As any health care provider who has engaged in the provision of substance use disorder (SUD) treatment can tell you, understanding the application of HIPAA and 42 CFR Part 2 is anything but clear cut. In an effort to alleviate some of the confusion and ultimately remove unnecessary barriers to care, the US Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR) and in coordination with the Substance Abuse and Mental Health Services Administration (SAMHSA), has issued a Notice of Proposed Rulemaking to revise regulations related to the Confidentiality of Substance Use Disorder Patient Records regulations. The NPRM was posted on November 28, 2022 at Federal Register :: Public Inspection: Confidentiality of Substance Use Disorder Patient Records with a scheduled publication date of December 2, 2022.

The SUD treatment privacy regulations found at 42 CFR Part 2 were designed to be intentionally restrictive in order to ensure that individuals seeking treatment are able to do so without the fear of discrimination and/or criminal prosecution. However, in today’s era of more coordinated health care, the SUD treatment privacy regulations often can create an unintended barrier to care for SUD patients by delaying and making the coordination of health care services more difficult. Additionally, confusing for providers are the HIPAA privacy regulations which are not, in several important instances, aligned with 42 CFR Part 2.

In light of the above concerns and in response to the requirements of Section 3221 of the Coronavirus Aid, Relief and Economic Security Act  (CARES Act), the NPRM sets forth proposed solutions for coordination of HIPAA and 42 CFR Part 2, while still ensuring appropriate patient privacy. Public comments on the NPRM are due on or before January 30, 2023.  Interested parties can submit electronic comments at  by searching for the Docket ID number HHS–OCR– 0945–AA16.


This publication is for general information only. It is not legal advice, and legal counsel should be contacted before any action is taken that might be influenced by this publication.

About Gunster

Gunster, Florida’s law firm for business, provides full-service legal counsel to leading organizations and individuals from its 12 offices statewide. Established in 1925, the firm has expanded, diversified and evolved, but always with a singular focus: Florida and its clients’ stake in it. A magnet for business-savvy attorneys who embrace collaboration for the greatest advantage of clients, Gunster’s growth has not been at the expense of personalized service but because of it. The firm serves clients from its offices in Boca Raton, Fort Lauderdale, Jacksonville, Miami, Orlando, Palm Beach, Stuart, Tallahassee, Tampa, Vero Beach, and its headquarters in West Palm Beach. With over 240 attorneys and consultants, and more than 240 committed support staff, Gunster is ranked among the National Law Journal’s list of the 500 largest law firms and has been recognized as one of the Top 100 Diverse Law Firms by Law360. More information about its practice areas, offices and insider’s view newsletters is available at


Find a Professional

by Name

by Practice/Office