Dive Brief:
The HHS is wrapping up 2025 by nixing key Biden-era health IT policies. On Monday, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology, the main federal health IT agency, proposed two rules that would cancel certain provisions of a health IT rule from the Biden administration and pare back the government’s health IT certification program.
The ASTP/ONC said the changes would eliminate onerous red tape, increase clarity and lower costs for health IT developers.
They come as the Trump administration removes government guardrails around health technology, especially artificial intelligence — one of the proposals would axe “model card” requirements that AI companies share details about how AI tools used to treat patients are developed and tested.
Dive Insight:
In summer 2024, the Biden administration proposed a rule to improve free, unfettered data sharing between health insurers, providers and public health organizations by certifying the health IT software that public health agencies use.
The goal was to remove data siloes between healthcare entities, especially after the coronavirus pandemic exposed how weaknesses in the country’s health IT chassis could impede patient care.
Regulators finalized provisions around patient privacy and information blocking by the end of that year, but failed to cement all of the proposals before Trump assumed office in January. At the time, regulators said they could be included in future rulemaking.
But now, the HHS wants to withdraw many of the outstanding proposals, including new certification standards for certain application programming interfaces, protocols that allow different software systems to communicate with one another. The government is also pulling a first-of-its-kind requirement that health IT vendors exchange standardized public health data.
Also on Monday, the ASTP/ONC proposed a rule that would “aggressively” trim requirements for the agency’s health IT certification program, which allows health IT software to qualify for incentives in federal programs along with other competitive benefits.
Of the 60 criteria in the certification program, regulators want to remove 34 and revise 7, according to the proposed rule, called HTI-5. The ASTP/ONC said overhauling almost 70% of the criteria would nix requirements that are already well-established in the market, duplicative with other regulatory requirements or overly taxing on health IT companies.
Among criteria being revised is one that would remove AI “model card” transparency requirements for clinical decision support tools introduced by the Biden administration in 2023.
The regulation, which went into effect at the beginning of this year, required health IT vendors to submit a quasi-nutrition label for their AI tools, including information about the data their models were trained on and how they’re maintained to lower the chance of biased or faulty outputs.
“We have no publicly available evidence that transparency requirements in [the Biden administration’s model card rule] have led to positive impacts on patient care, such as removing deficient or untested algorithms, or testing a deployed algorithm on local data,” the HTI-5 rule reads. “Second, transparency regarding how a predictive or generative AI application was designed, developed, tested, evaluated, and should be used may not have the savings and benefits we anticipated.”
ASTP/ONC said HTI-5 is in line with an executive order Trump signed on Jan. 31 directing federal agencies to pare back regulatory burden. The healthcare department’s IT leads have taken the directive to heart, on Friday issuing a request for information on how to accelerate AI adoption in the sector.
And “HHS intends to dramatically expand its deregulatory efforts,” the new rule states.
Payers and providers have raced to weave AI into their operations, tempted by the opportunity to streamline easily automated operations like billing and communications. However, many have trod more carefully when it comes to patient-facing tools, given the high risk for errors.
The HTI-5 rule, if finalized, would also remove some exceptions to information blocking requirements that could have allowed actors like EHR developers to get around data-sharing rules.
HTI-5 is open for 60 days for public comment. The withdrawal of Biden-era health IT provisions in the HHS’ other proposed rule will be effective as soon as it’s published in the Federal Register, set for Dec. 29.
