Can the FDA handle mHealth regulation?

Jeff Rowe
Can the FDA handle mHealth regulation?

The federal Food and Drug Administration (FDA) may be in over its head, at least when it comes to keeping up with regulating mHealth apps.  

That was the message from speakers at a recent Food and Drug Law Institute conference in Washington D.C., who “painted an ominous picture of the agency so far charged with overseeing the mHealth app landscape.”  It may be, they said, that the app industry has overwhelmed the agency to a point that someone else – another federal agency, or Congress – may have to step in and take over.

According to Jeffrey K. Shapiro, a member of the Washington D.C. law firm of Hyman Phelps & McNamara P.C, “(The) FDA doesn't have a depth of experience here that necessarily justifies them heavily regulating this area. The current FDA regulatory framework was developed before today’s sophisticated cognitive computing and mobile and cloud based computing.”

That assessment comes at a time when mHealth is still struggling to find acceptance in many health systems, so any inertia could be, at best, counter-productive. Many mHealth entrepreneurs would like to see regulators take a more hands-off approach anyway, as they’re afraid a heavy hand could squander innovation and prevent the development of “game-changing tools and technology.”

On the other hand, some healthcare advocates worry that an unchecked industry could lead to tools and technology that can’t uphold promises and might end up harming or even killing patients.