FDA to focus on regulation of smartphones, wireless devices

As the number and array of health apps for mobile devices continue to explode, the federal government will keep its regulatory focus on a narrow band of products that pose the most potential risk to patients and consumers.

On Monday, the Food and Drug Administration issued a final draft of guidance on its regulatory strategy for health and wellness apps on smartphones and other wireless devices.

“We're not expanding our universe at all,” said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, at a briefing announcing the 43-page “Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff.”

The agency developed a framework targeting apps that are “intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device,” according to an FDA summary of the larger document.

These mobile apps meet the definition of medical device under the federal Food, Drug and Cosmetics Act and could pose a risk to a user's safety “if the mobile app were to not function as intended,” the FDA said.

Thus far, the FDA has cleared about 100 mobile medical applications, including approximately 40 in the past two years. The review process for mobile medical applications has taken 67 days on average to complete, Shuren said.

These fall into three broad categories.

One is mobile apps that transform a mobile platform into a regulated medical device, such as mobile electrocardiographs, systems that measure the electrical activity of the brain during sleep to diagnose sleep apnea and mobile apps that use an attachment to measure blood oxygen saturation for diagnosis.

Another is mobile apps that connect to and control another regulated device, such as a mobile app that alters the function or settings of an infusion pump.

And the final category is mobile apps that “display, transfer, store, or convert patient-specific medical device data from a connected device” such as an app that connects a hospital nursing station with a bedside monitor.

“I would suggest for any app developer who has any questions, talk to us,” Shuren said. “We'll give you feedback on what to do.”

What the FDA plans to watch but not regulate—exercising its “enforcement discretion”—are medical devices that pose minimal risk to patients and consumers. They include apps that help users self-manage a disease, organize and track their health information and enable patients or providers to interact with personal health records or electronic health-record systems. The FDA will not ask manufactures to submit premarket-review applications for those products or register and list the apps with the agency.

The FDA also has no plans to regulate the mobile devices themselves, or online app vendors such as Google Play or Apple AppStore.

The FDA issued draft guidance on mobile medical applications in mid-2011.

Today's announcement is separate from a process involving the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology at HHS to establish a regulatory scheme for other forms of health information technology.

In April, the federally chartered Health Information Technology Policy Committee created a workgroup with representatives from the FDA, FCC and ONC to advise all three on “key considerations to improve patient safety and promote innovation in health information technology, including mobile medical applications. Congress mandated the FDA to come up with a plan for a regulatory framework by January 2014.

Shuren said mobile applications that enable a physician to receive computerized decision support, which were not included in today's guidance, will be addressed in that upcoming framework.

“The report we'll put out will be sort of a proposed strategy for a regulatory framework,” he said. “It will of itself not be creating policy.”

About 200 mobile health apps have been co-branded with healthcare organizations, according to a recent analysis of the online offerings of those two mobile app marketplaces.

Health IT entrepreneur Dr. Bettina Experton was happy with the FDA approach.

“It's consistent with what they've said all along,” said Experton, president and CEO of Del Mar, Calif.-based Humetrix, developer of a mobile app that enables patients to download and organize their medical records using the federally sponsored Blue Button interoperability format.

“They were clearly distinguishing medical mobile apps attached to medical devices to those that are not and provide the tools for consumers to manage their health or personal information,” Experton said. “I think it's great that they've produced a final guidance because there is no conflict of regulation here,” she said, with requirements for information transfer set for the federal EHR incentive payment program under the American Recovery and Reinvestment Act.

Under Stage 2 of the EHR incentive payment program, providers must allow their patients to electronically view, download and transmit their medical records, while the Health Insurance Portability and Accountability Act also mandates that electronic copies of their records be made available to patients on request, if they have electronic record keeping systems.

Mobile apps, Experton said, “are likely to become the more practical, efficient way for providers to do VDT and on the patient side, they are likely to become the most commonly used tool and device to exercise that right.”

Follow Joseph Conn on Twitter: @MHJConn