Lexology January 13, 2026
The Department of Health and Human Services (HHS) previously finalized sweeping changes to 42 CFR Part 2 (Part 2), the federal rules protecting the confidentiality of substance use disorder (SUD) records. While designed to improve care coordination by further aligning 42 CFR Part 2 with the Health Insurance Portability and Accountability Act (HIPAA), these changes introduce substantial new compliance obligations for SUD programs regulated under 42 CFR Part 2 (Part 2 Programs) and entities that receive SUD records created by such Part 2 Programs (Lawful Holders). For Part 2 Programs and Lawful Holders that are not Covered Entities and Business Associates under HIPAA, these changes represent a material shift from the status quo. However, HIPAA-regulated entities, including those not operating...
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