Clinical Implementation of Artificial Intelligence in Gastroenterology: Current Landscape, Regulatory Challenges, and Ethical Issues

Artificial intelligence (AI) is set to rapidly transform gastroenterology, particularly in the field of endoscopy, where algorithms have demonstrated efficacy in addressing human operator variability. However, implementing AI in clinical practice presents significant challenges. The regulatory landscape for AI as a medical device continues to evolve with areas of uncertainty. More robust studies generating real-world evidence are required to ultimately demonstrate impacts on patient outcomes. Cost-effectiveness data and reimbursement models will be pivotal for widespread adoption. Novel challenges are posed by emerging technologies, such as generative AI. Ethical and medicolegal concerns exist relating to data governance, patient harm, liability, and bias. This review provides an overview for clinical implementation of AI in gastroenterology and offers potential solutions to current barriers.