The recent federal update to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2 is designed to protect patient’s privacy and confidentiality while increasing care coordination and integration. On March 28, 2024, C4BH was joined by Deven McGraw, Chief Regulatory & Privacy Officer of Ciitizen, to discuss the implications of the updated 42 CFR Part 2 (“Part 2”) ruling. 

Part 2 is a federal regulation under the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of Civil Rights (OCR) that protects a patient’s SUD treatment data. Part 2 focuses specifically on SUD data and applies to federally-supported “Part 2 programs” that provide SUD treatment. The rule goes into effect on April 16, 2024, however entities covered by the rule have until February 16, 2026 to implement. 

Key components of the rule change include: 

• Patient Consent: The rule change allows for a single patient consent for all uses and disclosure for treatment, payment, and health care operations. 
• HIPAA Alignment: The update aligns Part 2 with HIPAA in regard to penalties, breach notifications, and patient notice requirements. 
• Record Segregation: The final rule states that segmenting Part 2 records is not required, except for SUD Counseling Notes. SUD Counseling Notes are clinician notes that must be segmented from the patient record and protected in a special manner akin to psychotherapy notes under HIPAA.
• Legal Proceeding Restrictions: Prohibits combining a patient’s consent for a disclosure of records in a legal proceeding for a patient that has consented for a different use, not including SUD.

Looking Forward: Advancing Patient Privacy and Interoperability in California

The recent update to Part 2 supports efforts to advance and modernize consent management across health care. The update to Part 2 marks a critical milestone in the federal commitment to interoperability and advancing coordinated care. California and other states now must look to incorporate these principles into their health information exchange landscapes, and ensure patients receiving SUD treatment benefit from safe and secure information sharing. Consent-to-share is a priority and focus of C4BH’s work, and we look forward to supporting California’s efforts to modernize consent practices to improve whole person care. 

To read more about consent, check out our 2023 paper “Consent to Share: California’s Opportunity to Modernize Cross-Sector Data Sharing.”