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Senators are asking the FDA to clarify how it regulates medical apps

Senators are asking the FDA to clarify how it regulates medical apps

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As Google, Samsung, and soon Apple offer technologies for consumers to track health information on the go, a group of bipartisan senators are calling for more clearly defined regulation of those technologies by the US Food and Drug Administration. In a letter to the FDA today, Senators Michael Bennet (D-CO), Orrin Hatch (R-UT), Tom Harkin (D-IA), Lamar Alexander (R-TN), Mark Warner (D-VA), and Richard Burr (R-NC) asked for more information about the agency's policies, as well as oversight on mobile medical applications. That's despite a policy published by the FDA nearly six months ago.

"While the FDA's final guidance has provided clarity on the agency's approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated," the group wrote in its letter. "We urge the FDA to work with Congress to identify policies that will serve the best interests of patients and innovators alike."

There's a difference between apps about health, and apps that track it

That "final guidance" was referring to a set of suggestions published by the FDA last September, detailing the agency's oversight on medical apps used as an accessory to regulated medical devices, as well as any software that turns smartphones into a "regulated medical device." Those policies leave off non-medical apps that display or analyze data that's been gathered elsewhere.

The letter follows proposed legislation introduced last month called the PROTECT Act of 2014 that would amend the Federal Food, Drug, and Cosmetic Act. Some of the changes in that bill include removing the FDA's oversight on health software, as well as software used in clinics.