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 regulatory hurdles for health tech developers.
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.
ASTP/ONC estimated that the proposed changes would save healthcare tech developers more than 1.4 million compliance hours in the first year — or about 4,000 hours per organization, on average
As for dollars saved, the ASTP/ONC predicted that the new rule could save $1.53 billion in total.
In the proposed rule, HHS also said that it plans to clarify the definition of information blocking to make clear that it applies to automated access and data use, including by autonomous AI systems.
The agency said it is moving to tighten several information blocking exceptions, arguing they are being misused by some health tech developers to restrict data sharing and disadvantage competitors. In particular, HHS would remove or revise policies that allow organizations to unnecessarily delay or deny access to health data through technical or contractual barriers. The proposal would also remove a TEFCA-related exception that HHS says is no longer necessary and may be creating problems for organizations trying to share data.
HHS said its plan aligns with President Donald Trump’s executive orders on deregulation and dismantling anti-competitive regulatory barriers. The proposed rule is open for public comment for 60 days.
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