Table 4.

Risk categories for AI/ML medical devices, to be incorporated in ISO14971 risk analysis.

Data quality	Bias	Data storage/security/privacy	Overtrust
Incorrect data	Selection bias	Privacy failures	Overconfidence
Incomplete data	Confounding variables	Bias due to privacy	Perceived risk
Subjective data	Non-normality	Inability to contact patient	User workload
Underfitting	Proxy variables		Self-confidence
Overfitting	Implicit bias		Variation in social trust
Proxy Measure	Group attribution bias
	Experimental bias