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FDA aims to regulate medical apps

By one estimate, health-related smartphone apps could be a $6 billion business by 2015. By one estimate, health-related smartphone apps could be a $6 billion business by 2015.
Bloomberg News / July 20, 2011

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WASHINGTON - Tools that let smartphones monitor blood sugar or work as stethoscopes may face the same regulatory scrutiny as heart stents and ultrasound machines.

Such applications pose a potential risk and may have to meet Food and Drug Administration standards for medical devices, according to draft guidelines issued yesterday.

The FDA is focusing on apps that directly diagnose or treat conditions such as diabetes or that transform the smartphone into a medical device. The regulations would be the first for a market that Ilkka Korhonen, a former senior manager of Nokia Corp.’s wellness business program, estimates may climb to $6 billion in 2015.

“This area is growing exponentially,’’ said Bakul Patel, an FDA adviser. “We’re looking at the mobile applications that would pose a risk if they didn’t work as intended.’’ Regulators propose to standardize design and production of the apps.