MedCity News December 24, 2025
HHS proposed changes that would roll back many Biden-era policies, eliminate most health tech certification criteria, and scrap planned transparency requirements for healthcare AI tools. The agency argues the move will reduce regulatory burden and save developers time and money.
HHS released a new proposed rule this week aimed at rolling back several Biden-era health IT policies and slimming down the federal health IT certification program. The proposal, called HTI-5, would remove or revise nearly 70% of current certification criteria against which health tech products are certified.
There are currently 60 certification criteria within HHS’ health IT certification program — this plan seeks to remove 34 and revise seven. HHS said the goal is to cut costs and reduce...
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