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HHS Releases the HTI-5 Proposed Rule to Modernize the ONC Health IT Certification Program

The US Department of Health and Human Services (HHS), through ASTP/ONC, released the HTI-5 Proposed Rule.

A central component of the HTI-5 Proposed Rule is streamlining the ONC Health IT Certification Program. The proposals would remove over 50% of existing certification criteria and revise several others to reduce redundancy and lower compliance burden. These changes are projected to save certified health IT developers 1.4 million hours in the first year and contribute to an estimated $1.53 billion in total savings over time for developers, providers, and other stakeholders.

The HTI-5 Proposed Rule also includes updates to the information blocking regulations. Drawing from stakeholder feedback, the proposal edits definitions and adjusts several exceptions to reduce the potential for misuse and to strengthen HHS’s ability to ensure patient access to electronic health information.

In addition, the HTI-5 Proposed Rule advances a modern pathway for FHIR®-based APIs and supports the development of AI-enabled interoperability solutions.

The HTI-5 Proposed Rule will be open for public comment for 60 days upon publication in the Federal Register

More on HealthIT.gov → [click.connect.hhs.gov]

ASTP/ONC is also withdrawing certain proposals not yet finalized from the HTI-2 Proposed Rule. 

Read the notice → [click.connect.hhs.gov]

Last Updated: Dec 23, 2025