FDA to Regulate Some Health Apps

September 27, 2013

The U.S. Food and Drug Administration (FDA) will begin regulating some of the thousands of mobile health apps produced for smartphones, tablets and other mobile devices.

On Monday, the agency announced plans to regulate apps that turn these devices into medical equipment, such as apps that monitor heart rate, and medical attachments that plug into smartphones, like blood pressure arm cuffs.

More people than ever are turning to their smartphones, tablets or other mobile devices to keep their health on track, sparking exponential growth in mobile health technology, or mhealth. Just over 20 percent of U.S. adults use some form of technology to track their health data, according to a Pew Research Center survey of more than 3,000 people published in January. A Nov. 2012 Pew survey found that 19 percent of smartphone users have at least one health app on their devices. 

Certainly the most popular types of mhealth are apps that track physical activity, diet and weight loss. But thousands also target a wide range of major medical conditions, such as diabetes, HIV and depression. In mid-2012, the U.S. Food and Drug Administration (FDA) counted 17,288 health and fitness apps and 14,558 medical apps on the market.

In a statement, the FDA said the vast majority of apps, such as those for health and fitness, don’t need to be federally regulated because consumers won’t be harmed if they malfunction. But those that act as medical devices, which the FDA already regulates, need additional oversight.

“Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness and also gain access to useful information whenever and wherever they need it,” the agency said.

Many experts are calling for more rigorous testing of all mhealth apps to determine their actual health effects and how they match up to the developers’ claims.

Patricia Mechael, executive director of mHealth Alliance, an organization that advocates for better research on mhealth platforms, said technology developers usually have good intentions when developing their health apps. They research their target audience and the medical condition or health behavior they are trying to address.

But once the app has been designed, Mechael said too few developers continue to evaluate how their app performs to see if it delivers the outcomes they thought it would.

“Without rigorous evaluation to demonstrate the app’s impact on its intended user, it is difficult to determine whether the app is improving health outcomes, having no impact or, in rare cases, even having a negative impact,” Mechael said.

Recent data show that many apps flat-out fail to produce results. British researchers reviewed 334 reports of tests of mobile health apps. Only 75 of the tests met the rigorous standards medical researchers use to evaluate how an intervention affects health. Of those studies with optimal design, only three showed reliable signs of success. The study was published in the journal PLoS Medicine in January.

Consumers should look for apps that use information from reliable health sources, such as the U.S. Centers for Disease Control and Prevention (CDC) or the American Diabetes Association. Pay attention to any red flags raised in user reviews or trade publications. And remember that many apps still can’t replace a doctor’s guidance when it comes to managing health conditions.

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