Intended for healthcare professionals

Observations Yankee Doodling

Regulating medical apps: which ones and how much?

BMJ 2013; 347 doi: (Published 08 October 2013) Cite this as: BMJ 2013;347:f6009
  1. Douglas Kamerow, chief scientist, RTI International, and associate editor, BMJ
  1. dkamerow{at}

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.1

For example, you can now buy an AliveCor device for $199 that slips over your iPhone and records and transmits a one channel electrocardiogram with its app. For …

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