CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software
Frank Rademakers, Elisabetta Biasin, Nico Bruining, Enrico G. Caiani, Rhodri Davies, Stephen Gilbert, Erik Kamenjašević, Gearóid McGauran, G. A. O’Connor, Jean-Baptiste Rouffet, Baptiste Vasey, Alan G. Fraser
Abstract
The European CORE-MD consortium (Coordinating Research and Evidence for Medical Devices) proposes a score for medical devices incorporating artificial intelligence or machine learning algorithms. Its domains are summarised as valid clinical association, technical performance, and clinical performance. High scores indicate that extensive clinical investigations should be undertaken before regulatory approval, whereas lower scores indicate devices for which less pre-market clinical evaluation may be balanced by more post-market evidence.
Topics & Concepts
Computer scienceSoftwareArtificial intelligenceOperating systemArtificial Intelligence in Healthcare and EducationQuality and Safety in HealthcareBiomedical and Engineering Education