The Assistant Secretary for Technology Policy’s proposed HTI-2 rule had several ambitious components related to public health, imaging interoperability, USCDI Version 4, updated minimum standards code sets, bulk data, prior authorization, API capabilities and other topics. But the abbreviated final rule announced on Dec. 11 contained only TEFCA-related items.
In an e-mail response to a request for more information, an ASTP spokesman said that the scope of the HTI-2 proposed rule and the number of public comments received made it impracticable to finalize the rule in its entirety in a timely manner. “So we (ASTP) focused on a specific set of proposals we could finalize and publish in the Federal Register to be responsive to the public comments. Comments received in response to other proposals from the proposed rule are beyond the scope of this final rule and are still being reviewed and considered for purposes of issuing subsequent final rules, including another potential final rule before the end of this administration. Interested parties should also look out for the publication of the 2024 Fall Unified Agenda in the very near future.”
Of course, it is an open question whether new leadership at HHS in the next administration will take a different approach to data standards, regulation, and TEFCA.
The HTI-2 final rule finalizes certain Trusted Exchange Framework and Common Agreement-related proposals from the proposed rule. It amends the information blocking regulations by including definitions related to the TEFCA Manner Exception. It also implements provisions to support the reliability, privacy, security, and trust within TEFCA.
The rule establishes the processes associated with the qualifications necessary for an entity to receive and maintain designation as a Qualified Health Information Network (QHIN). The final provisions also establish the procedures governing onboarding of QHINs and designation of QHINs, suspension, termination, and administrative appeals to ASTP/ONC. It also codified requirements related to QHIN attestation for the adoption of TEFCA.
The HTI-2 Final Rule makes no changes to the TEFCA Manner Exception and adopts the TEFCA-related definitions as proposed. This means an actor’s practice of limiting the manner in which it fulfills a request for access, exchange, or use of electronic health information to only via TEFCA will not be considered information blocking when the practice follows certain conditions.
