The FDA’s Emergency Guidance for Mental Health and How Digital Health Manufacturers Are Responding

Health Law Weekly

22 May 2020
Reprinted with permission.

Bethany Hills and Jean Nguyen authored an article for the American Health Law Association's Health Law Weekly discussing how the Food and Drug Administration (FDA) is addressing the rise in mental health problems associated with the coronavirus pandemic by relaxing regulatory requirements for digital health therapeutic devices for psychiatric disorders.

“These circumstances may open up opportunities for digital health manufacturers,” the authors wrote, adding that we are already seeing movement. “Some digital health manufacturers are already taking advantage of the opportunity the FDA has provided. The relaxed regulatory requirements compliment the recent FDA efforts to promote development and innovation in the digital health space, but timing for new developments may be critical due to the transient nature of the Emergency Guidance.”

Read the full article.



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