In determining the allocation of system safety requirements to the ML component it is crucial that the system environment is considered. The system environment considered during system safety requirement allocation shall be explicitly defined in Artefact [B] to ensure consistency when determining ML safety requirements.
In developing an ML‐based cancer screening system, the clinical pathway within which that system is deployed will affect the safety requirements allocated to the ML system and must be documented. The extent to which the output of the system is scrutinised by an independent clinician is also an important consideration that must be captured.
ML components for mortality predictions for patients admitted to the Intensive Care Unit (ICU) with COVID‐19 are highly sensitive to criteria for ICU admission across hospitals, which in turn vary depending on ICU demand and capacity .