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FDA Lays Out Rules For Some Smartphone Health Apps

Update Date: Sep 25, 2013 08:36 AM EDT

The U.S. Food and Drug Administration issued a guidance for developers of medical mobile applications to regulate its functioning on smartphones. These mobile medical applications range from counting the calories burnt throughout the day to the heart rate monitors through your smartphone.

With the gradual rise of smartphones ranging from iPhones to several android devices, there came flood of medical applications to run on them. According to the Industry analysts, there are already 17,000 medical application available on various mobile platforms.

The FDA said that it wont target each and every medical application. As they posed lesser threat incase of malfunctioning. Instead the agency is going to regulate some handful of applications that turn smartphones into the devices.

“Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it,” said Dr. Jeffrey Shuren, director of the FDA’s medical device center.

Most health related apps are freely available to download and they perform some very basic functions. But few companies are developing applications and attachments which tends to do more serious tasks. Like the recent M7 chip in the iPhone 5S.

According to the FDA officials they have already approved 100 of the "mobile medical applications.

Last year FDA approved the sale of $199 heart monitor from the company AliveCor. The device works as an attachment and snaps on like a smartphone case with finger electrodes. These electrodes measure the user’s heartbeat. All you need to do is hold the device for 30 seconds and it delivers an approximate reading. Once the reading is received, it can be sent to a doctor for further analysis via email.

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