HHS’s CARES Act Final Rule | Read Full Report March 2024

HHS’s CARES Act Final Rule Better Aligns Part 2 Substance Use Disorder Patient Records Confidentiality Regulations with HIPAA


On February 8, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) jointly issued a final rule to amend the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 C.F.R. Part 2 (Part 2), applicable to certain federally assisted SUD treatment programs (Part 2 Programs), to implement Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The final rule modifies longstanding restrictions under Part 2. It newly permits disclosures of SUD patient records (Part 2 Records) for treatment, payment and health care operations purposes under a general consent and makes other changes to align Part 2’s record requirements with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy, breach notification and enforcement regulations applicable to protected health information (PHI).

OCR Director Melanie Fontes Rainer said, “The Final Rule strengthens confidentiality protections while improving care coordination for patients and providers. Patients can seek needed treatment and care for substance use disorder knowing that greater protections are in place to keep their records private, and providers can now better share information to improve patient care.”

The final rule compliance date is February 16, 2026, giving entities two years to make the necessary updates to their privacy, security and information-sharing practices. For more information about the CARES Act, see this On the Subject. For more information about the proposed rule issued under the CARES Act, see this On the Subject.