New Rule Enhances Patient Confidentiality in Substance Use Disorder Treatment

Department of Health and Human Services

WASHINGTON, D.C. — In a move to strengthen patient confidentiality and improve care for those struggling with substance use disorders (SUD), the U.S. Department of Health & Human Services (HHS) has announced a new rule modifying regulations around SUD patient records.

The amendment, announced on February 8, 2024, was made to the Confidentiality of Substance Use Disorder Patient Records regulations at 42 CFR part 2, known as “Part 2”. The final rule aligns certain aspects of Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules and the Health Information Technology for Economic and Clinical Health Act (HITECH).

This follows the implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which required HHS to bring the Part 2 program into closer alignment with HIPAA Privacy, Breach Notification, and Enforcement Rules.

HHS Secretary Xavier Becerra emphasized the importance of confidentiality in healthcare. He noted that the new rule would ensure people struggling with substance use disorders have their information kept as private as any other patient. The rule also aims to integrate behavioral health with other medical records more effectively.

“The Biden-Harris Administration has made it a priority to end the stigmatization of those living with substance use disorders and give health care providers the tools they need so they can treat the whole patient while continuing to protect patient privacy,” Becerra said.

According to OCR Director Melanie Fontes Rainer, the Final Rule strengthens confidentiality protections while improving care coordination for patients and providers. It allows patients to seek treatment for substance use disorder, knowing their records are private. Providers can now better share information to improve patient care.

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Miriam E. Delphin-Rittmon, the HHS Assistant Secretary for Mental Health and Substance Use and leader of SAMHSA, said the Final Rule supports access to care and treatment. It helps mitigate the discrimination and stigmatization often experienced by people with SUD, while continuing to apply stringent privacy protections.

The final rule includes several key modifications to Part 2:

  • It permits the use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
  • The rule allows redisclosure of Part 2 records by HIPAA-covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
  • The rule provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
  • It expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
  • The rule outlines new breach notification requirements applying to Part 2 records and provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.

This move is a significant step towards ensuring that those battling substance use disorders can seek and receive the help they need without fear of stigmatization or violation of their privacy. The changes will empower healthcare providers to deliver comprehensive care while upholding the highest standards of patient confidentiality.

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