- within Food, Drugs, Healthcare and Life Sciences topic(s)
- in United States
The Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), released the Health Data, Technology, and Interoperability: ASTP/ONC Deregulation Actions to Unleash Prosperity (HTI-5) Proposed Rule on December 22, 2025. This proposed rule represents one of the most significant rollbacks of federal health IT regulation in recent years, eliminating 34 of 60 certification requirements and revising seven others and in effect would alter nearly 70% of the ASTP/ONC's existing requirements. The deregulatory rule is considered an explicit effort to carry out President Trump's Executive Order 14192, "Unleashing Prosperity Through Deregulation." The proposed rule seeks to reduce burdens, offers flexibility to both developers and providers, and supports innovation through the removal and revision of certain certification criteria and regulatory provisions. The proposed rule also looks to address reported misuse and abuse of information blocking definitions and exceptions.
The 60-day comment period is due to expire on February 27, 2026. There is still a short window of opportunity left on the comment period, so healthcare organizations, health IT developers, providers, and other stakeholders should carefully evaluate the impact of these changes and consider submitting comments if interested in doing so.
Key Provisions of the HTI-5 Proposed Rule
- Certification Program Streamlining: The proposed rule would dramatically reduce the Health IT Certification Program requirements. Changes to the requirements include the removal of 34 of 60 certification criteria for electronic health record (EHR) systems and the revision of seven additional certification criteria. The proposed rule would also eliminate model card requirements for clinical decision support (CDS) algorithms introduced during the Biden administration.
- Information Blocking Revisions: The new rule proposes updating information blocking regulations to address reported misuse and abuse of definitions and exceptions. The rule would revise definitions to better promote electronic health information (EHI) access, exchange, and use. It would update exceptions to the information blocking prohibition, clarify when activities do not constitute information blocking, and work to ensure patients' access to their data is not improperly blocked.
- AI and Interoperability Focus: The rule emphasizes building a foundation for AI-enabled healthcare. It would advance Fast Healthcare Interoperability Resources (FHIR) based Application Programming Interfaces (APIs) to promote AI-enabled interoperability solutions, reduce Biden-era AI transparency requirements, and modernize standards and certifications to support AI innovation.
Parallels and Implications with the Cures Act
The HTI-5 proposed rule builds upon, and in some ways, reverses direction from the regulatory framework established by the 21st Century Cures Act of 2016.
Both the Cures Act and HTI-5 prioritize promoting seamless interoperability of health information, ensuring patients have access to their EHI, preventing information blocking practices that interfere with data exchange, and advancing health IT standards and certification programs.
However, there is a critical tension between the Cures Act and HTI-5 when it comes to transparency and innovation. The Cures Act established extensive certification requirements, mandatory information blocking prohibitions, and detailed standards. HTI-5 proposes to remove requirements deemed redundant or burdensome. The new rule shifts from prescriptive oversight to voluntary standards adoption and market-driven innovation, particularly for AI technologies.
The Cures Act emphasized transparency in the way health IT functions, while HTI-5 prioritizes reducing barriers to AI adoption.
Implications for Health IT Developers and Vendors
- Reduced Compliance Burden: If finalized, HTI-5 is projected to save the industry over $1 billion. Developers should review which certification requirements will be eliminated and, if necessary, plan or revise development roadmaps accordingly. On its face, there does not appear to be any additional costs to comply with the new rule or to maintain the current certifications. Developers may want to evaluate ways they can redeploy the resources previously earmarked for complying with and maintaining their certification requirements into developing new technology and using AI tools to accelerate such development.
- Competitive Dynamics: As intended, reduced barriers to entry would likely increase competition in the health IT marketplace. Established vendors should review how to enhance their products and marketing strategies in anticipation of the increased competition.
- AI Innovation Opportunity: The emphasis on AI-enabled interoperability and removal of model card requirements creates opportunities for AI product development. However, developers should monitor how the reduction of transparency requirements affects market acceptance and potential liability.
Implications for Healthcare Providers and Health Systems
- Information Blocking Clarity: The proposed revisions to information blocking exceptions are intended to provide greater clarity on permissible activities. Providers should review updated definitions to ensure compliance with refined standards.
- Vendor Selection Impacts: Changes to certification requirements may affect EHR procurement decisions. Providers should engage vendors early to understand how certification changes will impact system capabilities, particularly for interoperability and patient data access.
- Continuing Obligations: Providers remain subject to information blocking prohibitions under the Cures Act and must continue providing patients with timely, free access to their EHI.
Conclusion
The HTI-5 proposed rule represents a fundamental recalibration of federal health IT policy, moving from the prescriptive regulatory framework of the Cures Act toward a deregulatory model emphasizing market-driven innovation and AI advancement. While the rule promises significant cost savings and reduced administrative burden, it also raises important questions about transparency, patient safety, and the balance between innovation and accountability.
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