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FDA Regulations on Mobile Apps and Medical Devices


The proliferation of mobile computing platforms and the applications they run has exploded. There are over 40,000 health related applications on the iTunes store alone, and more to come with the release of Apple’s HealthKit this fall. Health care providers have access to technology that was the stuff of science fiction, and health care consumers can track their own health status and records with the swipe of a finger. On September 25, 2013, the FDA finally made its stand, issuing a Final Guidance on Mobile Medical Applications. FDA has approved to date about 100 mobile medical applications which focus, generally, on chronic condition management.

So when is an iPad no longer an iPad and instead considered a regulated medical device by the FDA? To help member institutions see this important distinction with more clarity, the Association of American Colleges (AAMC) hosted Pepper partner and chair of the firm’s Privacy, Security and Data Protection practice group, Sharon R. Klein, to explore how existing guidelines play into the larger picture of data privacy, patient care, and government regulations.

Watch Ms. Klein’s July 23, 2014 webinar and view additional resources, including webinar slides and previous publications, at