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Is the FDA Abandoning its mHealth App Regulation Plans?

Speakers at a recent conference said the agency may be in over its head in trying to regulate a fast-evolving ecosystem, and is now waiting on Congress to take the reins.

By Eric Wicklund

- Healthcare providers looking for guidance from the Food and Drug Administration on the regulation of mobile medical apps may have to wait a while – possibly a few years.

Speakers at a recent Food and Drug Law Institute conference in Washington D.C. painted an ominous picture of the agency so far charged with overseeing the mHealth app landscape, saying the industry may have overwhelmed the agency to a point that someone else – another federal agency, or Congress – may have to step in and take over.

“(I)t'll be quite a few years before we have a handle on this technology and how it's going to be regulated by the FDA, if at all,” Jeffrey K. Shapiro, a member of the Washington D.C. law firm of Hyman Phelps & McNamara P.C, told the conference, as reported by Bloomberg.

The FDA has been taking the lead in mHealth app regulation for several years, at first taking a hard line on governing software and hardware. But several recent updates – in which the agency has said it would exercise discretion in overseeing certain technologies – hint that its stance is softening, or at least evolving.

“(The) FDA doesn't have a depth of experience here that necessarily justifies them heavily regulating this area,” Shapiro said. “The current FDA regulatory framework was developed before today’s sophisticated cognitive computing and mobile and cloud based computing.”

“Experience has shown that the FDA’s almost 40-year-old regulatory framework is a bad fit for much of today’s health IT with its networked ecosystems, rapid iterative improvement, deep collaboration between providers and end-users and focus on clinical decision support (CDS) rather than direct diagnosis or treatment,” he added.

For its part, the FDA says it's still very much in control of the regulatory process for mHealth. In a report released this past August,, FDA officials say the agency remains committed to overseeing mHealth app regulation.

“These advances in the performance of the device program reflect a combination of programmatic improvements and innovative approaches to applying existing authorities, rather than changes to the basic framework for device oversight that was put in place almost 40 years ago. The existing framework assures that FDA's level of oversight matches the level of device risk, and applies flexible standards to premarket review of devices without compromising the standard for safety and effectiveness of devices,” the FDA report stated.

In addition, Bakul Patel, the FDA's associate director for digital health, recently told Reuters that the agency is adding new staff members to deal with an expected increase in medical grade devices requiring FDA approval.

“We’re going to see a lot of devices over the next couple of years for every chronic condition of mankind that are FDA-regulated because they all involve a treatment loop,” Eric Topol, of the Scripps Translational Science Institute, told Reuters.

Coming at a time when mHealth is struggling to find acceptance in health systems, any inertia could be crippling. Business leaders and entrepreneurs have asked that the mHealth industry be left alone, saying a heavy hand could squander innovation and prevent the development of game-changing tools and technology. Healthcare advocates, on the other hand, worry that an unchecked industry could lead to tools and technology that can’t uphold promises and end up harming or even killing patients.

Speaking at the recent FDLI conference and with Bloomberg reporters, Shapiro said the FDA might be realizing its predicament. The agency had said it would issue final guidance on the regulation of decision support software by the end of this year, but hasn’t done so. It has also recently stepped back from plans to regulate consumer-facing technology and so-called “low risk” apps, and abandoned altogether its plans to regulate medical device data systems.

The FDA may be waiting on Washington to set the parameters of future mHealth regulation. At least two bills before Congress would define what the FDA can and cannot oversee, and some lawmakers have asked the Health and Human Services Department to weigh in on the matter as well. Some have even suggested creating a separate department under HHS to handle the issue.

“It's a dance between Congress and FDA on how this is going to be regulated and also on the actual policy,” Shapiro told Bloomberg.


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