The Final Part 2 Rule: HIPAA & Beyond for Substance Use Disorder Confidentiality


Written by Jessica Zeff @ Simply Compliance


Health and Human Services (HHS) issued a pivotal update with the finalization of the Confidentiality of Substance Use Disorder Patient Records regulation, often referred to as the Final Part 2 Rule, on February 16. This rule revises 42 C.F.R. Part 2 and introduces significant changes aimed at both aligning with existing privacy standards under HIPAA and the Health Information Technology for Economic and Clinical Health Act, and establishing additional protections unique to substance use disorder (SUD) records.

Harmonization with HIPAA

One of the most noteworthy aspects of the Final Part 2 Rule is its steps toward harmonization with the Health Insurance Portability and Accountability Act (HIPAA). Previously, Part 2 programs were primarily governed by more stringent confidentiality requirements compared to general medical records, reflecting the sensitive nature of SUD treatment records. The new rule changes include:

Breach Notification: Part 2 programs are now subject to HIPAA’s breach notification obligations, which means they must inform patients and federal entities about unauthorized disclosures of protected health information, aligning with HIPAA’s emphasis on patient privacy and security.

Consent Provisions: The rule simplifies the patient consent process by introducing a one-time consent form that can cover all future uses and disclosures for treatment, payment, and healthcare operations (TPO), mirroring HIPAA’s authorization practices. This adjustment significantly reduces the administrative burden on healthcare providers while still protecting patient rights.

Beyond HIPAA: Additional Safeguards

While the Final Part 2 Rule makes strides in aligning with HIPAA, it also introduces specific provisions that extend beyond the typical HIPAA requirements:

Protection for SUD Counseling Notes: The rule introduces a new category of protected information termed “SUD counseling notes.” These notes are akin to psychotherapy notes under HIPAA but are subjected to even stricter confidentiality measures. They must be kept separate from other medical records and cannot be accessed without explicit, separate consent from the patient, safeguarding the delicate nature of SUD therapy discussions.

Redisclosure Regulations: Under the new rule, if a patient consents to the use of their data for TPO purposes, this information may be redisclosed in line with HIPAA regulations. This is a significant shift from previous Part 2 regulations, which were more restrictive about the redisclosure of SUD treatment information.

Legal Protections: The rule maintains that SUD records cannot be used in civil, criminal, or administrative proceedings without a separate written consent from the patient, emphasizing the protection of individuals in recovery.

Implementation and Compliance

HHS has provided a two-year compliance window for Part 2 programs to adapt to these new regulations. This period is critical for entities previously not covered by HIPAA, as these changes represent a substantial compliance shift. Additionally, the rule recognizes the evolving nature of healthcare delivery and the integration of health information technologies by facilitating better coordination and integration of SUD treatment information within the broader healthcare system.


The Final Part 2 Rule represents a significant development in the confidentiality and accessibility of substance use disorder treatment records. By aligning closer with HIPAA while also introducing new safeguards specific to SUD records, HHS is acknowledging the unique needs of this patient population. For healthcare compliance professionals, understanding and implementing these changes is crucial for ensuring that SUD patients receive the care they need while maintaining their right to privacy.