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Digital therapeutics companies are eager to show their work.

Five days before President Biden took office, the Department of Health and Human Services proposed a rule to exempt a laundry list of medical devices from typical regulations, including newly cleared apps to treat psychiatric disorders. Now, their creators have pushed back, demanding that digital therapeutics need and deserve regulatory scrutiny.


“If HHS’ proposal is finalized, it is no exaggeration to state that public health will be undermined,” states a comment filed this month by Pear Therapeutics in response to the proposal.

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