Compliance Deadline Approaches for 42 CFR Part 2 Amendments: Enhanced Penalties and & Enforcement Process

Under recent amendments, regulated entities that violate 42 CFR Part 2 – the federal law protecting the confidentiality of patients’ substance use disorder (SUD) information – now face expanded civil and criminal penalties, along with other enhancements to the enforcement process. Regulated entities should be prepared for increased legal exposure as federal regulators gain new enforcement authority.

As summarized in recent Pulse Check articles (Part 1, Part 2, and Part 3), 42 CFR Part 2 underwent significant amendments in a Final Rule published on February 16, 2024, by the U.S. Department of Health and Human Services (HHS). The compliance deadline for those amendments is February 16, 2026.

Summary of Key Changes: Penalties and Enforcement

Below is a summary of key changes related to penalties and enforcement.

• HIPAA penalties apply to Part 2 violations. Prior to the 2024 amendments, Part 2 violations were subject to criminal penalties: $500 for the first offense and $5,000 for subsequent offenses. These criminal penalties were rarely imposed. Under the 2024 amendments, HIPAA penalties now apply to Part 2 violations, including civil penalties ranging from $141 to $2.1 million per violation (adjusted annually for inflation), criminal fines, and possible imprisonment for the most serious violations.
• HIPAA enforcement process applies to Part 2 violations. The provisions of the HIPAA Enforcement Rule (i.e., 45 CFR part 160, subparts C, D, and E) now apply to noncompliance with Part 2 in the same manner as they apply to covered entities and business associates for noncompliance with HIPAA. This means HIPAA’s processes related to compliance reviews, investigations, and other enforcement protocols now apply to Part 2 violations. In addition, patients receiving SUD services can now file a complaint directly with the Secretary of HHS for an alleged violation of Part 2.Like HIPAA, Part 2 does not provide patients with a private right of action.
• Regulated Entities must self-report breaches in violation of Part 2. The amendments apply the same requirements of the HIPAA Breach Notification rule to breaches of SUD records under Part 2. This means that regulated entities that experience a breach of SUD information must notify impacted patients, HHS’s Office of Civil Rights, and potentially the media. These reports must be made within specific timelines as required by HIPAA. For example, impacted patients must be notified within 60 days of discovery of a breach impacting their SUD information.

Takeaways

Regulated entities may see an increase in enforcement activity pertaining to Part 2 violations now that the government has new penalties and enforcement tools in its toolbox. HHS-OCR, the federal agency the enforces HIPAA, has a long history of actively enforcing privacy and security violations under HIPAA. Historically, enforcement of Part 2 violations has been limited, however, based on the 2024 amendments, it is reasonable to anticipate that HHS-OCR may take a more active role in enforcing the protections affording to SUD information under Part 2.

The Woods Rogers Pulse Check offers concise, timely insights on emerging trends and key developments in healthcare law—keeping you informed and ahead of change. Our multidisciplinary team understands the complexities of the healthcare industry and provides strategic legal guidance tailored to your needs. Whether you're facing a challenging compliance issue, a critical business transaction, a government investigation, or potential litigation, we deliver clear, coordinated solutions. With deep experience in regulatory, transactional, and litigation matters, our attorneys work collaboratively to help healthcare organizations navigate risk and move forward with confidence. 

Want the latest healthcare updates delivered directly to your inbox? Sign up for our Health Law mailing list.