Friday, March 22, 2013

FDA Clarifies Plans for Mobile Health App Regulation

Wellness, fitness and medical resource apps will also not be regulated, noted Jennifer Kent, a research analyst at Parks Associates.

"Medical apps with low-risk to consumers, such as an e-book of medical information, will not be worth the FDA's time," Kent told eWEEK in an email. "Peripherals and apps that turn a mobile device into a medical device in some way—a common example is using an iPhone as a wireless glucometer—will be regulated," said Kent.

When guidelines are finalized, the FDA will publish a list of apps on its Web site that have been approved by the agency, said Foreman. Secretary of Health and Human Services Kathleen Sebelius is required to submit recommendations for a "regulatory framework" that includes mobile medical apps by January 2014, according to Foreman.

The FDA has been criticized for the delay in finalizing its guidelines on regulating mobile apps. It published its draft guidelines in 2011.

"The FDA has acknowledged that they need to publish the final regulatory guidelines as soon as possible to clear away the uncertainty that some claim is depressing the market or driving m-health companies overseas," said Kent.

Although many developers are going ahead with their work on creating new mobile apps, those companies such as pharmaceutical manufacturers creating apps that could affect doctors' decisions and control important medical equipment connected to patients have been impeded by the FDA's delay, according to Ben Chodor, CEO of mobile health app store Happtique, which launched its own certification program for mobile health apps. Chodor testified in the mobile health hearing on March 19.

"I don't think companies are not building apps because they're worrying about the FDA, but there's a subset of companies out there who want to build clinical apps—and clinical devices connected to apps—and those are the guys that are sitting on the sidelines," Chodor told eWEEK.

App developers want to avoid having hospitals start using apps and then have to pull it three months later if the FDA hasn't cleared it, said Chodor.

The government is looking to strike a balance of oversight of medical apps while still encouraging innovation, the FDA's Foreman told the House subcommittee.

"We believe that focusing FDA oversight on a narrow subset of mobile apps will encourage the development of new products while providing appropriate patient protections," said Foreman.

"The key for the FDA is to fulfill their responsibility of protecting consumer safety without unnecessarily burdening industry and suppressing innovation," said Kent.

From the article, "FDA Clarifies Plans for Mobile Health App Regulation" by Brian T. Horowitz.

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