FDA Workshop on Interoperability

FDA Workshop on Medical Device Interoperability
January 25-26-27, 2010
FDA White Oak Campus, Silver Spring, MD

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)

The 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) held a public workshop entitled ‘‘Medical Device Interoperability: achieving safety and effectiveness.’’ 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.

We planned 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 postmarket 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” composed of medical devices?
Any other issues relevant to assuring the safety and effectiveness of interoperable medical devices.

There was broad representation from stakeholders both in-person and by web.

Thank you to all who participated!

Participation was invited for submission of interoperability scenarios and for discussion panels. The list of submitted use case presentations is available for download. See below.

Workshop slides have been posted.
The final agenda includes links to online video.

	Final Workshop Agenda (includes links to online video) March 7, 2010
	Call for presentations and presentation submission form
	Registration List
	Summary of submitted use case presentations in Word or PDF
	Federal Register notice
	Background material:
	prior related meetings
	FDA position statement on interoperability
	Preparation/security clearance for non-U.S.A. citizens (please check back for link)
	Steering committee
	Contact the steering committee with additional ideas, feedback, volunteer to help with follow up
	Contact - meeting logistics

Opening Plenary Speakers:

Charles P. Friedman, PhD., Chief Scientific Officer, Office of the National Coordinator for Health Information Technology

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