The Assistant Secretary for Know-how Coverage’s proposed HTI-2 rule had a number of bold parts associated to public well being, imaging interoperability, USCDI Model 4, up to date minimal requirements code units, bulk knowledge, prior authorization, API capabilities and different subjects. However the abbreviated ultimate rule introduced on Dec. 11 contained solely TEFCA-related objects. 

In an e-mail response to a request for extra info, an ASTP spokesman stated that the scope of the HTI-2 proposed rule and the variety of public feedback acquired made it impracticable to finalize the rule in its entirety in a well timed method. “So we (ASTP) targeted on a particular set of proposals we may finalize and publish within the Federal Register to be aware of the general public feedback. Feedback acquired in response to different proposals from the proposed rule are past the scope of this ultimate rule and are nonetheless being reviewed and thought of for functions of issuing subsequent ultimate guidelines, together with one other potential ultimate rule earlier than the top of this administration. events also needs to look out for the publication of the 2024 Fall Unified Agenda within the very close to future.”

After all, it’s an open query whether or not new management at HHS within the subsequent administration will take a unique strategy to knowledge requirements, regulation, and TEFCA. 

The HTI-2 ultimate rule finalizes sure Trusted Change Framework and Frequent Settlement-related proposals from the proposed rule. It amends the data blocking laws by together with definitions associated to the TEFCA Method Exception. It additionally implements provisions to assist the reliability, privateness, safety, and belief inside TEFCA. 

The rule establishes the processes related to the {qualifications} crucial for an entity to obtain and keep designation as a Certified Well being Data Community (QHIN). The ultimate provisions additionally set up the procedures governing onboarding of QHINs and designation of QHINs, suspension, termination, and administrative appeals to ASTP/ONC. It additionally codified necessities associated to QHIN attestation for the adoption of TEFCA. 

The HTI-2 Remaining Rule makes no adjustments to the TEFCA Method Exception and adopts the TEFCA-related definitions as proposed. This implies an actor’s apply of limiting the style through which it fulfills a request for entry, alternate, or use of digital well being info to solely by way of TEFCA won’t be thought-about info blocking when the apply follows sure circumstances.