperability Ventures
The purpose of this workshop is to discuss a large number of issues at
the workshop, including, but not limited to:
- What are the types of clinical scenarios that would make use of
medical device interoperability?
- What are the issues associated with premarket and post-market
studies for interoperable medical devices?
- What tools (e.g. standards, guidances) are in place or need to
be developed to assure safety and effectiveness of interoperable
medical device systems; what issues should they address?
- What organizations are in place to assure safety and
effectiveness of interoperable medical device systems and what are
- What are the risks associated with medical device
interoperability and “systems of systems” composing medical devices?
- What are other issues relevant to assuring the safety and
effectiveness of interoperable medical devices?
Draft Agenda is available at: