February 5, 2023

Volume XIII, Number 36

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February 03, 2023

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HHS Proposes Rule to Align Part 2 Records and HIPAA

On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2) to implement statutory amendments passed under Section 3221 of the Coronavirus Aid, Relief, and Economics Security (CARES) Act (42 U.S.C. 290dd-2). Comments are being accepted for 60 days from publication.

HHS indicates in the proposed rule that the current confidentiality provisions under Part 2 (which Part only applies to SUD treatment records as defined in the Part)  differ from those of HIPAA and create “dual obligations and compliance challenges” for HIPAA covered entities that maintain both protected health information (PHI) and Part 2 records and, therefore, are responsible for both sets of rules, as well as potential informational barriers for treating providers. The proposed changes aim to align the requirements of Part 2 with the HIPAA Privacy Rule to provide greater care coordination so that treatment and recovery supports for SUD are more accessible for patients with SUD challenges.

Key proposed changes align the use and disclosure of Part 2 treatment records with the HIPAA requirements, as follows:

  • Disclosure: A single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations (TPO) of Part 2 records. In addition, revised rules regarding the permitted re-disclosure of Part 2 records consistent with the HIPAA Privacy Rule, subject to certain exceptions.

  • Patient Rights: New patient rights to obtain an accounting of disclosures and to request restrictions on certain disclosures of Part 2 records, and related updates to the HIPAA Privacy Rule Notice of Privacy Practices requirements concerning patient rights and uses and disclosures of Part 2 records. The changes also provide for expanded prohibitions on the use and disclosure of Part 2 records in certain legal proceedings, as well as establishing a process for patients to make complaints for Part 2 violations.

  • Enforcement: New HHS enforcement authority, including the imposition of civil monetary penalties for violations of Part 2.

  • Breach Notification: Updated breach notification requirements to HHS and affected patients.

The proposed compliance date is 24 months following publication of the final rule, thereby providing enough lead time for entities to comply.  We will continue to monitor changes to Part 2 resulting from any final rule issued by HHS.

Copyright © 2023 Robinson & Cole LLP. All rights reserved.National Law Review, Volume XII, Number 334

About this Author

Yelena Greenberg Healthcare Attorney Robinson Cole Law Firm

Yelena Greenberg advises hospitals, academic medical centers, nursing homes, physician groups, and university health centers and clinical programs on a broad range of health law issues. Lena is a member of the firm’s Health Law Group.


Lena advises health care clients on various privacy-based regulatory matters, including compliance with the 

Health Insurance Portability and Accountability Act (HIPAA) and its intersection with the Telephone Consumer Protection Act (TCPA, the Family Education Rights and Privacy Act (FERPA), and the 21st...

Danielle H. Tangorre Attorney Health Law Robinson Cole Law Firm Albany

Danielle H. Tangorre represents and advises a broad range of health care providers, including clinical laboratories, long-term care facilities, behavioral health providers, substance abuse providers, physician group practices and licensed healthcare providers. She is a member of the Health Law Group. 


Danielle advises clients on operational and compliance issues, federal and state fraud and abuse laws, including the Stark law, Anti-Kickback Statute and the Eliminating Kickbacks in Recovery...