Major mHealth App Regulation, Increased Transparency Expected Soon

Often compared to the health supplement industry, the mHealth app market is “largely unregulated.”

As covered in compelling detail Sunday by Brie Zeltner of The Plain Dealer, consumers today are mostly put in a position to rely on word of mouth or clever marketing to find mobile apps that serve their healthcare needs.

“That’s about to change,” Zeltner writes, “as the federal government, a private mobile app management company and academic researchers are stepping forward to inject order and possible regulation into the rapidly expanding industry.”

There are about 40,000 health apps available for smartphones or tablets, produced by doctors, software developers, pharmaceutical companies and hospital systems, among others.

Ordinarily, such a selection for consumers would be welcomed. But there are problems – potentially serious – associated with this copious array of apps. As it turns out, only 75 medical apps or so have FDA approval.

“Right now, apps can be written by two kids in the basement or by a team of surgeons at a major hospital, and it’s very hard to differentiate which is which,” says Alain Labrique, director of the Johns Hopkins University Global mHealth Initiative.

“Consumers who are depending on these kinds of apps to manage their health or disease need technologies that are based on sound evidence,” he said.

The calls are growing louder and more intense for strict regulation of apps that claim to treat certain conditions or even offer information that,  if incorrect or misused, could cause serious harm.

“People have called this the new era of snake oil,” Labrique argues. “There are a lot of claims being made about what apps could do for you. What’s often lacking is the validation of these systems.”

From the looks of it, the quest for validation will be fulfilled – and soon – in the wake of consumer demands for increased transparency and regulation.

“As Happtique and other organizations try to provide some guidance to the developers and consumers, what we end up with is a little more informed choice to help us make selections in a smarter way,” Labrique concludes.

To read the comprehensive report from the Plain Dealer, click here.

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