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Medical apps face new FDA regulation

The FDA currently regulates medical devices. But what happens if that medical device is your smartphone?

So far, the nearly 100,000 mobile healthcare apps on the market have sat in a regulatory gray zone. But this week, the FDA announced its final decision on which kinds of apps it will monitor.

The FDA is going to regulate programs that do things like EKG measurements, or monitoring your insulin levels. Lauren Fifield is a Senior Health Policy Advisor at Practice Fusion. And for her, the FDA's definition of which apps get regulated was refreshingly straightforward.

“If it acts like a duck, if it walks like a duck, if it quacks like a duck, then it probably is a duck,” she says. "If it acts like a medical device, then it should probably be treated like a medical device.”

Producers of apps that do non-invasive things, like remind you to take your pills or count your calories, can now move forward without having to worry about FDA regulations. Fifield and others say this clarification is good for the industry.

“In terms of lightweight information management tools,” says healthcare and tech investor Esther Dyson, “I think it's going to be marvelous.”

Dyson imagines it won't be long until apps can do noninvasive blood sugar tests -- not for medical purposes, but just for the patient's own understanding.

“Just to see the impact of eating the doughnut versus eating cottage cheese with strawberries,” she says, “can be tremendously helpful to people trying to figure out how their bodies work and how to treat them better.”

Laurence Baker is an economist at Stanford. He says even the companies that face FDA regulations should be relieved. At least now the expectations are clear.

“A lot of folks,” he says, “who have been sitting there saying, 'Well, we're not sure so we'll wait a little longer,' they get some clarity and they can make their plans and move forward.”

Baker says the push for new medical apps is only going to grow in the coming years.

About the author

Audrey Quinn is a reporter in New York City.

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