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Former FDA digital health policy leader heads to Mayo Clinic

Sonja Fulmer, who had been acting director of the agency's Center for Devices and Radiological Health, is reported to be taking a lead policy role at the Minnesota health technology innovator.
By Andrea Fox , Senior Editor
Sonja Fulmer, former acting director of CDRH

Photo: LinkedIn

The former acting director of the Digital Health Center of Excellence in the U.S. Food and Drug Administration's Center for Devices and Radiological Health, has reportedly accepted a new position as senior director of health policy at Mayo Clinic.

Sonja Fulmer had been named acting director of the FDA center, which provides advice and support for regulatory reviews of digital health technology, in April, weeks after the departure of its former director Troy Tazbaz, who served two years. (Tazbaz returned to Oracle, where he previously served for more than 10 years, as senior vice president for data center planning.)

Fulmer served just four months in that role under the Trump administration. She had previously worked for nearly two years as the center's deputy director under Tazbaz. In August, she announced that she was leaving the FDA after 11 years.

During her time there, the CDRH focused on building strategic partnerships, updating and implementing a regulatory framework for digital health and coordinating with other agencies.

Its Digital Health Center of Excellence issued draft guidance for medical device manufacturers implementing artificial intelligence into their products and released a discussion paper on health equity in medical devices, requesting public comments on device performance across populations.

"It has been my pleasure to tackle the interesting challenges and rewarding opportunities to promote responsible digital health innovation," Fulmer said in a social media post last month, adding that she was grateful for the chance to work across the agency, HHS and with international regulators.

We reached out to Mayo Clinic for a statement and will update this story if one is provided.

Fulmer is not the first federal health technology leader to make the move to the Rochester, Minnesota-based health system.

She follows Micky Tripathi, the longtime health IT pioneer who served as national coordinator for health IT and acting chief artificial intelligence officer at HHS. He became Mayo Clinic's chief AI implementation officer in April.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.

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