Comprehensive Analysis of the Health Data, Technology, and Interoperability - Protecting Care Access (HTI-3) Final Rule: Changes from Proposed Rule

The HTI-3 Final Rule incorporates several changes from the original proposed rule to address stakeholder feedback, operational feasibility, and evolving healthcare needs. Below is a detailed breakdown of what was added, removed, or edited compared to the proposed rule:

Changes Introduced in the HTI-3 Final Rule

1. Information Blocking Adjustments

Privacy Exception Updates (§171.202):

• Proposed Rule: Restricted individual-requested limitations to cases where other laws did not mandate sharing.

• Final Rule Change: Broadened to allow individuals to request EHI restrictions regardless of existing legal mandates, as long as the actor complies with sub-exception requirements. This addresses concerns about respecting patient autonomy while aligning with broader privacy goals.

• Removed from Proposed Rule: Requirement for actors to document and justify the decision to honor individual restrictions based on external legal obligations.

Infeasibility Exception Updates (§171.204):

• Proposed Rule: Focused narrowly on technical infeasibilities, such as interoperability challenges.

• Final Rule Change: Expanded the segmentation condition to cover all sub-exceptions under the Privacy Exception and the new Protecting Care Access Exception. This provides flexibility for actors dealing with overlapping or conflicting data-sharing requirements.

• Edited Proposal: Simplified language around segmentation to reduce ambiguity and allow actors more discretion in handling technical limitations.

Protecting Care Access Exception (§171.206):

• Proposed Rule: Introduced as a concept to protect reproductive health information but lacked clear operational definitions.

• Final Rule Change: Codified this as a formal exception with a detailed “good faith belief” standard. Actors are now explicitly protected when withholding EHI to shield patients or providers from legal risks associated with reproductive health care.

• New Addition: Explicit alignment with the definition of “reproductive health care” under 45 CFR 160.103 to ensure standard interpretation across states.

2. Revised Certification Criteria