Why the FDA doesn't need to be replaced as mHealth regulator

Last week in this spot, I posed a question about creating a mobile health administration to regulate and handle oversight of mHealth technology, from apps to devices. Such a federal agency, I surmised, could replace what the U.S. Food and Drug Administration, Federal Trade Commission and other regulatory organizations are doing in determining what should be regulated and what shouldn't be regulated.

I pitched the question, figuring that given all the man hours and years already spent trying to decipher where and how mobile tech fits into the FDA and other agencies' purviews, maybe starting from scratch would be the best option.

But I stand corrected given some excellent feedback from a reader and from someone who knows much more than I about the regulatory environment and what's been accomplished to date.

One FierceMobileHealthcare reader scored several legitimate points as to why such an agency may not be the best solution, pointing out that ultimately, mHealth is really just software and hardware devices.

"How can you say that software that runs on a mobile device should be regulated by a different agency with presumably different regulations than software that runs on a PC or server?" the reader said. "How can you say that software functionality that's accessed on a web site by a PC browser should be regulated by the FDA and the same functionality accessed from an app on mobile device by this new mHealth agency? What if my company provided both? Would we have to deal with two different regulators?"

The idea of two different regulators would obviously be a nightmare and not anything close to a better situation.

The reader also believes the FDA is taking a good approach with app guidance.

"FDA ... have actually taken a fairly light touch with their mobile medical app guidance, focusing only on the higher risk types of devices, leaving many others as discretionary and defining many as unregulated," the reader said. "Any new agency will still have to work with the others--they couldn't be 'Lone Rangers.' [In my honest opinion], it would make things more, not less, complicated."

And in fact the FDA is taking a light touch. On Friday it issued guidance on deregulation of a slew of devices, many of which fall into the mHealth realm.

Nathan Cortez, an associate professor and associate dean for research at SMU Law School, also believes a new agency would not be the best approach in mHealth regulation. As he told FierceMobileHealthcare in an email interview, the FDA has been doing the job of regulating medical software since the 1970s.

"Between the FDA, FTC, FCC, and ONC, I think mHealth products are pretty well covered by federal regulators," Cortez told FierceMobileHealthcare. "I do worry about over-relying on the ONC to regulate the safety of health IT products. I actually think the FDA is well positioned to ensure mHealth products are safe and effective."

Cortez added that ONC, unlike FDA, does not have real regulatory authority. "It can't bring enforcement actions," he said. To that end, he said, rather than creating a new agency from scratch, it probably would be more efficient to give the FDA more resources.

"The FDA does have a long history with software and some internal expertise--just not enough," Cortez said. "I do think mHealth apps are becoming more ambitious--trying to do more--and that it's important for FDA to ensure that these products are relatively safe and work as claimed."

While I'm backing off of my original assessment about creating a new agency, I don't regret asking the question. It served as a conversation starter on an important topic--mHealth regulation--that will continue to be debated as the industry continues to evolve. - Judy (@JudyMottl and @FierceHealthIT)

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