Substance Use Disorder Records Confidentiality: Long-Awaited HHS Final Rule Overhauling Part 2 Regulations
Aligning Part 2 More Closely With HIPAA, New Enforcement Authorities and Penalties, Preparing for Compliance

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Health
- event Date
Thursday, May 23, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE webinar will provide an in-depth look at the U.S. Department of Health and Human Services' Office for Civil Rights and Substance Abuse and Mental Health Services Administration (HHS-OCR-SAMHSA) long-awaited final rule that overhauls the federal Part 2 regulations on the confidentiality of substance use disorder (SUD) patient records. The panel will examine the extensive modifications that have been made to align Part 2 requirements more closely with HIPAA and will discuss the impact on Part 2 Programs and other healthcare providers, including those who are not regulated by HIPAA as covered entities. The panel will also offer best practices on preparing for compliance.
Faculty

Mr. Williams is experienced in assisting and advising clients with state and federal healthcare regulatory issues including compliance, HIPAA, and data privacy. His specific work experience includes HIPAA gap analysis and compliance plan; analysis of privacy-related regulatory questions for a variety of healthcare entities; assisting long-term care clients with state licensure and Medicare/Medicaid applications, and residency and admission contracts; regulatory advice and counsel regarding healthcare regulation; assisting clients with responding to data breaches; assisting clients with pharmacy, healthcare clinic, healthcare clinic establishment and other licensure applications; and assisting clients with various local healthcare permits, including biomedical waste, group care home and food sanitation permits. Mr. Williams also has experience assisting clients from nonprofit corporations and religious institutions in obtaining IRS §501(c)(3) tax-exempt status, state tax-exempt status and charitable solicitation registration.

Ms. Pitman advises healthcare systems and providers and healthcare information technology (IT) businesses when navigating healthcare privacy and cybersecurity regulations, other healthcare regulations, and government reimbursement program matters. Her experience includes the development and ongoing management of comprehensive HIPAA compliance programs, including drafting and negotiating business associate agreements, policies and training. When a data breach or other privacy regulatory violation occurs, Ms. Pitman guides her clients through the process for responding to the breach and any subsequent federal or state government investigations. She also provides advice to clients related to the frequent changes associated with the many federal healthcare payment programs.
Description
HHS recently finalized its long-awaited rule updating the federal SUD patient records regulations at 42 CFR Part 2, effective Apr. 16, 2024, to more closely align with HIPAA requirements, especially regarding patient consent, notice of confidentiality, and redisclosure of SUD records. While the final rule adopts many of the provisions introduced in the proposed rule, it also makes significant modifications of which counsel should be aware.
Key provisions of the final rule include: (1) changes to patient consent requirements for uses, disclosures, and redisclosures of SUD records; (2) alignment of certain patient rights and notice requirements under Part 2 with those under HIPAA; (3) alignment of Part 2 penalties with civil and criminal enforcement authorities that also apply to HIPAA violations; (4) application of the HIPAA Breach Notification Rule to Part 2 programs with respect to breaches of unsecured SUD records; and (5) the addition of many definitions borrowed in large part from HIPAA definitions and new definitions unique to the final rule including that of SUD counseling notes.
Although the final rule provides an enforcement date 22 months after the effective date, given the expansive scope of the final rule, counsel and their affected clients should prepare for implementation now including evaluating what programs may be subject to Part 2 and the final rule, updating consent policies and forms, updating patient notices, and ensuring that health information management systems are compliant.
Listen as our expert panel provides an in-depth look at HHS's final rule governing Part 2 SUD patient records confidentiality and offers best practices for preparing for compliance.
Outline
- Introduction: rule history
- HHS-OCR-SAMHSA final rule
- Patient consent
- Patient rights and notice
- Other uses and disclosures
- Segregation of Part 2 data
- New definitions
- Safe harbor for investigative agencies
- Penalties and enforcement
- Breach notification
- Patient complaints
- Additional considerations
- Assisting clients to prepare for compliance: practitioner takeaways
Benefits
The panel will review these and other key considerations:
- How does the final rule differ from the 2022 proposed rule?
- How does the final rule align Part 2 SUD patient records confidentiality requirements more closely with HIPAA?
- What impact will the final rule have on Part 2 Program current consent and notice documents? On information management?
- What should counsel and clients be doing now to prepare for the final rule's implementation?
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