Navigating the EU AI Act: implications for regulated digital medical products
Mateo Aboya b✉, Timo Minssenc d, Effy Vayenae
- aCentre for Law, Medicine, and Life Sciences (LML), Faculty of Law, University of Cambridge, Cambridge, UK. ma608@cam.ac.uk
- bTranslational Health Sciences, Medical Sciences Division, University of Oxford, Oxford, UK. ma608@cam.ac.uk
- cCentre for Advanced Studies in Bioscience Innovation Law, Faculty of Law, University of Copenhagen, Copenhagen, Denmark
- dCentre for Law, Medicine, and Life Sciences (LML), Faculty of Law, University of Cambridge, Cambridge, UK
- eDepartment of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland
- ✉Corresponding author
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Abstract
The integration of artificial intelligence (AI) into regulated digital medical products is expected to transform the landscape of healthcare diagnosis. Both US and European Patent Office data show robust and rising patenting of medical AI inventions, reflecting an increased level of innovation at the invention stage 1 . These developments are not limited to early-stage innovation; they are now paralleled by a significant surge in actual practical applications of AI in healthcare, resulting in the development and market introduction of a new generation of commercially available medical AI products. The number of medical devices incorporating AI/ML continues to increase. In fact, the U.S. Food and Drug Administration (FDA) has already reviewed and authorized over 690 AI/ML-enabled medical devices, underscoring the growing importance of this technology in clinical settings 2 .
TL;DRThe AI Act’s impact on digital medical products, such as medical devices, is analyzed to determine how the AI Act apply to AI/ML-enabled medical devices and what are the obligations of ‘providers’ of these AI systems. (Semantic Scholar)