Auditing fairness in clinical AI systems using provenance-based simulation: a comparative and regulatory perspective.

Introduction: The adoption of Artificial Intelligence (AI) in clinical decision support has encountered obstacles due to algorithmic bias and lack of transparency. To address this, we developed an auditing framework using detailed data provenance to audit fairness. Methods: We simulated audits on a synthetic patient dataset ( Results: Logistic regression achieved 75.2 ± 1.0% accuracy (AUC = 0.806 ± 0.030) and random forest achieved 70.1 ± 1.4% accuracy (AUC = 0.745 ± 0.020). Provenance logs successfully detected gender biases in both models. Logistic regression exhibited statistically significant bias (EOD = +0.256, Discussion: Despite lower accuracy, random forest showed 57% less bias than logistic regression, challenging assumptions that interpretability guarantees fairness. We introduce a standardized AI Fairness Provenance Record documenting data origin, model choices, and bias metrics, enabling auditors to trace decisions to their source. This framework maps to FDA transparency guidelines and ONC HTI-1 requirements, demonstrating how provenance-based auditing supports regulatory compliance and provides a pathway toward more responsible and equitable AI in clinical settings.