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Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU
0
Zitationen
5
Autoren
2025
Jahr
Abstract
The current regulatory landscape for medical AI system validation in Europe is complex, evolving, and presents some conflicting principles. Key areas that need to be addressed in future soft law instruments include data anonymization and interplay between the Medical Devices Regulation, AI Act, and General Data Protection Regulation. Policymakers should invest in regulatory science to ensure that regulatory frameworks are evidence-based and prioritize patient safety while fostering innovation.
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