Internal vs External HIPAA audits

Internal and external HIPAA audits are not interchangeable; they are complementary tools in a comprehensive compliance strategy. Internal audits are conducted by the organization’s own team and are designed to be proactive, while external audits are conducted by outside organizations and are often triggered by incidents like data breaches. By leveraging both, organizations can ensure they meet HIPAA requirements, protect patient data, and maintain trust with stakeholders.

What are internal HIPAA audits?

Internal HIPAA audits are conducted by an organization’s own compliance team or designated personnel. They are designed to proactively identify and address compliance gaps. These audits are usually scheduled at regular intervals or triggered by specific events, such as a policy update or a minor incident involving PHI.

Focus areas of internal audits

• Ensuring adherence to the Privacy Rule, which governs patient access to their health data.
• Evaluating the implementation of the Security Rule, including encryption, access logs, and system safeguards.
• Training staff on HIPAA policies and monitoring their compliance.
• Assessing risk management strategies to identify and mitigate vulnerabilities.

Advantages of internal audits

• Cost-effective: Uses in-house resources, reducing the financial burden.
• Flexibility: Can be conducted at any time, enabling prompt issue resolution.
• Fosters a culture of compliance: Encourages ongoing vigilance within the organization.

Challenges of internal audits

• Limited objectivity: Internal auditors may overlook issues due to familiarity or bias.
• Resource intensive: Requires dedicated time and personnel, which might strain smaller organizations.
• Expertise constraints: Compliance teams may lack specialized HIPAA knowledge.

What are external HIPAA audits?

External HIPAA audits are performed by third-party organizations, consultants, or, in some cases, government entities like the Office for Civil Rights (OCR). These audits are typically more formal and occur periodically or in response to specific triggers, such as data breaches, compliance complaints, or certification requirements.

Focus areas of external audits

• Comprehensive review of HIPAA policies, procedures, and technical safeguards.
• Validation of internal audit findings for accuracy and thoroughness.
• Identification of risks or vulnerabilities that internal audits might miss.
• Certification or compliance verification to meet regulatory standards.

Advantages of external audits

• Unbiased perspective: Independent auditors bring objectivity to the process.
• Specialized expertise: External auditors are often well-versed in HIPAA regulations and trends.
• Detailed insights: Offers comprehensive recommendations for strengthening compliance.

Challenges of external audits

• Costly: Hiring external auditors can be expensive.
• Operational disruptions: Audits can temporarily impact regular workflows as key personnel may be unavailable for their usual tasks if they are required to meet with auditors, clarify records, or provide explanations.
• Limited frequency: Typically conducted less often than internal audits.

Internal vs External HIPAA audits: A comparison

Why you need both audits

“The Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) requires HHS to periodically audit covered entities and business associates for their compliance with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules,” says the HHS. However, internal and external audits serve different but complementary purposes. Internal audits are your first line of defense, enabling you to identify and resolve issues before they escalate. They also help ensure continuous compliance and prepare your organization for external reviews. On the other hand, external audits bring a fresh perspective, validating your internal efforts and providing additional insights into compliance risks.

See also: HIPAA Compliant Email: The Definitive Guide

Best practices for HIPAA compliance audits

• Establish a regular schedule: Conduct internal audits quarterly or semi-annually to maintain a proactive approach.
• Engage experts for external audits: Schedule an external audit at least annually or after significant events like a data breach.
• Document everything: Keep detailed records of audit findings, corrective actions, and follow-ups.
• Act on findings: Use insights from both audit types to continuously improve your HIPAA compliance program.
• Train staff: Ensure employees are up-to-date on HIPAA requirements and understand their role in maintaining compliance.

Related: 

• How to prepare for a HIPAA audit
• The guide to HIPAA audits

FAQs

What happens if an organization fails a HIPAA audit?

If an organization fails a HIPAA audit, it may face fines, corrective actions, or other penalties depending on the severity of the violations. The organization will need to take immediate steps to address any compliance gaps, implement corrective measures, and ensure ongoing adherence to HIPAA regulations.

What are some common HIPAA audit mistakes to avoid?

• Inadequate documentation: Failing to keep detailed records of compliance efforts and audit findings.
• Neglecting employee training: Not providing adequate training on HIPAA rules and responsibilities.
• Ignoring audit results: Not addressing identified issues or risks after an audit.
• Limited scope: Focusing only on one area of compliance, such as security, and neglecting others like privacy or breach notification.