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Mobile Medical Apps and Product Liability

By Beth S. Rose
February 29, 2016

What types of applications do you have on your smartphone? Besides the usual ' Facebook, Twitter, Google and Instagram, chances are that you have a health-related app as well. Think Fitbit (counting steps per day), MyFitnessPal (tracking calories and exercise) or Hello Heart (monitoring blood pressure). Perhaps you know someone with diabetes who uses an app to remotely monitor glucose data. We routinely obtain these apps “free” or at minimal cost from the App Store.

News flash: The Food and Drug Administration (FDA) considers some of these apps to be medical devices subject to agency regulation and oversight. Indeed, earlier this year, the FDA published its final guidance document that explains when it considers mobile apps to be mobile medical applications (MMA) and thus, medical devices subject to regulation. This article examines the FDA's current approach to MMAs and explores the potential implications for product liability litigation if they malfunction.

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