FDA Releases Draft Of Mobile Health App Guidelines

| July 21, 2011

The Washington Post (7/19, Overly) in its Capital Business column reported that the Food and Drug Administration has "proposed its first-ever regulations of the burgeoning mobile health industry" Tuesday, concentrating on a "segment of applications that officials described as being akin to medical devices." FDA policy adviser Bakul Patel, who helped develop the guidelines, "said the agency sought to balance the potential for innovation with patient safety in the rapidly changing mobile space." The guidelines suggest "three types of applications should require the FDA's sign off: a mobile application that acts as an accessory to a regulated medical device, turns a mobile gadget into such a device or makes suggestions regarding a patient's diagnosis or treatment."



Category: Pathology News

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