臨床予測における生成AIの利用 - 欧州の視点

The use of Artificial Intelligence in the medical field is well-established. Recent advances in the use of generative AI have significantly accelerated experimentation, but also adoption on smart, AI-driven systems in the prediction of potential outcomes of therapies in clinical prediction. In this chapter we are providing an overview of the field, its most prevalent challenges and AI-technologies that are already in use, in particular those already certified as medical products. We are providing details on promising approaches and how AI has been applied on clinical prediction in the specific product. In the second part, we will provide a review of relevant research in the domain, in particular systems that leverage generative AI solutions, with a focus on the potential readiness for near-term market release, as well as providing a high degree of innovation, while proposing a positive outcome for patients and medical professionals. Finally, we will give an outlook on the regulatory and standardization aspects of using AI-based medical products for prediction of outcomes in Europe, giving an overview on recent legal developments and how they might impact developers and potential users of such systems.