The Ethics of Autonomous Clinical AI: Shifting From Model Accuracy to Model Impact

The ethics of autonomous clinical AI are controversial. Traditional ethics assessments have focused on AI model performance rather than health system outcomes. Nichol and colleagues translate established research ethics principles into 9 practical recommendations for trials of autonomous clinical AI. Their findings support an evolution in clinical trial design. The accuracy and performance of the model is important, but the ethical unit of evaluation should be the complete care pathway, with prespecified obligations for subgroup performance, follow-up care, system failures, and model change.