FDA Says It Will Clarify Digital Health Regulations

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By Mike Stankiewicz

Digital health product developers will soon receive more clarity on what products the FDA will regulate.

Food and Drug Administration Commissioner Scott Gottlieb said in a June 15 blog post that the agency is putting together a “digital health innovation plan” that includes guidance on how digital wellness and health software will be regulated. These include low-risk fitness trackers and mobile apps that provide users with wellness help such as diet guides and nutritional and weight tracking. Proponents say such software promotes healthier lifestyles.

The new approach is intended to eliminate regulatory ambiguity and will drive innovation. “Developers don’t always know if a product they are developing is within FDA’s regulatory scope,” William Garvin, a Washington-based life sciences attorney at Buchanan Ingersoll & Rooney PC, told Bloomberg BNA June 16. “That can be costly and slow down development and innovation.”

The market for digital health technology continues to expand. Gottlieb said last year there were an estimated 165,000 health-related apps available for Apple or Android smartphones and forecasters predict that such apps would be downloaded 1.7 billion times by 2017.

The 21st Century Cures Act, a 2016 law, said that software and apps that are intended only for maintaining or encouraging a healthy lifestyle should not be regulated by the FDA because such technology poses a low risk to users but provides valuable health information. But little clarity has come out since.

“During the winter, before Dr. Gottlieb took over, FDA seemed still unsure what to do,” Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, told Bloomberg BNA Jun 16. “It’s amazing what an election will do. Now FDA seems to be committed to publishing guidance in the coming months.”

The FDA plans to go beyond the legislation and provide guidance on other low-risk items not covered under the 21st Century Cures Act, that will not be subjected to certain premarket regulatory requirements so the agency can give more attention to higher-risk priorities. “Legislation always covers at best a few of the larger categories, and there is truly much more work to be done,” Thompson said.

Gottlieb said the agency is also considering whether it can create a third-party certification program where low-risk digital health products could be “marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA premarket review.”

Praise, Concern

Digital health experts praised the FDA for providing more clarity to device developers.

“This will encourage investors to come to the table and will allow developers to expand their scope of development,” Garvin said. “If you’re developing these products, you are worrying about whether or not what you’re developing will be subject to regulation and what you need to do to get your device to the market. Many times its unclear.”

Thompson, quoting the agency official’s posting, said the FDA is “expressly acknowledging that ‘ambiguity regarding how FDA will approach new technology can lead innovators to invest their time and resources in other ventures.’ Honestly, that’s exactly the point we’ve been trying to make.”

Thompson is a Bloomberg BNA advisory board member.

But Garvin said the guidance wouldn’t fix everything.

“There’s always going to be some gray areas of regulation that exist with FDA, and regulatory information won’t be immediately or conveniently clear for every device,” he said. “But this will certainly narrow that down.”

Diana Zuckerman, president of the National Center for Health Research, a Washington-based nonprofit, is concerned that the FDA’s regulatory policy decision could put some people at risk. “If you have an app that tells you your blood pressure is too high, or pulse rate is too low then people’s lives are really at stake and it would be nice to have confidence that these apps are regulated and tested,” she told Bloomberg BNA June 16.

Zuckerman said this could be more of a push for deregulation, not innovation. “It looks a lot more like deregulation,” she said. “This would allow thousands of apps and software to not be regulated until after they are on the market, or at all.”

To contact the reporter on this story: Mike Stankiewicz in Washington at mstankiewicz@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The FDA blog post on digital health products is at http://src.bna.com/pWa.

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