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

Aligning Part 2 More Closely With HIPAA, New Enforcement Authorities and Penalties, Preparing for Compliance

A live 90-minute CLE video webinar with interactive Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Thursday, May 23, 2024 (in 5 days)

1:00pm-2:30pm EDT, 10:00am-11:30am PDT

or call 1-800-926-7926

This CLE webinar will provide an in-depth look at the U.S. Department of Health and Human Services' Office for Civil Rights and Substance Abuse and Mental Health Services Administration (HHS-OCR-SAMHSA) long-awaited final rule that overhauls the federal Part 2 regulations on the confidentiality of substance use disorder (SUD) patient records. The panel will examine the extensive modifications that have been made to align Part 2 requirements more closely with HIPAA and will discuss the impact on Part 2 Programs and other healthcare providers, including those who are not regulated by HIPAA as covered entities. The panel will also offer best practices on preparing for compliance.


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.



  1. Introduction: rule history
  2. HHS-OCR-SAMHSA final rule
    1. Patient consent
    2. Patient rights and notice
    3. Other uses and disclosures
    4. Segregation of Part 2 data
    5. New definitions
    6. Safe harbor for investigative agencies
    7. Penalties and enforcement
    8. Breach notification
    9. Patient complaints
    10. Additional considerations
  3. Assisting clients to prepare for compliance: practitioner takeaways


The panel will review these and other key considerations:

  • How does the final rule differ from the 2022 proposed rule?
  • How does the final rule align Part 2 SUD patient records confidentiality requirements more closely with HIPAA?
  • What impact will the final rule have on Part 2 Program current consent and notice documents? On information management?
  • What should counsel and clients be doing now to prepare for the final rule's implementation?


Pitman, Beth Neal
Beth Neal Pitman

Holland & Knight

Ms. Pitman advises healthcare systems and providers and healthcare information technology (IT) businesses when...  |  Read More

Williams, Eddie
Eddie Williams, III

Holland & Knight

Mr. Williams is experienced in assisting and advising clients with state and federal healthcare regulatory issues...  |  Read More

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You may pre-order a recording to listen at your convenience. Recordings are available 48 hours after the webinar. Strafford will process CLE credit for one person on each recording. All formats include course handouts.

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