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FDA requests regulations on Medical Apps

9:35 AM, Apr 29, 2013   |    comments
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doctors are using their smartphones for more than calls and email, new apps make it possible to listen to a patient's heart beat, or calculate medicine dosages, from your phone or tablet.

a majority of apps won't hurt patients if they fail -- but a few might -- and the FDA is determining which apps need some oversight.

experts at the FDA say mobile apps that aim to transform a phone or tablet into a medical device, or act as an accessory to an already approved device, will need to be approved by the agency.

for example, one app performs an e-c-g, another controls the delivery of insulin to diabetics. doctors can also review x-rays on their phone and calculate radiation dosages.

the FDA is worried about the consequences of those apps not working properly, and are asking developers to submit the app for approval.

FDA experts say only a fraction of medical apps would need to go through the approval process.

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