FDA establishes health innovation center, says ‘most cutting-edge digital health technologies’ should come out of US

The FDA launched its Digital Health Center of Excellence Sept. 22 to foster healthcare innovation research and create strategic initiatives for digital health technologies.

The newly launched center, a part of the FDA’s Center for Devices and Radiological Health, will provide internal and external partners with resources and advice on new technology development to redefine the agency’s digital health device oversight.

“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.,” FDA Commissioner Stephen Hahn, MD, said in a news release. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings.”

The FDA appointed Bakul Patel, who has led the agency’s digital health device-related regulatory and scientific efforts since 2010, as the center’s first director.

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