FDA dilemma: When apps race ahead of regulatory prowess

From phone and tablet apps that help providers review imaging data to functions that turn phones into cardiac monitors, mobile health – or mHealth – is one area where the tide of innovation is turning to develop better patient care. Can the FDA keep up with new mHealth apps to ensure they are safe and effective?

Not as currently set up, according an article published online July 24 in the New England Journal of Medicine. In exploring mHealth technologies and the FDA’s place in the evolving medical app market, medical legal experts led by Nathan G. Cortez, JD, of Southern Methodist University Dedman School of Law in Dallas, reviewed recent plans brought to Congress to change how the FDA oversees mHealth apps.

The FDA’s role in regulating mHealth technologies has been murky, with some applications falling under the FDA’s “device” regulations while others do not based on the class system developed for more slowly evolving drug, device and biologic technologies. Only class III (high risk) classified apps are actively pursued.

However, the authors found only one class III app cleared in 2002 for use as electrocardiograph software, which was later downgraded to class II (moderate risk). Class II devices do not require as much notification or oversight. Class I (low risk) devices are mostly exempt from the FDA notification processes.

Attempts through the FDA Safety and Innovation Act of 2012 to redefine classes to stimulate growth have fallen flat in ensuring safety because proposed definitions do not adequately encompass all mHealth apps being developed. Industry and congressional groups have argued unregulated growth of mHealth allows more innovation. But Cortez et al wrote that there is a clear need to regulate products in some respect to protect patients and providers, citing as examples applications by Pfizer and Sanofi Aventis for flawed apps as well as less well monitored apps created by smaller companies.

“Broader reviews show mHealth apps that make claims lacking scientific support, are designed without the input of a medical professional, or even contravene evidence-based guidelines,” they wrote.

Cortez et al  suggested an alternative to removing mHealth technologies from FDA purview entirely, as was suggested by some bills that have gone before Congress in recent years. They proposed a system be put in place that not only recognizes the FDA’s role in ensuring the safety and utility of these technologies, but also includes strong interaction with other agencies without compromising the FDA’s mission, budget and ability to assess technologies in a timely fashion.

Cortez et al recommended the creation of a dedicated center within the FDA for mHealth technologies and to consider either increasing the FDA budget or allowing the FDA to charge fees similar to current user fees for drug approvals. As Cortez et al wrote, “With potentially thousands of mHealth products under the FDA’s domain, agency authority will be undermined if the FDA cannot enforce its requirements.”

The team expressed concern about proposed changes to FDA purview. “Without the rigors of FDA oversight, it will be harder for them [physicians] to trust the advice their devices give them. Moreover, the creation of precise statutory definitions for FDA jurisdiction over mHealth products risks anchoring the authority of the FDA to existing products, which could create problems for future technologies.”