Results of the Ninth Scientific Workshop of the European Crohn's and Colitis Organisation (ECCO): artificial intelligence in IBD: regulatory and methodological considerations.

With the rapid growth of artificial intelligence (AI) applications in the field of inflammatory bowel disease (IBD), an increasing number of regulatory and methodological considerations have become apparent. Currently, there remains much uncertainty and limited experience in the field of IBD regarding some of the regulatory and methodological pitfalls to be considered when developing and deploying AI applications for positive clinical and health system impact. Accordingly, an expert panel was convened by the European Crohn's and Colitis Organisation to review the published literature and provide an overview of key regulatory aspects for the application of AI in IBD. This article discusses and, where possible, provides guidance on key methodological and regulatory considerations for AI in IBD. Topics covered include: potential clinical application-focused algorithm design; ethical, moral and legal considerations; regulatory agency perspectives; an overview of regulatory submission and consideration of reimbursement. By providing clinicians with a primer to key regulatory and methodological considerations, we hope to accelerate knowledge translation and implementation of AI-enabled digital health innovations in clinical practice and ultimately improve outcomes for people living with and caring for those living with IBD.