The Legal and Ethical Framework for Artificial Intelligence in Gastrointestinal Endoscopy: A World Endoscopy Organization International Consensus Statement

Abstract

The OperA (Optimising Colorectal Cancer Prevention through Personalized Treatment with Artificial Intelligence) project aims to transform colorectal cancer care through artificial intelligence (AI) innovations. Recognizing that legal and ethical challenges remain key obstacles to clinical integration, this Delphi study sought to identify and prioritize such concerns in the context of gastrointestinal (GI) endoscopy. Fourteen international experts participated in a 2-round Delphi process. In round 1, the steering committee, with feedback from participants, proposed legal and ethical issues pertaining to AI in endoscopy. Round 2 involved iterative rating and refinement of these issues to achieve consensus on their importance. Consensus was reached on 10 key statements spanning 3 thematic domains: data governance, medicolegal implications, and equity and bias. Experts emphasized the need for robust data protection, transparent algorithmic development, and institutional clarity on data ownership. Liability concerns related to AI-assisted diagnosis and automated reporting were highlighted, alongside calls for guidance from legal and professional bodies. Finally, participants underscored the importance of demographic diversity in training data sets and transparent reporting practices to mitigate bias and ensure equitable AI deployment. As AI tools become increasingly integrated into the clinical practice of gastroenterology, addressing legal, ethical, and equity-related challenges is essential. This expert consensus provides a foundation for developing guidelines and regulatory frameworks to support responsible AI adoption in GI endoscopy.

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