On Nov. 28, 2022, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) and the Office for Civil Rights (“OCR”), both agencies within the U.S. Department of Health and Human Services (“HHS”), provided notice of proposed rulemaking seeking comments from the public regarding updates to the regulations known as “Part 2” – the short name for the regulations at 42 C.F.R. Part 2 that address confidentiality of patient records in the context of substance use disorders. Though announced, the proposed rules will not be published in the Federal Register until Dec. 2, 2022. The HHS website includes a summary list of the proposed changes to Part 2, including updates to consent requirements, redisclosure permissions, patient rights, enforcement and others.
These changes are more than two years in the making. The CARES Act, which became law on March 27, 2020, includes language amending the statute underlying Part 2 to bring it more into line with HIPAA’s Privacy Rule. The CARES Act required promulgation of regulations amending Part 2 to take effect no earlier than the end of March 2021. On July 15, 2020, SAMHSA published a final rule in the Federal Register updating Part 2 (with a fact sheet that summarizes those changes). The July 2020 changes to Part 2 had been in development for years before the enactment of the CARES Act, with proposed rulemaking dating back to early 2016. On April 9, 2021, SAMHSA released a statement that SAMHSA and OCR were working on proposed rulemaking to implement regulatory changes to Part 2 in response to the CARES Act. Since the April 2021 statement, there had not been a further update on the efforts until the Nov. 28 announcement.
Comments are due 60 days after publication in the Federal Register.