Audit Logging

What problem does it solve?

This Skill ensures that critical events within a medical device are logged securely and reliably, providing an auditable trail for compliance, security, and forensic analysis.

Core Features & Use Cases

• Event Scoping: Defines what types of events (security, safety, configuration, access) must be logged.
• Log Integrity: Implements mechanisms to protect logs from tampering.
• Timestamp Reliability: Ensures accurate and synchronized timestamps for event ordering.
• PHI Minimization: Guides on handling Protected Health Information within logs.
• Retention & Export: Establishes policies for log storage, backup, and retrieval.
• Use Case: A Class C medical device must log all critical safety events, user authentication attempts, and system configuration changes. This Skill provides the requirements to ensure these logs are tamper-proof, accurately timestamped, and retained for regulatory review.

Quick Start

Implement audit logging for your medical device according to the requirements in this skill.