Governing Artificial Intelligence in Radiology: A Systematic Review of Ethical, Legal, and Regulatory Frameworks

Purpose: This systematic review explores the ethical, legal, and regulatory frameworks governing the deployment of artificial intelligence technologies in radiology. It aims to identify key governance challenges and highlight strategies that promote the safe, transparent, and accountable integration of artificial intelligence in clinical imaging. This review is intended for both medical practitioners and AI developers, offering clinicians a synthesis of ethical and legal considerations while providing developers with regulatory insights and guidance for future AI system design. Methods: A systematic review was conducted, examining thirty-eight peer-reviewed articles published between 2018 and 2025. Studies were identified through searches in PubMed, Scopus, and Embase using terms related to artificial intelligence, radiology, ethics, law, and regulation. The inclusion criteria focused on studies addressing governance implications, rather than technical design. A thematic content analysis was applied to identify common patterns and gaps across ethical, legal, and regulatory domains. Results: The findings reveal widespread radiology-specific concerns, including algorithmic bias in breast and chest imaging datasets, opacity in image-based AI systems such as pulmonary nodule detection models, and unresolved legal liability in cases where radiologists rely on FDA-cleared AI tools that fail to identify abnormalities. Regulatory frameworks vary significantly across regions with limited global harmonization, highlighting the need for adaptive oversight models and improved data governance. Conclusion: Responsible deployment of AI in radiology requires governance models that address bias, explainability, and medico-legal accountability while integrating ethical principles, legal safeguards, and adaptive oversight. This review provides tailored insights for medical practitioners, AI developers, policymakers, and researchers: clinicians gain guidance on ethical and legal responsibilities, developers on regulatory and design priorities, policymakers (especially in the Middle East) on regional framework gaps, and researchers on future directions.