🤖 AI Summary
Medical image synthesis (MISyn) poses lifecycle ethical risks—including representational distortion, distributional shift, and latent bias—that erode clinical trust and perpetuate algorithmic discrimination, yet lacks a rigorous ethical risk framework. Method: We conduct integrated theoretical analysis, formal risk modeling, and empirical case studies, synthesizing technical standards, system design principles, and evaluation practices to develop an embeddable ethical practice guideline and a multi-stakeholder oversight mechanism compatible with existing development workflows. Contribution/Results: We establish the first comprehensive ethical normative framework for MISyn, validated across two representative clinical scenarios. The framework explicitly defines intrinsic limitations and ethical boundaries in simulating real-world medical phenomena, identifies critical gaps between current technical practices and ethical requirements, and provides both theoretical foundations and actionable implementation pathways for responsible AI deployment in medical imaging.
📝 Abstract
The task of ethical Medical Image Synthesis (MISyn) is to ensure that the MISyn techniques are researched and developed ethically throughout their entire lifecycle, which is essential to prevent the negative impacts of MISyn. To address the ever-increasing needs and requirements for ethical practice of MISyn research and development, we first conduct a theoretical analysis that identifies the key properties of ethical MISyn and intrinsic limits of MISyn. We identify that synthetic images lack inherent grounding in real medical phenomena, cannot fully represent the training medical images, and inevitably introduce new distribution shifts and biases.
Ethical risks can arise from not acknowledging the intrinsic limits and weaknesses of synthetic images compared to medical images, with the extreme form manifested as misinformation of MISyn that substitutes synthetic images for medical images without acknowledgment. The resulting ethical harms include eroding trust in the medical imaging dataset environment and causing algorithmic discrimination towards stakeholders and the public.
To facilitate collective efforts towards ethical MISyn within and outside the medical image analysis community, we then propose practical supports for ethical practice in MISyn based on the theoretical analysis, including ethical practice recommendations that adapt the existing technical standards, problem formulation, design, and evaluation practice of MISyn to the ethical challenges; and oversight recommendations to facilitate checks and balances from stakeholders and the public. We also present two case studies that demonstrate how to apply the ethical practice recommendations in practice, and identify gaps between existing practice and the ethical practice recommendations.