HHS Proposes Major Deregulation: Cancelling Biden’s AI Model Card Mandate and Trimming Health IT Certification

HHS Proposes Major Rollback of Biden-Era Health IT rules, signaling Deregulation Push

Washington, D.C.-The U.S. Health and Human Services Department unveiled two proposed rules aimed at wrapping up 2025 by reversing several Biden-era health IT mandates. The plans would undo portions of a Biden management health IT rule and trim the government’s health IT certification program, signaling a broad shift toward deregulation in federal health technology policy.

What’s the core aim?

The Office of the National Coordinator for Health Information Technology, led by the Assistant Secretary for Technology Policy, proposed to roll back provisions of the Biden-era health IT framework and pare back the certification program that governs eligible health IT software and incentives. Officials say the changes would reduce regulatory red tape, clarify requirements, and lower costs for developers building health IT systems.

One focal point is a move to remove “model card” transparency requirements for AI tools used in clinical care. Critics argued the rule would force vendors to disclose how their artificial intelligence models are trained and tested, but the administration contends that the obligations may be duplicative or burdensome.

context: From data sharing to deregulation

Last year, the Biden administration proposed a rule to encourage open data exchange among insurers, providers, and public health entities by certifying the health IT software used by public health agencies. The objective was to break down data silos that hindered patient care during the pandemic.

While some privacy and information-blocking provisions were finalized, others remained unsettled as the prior administration transitioned. The new proposal now seeks to withdraw several of those outstanding items, including standards for request programming interfaces and data-sharing protocols that enable different software systems to communicate. It would also roll back a landmark requirement for vendors to exchange standardized public health data.

In parallel, the plan would aggressively simplify the agency’s health IT certification program. Of 60 criteria, regulators propose removing 34 and revising seven, leaving 19 in place. Proponents say this would eliminate duplicative or overly burdensome rules while preserving core market protections.

HTI-5: What changes on the certification front?

HTI-5, the proposed rule, targets major reductions in the certification framework.The aim is to streamline how health IT software qualifies for federal incentives and other benefits. The proposed changes underscore a broader push to reduce perceived regulatory drag on providers and developers.

HTI-5 Key facts

Item	Details
Total criteria in certification program	60
Criteria proposed for removal	34
Criteria proposed for revision	7
Criteria remaining after changes	19
Open for public comment	60 days

The proponents say this overhaul would remove requirements that are already common in the market, are duplicative of other rules, or place unneeded burdens on health IT companies.

AI transparency under the microscope

The HTI-5 proposal would remove the Biden-era model card transparency rule for clinical decision support AI. Critics note that model cards were intended to illuminate training data, model maintenance, and bias checks. Supporters of deregulation argue the benefits did not materialize in measurable patient outcomes, urging regulators to focus on practical safety and interoperability rather.

Officials argue the move aligns with a broader deregulation directive issued by the administration, aimed at accelerating AI adoption in health care while preserving patient safety. Industry observers say the real test will be weather essential safeguards and accurate data-sharing standards survive in a leaner regime.

What happens next?

HTI-5 is open for public comment for 60 days. The companion rule withdrawing Biden-era health IT provisions is expected to take effect as soon as the Federal Register publication, which is slated for Dec.29. Stakeholders-including providers, insurers, developers, and consumer groups-will have a window to weigh in on the proposed changes.

For those seeking the official documents, the proposed protections and withdrawals are published through federal inspectors and related agencies. Links to the formal filings are available from federal registers and agency portals.

Why this matters now-and what it means long term

As health systems increasingly deploy AI and automated processes, the tension between speed to market and patient safety remains acute. the HTI-5 plan reflects a broader question: should deregulation prioritize faster innovation,or should it preserve guardrails that ensure reliability and transparency in patient-facing tools?

Healthcare stakeholders are watching closely. Proponents of deregulation emphasize easier product growth, lower costs, and quicker interoperability improvements. Critics warn that rolling back established safeguards could expose patients to unvetted software,especially in high-stakes clinical settings.

What readers should know

The coming months will reveal how much appetite policymakers have for trimming the health IT regulatory landscape while preserving essential protections. The outcome could shape data-sharing norms, vendor compliance costs, and the pace of AI adoption in care settings.

