CMI briefingHHS OCR / SAMHSABehavioral Health

42 CFR Part 2 — Substance use disorder record privacy

Updated federal privacy rules for SUD treatment records, now more closely aligned with HIPAA than under the prior rule.

42 CFR Part 2 (HHS/SAMHSA final rule issued Feb. 8, 2024; compliance date Feb. 16, 2026) · Updated Nov 5, 2026

This page is CMI's own briefing on the topic, written by CMI. It is not the text of the regulation. Read the regulation itself in the Regulatory hub or at the official source.

What it governs: Confidentiality of substance use disorder (SUD) treatment records maintained by federally assisted programs, a stricter and more specific standard than general HIPAA.

Current rule: HHS (OCR and SAMHSA) issued the final rule aligning Part 2 with HIPAA on February 8, 2024. It took effect April 16, 2024, and the compliance date was February 16, 2026. OCR announced it would accept complaints from that date, and enforcement follows the HIPAA process and penalty structure.

DateEvent
February 8, 2024Final rule issued
April 16, 2024Rule took effect
February 16, 2026Compliance date; OCR began accepting complaints

Key changes:

AreaWhat changed
ConsentA single patient consent may cover all future uses and disclosures for treatment, payment and health care operations. HIPAA-regulated recipients may redisclose in line with the Privacy Rule.
Record segregationPart 2 records no longer need to be segregated from other records.
Breach notificationThe HIPAA Breach Notification Rule applies to Part 2 records.
Notice of Privacy PracticesMust be updated to describe Part 2 protections and patient rights.
Patient rightsPatients can get an accounting of disclosures, request restrictions, and complain to HHS; covered entities must have a complaint process.
ProceedingsUse of records or testimony in proceedings against a patient remains restricted without consent or a court order.

Practical takeaway: Confirm that your NPP, consent form, breach plan and complaint process were updated by February 16, 2026.

Last verified against agency sources on October 30, 2026.

View the official source ↗

General information, not legal advice. Requirements change; confirm against the official source before you act, or ask us how this applies to your organization.