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Confidentiality of Substance Use Disorder (SUD) Patient Records (2024)

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The Confidentiality of Substance Use Disorder (SUD) Patient Records rule is a significant rule issued by the U.S. Department of Health and Human Services effective April 16, 2024, that implemented section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.[1]

HIGHLIGHTS
  • Name: Confidentiality of Substance Use Disorder (SUD) Patient Records rule
  • Action: Final rule
  • Type of significant rule: Other significant rule

    • Timeline

    The following timeline details key rulemaking activity:

    Background

    The CARES Act, specifically Section 3221, enacted statutory changes to increase alignment between regulations protecting Substance Use Disorder (SUD) patient records under Title 42 CFR part 2 and HIPAA regulations governing protected health information. These changes, proposed in a notice of proposed rulemaking on December 2, 2022, aim to enhance confidentiality and disclosure standards for SUD patient records while harmonizing with broader healthcare privacy regulations.[1]

    Summary of the rule

    The following is a summary of the rule from the rule's entry in the Federal Register:[1]

    “ The United States Department of Health and Human Services (HHS or “Department”) is issuing this final rule to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Department is issuing this final rule after careful consideration of all public comments received in response to the notice of proposed rulemaking (NPRM) for the Confidentiality of Substance Use Disorder (SUD) Patient Records. This final rule also makes certain other modifications to increase alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to improve workability and decrease burden on programs, covered entities, and business associates.[2] ”

    Summary of provisions

    The following is a summary of the provisions from the rule's entry in the Federal Register:[1]

    The final rule implements various amendments to regulations governing the confidentiality and disclosure of Substance Use Disorder (SUD) patient records. It includes provisions aligning with statutory changes and HIPAA regulations, such as clarifying the authority for disclosing records under court orders and compelling disclosures necessary for enforcement. Additionally, it establishes procedures for civil and criminal penalties, patient complaints, record disposition, notice requirements, patient access to records, security measures, and disclosures for public health and research purposes. The rule aims to enhance privacy protections while balancing the needs of healthcare operations and law enforcement.

    Significant impact

    See also: Significant regulatory action

    Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.

    Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]


    The text of the Confidentiality of Substance Use Disorder (SUD) Patient Record states that OMB deemed this rule significant, but not economically significant:

    “ The Office of Management and Budget (OMB) has determined that this proposed rule is a significant regulatory action under section 3(f) of E.O. 12866, but not under section 3(f)(1).[2] ”

    Text of the rule

    The full text of the rule is available below:[1]

    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 Federal Register, "Confidentiality of Substance Use Disorder (SUD) Patient Records," February 16, 2024
    2. ↑ 2.0 2.1 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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