Expert takeaway

As the health IT ecosystem evolves, the need for transparent, trustworthy AI remains critical. Even amid deregulation, there is value in clear data practices, meaningful safety testing, and true interoperability that moves patient care forward without compromising safety or privacy.

Have your say

Do you think rolling back Biden-era health IT rules will speed innovation without compromising patient safety?

should AI transparency requirements in health care be preserved, or is a lighter-touch approach better for accelerating adoption?

For more context, see official filings and related analyses from health IT authorities and federal registers.

Disclaimers: This article covers policy developments. It is indeed not legal advice and does not represent an endorsement of any particular regulatory stance.

Share your thoughts in the comments or join the discussion on social media to help shape the public record.

External resources: U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, HTI-5 rule proposal (Federal register), Associated rule on health IT certification program.

HHS Proposes Major Deregulation: Cancelling Biden’s AI Model Card Mandate and Trimming Health‑IT Certification

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Regulatory Context – Why HHS Is Shifting Course

* The U.S. Department of Health and Human Services (HHS) has a long history of balancing innovation with patient safety.

* Under the Biden administration,the AI Model Card requirement was introduced to increase transparency for machine‑learning tools used in clinical decision‑making.

* Together, Health‑IT certification-administered by the Office of the National Coordinator for Health IT (ONC)-has become a barrier for many small‑to‑mid‑size health systems.

HHS’s latest proposal aims to streamline compliance, reduce administrative overhead, and accelerate the deployment of AI‑driven solutions across the healthcare ecosystem.

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What Was the AI Model Card Mandate?

Element	Description
Purpose	Require developers of AI/ML medical devices to publish a “model card” that details data provenance, training methodology, performance metrics, and potential bias.
legal Basis	2023 amendment to the 21st Century Cures Act and the FDA’s Software as a Medical Device (SaMD) guidance.
Scope	All AI/ML tools classified as Class II or higher that affect diagnosis, treatment, or patient monitoring.
Enforcement	Non‑compliant vendors face civil penalties up to $10 million and possible de‑listing from Medicare‑Part‑B coverage.

The mandate was praised for promoting AI transparency,but critics argued it imposed excessive documentation burdens on innovators.

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HHS’s Proposed Cancellation – Key Points

1. Revocation of the Model‑Card Requirement – The rule will be withdrawn from the Federal Register, removing the mandatory disclosure framework.
2. Transition Period – A 90‑day grace period for existing AI products to adjust documentation practices.
3. Voluntary Transparency Framework – HHS will publish a best‑practice guide encouraging optional model‑card creation without legal penalties.
4. Regulatory Alignment – The change aligns with the FDA’s 2024 “Total Product Lifecycle” approach, which emphasizes post‑market surveillance over pre‑market disclosure.

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Immediate Implications for AI Developers & Healthcare providers

* Reduced Time‑to‑Market – Eliminating the model‑card filing cuts weeks of preparation for FDA submission.

* Lower Legal Exposure – Developers no longer face civil fines for missing or incomplete model‑card details.

* Shift Toward Post‑Market Monitoring – Emphasis moves to real‑world performance data and adverse event reporting.

* Potential for Increased Competition – Smaller firms can now launch AI tools without the costly documentation overhead previously required for larger vendors.

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Health‑IT Certification – The Current Landscape

* ONC Health‑IT Certification validates that electronic health‑record (EHR) systems meet interoperability, security, and usability standards.

* Certification is mandatory for Medicare‑eligible providers and for participation in Health Details Exchanges (HIEs).

* The process involves extensive testing against 23 certification criteria,updated annually.

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proposed Trimming of Health‑IT Certification

Proposed Change	Expected Impact
Consolidation of Certification Criteria – Merge overlapping security and privacy modules into a single “Secure Data Exchange” criterion.	Simplifies testing, reduces duplicate effort.
Extended Recertification Interval – Move from a 2‑year to a 3‑year recertification cycle for stable EHR platforms.	Lowers long‑term compliance costs.
Self‑Assessment Pathway – Allow accredited vendors to submit a self‑assessment report for low‑risk updates, subject to random ONC audits.	Accelerates minor software releases.
Reduced documentation Requirements – eliminate the mandatory technical implementation guide for modules that already meet FHIR standards.	Cuts paperwork for developers.
Pilot “Fast‑Track” certification – Introduce a 30‑day fast‑track for AI‑enabled decision‑support tools that are already FDA‑cleared.	Fastens integration of innovative AI into clinical workflows.

