Barriers and pitfalls for artificial intelligence in gastroenterology: Ethical and regulatory issues

Abstract Artificial intelligence (AI)-based technologies are developing rapidly, offering great promise for gastroenterology and particularly endoscopy. However, there are complex barriers and pitfalls that must be considered before widespread real-world clinical implementation can occur. This review highlights major ethical concerns related to data privacy and sharing that are essential for the development of AI models, through to practical clinical issues such as potential patient harm, accountability, bias in decisions, and impact on workforce. Finally, current regulatory pathways are discussed, recognizing that these need to evolve to deal with unique new challenges, such as the adaptive and rapidly iterative nature of AI-based technologies, while striking a balance between ensuring patient safety and promoting innovation.