All terms
Explainability and Interpretability
Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Explainability provides post-hoc rationalizations of model decisions; interpretability is a property of inherently transparent models. Both feed clinician trust and inform Human Factors design.What this means in practice
EU AI Act high-risk requirements and FDA Good Machine Learning Practice both expect manufacturers to address explainability proportionate to clinical risk.Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
FDA·2MDCG·1
- 1
FDA GMLPVerifiedFDAfda.gov
- 2
MDCG Software GuidanceVerifiedMDCGhealth.ec.europa.eu
- 3
FDA - Software as a Medical Device (SaMD)VerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.