The Biden administration is taking a significant step to improve treatment and care coordination for individuals with substance use disorders (SUDs). On Monday, the civil rights office of the U.S. Department of Health and Human Services (HHS), together with the Substance Abuse and Mental Health Services Administration (SAMHSA), issued a notice of proposed rulemaking to update 42 CFR part 2, a federal regulation that governs the privacy of patients receiving SUD treatment. These changes directly impact substance use disorder privacy rules, which have long restricted how providers can share patient information.
Currently, 42 CFR part 2 is designed to protect patient confidentiality, but many healthcare providers and behavioral health advocates argue that these substance use disorder privacy rules have become outdated. The law can make care coordination cumbersome, slow down treatment, and act as a barrier to integrating SUD services with broader healthcare initiatives. A congressional report previously cited 42 CFR part 2 as an obstacle to adopting electronic health records (EHRs), which are critical for modern healthcare.
Nearly all Medicaid managed care plans surveyed by the Institute for Medicaid Innovation indicated that these substance use disorder privacy rules prevent them from fully integrating behavioral health services. As a result, patients often experience fragmented care, delays in treatment, and missed opportunities for early intervention. HHS Secretary Xavier Becerra explained, “Varying requirements of privacy laws can slow treatment, inhibit care, and perpetuate negative stereotypes about people facing substance use challenges. This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure.”
The proposed rule builds on changes mandated by the CARES Act in March 2020, which directed HHS and SAMHSA to revise 42 CFR part 2. Despite this congressional mandate, SAMHSA noted last year that work on the proposed rule was still ongoing, reflecting the complexity of balancing privacy protections with improved care coordination.
Key Provisions of the Proposed Rule
If finalized, the rule would introduce several important changes to modernize substance use disorder privacy rules:
- Single Future-Use Release: Patients would sign one authorization allowing providers to use and disclose their 42 CFR part 2 records for future care purposes, reducing repetitive paperwork.
- Redisclosure Permissions: Certain entities that receive 42 CFR part 2 records could redisclose them under defined conditions, supporting better communication while maintaining privacy.
- Limitations on Court Use: The rule would restrict how 42 CFR part 2 records are used or disclosed in legal proceedings, preventing misuse of sensitive information.
- Patient Rights: Patients would have the right to request an accounting of their records’ disclosures and impose restrictions on how their information is shared.
- Retention of Penalties: Civil and criminal penalties for violations of substance use disorder privacy rules would remain, ensuring accountability.
- Protection of Complaint Rights: Providers could not require patients to waive Part 2 complaint rights as a condition of care.
HHS officials note that these changes aim to bring 42 CFR part 2 closer in alignment with major health information laws, including the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act. Aligning these regulations will make it easier for providers to integrate SUD treatment into broader healthcare services while protecting patient confidentiality.
“One of SAMHSA’s priorities is working to make effective treatments and recovery supports for SUD more accessible to all Americans,” said Miriam Delphin-Rittmon, HHS assistant secretary for mental health and substance use. “Bringing Part 2 requirements into closer alignment with HIPAA will support more effective coordination for people accessing care. At the same time, the proposed rule mitigates the discrimination and stigma that we know too often people with SUDs experience.”
Why This Change Matters
The current substance use disorder privacy rules have far-reaching implications. Patients may hesitate to seek treatment out of concern that sensitive information could be disclosed, and providers struggle to coordinate care across different systems. Updating these rules can ensure privacy while enabling providers to communicate efficiently, integrate care, and improve patient outcomes.
Behavioral health experts argue that the existing substance use disorder privacy rules can inadvertently perpetuate stigma and limit access to treatment. Effective SUD care often requires multiple providers—including therapists, social workers, and primary care physicians—working together. By enabling secure information sharing while protecting privacy, the proposed rule could improve monitoring, interventions, and long-term recovery outcomes for patients.
Next Steps
The proposed rule is now open for public comment, giving patients, providers, and advocacy groups the chance to share their input. After reviewing feedback, HHS will finalize the rule. Until then, the current substance use disorder privacy rules remain in effect.
If enacted, this rule could modernize SUD care, helping providers coordinate treatment while safeguarding patient confidentiality. By updating substance use disorder privacy rules, the federal government aims to make care more accessible, better coordinated, and less stigmatized—paving the way for improved recovery outcomes nationwide.
