The Wild, Wild West of health apps: Can the FDA restore order without stifling innovation?

January 10, 2012 by MassDevice

The Wild, Wild West of health apps: Can the FDA restore order without stifling innovation?

"Buffalo Bill's Wild West" show poster
(cliff1066-TM/Flickr)

By Elizabeth Phillips 

The Food and Drug Administration's proposed mobile health app guidelines, published in July, are a step in the right direction. But many concerns remain. In taming the Wild West, will the FDA go too far into overregulation? Will the new rules stifle the growing industry of app development by small startups or internal hospital developers? Can we continue innovating in the current state?

Consumers feel the uncertainty too. When considering the use of an app, how do you know whether it's providing correct information?  Where is that information coming from? Is it safe to put your personal information into the app? Who else is accessing your information and where are they sharing it?

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Consumers feel the uncertainty too. When considering the use of an app, how do you know whether it's providing correct information?  Where is that information coming from? Is it safe to put your personal information into the app? Who else is accessing your information and where are they sharing it?

These concerns are reflected in letters of feedback to the FDA's draft guidance (PDF); the public commenting period closed last month. Most feedback was aimed at making sure people are using secure, accurate health apps, without discouraging app development

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