FDA To Regulate Some Mobile Health Apps

In a move that many medical companies are applauding, the U.S. Food and Drug Administration (FDA) has issued final guidance for developers of mobile medical apps designed to perform the same functions, like diagnosing abnormal heart rhythms, as traditional medical devices. The overarching conclusion: the FDA won't bully medical app developers.

Among other tasks, mobile medical apps currently on the market can transform a smartphone into a mobile ultrasound device, or function as the "central command" for a glucose meter used by a person with insulin-dependent diabetes.

"Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "The FDA's tailored policy protects patients while encouraging innovation."

Focusing on Higher-Risk Apps

The FDA acknowledges that mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.

Because the majority of mobile apps pose minimal risk to consumers, the FDA aims to exercise enforcement discretion -- meaning it will not enforce requirements under the Federal Drug and Cosmetic Act. The agency will instead focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.

Specifically, the FDA will take a closer look at mobile medical apps that are intended to be used as accessories to regulated medical devices, such as applications that allow a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or a mobile tablet.

The agency is also...

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