July 20th, 2011

Los Angeles Times reports:

The Food and Drug Administration has introduced a proposal that would allow it to regulate smartphone and tablet apps that relate to health and medical needs.

The FDA on Tuesday said it would seek “input on its proposed oversight approach for certain mobile applications specific to medicine or healthcare called mobile medical applications (‘apps’) that are designed for use on smartphones and other mobile computing devices.”

The agency said in a statement that its proposed approach “encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.”

“The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery,” said Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, in the statement. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”

For the rest of the story, read the Los Angeles Times


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