ONC Final Rule Updates Health IT Certification for Interoperability

An ONC final rule scheduled for publication on January 9, 2024, will make several updates to the ONC Health IT Certification Program to advance interoperability.

The “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” final rule implements the EHR Reporting Program provision of the 21st Century Cures Act by creating new conditions for health IT developers under the Health IT Certification Program.

For instance, the final rule implements the Cures Act’s requirement to adopt an “Insights Condition” for certified health IT developers to report certain metrics as part of participation in the ONC Health IT Certification Program. The metrics aim to give ONC more insight into how organizations use certified health IT.

Additional program updates include revised certification criteria for “decision support interventions,” “patient demographics and observations,” and “electronic case reporting.”

The final rule also requires certified health IT developers to update to the United States Core Data for Interoperability (USCDI) Version 3 standard as of January 1, 2026. USCDI v3 includes updates focused on advancing more accurate and complete patient data that aims to promote equity, reduce disparities, and support public health interoperability.

Additionally, the final rule aims to enhance health information exchange (HIE) under the information blocking regulations. The enactment of these provisions is set to advance interoperability, improve algorithm transparency, and support the access, sharing, and use of electronic health information (EHI).

The requirements aim to make it possible for clinical users to access a baseline set of information about the algorithms they use to drive decision-making and the assessment of algorithms for fairness, appropriateness, validity, effectiveness, and safety.

This final rule also updates several technical standards in the ONC Health IT Certification Program to drive interoperability, enhance health IT certification, and mitigate burden and costs for health IT developers and end-users.

The effective date for the final rule is 30 days after publication in the Federal Registrar.