HHS Slashes Health Data Rules to Unleash Tech Innovation Wave
Published Date: 12/29/2025
Proposed Rule
Summary
This new rule aims to cut red tape around health data technology, making it easier for developers and healthcare providers to innovate and share info. It fixes problems with confusing rules about blocking information and offers more flexibility, saving time and money. Comments on the proposal are open until February 27, 2026, so stakeholders can weigh in before changes take effect.
Analyzed Economic Effects
5 provisions identified: 5 benefits, 0 costs, 0 mixed.
Big Cut to Certification Requirements
The rule would remove 34 certification criteria, revise 7, and retain 19 currently in the ONC Certification Program. HHS estimates a present value of $1.53 billion in cost savings (2024 dollars, discounted at 7%) beginning in 2027 and also estimates $284,132 in reviewer costs for about 644 reviewers. The changes are intended to reduce time and administrative burden for certified health IT developers and clinicians.
Tighter Information-Blocking Rules
The proposal would revise information-blocking rules by removing the 'third party seeking modification' use condition from the Infeasibility Exception and revising or removing the 'manner exception exhausted' condition. It would also revise the Manner Exception to bar contracts that are not market rate, contracts of adhesion, or that contain unconscionable terms, and would remove the TEFCA Manner Exception (subpart D). These changes are framed to reduce misuse that withholds electronic health information (EHI) and to promote access, exchange, and use of EHI.
Definitions Now Cover Automated and AI Access
The proposal would revise the 'access' and 'use' definitions to explicitly include automated means of access, exchange, or use of EHI, 'including, without limitation, autonomous AI systems.' As an alternative, it would also consider similarly revising the 'exchange' definition. This change clarifies that automated and AI-driven access is within the scope of the information-blocking rules.
Adopt USCDI v3.1 and Remove Outdated Standards
The proposed rule would adopt United States Core Data for Interoperability (USCDI) version 3.1 at Sec. 170.213 and remove certain outdated standards referenced by certification criteria. In some cases, the rule would allow a standards transition period until January 1, 2027. These updates are intended to align the Certification Program with current interoperability priorities.
Less Real-World Testing and Reporting Burden
The proposal would descope the 'Real World Testing' Condition and Maintenance of Certification requirements and remove or limit 'Insights' reporting measures, limiting Insights reporting to the 'use of FHIR in apps through certified health IT' measure. These changes align with prior enforcement discretion notices and are intended to reduce reporting and testing burdens on health IT developers.
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Key Dates
Department and Agencies
Related Federal Register Documents
2026-21943, Health Data, Technology, and Interoperability: ONC Deregulatory Actions To Unleash Prosperity
Starting December 28, 2026, new rules will make health tech easier and less costly for developers and healthcare providers by cutting red tape and updating certification standards. These changes help speed up innovation and improve how health data moves between systems, benefiting patients and the industry alike. Some updates kick in January 1, 2027, so everyone has time to adjust and thrive.
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Previous / Next Documents
Previous: 2025-23890, Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Withdrawal
The government is officially pulling back some health data rules they proposed last year, so those changes won’t happen for now. This affects healthcare tech companies, patients, and public health groups who were expecting new ways to share and protect health info. The withdrawal takes effect December 29, 2025, meaning no new costs or changes from these proposals will hit soon.
Next: 2025-23917, Required Use by Foreign Applicants and Patent Owners of a Patent Practitioner
Starting soon, foreign inventors and patent owners will need to work with a registered U.S. patent expert to file or manage their patents. This change helps the USPTO keep things fair, fight fraud, and match rules used in other countries. If you’re affected, get ready to team up with a licensed patent pro by early 2026—no extra fees mentioned yet, but don’t miss the January 28 comment deadline!