On August 25, 2025, the U.S. Department of Health and Human Services (“HHS”) delegated the administration and enforcement (the “Delegation”) of 42 C.F.R. Part 2 (“Part 2”), the federal rules governing the confidentiality and...more
On April 4, 2024, a final rule published on February 2, 2024 (the Final Rule) went into effect that concerns medication for the treatment of opioid use disorder. The Final Rule, published by the Substance Abuse and Mental...more
On February 8, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) jointly issued a final rule to amend the...more
The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance...more
On February 2, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that expands access to medications for the treatment of opioid use disorder (OUD) via telehealth modalities and “take-home” doses....more
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) released its anticipated Final Rule last week. The Final Rule revises...more
After more than a year since the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued the proposed changes to the...more
The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more
On February 8, 2024, the federal Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2 (Part 2) were revised in part to increase patient protection and streamline patient consent...more
On February 8, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), released final rule (Final Rule)...more
This Week in Washington: House assigns members to committees and finalizes committee chairmanships...more
In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary...more
On July 15, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule that, for the third time in as many years, significantly amended its regulations on the confidentiality of...more
Earlier this month, the Substance Abuse and Mental Health Services Administration (SAMHSA) within the U.S. Department of Health and Human Services (HHS) issued a final rule implementing updates to 42 C.F.R Part 2 (Part 2),...more
On July 15, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA), a branch of the U.S. Department of Health and Human Services (HHS), published its much-anticipated final rule to revise 42 C.F.R. Part...more
On July 15, 2020, a final rule revising the federal regulations governing the Confidentiality of Substance Use Disorder Patient Records (also known as 42 C.F.R. Part 2 or Part 2) was published. The revised rule will implement...more
The Situation: The two-year grace period for updating agreements of "lawful holders" (i.e., recipients named on patient consent forms obtained pursuant to the Part 2 Rule) with contractors, subcontractors, and legal...more
In the second episode of our series on the national opioid crisis, Gina Bertolini discusses the overlay of recent guidance concerning privacy laws such as the Health Insurance Portability and Accountability Act (HIPAA) and...more
On Jan. 3, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued its final rule regarding the Confidentiality of Substance Use Disorder Patient Records Part 2. These changes become effective Feb....more
The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule (Rule) updating the Confidentiality of Substance Use Disorder Records, 42 CFR part 2 (Part 2), to expand the circumstances under...more
On January 3, 2018, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) published a final rule (“Final Rule”) to further update the Confidentiality of Substance Use Disorder Patient Records regulations...more
A final rule from the Substance Abuse and Mental Health Services Administration establishes requirements for the exchange of patient information between substance abuse treatment programs and their agents and contractors. ...more
A final rule published on January 18 implements the first major revisions to the federal regulations governing the confidentiality of substance-use disorder patient records (Part 2) since 1987. It finalizes a proposal from...more