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 matters. However the abbreviated last rule introduced on Dec. 11 contained solely TEFCA-related objects.
In an e-mail response to a request for extra info, an ASTP spokesman mentioned that the scope of the HTI-2 proposed rule and the variety of public feedback obtained made it impracticable to finalize the rule in its entirety in a well timed method. “So we (ASTP) centered on a particular set of proposals we might finalize and publish within the Federal Register to be aware of the general public feedback. Feedback obtained in response to different proposals from the proposed rule are past the scope of this last rule and are nonetheless being reviewed and regarded for functions of issuing subsequent last guidelines, together with one other potential last 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.”
In fact, it’s an open query whether or not new management at HHS within the subsequent administration will take a special method to knowledge requirements, regulation, and TEFCA.
The HTI-2 last rule finalizes sure Trusted Trade Framework and Widespread Settlement-related proposals from the proposed rule. It amends the knowledge blocking rules 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 Info 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 Closing Rule makes no modifications to the TEFCA Method Exception and adopts the TEFCA-related definitions as proposed. This implies an actor’s follow of limiting the style by which it fulfills a request for entry, change, or use of digital well being info to solely by way of TEFCA is not going to be thought of info blocking when the follow follows sure situations.