HHS Fact Sheet – 42 CFR Part 2 Final Rule 

U.S. Department of Health and Human Services (HHS) Notification

On February 8, 2024, the U.S. Department of Health & Human Services (HHS) through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights (OCR) announced final rule changes to 42 CFR Part 2 (“Part 2”), the federal law that protects the confidentiality of substance use disorder (SUD) treatment records. The changes in the final rule implement provisions of the CARES Act (enacted March 27, 2020), which required HHS to align certain aspects of Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules and the Health Information Technology for Economic and Clinical Health Act (HITECH).

This HHS Fact Sheet provides further information about the final rule changes.

Key Points

The New Part 2 Rule modifications:

  • Include changes to patient consent requirements
  • Permit disclosures without patient consent to public health authorities according to the standards under HIPAA
  • Restrict the use of records and testimony against patients without consent or a court order
  • Add a right to file a complaint directly with the Secretary for an alleged violation of Part 2
  • Change the requirements for segregating Part 2 data
  • Align enforcement and imposition of penalties with HIPAA
  • Apply the same breach notification requirements found in HIPAA
  • Align patient notice of privacy practices with HIPAA
  • Create safe harbor requirements
  • Create a right for patients to opt out of fundraising communications