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AMIA advises FDA on clinical decision support
Date:9/14/2011

expert at using technology to access pertinent information, and thereby streamlining healthcare delivery and improving overall health."

The Sept. 12-13 workshop fostered discussion between FDA officials and interested stakeholders about the FDA's proposed oversight approach to mobile medical applications. The applications under discussion are those that serve as accessories to other medical devices, that are stand-alone software that provide clinical decision support, and that are for use on smartphones and other mobile computing devices. Prior to the workshop, the FDA had identified a subset of mobile medical applications that might have impact on the performance of currently regulated medical devices, and as such would require FDA oversight.

In its presentation, AMIA focused on several key areas:

  • The need for the FDA to articulate how it characterizes and defines "CDS".
  • The need to coordinate efforts among federal agencies and public- and private-sector research and practice communities.
  • The potential limitations if FDA focuses too narrowly on CDS, and considers CDS on mobile devices as somehow separate from CDS based on other delivery methods or contexts.
  • The importance of addressing rapidly emerging and converging technologies and devices along with new and evolving forms of patient care delivery (such as medical homes and accountable care organizations) and payment methods.


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Contact: Nancy Light
nlight@amia.org
301-657-5903
American Medical Informatics Association
Source:Eurekalert

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