Towards Quality Management of Artificial Intelligence Systems for Medical Applications

The use of artificial intelligence systems in clinical routine is still hampered by the necessity of a medical device certification and/or by the difficulty of implementing these systems in a clinic's quality management system. In this context, the key questions for a user are how to ensure robust model predictions and how to appraise the quality of a model's results on a regular basis. In this paper we discuss some conceptual foundation for a clinical implementation of a machine learning system and argue that both vendors and users should take certain responsibilities, as is already common practice for high-risk medical equipment. We propose the methodology from AAPM Task Group 100 report No. 283 as a conceptual framework for developing risk-driven a quality management program for a clinical process that encompasses a machine learning system. This is illustrated with an example of a clinical workflow. Our analysis shows how the risk evaluation in this framework can accommodate artificial intelligence based systems independently of their robustness evaluation or the user's in-house expertise. In particular, we highlight how the degree of interpretability of a machine learning system can be systematically accounted for within the risk evaluation and in the development of a quality management system.