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April 11, 2023

ONC Announces New ‘HTI-1’ Proposed Rule with Information Blocking Regulation Updates

The Office of the National Coordinator for Health Information Technology (ONC) announced a new proposed rule on April 11, 2023, titled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing.” As noted in an accompanying blog post, ONC plans to refer to future related rules with the shorthand HTI, and this proposed rule is thus given the shorthand “HTI-1.”

In the same blog post, ONC’s Executive Director of Policy provided key HTI-1 proposed rule highlights:

The proposals span the health information technology (health IT) horizon, including proposals on the movement of health information electronically, on new data standards that help ensure that information can be understood when it enters and leaves a system, on electronic case reporting that supports public health and emergency response across the country, and on algorithm transparency so that health IT users have more information about the algorithms enabled by or interfacing with the certified technology they use for care.

The HTI-1 proposed rule also includes the first set of substantive updates to ONC’s information blocking regulations since ONC published its initial set of final information blocking regulations on May 1, 2020. Another newly posted ONC informational webpage characterizes these information blocking regulation updates as “[m]odifying and expanding exceptions in the information blocking regulations to support information sharing and certainty for regulated actors.”

Specific updates to the information blocking regulations (45 CFR 171) in the HTI-1 proposed rule include:

  • New and revised regulatory definitions, including a revised definition of “Information Blocking.”
  • A revised Infeasibility Exception.
  • Updates to the Content and Manner Exception — which would be renamed to “Manner Exception” and include a Trusted Exchange Framework and Common Agreement (TEFCA) manner component.

The HTI-1 proposed rule announcement is a long-awaited information blocking regulation development. At the same time, there is still no final US Department of Health and Human Services Office of Inspector General (HHS OIG) rule for information blocking enforcement (which would finalize HHS OIG’s proposed enforcement rule published on April 24, 2020). However, the HHS OIG final enforcement rule was just listed as received and “pending review”  by the U.S. Office of Information and Regulatory Affairs on April 7, 2023. So, while the text of the HHS OIG final enforcement rule is still unknown, there is confirmation that it is progressing through regulatory drafting and review processes.

The scheduled publication date of ONC’s official HTI-1 proposed rule is April 18, 2023. This publication date also marks the beginning of the public comment period, which will run to 11:59 pm E.T. on June 20, 2023.

We will be reviewing the HTI-1 proposed rule and preamble in further detail and providing additional observations, especially as they relate to information blocking. In the meantime, below are a few links that may be of help as you navigate this proposed rule:

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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