On December 13, the Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule, which updates the ONC Health IT Certification Program. The purpose of this final rule was to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.

The CAP’s priority issues in the HTI-1 proposed rule were:

• Laboratory Data Interoperability Request for Information:
  In a June 20 comment letter, the CAP stated that because the laboratory ecosystem is uniquely broad and complex, certification of Laboratory Information Systems (LIS) is not currently feasible. The ONC did not implement LIS certification in this final rule.
• Artificial Intelligence:
  The ONC finalized transparency requirements for the artificial intelligence (AI) and other predictive algorithms that are part of certified health IT. This provision is effective December 31, 2024. The CAP supported this provision.
• USCDI v3:
  The CAP supported the transition from United States Core Data for Interoperability (USCDI) Version 1 to USCDI Version 3. In the Final Rule, the ONC set USCDI Version 3 to replace USCDI Version 1 as the baseline USCDI standard for ONC Certification as of January 1, 2026.
• Patient Requested Restrictions Certification Criterion:
  The CAP had supported the “Patient Requested Restrictions Certification Criterion” as written in the HTI-1 proposed rule. In the final rule, the ONC decided not to finalize most of their proposals for patient requested restrictions at this time.
• Information Blocking: The CAP supported the Information Blocking Provisions but reiterated the need for additional work on Information Blocking rules as it relates to reducing potential patient harm and improving care coordination by allowing some limited blanket delays for specific kinds of tests. In the final rule, the ONC refined its definition of terms such as “offer health IT” and the ONC also revised two exceptions (the Infeasibility and Manner exceptions) and created a new exception to the Information Blocking Rule.

Because the ONC decided to defer any action on laboratory information system (LIS) certification to future rulemaking, the final rule will have minimal direct impact on pathology.