Industry braces for Trump rollback of Biden health AI regulation

A Biden-era regulation requiring health IT developers seeking federal certification for their products to disclose information about artificial intelligence algorithms to clinicians will likely be abolished or significantly narrowed under the Trump administration, a lobbyist, two lawyers and officials from three different trade groups told Inside Health Policy.

The health AI regulation drawing stakeholder attention is the HTI-1 final rule’s 31 “source attribute” requirements for “predictive decision support interventions (PDSIs).”

The ramifications of the expected regulatory shift could be...