Mapping the Landscape of Care Providers’ Quality Assurance Approaches for AI in Diagnostic Imaging

The discussion on artificial intelligence (AI) solutions in diagnostic imaging has matured in recent years. The potential value of AI adoption is well established, as are the potential risks associated. Much focus has, rightfully, been on regulatory certification of AI products, with the strong incentive of being an enabling step for the commercial actors. It is, however, becoming evident that regulatory approval is not enough to ensure safe and effective AI usage in the local setting. In other words, care providers need to develop and implement quality assurance (QA) approaches for AI solutions in diagnostic imaging. The domain of AI-specific QA is still in an early development phase. We contribute to this development by describing the current landscape of QA-for-AI approaches in medical imaging, with focus on radiology and pathology. We map the potential quality threats and review the existing QA approaches in relation to those threats. We propose a practical categorization of QA approaches, based on key characteristics corresponding to means, situation, and purpose. The review highlights the heterogeneity of methods and practices relevant for this domain and points to targets for future research efforts.