FDA Mobile Apps Loophole Hazardous For Healthcare
July 23rd, 2014
Posted by Stephanie Kreml, M.D.
This post is originally published on InformationWeek Healthcare, July 23, 2014
THE FDA’S RELUCTANCE TO OVER-REGULATE MEDICAL APPS OPENS A PITFALL FOR HEALTHCARE ORGANIZATIONS THAT INNOVATE TOO FAR AHEAD OF THE CURVE.
The FDA’s recent guidance on mobile medical apps creates a gray area in which the agency will not automatically require approval for all new mobile medical apps, but may exercise “enforcement discretion,” depending on how the app functions, the risks it introduces to patients/consumers, and its intended use.
Read full post on InformationWeek Healthcare.
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