OCR Issues Part 2 Guidance Ahead of the February 2026 Compliance Deadline

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has released new compliance materials governing the confidentiality of substance use disorder patient records (known as the “Part 2 regulations” as they are codified at 42 C.F.R. Part 2) ahead of the February 16, 2026 compliance date required by the HHS 2024 Final Rule on Confidentiality of Substance Use Disorder (SUD) Patient Records. 

The 2024 final rule better aligns Part 2 regulations with HIPAA regulations in areas where the privacy frameworks previously differed on the requirements for protecting patients substance use disorder records. This release of compliance materials marks the first time OCR has issued such guidance under its expanded enforcement authority. Previously, the Substance Abuse and Mental Health Services Administration regulated compliance with Part 2 regulations but now OCR oversees both HIPAA and Part 2 enforcement. 

For additional context on sharing mental and behavioral health information under HIPAA regulations, see OCR's HIPAA guidance, including facts sheets and FAQs.

Compliance Date Approaching

The key date, as set out in the final rule is February 16, 2026. Beginning on this date, the public may file Part 2 complaints and report breaches, and OCR will initiate investigations and civil enforcement actions. 

OCR has indicated it will provide additional information in a future announcement, including details on how to file Part 2 complaints and breach reports. OCR also plans to release a Model Part 2 Patient Notice and an updated HIPAA Privacy Rule Notice of Privacy Practices.

Reed Smith will continue to monitor these developments. If you have questions about Part 2 updates or related topics, please reach out to the authors of this post or other members of the Reed Smith team.