FDA hands down guidance on mobile apps

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The Food and Drug Administration has issued final guidance on mobile medical apps.

Mobile apps are taking off in the healthcare sphere. The FDA noted their ability to allow “doctors to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.”

The FDA guidance focuses on mobile medical apps that are intended to be used as an accessory, such as a healthcare specialist looking at a medical image from a picture or communication system on a smartphone or tablet. Additionally, it oversees applications that turn the mobile device into a regulated medical device. The latter may include a smartphone meant to become an ECG machine to detect abnormal heart rhythms, or one that can monitor glucose levels for diabetic patients.

The FDA does not oversee consumer use of apps from distributors such as iTunes, Blackberry's app store, or Google Play. Many senior care vendors have entered the market in this way for activity-related apps, games and cognitive exercises, or ones for fitness monitoring or tracking calories.

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

The agency said it intended to use discretion for apps that help patients self-manage their disease, track health information or document health conditions. Apps that “automate simple tasks” for providers or allow interaction with an electronic health record also fall into this category.

The agency has cleared about 100 mobile medical applications over the past decade. Around 40 of those were cleared since 2011.


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