FDA sets up center to 'modernize' digital health regulations

The Food and Drug Administration on Tuesday launched a new center tasked with coordinating and supporting the agency’s efforts to “modernize” its approach to regulating digital health technologies, such as apps and wearables categorized as medical devices.

The vision for the center is to provide manufacturers, FDA staff and others with resources to help speed development of digital technologies that are safe and effective, FDA officials said. The Digital Health Center of Excellence will sit within the Center for Devices and Radiological Health.

Digital health products can be tricky to regulate, according to the FDA, since unlike traditional devices, digital health software tends to be updated more frequently.

“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Dr. Stephen Hahn in a statement. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology.”

The FDA appointed Bakul Patel, who previously served as director of the digital health division at the Center for Devices and Radiological Health, as the digital health center’s director.

Much of the center’s operations and structure are still under development, according to the FDA.

One of the digital health center’s initial efforts will involve creating a network of digital health experts to provide the FDA with feedback on issues and priorities within the space.

Figuring out how to regulate digital health products has been an ongoing area of focus for the FDA.

The FDA last year released guidelines clarifying which types of medical software fall under the agency’s regulatory oversight. Clinical-decision support software designed to help providers and patients manage serious or critical conditions were considered part of the agency’s purview, while software designated as low risk—such as apps that encourage healthy lifestyles—were excluded.

The FDA made one of its biggest digital health moves to date in 2017, when it launched the Digital Health Software Precertification Program. The pilot program, which is meant to inform development of a future regulatory model for digital health, reviews product developers, rather than individual devices.

Source: modernhealthcare.com

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