Issued2024-02-16

Confidentiality of Substance Use Disorder Patient Records (42 CFR Part 2)

Final RuleSector

Summary

Aligns Part 2 confidentiality requirements more closely with HIPAA/HITECH pursuant to the CARES Act, allowing a single consent for future treatment, payment and health care operations uses and disclosures, and harmonizing breach-notification and enforcement provisions. The rule protects records in legal proceedings; HHS stated that CARES Act antidiscrimination provisions would be implemented in a separate rulemaking.

Healthcare Implications

AI analytics and decision support using covered SUD records must follow applicable Part 2 consent, redisclosure and legal-proceeding restrictions. Under 42 CFR 2.12(d)(2)(i)(C), a Part 2 program, covered entity or business associate receiving records under a single consent for treatment, payment and health care operations is not required to segregate or segment those records. Compliance with the 2024 final rule was required by February 16, 2026.

Impact Level

Medium

Keywords

Privacy & Data

Stakeholders

Providers & Health Systems; Patients & Public; Regulators & Government