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The U.S. Food and Drug Administration is laying the groundwork for oversight of mobile applications that are focused on medicines or health care.
The FDA said this morning that it is seeking input on its proposed oversight approach for mobile medical apps. The agency emphasized that it will not regulate all apps or devices, only those that are specific to medicine or health care.
The agency noted that the mobile medical apps include functions such as monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device. In a press release, the agency cited market research showing that 500 million smartphone users worldwide will be using a health-care application by 2015. The FDA invited comments at a government website. Comments can be submitted within 90 days. The draft guidance is available on an FDA site.
“The use of mobile medical apps on smart phones and tablets is revolutionizing health-care delivery,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. “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.”
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