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FDA Defines Its Authority Over Mobile Medical Apps

Margaret Dick Tocknell, for HealthLeaders Media, July 20, 2011

The burgeoning mobile medical applications business got a look on Tuesday at how the government plans to regulate some of the industry.

The U.S. Food and Drug Administration's draft guidelines signal that of the thousands of mobile medical apps available today, it will seek to oversee only a small subset of apps – the ones physicians would most likely use to diagnose or monitor a patient's medical condition. These include applications that could impact how a currently regulated medical device (such as ultrasound equipment) performs. Apps that could transform smartphones or tablets into regulated medical devices (such as a blood glucose meter) could also qualify for FDA oversight.

An app that allows a doctor to view a medical image on an iPhone would also fall under the proposed guidelines as would one that turns an iPad into an EKG device to determine if a patient is having a heart attack.

Mobile apps that would not come under the guidelines include applications that would allow a physician to view a medical video or an application that could automate general office operations.

The healthcare community, especially hospitals and physicians, has been waiting for the FDA to reveal its plans to oversee the fast-growing mobile medical apps industry.

"The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health in a 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."

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