45 CFR § 164.312(b)
Requires implementation of hardware, software, and procedural mechanisms to record and examine activity in systems that contain or use ePHI. Defines what events to log, how long to retain logs, and who reviews them.
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Version 1.0·Effective [EFFECTIVE DATE]·Approved by [PRIVACY/SECURITY OFFICER NAME]
This policy requires the implementation of hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI at [PRACTICE NAME]. Audit controls create the evidentiary trail necessary to detect unauthorized access, support incident investigations, and demonstrate compliance.
This policy applies to all information systems that create, receive, maintain, or transmit ePHI, including EHR systems, practice management software, patient portals, email systems, file servers, network devices, cloud services, and physical access control systems. It applies to all workforce members responsible for configuring, maintaining, or reviewing these systems.
[PRACTICE NAME] shall implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI, as required by 45 CFR § 164.312(b). Audit logs shall be generated, protected, retained, and reviewed according to the procedures established in this policy.
Audit Log: A chronological record of system activities maintained by a system that is sufficient to enable the reconstruction, review, and examination of a sequence of events surrounding or leading to an activity.
Audit Trail: The aggregate of audit log entries across systems that documents the who, what, when, where, and how of system activity.
Log Integrity: The assurance that log entries have not been tampered with, altered, or deleted.
SIEM (Security Information and Event Management): A system that collects, correlates, and analyzes log data from multiple sources to detect anomalies and potential security incidents.
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