HHS 42 CFR Part 2 Rulemaking Fact Sheet

Issuance of the 2022 Notice of Proposed Rulemaking

The U.S. Department of Health and Human Services (HHS), through the Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), has announced proposed changes to the Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 CFR part 2 (“Part 2”). This HHS Fact Sheet describes the proposed changes.

*Please note that all materials on the CoE-PHI website reflect current law.

Key Points

  • HHS announced these changes by issuing a Notice of Proposed Rulemaking (NPRM) published in the Federal Register.
  • The NPRM aims to align Part 2 more closely with certain aspects of the Health Information Portability and Accountability Act (HIPAA).
  • The changes are required by the Coronavirus Aid Relief and Economic Security (CARES) Act of 2020, which amend certain provisions of the statute underlying Part 2.
  • HHS is currently accepting public comments on the proposed rule.
  • The proposed changes to Part 2 will not take effect until the completion of the rulemaking process. Until that time, the current law and regulations continue to apply.