Audit controls enable organizations to detect unauthorized access or unusual activity involving protected health information (PHI) or electronic protected health information (ePHI), ensuring data is only accessed by authorized personnel, and identifying potential security breaches or violations.
Audit control refers to the technical mechanisms that enable an organization to monitor the activity within systems that store, process, or transmit sensitive information, particularly PHI and ePHI. These mechanisms provide a way to track who accessed what information, when it was accessed, and what actions were taken.
According to HIPAA's Security Rule, audit controls are mandatory for any entity handling ePHI. They are a vital tool for preventing unauthorized access, investigating potential security breaches, and ensuring transparency in data management. The “Security Rule does not identify data that must be gathered by the audit controls or how often the audit reports should be reviewed. A covered entity must consider its risk analysis and organizational factors, such as current technical infrastructure, hardware and software security capabilities, to determine reasonable and appropriate audit controls for information systems that contain or use EPHI,” writes the HHS in the HIPAA Security Series 4.
Audit controls play a crucial role in achieving HIPAA compliance by supporting two key objectives:
See also: HIPAA Compliant Email: The Definitive Guide
The implementation of audit controls varies depending on the size, structure, and technological capabilities of an organization. However, certain components remain essential across all healthcare organizations:
Access logs document every instance when PHI or ePHI is accessed, including the user’s identity, the time and date of access, and the type of activity performed. These logs serve as a transparent record for internal and external auditors, allowing organizations to detect any unauthorized access or suspicious activity.
User activity monitoring tracks the behavior of individuals who access the organization’s health information systems, ensuring users only access the data they are authorized to view. Advanced monitoring tools may alert administrators if users attempt to access restricted areas of the system or perform abnormal actions.
Audit trails provide a detailed history of system activity, showing every interaction with PHI or ePHI, including creation, modification, and deletion of records. Audit trails maintain a comprehensive record of how health data is handled and for detecting any unauthorized actions.
Related: The role of audit trails for HIPAA compliance
Automated alerts are a proactive feature of audit control systems. They notify administrators in real time when specific conditions, such as failed login attempts or attempts to access restricted data, are met. These alerts allow for swift intervention and remediation to minimize the impact of potential breaches.
Periodic internal and external audits ensure that an organization's audit control mechanisms are working. During these audits, access logs, user activity, and system configurations are reviewed to identify gaps in compliance and improve security practices.
To implement a comprehensive audit control system, healthcare organizations must follow best practices in security and compliance. Here are steps to consider:
When audit control mechanisms are properly implemented, they provide numerous benefits:
HIPAA does not specify a specific duration for retaining audit logs, but best practices recommend keeping logs for at least six years. This time frame aligns with HIPAA’s requirement to retain documentation related to security practices, which is important for historical audits and investigations.
Audit logs should be reviewed regularly, with the frequency depending on the size of the organization and the volume of sensitive data handled.
Some common challenges include:
Addressing these challenges often requires specialized software solutions and dedicated personnel for security management.