FDA's Baku Patel: mHealth app, device makers should lead compliance effort

Regulatory compliance of mHealth technology must start with app and device makers, who should drive industry compliance activity, according to the U.S. Food and Drug Administration's Bakul Patel.

Patel, associate director for digital health at the FDA, told the Financial Times that mHealth app and device developers must determine where their tool falls within three specific review categories and ensure compliance if it falls into the medical device realm of diagnosis and treatment. Fitness trackers are not considered such devices as they monitor and track health and activity. Devices that perform some diagnostic capability but pose very little risk to patient health also typically don't require agency oversight.

Patel also noted that device capability isn't the only regulatory aspect the FDA takes into consideration when assessing devices. An app or device maker must also be able to respond to any issues and customer complaints.

"If problems arise, you should have a business organization that can spot it, fix it and make sure your products are not hurting people," Patel said.

In a study published last month in JAMA Internal Medicine, researchers who revealed that a once-popular blood pressure app provides three-quarters of users with incorrect readings. They recommended that app developers, distributors and regulatory bodies set and follow standards for valid mHealth technologies.

Not everyone in the industry is convinced current FDA oversight is working well. Scott Gottlieb, M.D., a former FDA official, wrote in a Forbes commentary that the FDA's approach of "we'll know it when we see it" is scaring off innovators and leading mHealth vendors in limbo.

Patel said he believes mHealth vendors must be at the forefront in developing standards that help mHealth innovations meet FDA compliance requirements.

"I think about the Apples, Googles, Samsungs of the world as people who create standards that are in a way platforms that other people can iterate on," he told the Financial Times.

For more information:
- here's the Financial Times article