Enhancing diagnostic safety: addressing knowledge gaps for using human factors tools in the safe and effective use of AI - a proposed research agenda.

INTRODUCTION: Identify knowledge gaps in applying artificial intelligence in clinical settings, using medical imaging as a primary use case to enhance diagnostic efficacy, efficiency, and patient and provider safety. METHODS: We convened a two-day workshop with 18 interdisciplinary experts from three countries. Experts represented quality and patient safety, human factors and systems engineering, radiology and other medical specialties, nursing, medical informatics, cognitive and perceptual psychology, psychometrics and statistics, and machine learning, drawn from academia, industry, health systems, and government. RESULTS: We identified by consensus six major knowledge-gap domains, with specific research questions for each domain: development, validation, integration and sustainability; redesign of existing healthcare systems; human and team augmentation; deployment of adaptive-learning "Foundation Models;" and balancing innovation, standardization, and regulatory oversight. CONCLUSIONS: We recommend employing a multidisciplinary collaborative approach in future research to leverage transformational AI capabilities anticipated in the next 5-7 years for each of the identified knowledge-gap domains, including ensuring that clinical AI supports diagnostic decision-making, integrates into clinical workflows, and mitigates risks related to automation bias, overreliance, fragmentation of care, and unintended consequences.