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.

Opening Plenary Speakers

  • 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, FDA/CDRH
  • 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 their roles?
  • 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?

A Draft Agenda is available at:


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