Substance Use Disorder Records Confidentiality: Long-Awaited HHS Final Rule Overhauling Part 2 Regulations

Description

HHS recently finalized its long-awaited rule updating the federal SUD patient records regulations at 42 CFR Part 2, effective Apr. 16, 2024, to more closely align with HIPAA requirements, especially regarding patient consent, notice of confidentiality, and redisclosure of SUD records. While the final rule adopts many of the provisions introduced in the proposed rule, it also makes significant modifications of which counsel should be aware.

Key provisions of the final rule include: (1) changes to patient consent requirements for uses, disclosures, and redisclosures of SUD records; (2) alignment of certain patient rights and notice requirements under Part 2 with those under HIPAA; (3) alignment of Part 2 penalties with civil and criminal enforcement authorities that also apply to HIPAA violations; (4) application of the HIPAA Breach Notification Rule to Part 2 programs with respect to breaches of unsecured SUD records; and (5) the addition of many definitions borrowed in large part from HIPAA definitions and new definitions unique to the final rule including that of SUD counseling notes.

Although the final rule provides an enforcement date 22 months after the effective date, given the expansive scope of the final rule, counsel and their affected clients should prepare for implementation now including evaluating what programs may be subject to Part 2 and the final rule, updating consent policies and forms, updating patient notices, and ensuring that health information management systems are compliant.

Listen as our expert panel provides an in-depth look at HHS's final rule governing Part 2 SUD patient records confidentiality and offers best practices for preparing for compliance.