New Federal Privacy Standards for SUD Treatment Records by 2026

New federal privacy standards will come into effect for substance use disorder (SUD) treatment records by early 2026, requiring compliance from SUD providers, health plans, clinicians, health information exchanges (HIEs), and vendors. Organizations failing to meet these standards will face enforcement and penalties similar to those under the Health Insurance Portability and Accountability Act (HIPAA).

In a recent podcast, attorneys from Epstein Becker Green, including Lisa Pierce Reisz, David Shillcutt, and Laura DePonio, joined Nichole Sweeney, General Counsel and Chief Privacy Officer at CRISP, to discuss the implications of the 42 CFR Part 2 final rule. They highlighted crucial changes, the importance of patient consent, and the operational challenges organizations may encounter.

Key Changes Under the New Rule

One of the significant shifts with the new rule is the adoption of HIPAA’s enforcement and penalty structure for SUD treatment records. This change aims to streamline compliance and create a more uniform approach to the protection of sensitive health information. The attorneys emphasized that while the new standards align with HIPAA, they do not replace it.

Another critical aspect of the final rule is the focus on patient consent. The podcast panel noted that patient consent will remain central to the sharing of SUD treatment records. This is vital in ensuring that individuals maintain control over their sensitive information while also facilitating necessary access for treatment and care coordination.

Operational Readiness and Compliance Duties

The discussion also highlighted the operational readiness challenges that organizations will face under the new regulations. According to the panel, operational readiness—not merely technological upgrades—will be the most significant hurdle for many entities. Organizations need to prepare their processes and workflows to align with the new compliance requirements effectively.

Additionally, payors and HIEs will experience major shifts in their data access and compliance obligations. These changes will necessitate a reevaluation of current practices and a commitment to ongoing compliance training for staff.

The podcast concluded with a call to action for organizations to stay informed about these changes, emphasizing the risks associated with non-compliance. As the 2026 deadline approaches, understanding the adjustments required under the 42 CFR Part 2 final rule will be essential for maintaining compliance and protecting patient privacy.

By engaging with legal experts and preparing for these upcoming standards, organizations can navigate the complexities of SUD treatment record confidentiality and ensure they meet federal requirements.