Record the event in an incident log capturing cause: Which documentation action best satisfies this governance
The objective calls for logging the incident with cause, impact, and remediation and incorporating it into the post-market monitoring plan.
The question
After deployment, a hospital's triage-support model produces a burst of dangerously wrong prioritizations traced to an unanticipated patient sub-population, and clinicians catch it before harm occurs. Leadership wants to ensure the organization can demonstrate how such issues are captured, analyzed, and watched for going forward. Which documentation action best satisfies this governance expectation?
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- Update the model's public-facing marketing materials to describe the improved safeguards now protecting previously underserved patient sub-populations.Plausible as communication, but marketing copy is not incident documentation and provides no analyzable record or forward monitoring of the risk.
- Draft a new employee code-of-conduct clause reminding clinical staff to always exercise independent judgment when using automated triage tools.Plausible as a policy reinforcement, but a conduct clause neither records the specific incident nor establishes monitoring for the identified failure mode.
- Record the event in an incident log capturing cause, impact, and remediation, and fold the failure pattern into the post-market monitoring plan. ✓Correct because the objective pairs documenting incidents, issues, and risks with maintaining post-market monitoring plans, which is exactly what captures the event and watches for recurrence.
- Archive the exact model weights and the full training dataset snapshot so the vendor can later reproduce the version that was running at the time.Plausible for reproducibility, but preserving artifacts is not the same as documenting the incident's cause, impact, and remediation or planning post-market monitoring.
The trap
Assuming reproducibility artifacts or policy reminders satisfy the requirement to document the incident and update monitoring. How to remember it
The objective calls for logging the incident with cause, impact, and remediation and incorporating it into the post-market monitoring plan.
How many of these would you get right?
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Every answer, right and wrong, comes with its own explanation.
