• Article

Regulating medical apps: Which ones and how much?

The FDA has issued sensible guidance

Close to 100?000 health related apps for smartphones are now available on the two major mobile device software platforms, Apple’s iOS and Google’s Android. Medical apps have generated more than three million US downloads on iOS alone.1 By 2015 an estimated 500 million smartphone users worldwide will use some type of medical app,2 and the global market for mobile health apps may reach $26bn (£16bn; €19bn) by 2017.1

Early apps related to health were designed simply to track exercise or weight loss or to provide instruction on diet or smoking cessation. More recently, though, designers have begun linking smartphones’ computing and display power with custom designed hardware to create functioning portable medical devices. Around 15% of these apps are designed for healthcare professionals, but most are being marketed to patients to gather, track, analyze, and transmit medical data.


Kamerow, D. (2013). Regulating medical apps: Which ones and how much? BMJ (Clinical research ed.), 347, f6009. https://doi.org/10.1136/bmj.f6009

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