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Medical apps get the once over from the FDA

The Breathometer (pictured above) is a smartphone attachment that lets you measure your own breath alcohol level.

App developers and entrepreneurs are quickly turning our smart phones and tablets into medical devices. There are apps that act as stethoscopes, control the delivery of insulin, and allow doctors to view x-rays on their own smartphones.

Some of the mobile apps have become so sophisticated they actually require FDA approval. And that’s been a surprise to some developers like Charles Yim. Yim has created Breathometer, an app that converts your smartphone into a breathalyzer. For $20 bucks you get a sensor that plugs into the phone and, voila!

“In seconds you can actually get your breath alcohol concentration level. From there you can decide whether you are fit to drive,” he says.

Yim didn’t find out Breathometer needed FDA approval until he submitted the app to Apple. He isn’t the only developer caught off guard. The mobile medical app market is exploding. Earlier this month the research and consulting firm research2guidance projected the global market will reach $26 billion by 2017.

As the ranks of developers swell, attorney Areta Kupchyk,who represents Breathometer, says the FDA is establishing clearer guidelines for approval.

“Where you are turning the smartphone, actually into a medical device," says Kupchyk. "So one example is if your smartphone now has an app that can measure your heart beat by putting your finger on the screen, and then that gets transmitted to a physician."

The FDA says most mobile medical apps won’t need approval. But those like Yim’s Breathometer or an app that controls the delivery of insulin will because users depend on their accuracy.

“You have now added on a large amount of costs and time to get your app to market,” says Alex Moazed, president of Applico, a firm that develops apps and provides mobile strategies.

Costs for lawyer’s fees and testing can run into the hundreds of thousands. The extra time could be up to a year or more. Some in the industry say the red tape is stifling. And attorney Gerry Hinkley says the process may discourage some developers.

“I mean you go off and develop a killer game instead of something that is going to cure cancer,” says Hinkley.

But he says with the potential payoff, most developers will happily keep finding ways to turn a phone into something out of science fiction.

 

About the author

Dan Gorenstein is the senior reporter for Marketplace’s Health Desk. You can follow him on Twitter @dmgorenstein.

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