The FDA's Hazardous Plan to Regulate Mobile Medical Apps

One of the few bright spots in the current economy is sales of smartphones, tablet computers, and e-readers.  Led by three U.S. companies -- Apple, Google (Android), and Amazon -- the worldwide market for these gadgets is expected to reach $190 billion this year.  Driving much of the growth is a rapidly expanding universe of "apps" that offer exciting new capabilities such as helping patients manage their diabetes and letting physicians pull up CT scans from any location. Now the U.S. Food and Drug Administration wants to apply the brakes to this growth market.  The FDA released draft guidelines for regulating mobile medical applications on July 19, 2011 and is giving the public ninety days to comment.  If the FDA goes through with its plan, it could undermine the very things that make mobile medical apps so attractive to small developers: low entry cost and quick time-to-market. The FDA portrays this attempt to expand its fiefdom as uncontroversial.  The...(Read Full Article)

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