Healthcare Technology Featured Article

June 21, 2012

Should FDA Regulate Mobile Health Apps?

Seems like just about everyone has their hand in the pot.

Did you know that the Food and Drug Administration (FDA) could have been involved in the recent Federal Communications Commission (FCC) ruling to open up a slice of the wireless spectrum to mobile body area networks (MBANS) and other issues regarding mobile health apps?

Congress has apparently “sidestepped” a knock-down drag-out fight with the FDA over the FDA's authority to regulate mobile apps, by allowing more time for a study of the issue by the US Department of Health and Human Services (HHS), according to a story by Eric Wicklund.

Wicklund writes that, according to multiple sources, House and Senate negotiators have modified part of the FDA Safety and Innovation Act to let the FDA move forward on planned regulations for mobile medical apps, finally concluding endless back-and-forth discussion over whether the FDA “has the authority to regulate this fast-growing industry.”

For those who see the discussion as apples and oranges, the FDA got involved last year when the multitude of health-related apps turning smartphones and wireless tablets into “personal nutritionists, gym buddies and physicians” attracted the attention of federal regulators.

During a recent #mHealth tweet chat about this very issue, medical students, physicians and health IT professionals all agreed that some kind of approval process is needed in order to protect patients, according to Deanna Pogorelc of MedCity News, but that the FDA shouldn’t be the source to regulate it.

Some tweeters wanted to know how the FDA would keep up with constantly changing and upgraded apps when it doesn’t have the people to police – or prevent – food from causing deadly illnesses.

And let’s not forget the Federal Trade Commission (FTC), which has also weighed in on the issue, saying in in March that FTC’s “broad mandate is to keep an eye out for unfair or deceptive acts or practices, as well as false or misleading claims,” including “acts or claims that cause or are likely to cause substantial harm to consumers that is not avoidable or counterveiled by benefits to consumers or competition.”

 “There are a lot of agencies that have at least some regulatory jurisdiction here: FDA, FCC, FTC, CMS and ONC all have a little piece of the pie,” Joel White, executive director of Health IT Now, said in a recent story in "For example, the Office of the National Coordinator for Health IT is pushing for electronic medical record standards, while the Center for Medicare and Medicaid Services is developing Accountable Care Organization standards. Simultaneously, the Federal Communications Commission is creating requirements for enforcing communications requirements between mobile phones."

What about mobile health apps? White believes Congress should have a role in “helping develop a framework that makes sense for mobile health technologies as they exist today, but is flexible enough to evolve with the market,” Wicklund quoted him.

Many agree that clarity is needed on the role the FDA would play, and that more time is needed to accomplish this.

Edited by Braden Becker

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