FDA Plans to Clarify Digital Health Regulations


Digital health product developers will soon receive more clarity on what digital health 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 life sciences attorney at Buchanan Ingersoll & Rooney PC, told me 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 the end of 2017.

The 21st Century Cures Act, a 2016 law, said 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.

Digital health experts lauded the FDA for planning to provide 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 told me. “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 it’s unclear.”

But not everyone was happy with the announcement.

Read my full article here.

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