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Office for Civil Rights Announces Civil Enforcement Program for Confidentiality of Substance Use Disorder Patient Records

HIPAA confidentiality under the new SUD requirements

Landmark Enforcement Program for Substance Use Disorder (SUD) Records

The U.S. Department of Health and Human Services Office for Civil Rights announced a new enforcement program. This program protects the confidentiality of substance use disorder patient records. OCR will enforce statutory and regulatory requirements under federal law.

This program introduces civil enforcement for covered substance use disorder programs for the first time. HHS will enforce safeguards to protect substance use disorder patient records. Patients deserve treatment without sacrificing privacy or legal protections.

The program enforces confidentiality provisions under section 3221 of the CARES Act. The regulation appears at 42 CFR Part 2.
Covered entities must comply with all requirements beginning February 16, 2026.

  • OCR may investigate entities that fail to protect substance use disorder patient records.
  • Penalties applied will be consistent with HIPAA Privacy, Security, and Breach Notification Rules.
  • Resolution agreements may be implemented to resolve violations.
  • Civil monetary penalties for noncompliance may be applied.
  • Corrective action commitments may also be applied.
  • HIPAA Notice of Privacy Practices may need to be updated.

Compliance will improve care coordination among providers and strengthen patient confidence in substance use disorder treatment providers.

Beginning February 16, 2026, OCR will accept complaints alleging confidentiality violations. Entities may access resources at the HHS OCR Part 2 webpage.

This program supports national policy objectives under Executive Order 14379.
The initiative addresses addiction through treatment, recovery, and self-sufficiency.

Section 3221 of the CARES Act aligns substance use disorder privacy standards with HIPAA standards.
It also aligns standards with the HITECH Act. This rule updated confidentiality protections under 42 CFR Part 2. This rule improves coordination among treating providers. Strengthens confidentiality protections through civil enforcement.
It also improves integration of behavioral health information and improved patient health outcomes.

Aris Medical Solutions helps medical practices and business associates understand HIPAA expectations and reduce risk – step by step.

Our HIPAA Keeper™ was designed to help organizations:

  • Understand where they stand
  • Organize required documentation
  • Maintain compliance over time
  • Be prepared if questions ever arise

Additionally, you will have a HIPAA security analyst to guide and assist you when you need help.

To find out where you stand with your compliance, schedule a free HIPAA checkup today at Aris Medical Solutions.

About Suze Shaffer

Suze Shaffer is the Owner and President of Aris Medical Solutions, a healthcare compliance company dedicated to simplifying HIPAA compliance. Through its online compliance solution, the HIPAA Keeper™, Aris Medical Solutions provides healthcare providers and business associates with the tools, documentation, training, and expert guidance needed to achieve and maintain HIPAA compliance.

Through the HIPAA Keeper™, Aris has assisted organizations nationwide with conducting risk analyses, developing risk management plans, implementing HIPAA Privacy and Security policies and procedures, and strengthening safeguards for protected health information. Aris Medical Solutions also considers applicable federal and state privacy and security requirements to help clients build a more comprehensive compliance program.

Suze is also a speaker and has presented at numerous conferences and professional events on HIPAA compliance, cybersecurity, risk management, and data breach prevention. Helping organizations understand their responsibilities and identify vulnerabilities before they result in a breach, audit, or investigation. She believes effective compliance begins with education. By helping organizations understand not only what they are required to do, but why those safeguards are important, organizations are better prepared to protect patient information and reduce their compliance risks.

At Aris Medical Solutions, the mission is simple: “Simplifying HIPAA” through education, expert guidance, and the HIPAA Keeper™, Aris Medical Solutions helps organizations turn complicated compliance requirements into a manageable, ongoing process.

The information provided reflects regulatory requirements and guidance available at the time of writing and is intended for educational purposes only. It should not be considered legal advice.

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