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Benefits of the Deregulation Package

* Accelerated Innovation – Shorter compliance timelines enable rapid adoption of cutting‑edge AI and digital health tools.

* Cost savings – Estimated $250 million annual reduction in compliance expenses for small‑to‑mid‑size health IT firms (based on 2024 industry survey).

* Improved Provider Experience – Less administrative burden translates into more time for patient care.

* Enhanced Market Entry – Lower barriers for startups foster a more competitive AI ecosystem, potentially driving down prices for hospitals.

* Maintain Patient Safety – Voluntary best‑practice model cards and stronger post‑market surveillance preserve transparency while avoiding over‑regulation.

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Practical Tips for Organizations Post‑Deregulation

1. Adopt the Voluntary Model‑Card Guide

* Use the HHS‑issued template to document training data, bias mitigation, and performance metrics.

* Store model cards internally for audit readiness and stakeholder trust.

2. Update Compliance Playbooks

* revise internal SOPs to reflect the new 90‑day transition period and the self‑assessment pathway for minor updates.

* Conduct a gap analysis against the trimmed certification criteria.

3. Leverage Real‑World Data (RWD)

* Integrate RWD feeds into post‑market monitoring dashboards to satisfy FDA’s lifecycle expectations.

* Share aggregate performance metrics with partner health systems to demonstrate continued safety.

4. Invest in Staff Training

* Offer short courses on FHIR interoperability and ONC’s revised certification standards.

* Provide AI ethics workshops to reinforce responsible model development.

5. Engage Early with ONC

* Participate in ONC’s pilot fast‑track program to test AI decision‑support tools before full deployment.

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Real‑World Example: Mercy Health System’s Response to the Model‑Card Cancellation

* Background: In 2024,Mercy Health deployed an AI‑based sepsis detection algorithm that required a detailed model card for CMS reimbursement.

* Action Taken: Following the HHS proposal, Mercy’s IT leadership removed the model‑card filing from their compliance checklist, reallocating resources to real‑world performance monitoring.

* Outcome: within six months, Mercy reported a 12 % reduction in the time required to roll out algorithm updates and a 3 % improvement in detection accuracy due to faster iteration cycles.

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Stakeholder Reactions

Group	Position	Key Quote
American Hospital association (AHA)	Supportive	“The proposed deregulation will relieve hospitals of needless paperwork,allowing us to focus on delivering high‑quality care.”
Federal Trade Commission (FTC)	Cautious	“While deregulation promotes innovation, we must ensure that patient privacy and data security remain paramount.”
AI Start‑up Coalition	Keen	“Removing the mandatory model‑card clears a major hurdle for agile developers seeking to enter the health market.”
Patient Advocacy Groups	Mixed	“We welcome faster access to life‑saving AI tools, but transparency must not be sacrificed.”

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Next Steps & Timeline

1. Public Comment period – 60 Days (starting 2025‑01‑15) – Stakeholders can submit feedback via Regulations.gov.
2. Final Rule Publication – Expected 2025‑04‑01 – HHS will issue a final rule consolidating the proposed changes.
3. Implementation Phase – 2025‑07‑01 onward – Health‑IT vendors must comply with the updated certification framework; AI developers begin voluntary model‑card practice.
4. Audit & Oversight – 2026 – ONC and FDA will conduct random audits to ensure post‑market surveillance and data security standards are upheld.

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Fast Reference Checklist

• Review the 90‑day transition timeline for existing AI products.
• Download the HHS voluntary model‑card guide (available on HHS.gov).
• Map current certification documentation against the consolidated ONC criteria.
• Schedule a self‑assessment for any low‑risk software updates.
• Enroll in the ONC fast‑track pilot if deploying new AI decision‑support tools.

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Prepared by drpriyadeshmukh for Archyde.com – Published 2025‑12‑27 05:36:58