Blurred lines not a good anthem for mHealth regulation

Before the Federal Trade Commission or Food and Drug Administration tackle another mobile health technology investigation, the two federal agencies--both of which are charged with protecting consumers--need to huddle up in a conference room, lock the door and not come out until they produce a clear map of what they're responsible for when it comes to oversight and regulating such tools.

Why? Because right now it's getting quite difficult to figure out who's keeping on eye on the shallow end of the mobile health technology pool and who's watching the deep end. And anyone who's had a pool or spent time at a public pool know that a lack of supervision at either end can lead to potential disaster.

In its own words, the FTC describes itself as working "for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them." The FDA, for its part, describes its focus as being "responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."

Up until the past few weeks, what we were hearing from the FTC and FDA regarding mHealth technology was welcome news. Neither seems interested in creating a rash of new rules for fear of stemming mHealth innovation.

Yet inaction and timidness can boast just as many downsides and pitfalls as jumping forward and making new rules without little thought on how those rules may affect others. It's akin to a new leader of a business division or an entire company. What CEO runs around enacting change, acting in more a whimsy than strategic fashion, and lasts long in the role?

Why am I so focused on getting the FTC and FDA to decide who's life guarding what in the mHealth pool? Because I don't want mHealth technology innovation to drown, or for a disaster related to an unchecked mHealth tool to cause such havoc it stops others from jumping into the pool and making waves (in a good way).

For the second time in less than a month the FTC is taking action on software that failed to provide consumers what the app makers promised. The first case related to a PC game that boasted it could help boost a child's learning and cognitive ability. Then Monday brought news the FTC is fining two app makers who claim their software can help identify melanoma risk.

The FTC determined the companies deceived consumers and did not provide evidence the products were scientifically sound and able to deliver on their promise.

No one is disputing the action the FTC has taken with the product makers. What is in dispute, though, is whether it was the FTC's role to take action. There's a murkiness in trying to understand why the FTC stepped in and not the FDA.

As health attorney Brad Thompson of Epstein Becker Green tells FierceMobileHealthcare regarding the latest legal action, the FTC stepping up could indicate a trend in which the FDA is sidestepping what may be considered dicey issues within its own jurisdiction--as the melanoma app appears to fall into the medical device category. While the FTC has the right to take enforcement action, the lack of action, or even input from the FDA, is puzzling, he says.

In its release on the melanoma app settlements, the FTC states it is part of the National Prevention Council, which "provides coordination and leadership at the federal level regarding prevention, wellness and health promotion practices," and that the melanoma app cases "advance the National Prevention Strategy's goal of increasing the number of Americans who are healthy at every stage of life. These cases are part of the FTC's ongoing efforts to protect consumers from misleading advertising," the agency says.

That may be all well and good, but it really doesn't answer the big question: Is the FTC going to be the one and only lifeguard when it comes to the mHealth technology pool. Additionally, what role, if at all, will the FDA play as more mHealth cases come to light?

I'm not too sure the FTC or FDA can answer that question at this point, but I am sure it needs to be answered and that both need to be supervising the growing mHealth pool before a proverbial drowning thwarts innovation. - Judy (@JudyMottl and @FierceHealthIT)

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