Monday, September 23, 2013
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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