Research in Brief: BIDMC Gastroenterologist Leads First Global Consensus on Legal and Ethical Standards for AI in Endoscopy

International Framework Addresses Emerging Challenges as AI Enters Clinical Practice

BOSTON — As artificial intelligence tools increasingly enter gastrointestinal medicine, a team of international experts led by Tyler M. Berzin, MD, of Beth Israel Deaconess Medical Center (BIDMC), has developed the first comprehensive framework to guide their responsible use. The consensus statement, published in the Annals of Internal Medicine, establishes principles for data governance, medicolegal accountability, and equity that will help clinicians, institutions, and regulators navigate this rapidly evolving landscape.

"As AI tools rapidly enter clinical practice, we need more than technical validation — we need clear, ethical, and legal frameworks to guide their responsible use," said Dr. Berzin, a gastroenterologist at BIDMC and faculty member at Harvard Medical School who served as senior author on the project.

The consensus emerged from a rigorous Delphi process involving 14 experts from 11 countries across four world regions. Participants reached agreement on ten statements organized around three areas: data governance, medicolegal accountability, and equity and bias. The project was undertaken at the initiative of the World Endoscopy Organization and received endorsement from the European Society of Gastrointestinal Endoscopy.

Data governance: AI systems must comply with local data protection regulations, protect patient privacy through anonymization, and maintain transparency when algorithms are updated. Healthcare organizations should establish clear policies on data ownership, particularly when working with commercial AI vendors.

Medicolegal accountability: When AI-assisted decisions lead to adverse outcomes, who bears responsibility? The panel calls for professional societies and legal experts to provide guidance. Additionally, novel AI-generated quality metrics should be rigorously validated before they influence clinical practice or regulatory standards.

Equity and bias: AI systems should be trained on demographically diverse datasets, with transparent reporting of study population characteristics. Research is needed to determine whether AI adoption risks widening healthcare disparities — for instance, if well-resourced centers gain access before safety-net hospitals.

The work is part of the OperA (Optimising Colorectal Cancer Prevention through Personalized Treatment with Artificial Intelligence) project, currently the largest international study focused on using AI to improve colon cancer prevention. Funded by the European Commission through the Horizon Europe mechanism, OperA represents a collaboration among leading institutions worldwide, with BIDMC serving as a key partner alongside University College London and the University of Oslo.

The statement arrives at a pivotal moment. AI-assisted detection of colon polyps has already entered clinical use, while other applications — including computer-aided diagnosis and automated report generation — are advancing rapidly. The framework is intended to evolve alongside the technology, providing a foundation that professional societies, regulators, and healthcare systems can build upon.

"The clinical promise of AI is inseparable from questions of safety, equity, and accountability," Berzin said. "Physicians, patients, health systems, and regulators are now confronting legal and ethical challenges we've never faced before in endoscopy. This framework is a starting point — a foundation we can build on as the technology evolves."

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center is a leading academic medical center, where extraordinary care is supported by high-quality education and research. BIDMC is a teaching affiliate of Harvard Medical School, and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is the official hospital of the Boston Red Sox.

Beth Israel Deaconess Medical Center is a part of Beth Israel Lahey Health, a healthcare system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, more than 4,700 physicians and 39,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education.