FDA Clarifies Plans for Mobile Health App Regulation

FDA mobile health app regulation will be "narrow," carried out "judiciously" and won't impede sales of smartphones, an agency director told a congressional subcommittee.

The U.S. Food and Drug Administration plans to regulate medical devices connected to smartphones, but consumer devices such as the iPhone and app stores like iTunes and Google Drive will remain clear of oversight, an FDA official told the House of Representatives' Subcommittee on Oversight and Investigations on March 21.

"[The] FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended," Christy L. Foreman, director of the FDA's Office of Device Evaluation at the Center for Devices and Radiological Health, told the congressional panel.

"Consistent with this balanced approach, [the] FDA would not regulate the sale or general consumer use of smartphones or tablets," Foreman said.

During three days of hearings on Capitol Hill, lawmakers explored how far mobile health app regulations by the FDA should go.

Mobile apps that measure patients' vital signs or control devices such as CT scanners will be regulated. Inaccurate programming of a drug infusion pump or a CT scanner could cause a drug or radiation overdose, Foreman explained.

"An inaccurate or malfunctioning mobile medical app that uses a sensor to diagnose skin cancer or to measure critically low blood oxygen levels in chronic lung disease patients could delay lifesaving diagnosis and treatment," she said.

Mobile apps that provide access to electronic health records (EHRs) will be free of regulation, according to Foreman.

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.

In fact, mobile health app developers don't consider the proposed regulations overreaching and look forward to possible FDA approval to establish legitimacy for their apps, she said.