Issued2024-12-16

HTI-2 Final Rule – Trusted Exchange Framework and Common Agreement (TEFCA)

Final RuleSector

Summary

Final rule implementing selected TEFCA-related proposals from the HTI-2 proposed rule. The rule amends information-blocking regulations by adding definitions related to the TEFCA Manner Exception, establishes 45 CFR Part 172 provisions governing TEFCA, supports reliability, privacy, security, and trust within TEFCA, and makes limited administrative updates to the ONC Health IT Certification Program.

Healthcare Implications

Strengthens the nationwide health-information exchange infrastructure that AI-enabled tools, analytics systems, and clinical workflows depend on for access to interoperable electronic health information. The rule is not AI-specific, but it affects health IT developers, health information networks, providers, and other actors by clarifying TEFCA governance and information-blocking rules that shape how health data can be accessed, exchanged, and used.

Impact Level

Medium

Keywords

Transparency & Governance; Privacy & Data; Safety & Risk

Stakeholders

Providers & Health Systems; Developers & Vendors; Regulators & Government; Patients & Public