The FDA eased rules for mental health apps during the pandemic. Now companies are bracing for it to tighten the reins

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In April 2020, as the horrors of the pandemic were beginning to unspool, the Food and Drug Administration announced an emergency policy giving companies wide berth to release apps to address a mental health crisis that experts feared would only get worse under lockdown.

The policy was intended to aid people in need while relieving pressure on the health care system and FDA. But it was also a boon to emerging companies developing novel, software-based treatments — sometimes called digital therapeutics — for depression, ADHD, substance use, and other conditions.

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