The Office for Civil Rights (OCR) has officially launched its third round of HIPAA audits, following previous assessments in 2012 and 2016. Learn 8 easy ways to prepare for an OCR HIPAA compliance audit and safeguard your health information against rising cyber threats. Past audits revealed widespread compliance gaps, prompting increased oversight.
A recent Office of the Inspector General (OIG) report criticized the limited scope of previous audits, emphasizing the need for stronger electronic protected health information (ePHI) protections. Meanwhile, cyber threats continue to escalate—OCR is already investigating 66 breaches in 2025, exposing 2.7 million patient records, with ransomware groups increasingly targeting healthcare.
Despite a slight decline in attack volume, ransomware remains a major threat, with new groups like Interlock emerging. Their attack on Texas Tech University Health Sciences Center exposed 1.4 million records after the institution refused to pay ransom.
As cyber risks intensify and audits become more rigorous, preparation is crucial. Here’s how you can strengthen your compliance and security posture ahead of your next OCR audit.
HIPAA Audits and Updates
OCR’s HIPAA audits are not new but have historically been inconsistent. As Andrew Mahler, Clearwater Vice President, Consulting Services, Privacy & Compliance explained in the February Cybersecurity Briefing, OCR’s audit history has followed a stop-start pattern since 2011:
- 2011–2012: First HIPAA audit program launched but paused after an initial round.
- 2016–2017: Phase 2 audits were conducted, leading to reports provided to Congress and the OIG.
- December 2024: Organizations began receiving notifications of a new audit round, marking the start of the third major audit cycle.
Iliana Peters, a distinguished expert in data privacy and security and a former senior official at HHS, noted that OCR has faced pressure from both Congress and within HHS to conduct these audits more regularly, especially given the increasing cybersecurity risks posed by business associates handling large amounts of ePHI.
“These audits provide OCR with insight into industry-wide compliance gaps,” Iliana explained. “We know that critical nodes in our healthcare ecosystem—such as business associates—may not be meeting compliance requirements, making the entire sector vulnerable.”
Historically, OCR has argued that resource constraints have prevented them from maintaining a regular audit program. However, recent enforcement efforts, increasing Congressional attention, and OCR’s available budget indicate that audits are likely here to stay.
For more details, OCR’s Audit Protocol is publicly available and outlines exactly what organizations should expect during an audit:
What to Expect from an OCR Audit
OCR plans to conduct about 50 audits in this round. Some organizations have reported that they are repeat audit subjects, suggesting OCR may be revisiting organizations previously flagged for compliance issues.
The Audit Process
Organizations selected for an OCR audit will receive an email notification, which will typically include:
- A 45-minute virtual meeting request to discuss the audit process.
- A request for information about the organization.
- A request for documentation related to specific HIPAA provisions.
Organizations will have 30 days to respond, though in some cases, extensions may be granted. As Iliana emphasized, these audits are intended to be cooperative and not punitive.
What Will Be Audited?
This audit round focuses solely on HIPAA Security Rule compliance, meaning Privacy Rule and Breach Notification Rule requirements are not included.
Iliana highlighted that OCR is particularly interested in whether organizations have a robust enterprise risk analysis aligned with HIPAA requirements.
“What they’re looking for here is whether or not you have that robust enterprise risk analysis in place, in conjunction with its guidance,” Iliana explained. “That includes an inventory of ePHI and the systems containing ePHI—from an IT perspective, that means devices, vendors, and all related security controls under the Security Rule.”
OCR is expected to evaluate organizations on key provisions such as: ✔ Risk analysis & management
✔ Information system activity review
✔ Security awareness and training
✔ Incident response and reporting
✔ Data backup & disaster recovery plans
✔ Audit controls and authentication measures
8 Ways to Prepare for an OCR HIPAA Compliance Audit
Even if your organization isn’t selected for an audit, now is the time to strengthen your HIPAA compliance strategy. Below are eight key steps to ensure you’re ready:
1. Conduct a Comprehensive Risk Analysis
OCR’s primary focus is on risk analysis and risk management. Ensure you:
- Identify where electronic protected health information (ePHI) is stored and processed.
- Assess potential risks and vulnerabilities.
- Document mitigation strategies.
- Update risk analyses regularly to reflect changes in systems and threats.
2. Maintain Up-to-Date Policies and Procedures
HIPAA compliance requires clear, documented policies covering:
- Incident response and breach notification.
- Access controls and authentication.
- Security awareness training.
- Business associate agreements (BAAs).
Make sure your policies are current, tailored to your organization, and not outdated templates from previous audits.
3. Implement Regular HIPAA Training
Security awareness training is critical. Employees should:
- Receive role-specific HIPAA security training.
- Understand phishing threats and cyber hygiene.
- Have documented proof of training participation.
4. Review Business Associate Agreements (BAAs)
If your organization shares ePHI with third-party vendors, you must:
- Maintain updated BAAs.
- Ensure vendors comply with HIPAA security requirements.
- Regularly review vendor security practices.
5. Strengthen Incident Response and Disaster Recovery Plans
OCR may review your incident response plan (IRP) and disaster recovery policies. Your plan should:
- Clearly define response protocols for security incidents.
- Assign responsibilities to key personnel.
- Be tested regularly through tabletop exercises.
6. Keep Up with Regulatory Changes
Regulations change frequently. Assign a compliance officer to:
- Monitor updates from OCR, HHS, and cybersecurity advisories.
- Update policies and training accordingly.
- Engage with industry associations for insights.
7. Conduct Mock Audits and Tabletop Exercises
Organizations should simulate OCR audits internally or with third-party consultants. These exercises can:
- Identify compliance gaps before an official audit.
- Ensure your organization is prepared to respond quickly.
- Reveal documentation weaknesses.
8. Maintain Thorough Documentation
A well-organized document repository will make an audit easier. Keep records of:
- Risk assessments and mitigation actions.
- Security training logs and attendance records.
- Policies, procedures, and revision histories.
- Business associate agreements and vendor risk assessments.
Final Thoughts
With cyber threats growing and audits becoming more rigorous, HIPAA compliance is more critical than ever. Proactively preparing today can help your organization avoid penalties, protect patient data, and strengthen overall security posture.
If you haven’t already, review OCR’s audit protocol and ensure your compliance team is ready should an audit notification arrive. Proactive preparation is the best defense against compliance issues.
Need guidance on strengthening your HIPAA security posture? We can help. Contact our team for compliance assessments, mock audits, and tailored cybersecurity solutions-
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