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Two researchers look at a projection screen displaying medical devices, scientific graphs and DNA — health tech coverage from STAT — Adobe

The federal government’s plan to boost its oversight of the use of artificial intelligence tools in health care drew censure from startups arguing that overregulation stifles new ideas. But as Washington forges ahead, founders say they’re in the dark about who will be regulated and how — and they’re urging policymakers to offer clarity.

As they race for a slice of the $4 trillion U.S. health care market, AI founders and investors say regulatory uncertainty is a hurdle, forcing them to build more slowly and meticulously document for fear of potential audits. That makes it harder to keep up with the tech industry’s breakneck pace, they tell STAT.

The regulatory uncertainty adds to the many challenges dogging young health tech ventures today: Last year investments in digital health startups shriveled to their lowest annual total since 2019, and leaders are desperate to preserve what little funds they have, including through layoffs.

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