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

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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Publication Details

Journal
Annals of Internal Medicine
Published
2025-12-08
DOI
https://doi.org/10.7326/annals-25-03415
Primary Topic
Artificial Intelligence in Healthcare and Education
Type
article
Field-Weighted Citation Impact
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article

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

Pu Wang, Folasade P. May, Lars Aabakken, Daniel de Araujo Dourado et al.
Annals of Internal Medicine
Artificial Intelligence in Healthcare and Education
article

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

Pu Wang, Folasade P. May, Lars Aabakken, Daniel de Araujo Dourado, Tomonori Yano, Michael F. Byrne, Evelien Dekker, Anna L. Silverman, Yutaka Saito, Helmut Messmann, Michael Bretthauer, Masashi Misawa, Omer F. Ahmad, Haruhiko Ogata, Pradeep Bhandari, Raf Bisschops, Tyler M. Berzin, Yuichi Mori, Uma Mahadevan, Cesare Hassan
article en

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.

Annals of Internal MedicineVol. 179(2)
Oslo University Hospital (NO), University College Hospital (GB), Beth Israel Deaconess Medical Center (US), Humanitas University (IT), Jichi Medical University (JP), University of Electronic Science and Technology of China (CN), Tokyo Fuji University (JP), University of California, San Francisco (US), Vancouver Hospital and Health Sciences Centre (CA), University Hospital Augsburg (DE), Vancouver General Hospital (CA), Portsmouth Hospitals NHS Trust (GB), SHOWA Medical University Northern Yokohama Hospital (JP), IT&D Informação Tecnologia e Desenvolvimento (Brazil) (BR), National Cancer Center Hospital East (JP), Amsterdam University Medical Centers (NL), VA Greater Los Angeles Healthcare System (US), IRCCS Humanitas Research Hospital (IT), University College London (GB), University of Amsterdam (NL), Icahn School of Medicine at Mount Sinai (US), KU Leuven (BE)
Openalex Percentile: Top 66%
Artificial Intelligence in Healthcare and Education
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