MDS2 (Medical Device) AUDT: AUDT Audit controls: disclose what the device logs, how logs are timed, exported, protected and reviewed

Discloses the device's ability to audit activity reliably. AUDT-1 asks whether the device generates its own audit records or reports in addition to the ordinary logs of its operating system (if not, AUDT-1.1 to 3.1 are N/A); whether the log records user IDs (1.1) and whether other PII appears in the audit trail (1.2), with notes on whether the data subject is identified per PII event and whether creation, display and export of PII can be told apart. AUDT-2 asks whether events are logged and which: successful and failed login or logout (2.1, 2.2), changes to user privileges (2.3), creation, modification or deletion of users (2.4), presentation of clinical or PII data such as display or print (2.5), creation, modification or deletion of data, stating which of the three are tracked (2.6), import or export from removable media with the level of detail (2.7), data or commands sent or received across a network or a direct point-to-point link (2.8), remote or on-site support activity (2.8.1), API and similar activity with the proprietary or standard APIs such as HL7 FHIR that are audited (2.8.2), emergency access, including whether the emergency user is asked for a name or hospital ID and whether data captured in an emergency session is flagged (2.9), other events such as software updates (2.10), and whether the audit capability is documented in more detail (2.11). AUDT-3: can the owner or operator choose which events are logged. AUDT-4: is there a list of the data attributes recorded, including date and time (4.1) and synchronisation by NTP or an equivalent source, or how the clock is set otherwise (4.1.1). AUDT-5: can log content be exported, by physical media (5.1), through the IHE ATNA profile to a SIEM (5.2), or by other communications such as external service devices or mobile apps (5.3), and are logs encrypted in transit or at rest (5.4). AUDT-6: can the owner or operator monitor and review the logs, and if not what the audit process is. AUDT-7: are logs protected from modification (7) and from access (7.1). AUDT-8: can the device analyse its own logs.