The U.S. Department of Health and Human Services (HHS) has recently announced modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations, marking a key development in healthcare. Since its inception in 1975, Part 2 regulations have safeguarded the privacy of individuals dealing with substance use disorders. The latest changes, finalized by the HHS through the Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), highlights a commitment to aligning with contemporary healthcare practices and legislation.
“Patient confidentiality is one of the bedrock principals in health care. People who are struggling with substance use disorders must have the same ability to keep their information private as anyone else. This new rule helps to ensure that happens, by strengthening confidentiality protections and improving the integration of behavioral health with other medical records,” said HHS Secretary Xavier Becerra.
These changes were prompted by legislative shifts, particularly section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. This required the HHS Secretary to align certain aspects of Part 2 regulations with HIPAA and the Health Information Technology for Economic and Clinical Health (HITECH) Act. These legislative changes allowed for a thorough review and adjustment of substance use disorder confidentiality rules.
The finalized changes, influenced by stakeholder feedback from the 2022 Notice of Proposed Rulemaking (NPRM), introduce important revisions to improve patient consent and redisclosure protocols. A key aspect is the permission for the use and disclosure of Part 2 records based on a single patient consent, streamlining future treatment, payment, and operations purposes. The rule also allows HIPAA-covered entities and business associates to share Part 2 records in line with the HIPAA Privacy Rule, representing an advancement in how information is shared.
The final HHS rule transforms enforcement by aligning penalties for Part 2 violations with HIPAA violations, simplifying enforcement for both HHS and SAMHSA. This change not only strengthens confidentiality protections but also introduces new patient rights, allowing them to obtain an accounting of disclosures and request restrictions on certain disclosures. This focus on patient empowerment and accountability demonstrates a thorough understanding of the changes to healthcare, where information privacy and patient involvement are key.
Healthcare professionals must prepare for compliance requirements taking effect two years post-publication as the final rule is set to be published in mid-February. The commitment from HHS to provide support for implementation and enforcement, coupled with the issuance of further guidance, highlights the importance of a smooth transition. This commitment is further emphasized by the HHS’s dedication to issuing additional guidance, providing healthcare professionals with the necessary resources and information to manage and comply with the new regulations seamlessly. Recognizing the complexity of healthcare systems, this commitment aims to ensure that the transition is as smooth as possible, minimizing disruptions in patient care and maintaining the integrity of confidentiality protections.
