Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (referred to herein as HTI-2 Part 1), and create a new Information Blocking exception under Protecting Care Access (referred to herein as HTI-2 Part 2), published on December 16th and 17th, respectively.
HTI-2 Part 1 focuses on changes to CFR Parts 170 and 171, finalizing updates to the Privacy and Security Framework criterion and certification, information blocking regulations including definitions related to the TEFCA Manner Exception, and several administrative updates. This regulation comes in the wake of recent policy developments released by the Recognized Coordinating Entity in coordination with ASTP/ONC. This rule is effective on January 15, 2025.
HTI-2 Part 2 finalizes proposals related to reproductive health data and information blocking regulations, including modifications to the existing information blocking exceptions (Privacy Exception and Infeasibility Exception) and a new information blocking exception (Protecting Care Access). This rule was effective upon publication.
The release of final rules HTI-2 Parts 1 and 2 is intended to advance interoperability and support the access, exchange, and use of electronic health information. We note that there are a number of proposed changes with regards to health IT certification that were not finalized. We expect that ASTP/ONC will continue to work on these changes with the intent of finalizing them in 2025.
For more information, please see our client alert summarizing the most relevant components of HTI-2 Parts 1 and 2.
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