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1 year ago
Some Health Apps Will Now Be Regulated by the FDA

There are apps to help you sleep better, lose weight, and eat better—and there's even one called STD Triage that encourages you to snap a picture of any funky below-the-belt situations so a medical professional can offer advice about it. But just because there's an app for that doesn't mean you should download it: Yesterday, the FDA introduced new guidance for developers of mobile applications that perform functions similar to traditional medical devices.

So while most health- and wellness-related apps will continue to be unregulated, a small subset that  have the potential to seriously screw with your health if they malfunction—think glucose monitors for insulin-dependent diabetics—will now undergo FDA review and will be assessed using the same standards used for other medical devices.

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

The FDA has stated that it plans to focus on regulating apps that:

  • -are designed to be used with a regulated medical device (this would include apps that let health care professionals make a specific diagnosis by viewing a medical image from a picture archiving and communication system)
  • -are designed to turn a mobile device into a medical device that would normally be regulated (this would include an app that transforms your phone into an electrocardiography machine to detect abnormal heart rhythms)


This is especially encouraging since the Journal of the American Medical Association of Dermatology recently published a disconcerting study that looked at smartphone apps designed to diagnose skin cancer based off of pictures taken by users. Alarmingly, researchers found that three out of the four smartphone apps studied labeled more than 30 percent of melanomas as “unconcerning."

Of course, most health apps don't come with such dire consequences if they malfunction (a calorie counter that's slightly off isn't going to cause anyone serious harm)—which is why the FDA will be reviewing only a relatively small number of the health apps out there. But it's still not totally clear which apps fall into the "must be reviewed" category (is a picture you snap of your mole considered a "medical image" in a "picture archiving and communication system," for example?). So you should continue to use these tips to make sure any health apps you're eyeing are safe to use before you download them.  

photo: Syda Productions/Shutterstock.com

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