"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."
"Notably, the rule would do away with proposed transparency requirements for healthcare AI tools - including so-called " model cards " that would have required vendors to disclose how clinical AI models are trained, deployed and tested. The Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health Information Technology (ASTP/ONC) argued there is no evidence that these transparency requirements have improved patient outcomes."
HTI-5 would remove 34 and revise seven of 60 certification criteria, cutting nearly 70% of the federal health IT certification program. The rule aims to reduce costs and regulatory hurdles for health technology developers. Proposed transparency requirements for healthcare AI tools, including model cards, would be eliminated. ASTP/ONC said there is no evidence those transparency requirements improved patient outcomes. ASTP/ONC estimated the proposal would save more than 1.4 million compliance hours in year one (about 4,000 hours per organization) and $1.53 billion total. HHS would clarify that information blocking covers automated access and autonomous AI and would tighten exceptions, removing a TEFCA-related exception and policies that enable technical or contractual delays.
Read at MedCity News
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