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    Final Rule: 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records

    On February 16, 2024, a final rule revising the federal regulations governing the Confidentiality of Substance Use Disorder Patient Records, 42 CFR Part 2 (Part 2), was released by the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services. The rule will go into effect on April 16, 2024, with a two year implementation period. A U.S. Department of Health and Human Services fact sheet outlining the changes is here and the final rule here (.pdf).  

    This final rule implements the confidentiality provisions of section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which required the alignment of certain aspects of 42 CFR Part 2 with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 Rule and the Health Information Technology for Economic and Clinical Health Act (HITECH).

    Key updates to 42 CFR Part 2 include:

    • Allows a single consent for all future uses and disclosures for treatment, payment, and health care operations.
    • Restricts the use of records and testimony in civil, criminal, administrative, and legislative proceedings against patients, absent patient consent or a court order.
    • Aligns Part 2 penalties with HIPAA by replacing criminal penalties currently in Part 2 with civil and criminal enforcement authorities that also apply to HIPAA violations.
    • Applies the same requirements of the HIPAA Breach Notification Rule to breaches of records under Part 2.
    • Aligns Part 2 Patient Notice requirements with the requirements of the HIPAA Notice of Privacy Practices.
    • Adds an express statement that segregating or segmenting Part 2 records is not required.
    • Creates a new definition for an SUD clinician’s notes analyzing the conversation in an SUD counseling session that the clinician voluntarily maintains separately from the rest of the patient’s SUD treatment and medical record and that require specific consent from an individual and cannot be used or disclosed based on a broad TPO consent. This is analogous to protections in HIPAA for psychotherapy notes.

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