In July 2011, the Food and Drug Administration (FDA) issued a draft guidance that proposed to treat certain mobile medical applications (apps) as medical devices. (See Mobile Medical Apps: The Slow Road to Regulation.) The guidance suggested that the FDA would only regulate apps that were used as accessories to FDA-regulated devices, such as apps that control the inflation and deflation of a blood pressure cuff, and apps that transformed mobile platforms into regulated devices, such as apps that allow for the attachment of electrocardiograph (ECG) electrodes. However, lawmakers have become concerned that the FDA’s plan could evolve into wholesale regulation of smartphones and tablets. The House Committee on Energy and Commerce Subcommittee on Communications and Technology held a series of hearings from March 19, 2013 through March 21, 2013 to pin the FDA down and address other concerns.
Smartphones as Medical Devices?
The first day of hearings was intended to provide an overview of the current role of mobile medical apps in the U.S., but it soon became clear that the lawmakers’ focus was on concerns that the FDA would overstep its boundaries and assume large-scale regulation of smartphones and tablets. The committee’s report for the day indicated that the purpose of the hearing was to discuss “how federal regulations and taxes could impact patients, hinder innovation, and increase costs for consumers.” Bradley Merrill Thompson, general counsel to the mHealth Regulatory Coalition, urged the FDA to finalize the guidance so that the development of stalled applications could continue, but to do so with the understanding that it would update the guidance periodically to ensure that it remains abreast of technological changes. Thompson, on behalf of the coalition, advocated for a balanced,risk-based approach to regulation that promotes patient safety without discouraging innovation.
The Committee also expressed concern that the FDA would apply the 2.3 percent medical device tax created by the Patient Protection and Affordable Act (PPACA) (P.L. 111-148) to smartphones and tablets. In its press release, the committee highlighted the opinion of Dr. George Ford, Chief Economist at the Phoenix Center for Advanced Legal and Economic Public Policy Studies. Ford opined that, “Uncertainty, delays, and the fixed costs related to the regulatory process reduce expected returns, and thus discourage firms from participating in the healthcare industry . . .[W]e must expect FDA review of mobile applications to slow innovation and to reduce competition.”
Current Use of Medical Apps
The second day of hearings was to focus on health care practitioners’ and patients’ use of medical apps for diagnostic purposes. The committee estimated that 500 million people would use medical apps by 2015 and emphasized the need for innovation. According to a report from research2guidance, there are currently 97,000 mobile health applications in major app stores, 15 percent of which are designed for health care professionals. The mobile health services market is expected to reach $26 billion by 2017. Witness Jim Bialick, Executive Director for the Newborn Commission, emphasized the importance of medical devices in delivering telemedicine to remote areas without access to care, referring to the use of such devices as, “the new house call.” Other witnesses expressed concern about the FDA’s ability to keep up with the rapid pace of technology, particularly when applying laws that were created before the technology even existed. A committee member argued that FDA regulation is likely to cause investors “to look for the next Angry Bird” app rather than the next medical app. Rep. Henry Waxman (D-Calif.), however, argued that committee members were using scare tactics to influence investors.
On the last day of hearings, Christy Foreman, Director of the FDA Office of Device Evaluation in the Center for Devices and Radiological Health, put committee members’ fears to rest, stating unequivocally that the FDA “would not regulate the sale or general consumer use of smartphones or tablets,” nor would it consider mobile platform manufacturers and entities that sell apps exclusively, such as the iTunes App store, to be medical device manufacturers. Items classified as medical devices would be subject to the medical device tax, unless they were sold through retail stores, in which case they would excluded from the tax. Foreman noted that app clearance generally takes about 67 days. Most apps would be considered lower-risk, so that pre-market testing would not be required. FDA new device applications filed by large companies cost $5,000, while applications filed by smaller companies cost about half that amount. The FDA hopes to release a final guidance by the end of the 2013 fiscal year.