Ethical and Governance Challenges of AI in Medical Imaging and Diagnostics: A Systematic Survey and Policy Framework Recommendations

Background/Objectives: Artificial intelligence (AI) is increasingly embedded within diagnostic imaging workflows, reshaping clinical decision-making, health system governance, and regulatory oversight. While technical advances in radiological AI have accelerated, governance mechanisms have struggled to keep pace with issues of bias, transparency, accountability, and lifecycle oversight. This study examines ethical, regulatory, and implementation challenges in AI-enabled diagnostic imaging, building on prior reviews that have often emphasised technical performance by integrating ethical risk domains with governance responses across the AI lifecycle. Methods: This study presents a PRISMA-ScR-informed systematic survey of 156 sources, including peer-reviewed publications, regulatory documents, policy reports, and professional guidance materials (2018–2025), synthesised through thematic analysis and lifecycle mapping spanning data acquisition, model development, deployment, monitoring, and continuous learning. Results: Drawing on both thematic insights derived from the reviewed literature and established ethical and regulatory frameworks, we propose a literature-derived conceptual ethical-governance framework organised around five pillars: equity and bias mitigation, explainability and transparency, accountability and oversight, privacy-preserving infrastructure, and adaptive regulatory alignment. Although illustrated through the Australian healthcare context, the framework is designed to be transferable to federated and multi-jurisdictional health systems. This review further identifies trust quantification as an underdeveloped but essential dimension of clinical AI governance, emphasising the need to integrate measurable indicators such as calibration, clinician–AI concordance, and patient acceptance into lifecycle-based evaluation. Conclusions: By bridging technical, ethical, and policy perspectives, this review proposes a structured conceptual governance framework to support safe, equitable, and trustworthy AI integration in digital health systems.