arXiv subjects

Zahra Raisi-Estabragh

Publications and source records attributed to Zahra Raisi-Estabragh.

3 recordsLinked to original sources

arXiv2026

Regulatory Approval Is Not Enough: Gaps in Trustworthy AI Reporting in FDA-Cleared Medical Devices

Background: AI/ML-enabled medical devices are increasingly deployed in healthcare under evolving regulatory frameworks. As these systems become more integrated into clinical decision-making, there is growing expectation that they demonstrate key dimensions of trustworthy AI to support clinician, patient, and public trust. Whether publicly available regulatory documentation provides sufficient evidence to independently assess the trustworthiness of cleared AI systems remains unclear. Methods: We analysed FDA AI/ML-enabled medical device summary reports published between 2021 and 2025. Reports underwent automated keyword screening followed by multi-stage manual consensus review to identify documented evidence for the six FUTURE-AI principles: Fairness, Universality, Traceability, Usability, Robustness, and Explainability. Descriptive, temporal, and clinical-domain analyses were performed. Multivariable logistic regression assessed whether year of clearance or clinical domain predicted higher reporting transparency, defined as evidence reported for three or more principles. Results: Of 1,105 FDA summary reports screened, 519 were included. Trustworthy AI reporting was limited and uneven. Nearly one quarter (24.7%) provided no evidence for any principle, and none documented evidence across all six. Robustness was most frequently reported (57.6%), while Traceability (8.3%) and Explainability (3.5%) were the most pronounced gaps. Neither year of clearance (OR 1.02, 95% CI 0.88-1.19) nor clinical domain (OR 0.73, 95% CI 0.46-1.15) predicted higher reporting transparency. Interpretation: Substantial, persistent trustworthy AI reporting gaps exist in FDA documentation. Regulatory approval alone should not be considered a proxy for trustworthiness. Standardised, audit-ready reporting across the AI lifecycle is needed to support independent assessment and responsible adoption of healthcare AI.

cs.CY↗

arXiv2024

A Perspective on Explainable Artificial Intelligence Methods: SHAP and LIME

eXplainable artificial intelligence (XAI) methods have emerged to convert the black box of machine learning (ML) models into a more digestible form. These methods help to communicate how the model works with the aim of making ML models more transparent and increasing the trust of end-users into their output. SHapley Additive exPlanations (SHAP) and Local Interpretable Model Agnostic Explanation (LIME) are two widely used XAI methods, particularly with tabular data. In this perspective piece, we discuss the way the explainability metrics of these two methods are generated and propose a framework for interpretation of their outputs, highlighting their weaknesses and strengths. Specifically, we discuss their outcomes in terms of model-dependency and in the presence of collinearity among the features, relying on a case study from the biomedical domain (classification of individuals with or without myocardial infarction). The results indicate that SHAP and LIME are highly affected by the adopted ML model and feature collinearity, raising a note of caution on their usage and interpretation.

stat.ML↗

arXiv2023

Characterizing the contribution of dependent features in XAI methods

Explainable Artificial Intelligence (XAI) provides tools to help understanding how the machine learning models work and reach a specific outcome. It helps to increase the interpretability of models and makes the models more trustworthy and transparent. In this context, many XAI methods were proposed being SHAP and LIME the most popular. However, the proposed methods assume that used predictors in the machine learning models are independent which in general is not necessarily true. Such assumption casts shadows on the robustness of the XAI outcomes such as the list of informative predictors. Here, we propose a simple, yet useful proxy that modifies the outcome of any XAI feature ranking method allowing to account for the dependency among the predictors. The proposed approach has the advantage of being model-agnostic as well as simple to calculate the impact of each predictor in the model in presence of collinearity.

stat.ML↗