Clipboard: Should the FDA have a say in development of health care apps?

Posted: July 11, 2012 at 10:19 pm


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By Chelsea Conaboy, Globe Staff

While writing about health and fitness mobile apps in February, I heard this question from some clinicians who had begun using the programs with patients: When does an app become a medical device? Rob Stein of National Public Radio reported yesterday that the Food and Drug Administration has posed the same question.

Stein asked it of Dr. Joseph Kvedar, director of the Partners HealthCare Center for Connected Health, in a story published yesterday. He writes:

After all, were 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 dermato logist by training. It just seems a little scary right now to have software making decisions about moles.

Stein reports that the Food and Drug Administration is considering regulating some apps, though not those that simply track health and lifestyle, helping you to keep count of calories or log miles run.

There are apps today that change a mobile platform into an EKG machine, Dr. Jeffrey Shuren, who leads the agencys center for devices, told Stein. When its being used to diagnose patients, its a medical device we believe subject to FDA oversight.

Such statements are getting pushback from app-makers who say the oversight could stall development.

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Clipboard: Should the FDA have a say in development of health care apps?

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July 11th, 2012 at 10:19 pm

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