Audit KeyFrom HHS OCR Cyber Newsletter:  Understanding the Importance of Audit Controls

Covered Entities and Business Associates should make sure that they appropriately review and secure audit trails, and they use the proper tools to collect, monitor, and review audit trails. Protecting audit logs and audit trails prevent intruders from tampering with the audit records and protecting their integrity. Not safeguarding audit logs and audit trails can allow hackers or malevolent insiders to cover their electronic tracks, making it difficult for Covered Entities and Business Associate to not only recover from breaches, but to prevent them before they happen.

According to the National Institute of Standards and Technology (NIST), audit logs are records of events based on applications, users, and systems, and audit trails involve audit logs of applications, users, and systems. Audit trails’ main purpose is to maintain a record of system activity by application processes and by user activity within systems and applications.

The HIPAA Security Rule provision on Audit Controls (45 C.F.R. § 164.312(b)) requires Covered Entities and Business Associates to implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information (ePHI). The majority of information systems provide some level of audit controls with a reporting method, such as audit reports. These controls are useful for recording and examining information system activity which also includes users and applications activity.

Examples of audit trails include:

Application audit trails – Normally monitor and log user activities in the application. This includes the application data files opened and closed, and the creating, reading, editing, and deleting of application records associated with ePHI.

System-level audit trails – Usually capture successful or unsuccessful log-on attempts, log-on ID/username, date and time of each log-on/off attempt, devices used to log-on, and the application the user successfully or unsuccessfully accessed.

User audit trails – Normally monitor and log user activity in a ePHI system or application by recording events initiated by the user, such as all commands directly initiated by the user, log-on attempts with identification and authentication, and access to ePHI files and resources.

Audit controls that produce audit reports work in conjunction with audit logs and audit trails. Audit logs and trails assist Covered Entities and Business Associates with reducing risk associated with: reviewing inappropriate access; tracking unauthorized disclosures of ePHI; detecting performance problems and flaws in applications; detecting potential intrusions and other malicious activity; and providing forensic evidence during investigation of security incidents and breaches. As part of this process, Covered Entities and Business Associates should consider which audit tools may best help them with reducing non-useful information contained in audit records, as well as with extracting useful information.

The HIPAA Security Rule does not identify what information should be collected from an audit log or trail or how often the audit reports should be reviewed. When determining reasonable and appropriate audit controls for information systems containing or using ePHI, Covered Entities and Business Associates must consider their risk analysis results and organizational factors, such as their current technical infrastructure, hardware, and software security capabilities. It is imperative for Covered Entities and Business Associates to review their audit trails regularly, both particularly after security incidents or breaches, and during real-time operations. Regular review of information system activity should promote awareness of any information system activity that could suggest a security incident or breach. Access to audit trails should be strictly restricted, and should be provided only to authorized personnel.

Questions that Covered Entities and Business Associates should consider:

• What audit control mechanisms are reasonable and appropriate to implement so as to record and examine activity in information systems that contain or use ePHI?

• What are the audit control capabilities of information systems with ePHI?

• Do the audit controls implemented allow the organization to adhere to their audit control policies and procedures?

• Are changes or upgrades of an information system’s audit capabilities necessary?


The original publication may be accessed here.

National Institute of Standardization and Technology (NIST Special Publication 800-12 An Introduction to Computer Security: The NIST Handbook)

Department of Health and Human Services, Office for Civil Rights (OCR)  (Technical Safeguards)

OCR’s Monthly Cyber Awareness newsletters and other HIPAA Security Rule Guidance Material may be found here.

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