The U.S. Department of Health & Human Services (HHS) has announced a final rule, effective February 8, 2024, modifying the confidentiality regulations for Substance Use Disorder (SUD) patient records under 42 CFR Part 2. This aligns Part 2 with HIPAA and HITECH as mandated by the CARES Act of March 27, 2020. Key Changes:
The U.S. Department of Health & Human Services (HHS) has announced a final rule, effective February 8, 2024, modifying the confidentiality regulations for Substance Use Disorder (SUD) patient records under 42 CFR Part 2. This aligns Part 2 with HIPAA and HITECH as mandated by the CARES Act of March 27, 2020.
Key Changes:
- Patient Consent
- Single consent for all future uses and disclosures related to treatment, payment, and health care operations.
- HIPAA-covered entities can redisclose records per HIPAA regulations.
- Uses and Disclosures:
- Allows de-identified record disclosure to public health authorities without patient consent.
- Limits use of records in legal proceedings without consent or a court order.
- Aligns penalties with HIPAA, using civil and criminal enforcement.
- Applies HIPAA Breach Notification requirements to Part 2 records.
- Aligns Patient Notice requirements with HIPAA.
- Safe Harbor:
- Provides safe harbor for investigative agencies acting with due diligence before requesting records.
- Clarifies required steps for agencies to qualify for safe harbor.
- Other Updates:
- No need to segregate Part 2 records.
- Right to file complaints directly with the Secretary for Part 2 violations.
- Defines and protects SUD counseling notes, requiring specific consent.
- Prohibits combining legal consent with other consents and mandates detailed consent documentation.
- Allows patients to opt out of fundraising communications.
- Unchanged:
- SUD treatment records cannot be used for prosecution without written consent or a court order.
- Audit/evaluation records cannot be used against patients without consent or a court order.
- Next Steps:
- The final rule can be accessed here.
- Compliance required two years post-publication.
- HHS will provide guidance and support for implementation.
- OCR will finalize changes to HIPAA Notice of Privacy Practices and implement CARES Act antidiscrimination provisions separately.
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