HHS Final Rule re: Confidentiality of SUD Patient Records at 42 CFR Part 2

February 8, 2024

HHS has released its final rule regarding modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2 (commonly called “Part 2”). 

In accordance with the bipartisan CARES Act of 2020, the final rule helps to bring Part 2 into alignment with HIPAA. The National Council submitted comment on this proposal last year. 

Specifically, the final rule:

  • Permits use and disclosure of Part 2 records from a single patient consent for all future uses and disclosures for treatment, payment, and health care operations.
  • Aligns Part 2 patient notice requirements with requirements under HIPAA.
  • Permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with HIPAA, with certain exceptions.
  • Establishes HHS enforcement authority, inclusive of penalties for Part 2 violations, and outlines breach notification requirements.

The rule is scheduled to be published in the Federal Register on February 16, 2024 with an effective date 60 days after its publication and a compliance date of February 16, 2026. You can read more at HHS’ final rule fact sheet.