What is a HIPAA corrective action plan?

A HIPAA corrective action plan is the enforcement process when a covered entity or business associate violates HIPAA regulations. It rectifies underlying compliance issues and implements safeguards to protect patient information. 

Understanding the purpose of a HIPAA corrective action plan

A HIPAA corrective action plan is designed to address the underlying privacy and security compliance issues that led to the violation. OCR may determine that further corrective action is necessary after conducting an investigation, entering into a resolution agreement, and imposing fines. 

A corrective action plan ensures that the covered entity or business associate takes significant steps to rectify the compliance issues. A corrective action plan typically imposes strict requirements, such as performing a closely monitored security risk analysis and developing a risk management plan. These measures are mandatory for organizations to have in place under the security rule, and the absence or improper execution of them often results in fines.

Read more: What is a HIPAA resolution agreement? 

Components of a HIPAA corrective action plan

A HIPAA corrective action plan outlines specific measures that must be undertaken to address the compliance issues. The plan may span a year or several years, depending on the severity of the violation. During this period, the entity must regularly report to OCR and submit to audits to demonstrate their progress. Some of the key components that a corrective action plan may include:

Adjustments to policies and procedures

A common requirement under a corrective action plan is developing, maintaining, and revising policies and procedures. The entity must provide a copy of these policies and procedures to HHS by a specified date and implement them upon HHS approval. This measure ensures that the organization has proper guidelines for compliance with various aspects of the privacy rule.

Regular reporting

A covered entity may be required to provide a written report to HHS summarizing the status of the corrective action plan within a specified deadline. Additionally, the entity may need to submit annual written reports until HHS determines the plan's completion. These reports allow HHS to monitor the entity's progress and ensure they are actively working to rectify the compliance issues.

Compliance training and education

A corrective action plan may mandate the implementation of compliance training and education programs to strengthen compliance efforts. This measure ensures that all employees and relevant individuals within the organization are well-informed about HIPAA regulations and their responsibilities in safeguarding patient information. 

Security risk analysis and risk management

One of the critical elements of a corrective action plan is the requirement to perform a security risk analysis and develop a risk management plan. The security risk analysis helps identify vulnerabilities and assess the potential risks to PHI's confidentiality, integrity, and availability. 

Third-party monitoring

In some cases, OCR may require the entity to hire a third party at its own expense to monitor compliance. This additional measure ensures independent oversight and provides assurance that the corrective actions are being implemented effectively. Third-party monitoring adds an extra layer of accountability and helps maintain the integrity of the corrective action plan.

Read more: How to avoid a HIPAA corrective action plan

Consequences of non-compliance 

Failure to comply with the terms of a corrective action plan can have serious consequences. It is considered a breach of the underlying resolution agreement and may lead to additional penalties. Therefore, covered entities and business associates must diligently adhere to the requirements outlined in the plan, submit the necessary reports, and implement the specified security measures within the set timeline.

See also: HIPAA Compliant Email: The Definitive Guide