Monday, September 23, 2013

FDA Releases Final Guidance for Mobile Health Applications

 

 

Monday, September 23, 2013

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On Monday, FDA issued final guidance for mobile health applications, Reuters reports (Clarke, Reuters, 9/23).

Background

In 2011, FDA requested public comment on how it should regulate smartphones, tablet computers and apps that collect health information or are used to monitor medical conditions (iHealthBeat, 6/26).

According to FDA, the agency has approved about 100 mobile medical apps over the last decade, about 40 of which have received clearance over the past two years (Dolan, MobiHealthNews, 9/23).

Details of Final Rule

According to the final rule, FDA will focus oversight on apps that:

  • Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or
  • Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine.

Note:  Information is curated from iHealthBeat, a publication of the California Health  Care Foundation (CHCF

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