Q. Would you please elaborate on the impact of this new requirement for Part 2 entities? 

 “The provisions of 45 CFR part 160 and subpart D of 45 CFR part 164 shall apply to part 2 programs with respect to breaches of unsecured records in the same manner as those provisions apply to a covered entity with respect to breaches of unsecured protected health information.”

A.

Legal Responsibilities

1. Breach Definition and Scope 

Part 2 programs must now treat any impermissible acquisition, access, use, or disclosure of patient records—or “breach”—in the same way HIPAA covered entities do. Under 45 CFR § 164.402, a breach is presumed whenever protected health information is improperly handled unless a documented risk assessment shows a low probability of compromise.

2. Notification Obligations• Notify affected individuals without unreasonable delay and no later than 60 days after discovery of the breach.

• Report to HHS:

• For breaches involving 500 or more records, notify HHS and media immediately.

• For breaches involving fewer than 500, submit an annual report to HHS.

• Include prescribed content in notices: description of the breach, steps individuals should take, and mitigation efforts B.

3. Enforcement and Penalties• Subject to HHS Office for Civil Rights (OCR) enforcement.

• Penalties mirror HIPAA tiers for violations due to willful neglect, potentially reaching up to $1.5 million per calendar year, per violation category.

Operational Responsibilities

1. Policies and Procedures

• Revise confidentiality manuals and Part 2 policies to incorporate HIPAA breach-notification provisions (45 CFR Part 160; 45 CFR § 164.400–414).

• Establish clear workflows for breach identification, investigation, risk assessment, and notification.

1. Risk Assessment and Encryption

• Implement the HIPAA-mandated risk-assessment framework to evaluate each potential breach across four factors:

1. Nature and extent of the information involved.

2. Unauthorized person(s) to whom the disclosure was made.

3. Whether the information was actually acquired or viewed.

4. Extent of mitigation efforts.

• Apply NIST-compliant encryption to render Part 2 records “secure.” Encrypted data are excluded from breach notification requirements.

1. Workforce Training

• Train all staff—including counselors and administrative personnel—on:

• New breach definitions and exceptions.

• Incident-reporting timelines and required documentation.

• Proper handling and encryption of electronic records.

1. Business Associate Considerations

• Identify and enter into Business Associate Agreements (BAAs) with any third parties that handle Part 2 records (e.g., EHR vendors, billing services).

• Ensure business associates notify the Part 2 program of breaches within 60 days of discovery.

Financial and Resource Impact

• Compliance Costs:

• System upgrades for encryption and logging.

• Development and maintenance of breach-response teams and annual breach-reporting infrastructure.

• Potential Fines: Failure to comply with breach-notification requirements may incur civil monetary penalties up to $1.5 million per violation category per year.

Effects on Patient Trust and Confidentiality

• Transparency: Prompt, clear breach notifications can bolster patient confidence by demonstrating accountability.

• Risk of Re-Identification: Despite encryption and mitigation, unauthorized disclosures of substance use disorder (SUD) records remain highly sensitive; robust breach response is essential to preserve the historical confidentiality protections of Part 2.

Implementation Challenges and Recommendations

1. Harmonizing HIPAA and Part 2 Standards

• Conduct gap analyses to resolve conflicts between Part 2’s stringent redisclosure bans and HIPAA’s permitted uses.

2. Timeline for Roll-Out/Establish a staged implementation:

1. Policy revision and staff training (0–3 months).

2. Technical upgrades and risk-assessment process development (3–6 months).

3. Dry-run breach exercises and final compliance audit (6–9 months).

3. Ongoing Monitoring

• Quarterly reviews of breach-response drills.

• Annual audit of breach logs against HHS report filings.

Conclusion

By subjecting Part 2 programs to HIPAA’s breach-notification regime, the rule aims to align the privacy safeguards for substance use disorder records with those for other medical records—but it demands significant legal, operational, and cultural shifts.

If you’d like to dive deeper into any specific operational challenges—such as crafting BAAs for EHR vendors—or explore templates for breach-notification letters tailored to Part 2 confidentiality requirements, visit ComplianceConsortium.org and fill out the “Contact Us” form, or, write to Dr.Jones@ComplianceConsortium.org.