When Does An App Need FDA’s Blessing?

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Some [apps] measure blood pressure and blood sugar and send the readings off to the doctor.

“Mobile technology is a true game changer for health care,” says Dr. Joseph C. Kvedar, founder of the Center for Connected Health in Boston. “It enables us to use that tiny computer in your hand to connect with you at any moment when we need to.”

But does somebody need to check these things to make sure they work?

After all, we’re not talking about apps that help you find a good restaurant or calculate your mortgage. These apps sometimes help make important decisions — sometimes life-and-death decisions.

“The ones that worry me are ones for instance where you can take an image of a skin lesion and then map it back to a database in the cloud and be told whether it should be evaluated for a melanoma or not,” says Kvedar, a dermatologist by training. “It just seems a little scary right how to have software making decisions about moles.”

Others calculate how much blood thinner to give heart attack patients, interpret blood tests in the emergency room — even help read X-rays, ultrasounds and CT scans.

As a result, the Food and Drug Administration has concluded that at least some apps should undergo review by the agency before being permitted on the market. “There are many mobile apps that are on the market that are medical devices,” Dr. Jeffrey Shuren, who heads the FDA’s Center for Devices and Radiological Health. “There are apps today that change a mobile platform into an EKG machine. When it’s being used to diagnose patients, it’s a medical device we believe subject to FDA oversight.”

But Shuren stresses that the FDA has no plans to review most apps, such as those that help with wellness, healthier lifestyles. Same goes for thoseused to help patients manage their medical conditions. “The risk to patients are very, very low,” he says.

by ROB STEIN at National Public Radio (NPR)

http://www.npr.org/blogs/health/2012/07/10/155977692/when-does-an-app-need-fdas-blessing?ft=1&f=1128&sc=tw

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