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ASTP releases HTI-2 final rule to drive interoperability

While the HTI-2 proposed rule included a wide range of initiatives, the final rule focuses on a scaled-back set of proposals related to TEFCA and information blocking.

Through the Assistant Secretary for Technology Policy, HHS has released the Health Data, Technology, and Interoperability: TEFCA (HTI-2) final rule. The HTI-2 final rule finalizes certain proposals related to the Trusted Exchange Framework and Common Agreement (TEFCA) from the HTI-2 proposed rule to advance health data interoperability.

ASTP received approximately 270 comment submissions on the wide range of proposals included in the HTI-2 proposed rule. However, for the purposes of this final rule, ASTP reviewed and responded to comments on a narrowed set of proposals.

In particular, the HTI-2 final rule updates the information blocking regulations to include definitions related to the TEFCA Manner Exception. The rule also applies provisions to support the reliability, privacy, security and trust within TEFCA.

Additionally, the HTI-2 final rule finalizes a new part of the Code of Federal Regulations for provisions related to TEFCA in 45 CFR Part 172. These final provisions aim to implement the Public Health Service Act section 3001(c)(9) as outlined in the Cures Act and give expanded transparency into TEFCA procedures.

An unpublished PDF version of the final rule is available on the Federal Register. HHS will officially publish the final rule on Dec. 16, 2024.

Hannah Nelson has been covering news related to health information technology and health data interoperability since 2020.

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