Healthcare News & Insights

FDA releases rules on mobile health apps

As mobile health apps have become more popular, some tools have appeared that could do more harm than good for patients. But now there’s some good news: The Food and Drug Administration has created guidelines for apps to help keep patients safe. 

mobile health appsMost problematic mobile health apps come in three categories. The first are those that track information about patients and could create privacy risks if that sensitive health data is sent to third parties or isn’t properly safeguarded.

The second group includes bogus apps that claim to do things that they don’t. For example, a Washington Post report from last year found an app that claimed to treat pain using sounds emitting from a smartphone, as well as one that could allegedly cure acne using light. Those and other similar apps have been downloaded thousands of times — often by people who paid for them — and in the worst case scenario, may have been chosen by patients over legitimate forms of care.

The third category contains legitimate apps such as those that track symptoms and help doctors determine treatments. If those malfunction, they could harm patients.

New rules announced

The FDA hopes to avoid those types of problems by regulating mobile health apps, according to a guidance document released by the agency.

According to the document, the FDA will treat mobile apps intended for health-related applications the same way it does any other medical device.  Basically, the rules state that when an application causes a mobile device to perform the functions of a medical device, the application will be regulated the same way as that device. The same goes for apps that are used to control or otherwise interact with an existing device.

For example, an app that uses a smartphone’s sensors to measure movements for patients with sleep apnea will be subject to the same requirements as a standalone device serving that purpose. Likewise, an app that connects to a blood pressure monitor and records that data will be subject to the same regulation as a blood pressure monitor.

So far, the FDA says it has cleared close to 100 of those mobile health apps.

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