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Legal Challenges in EU Medical AI Projects by Maryam Taki is a document available to read on EtoBox.

This article discusses the legal and regulatory challenges faced in developing medical AI systems in the EU, focusing on the complexities introduced by the General Data Protection Regulation (GDPR), Medical Devices Regulation (MDR), and the AI Act. Key issues include data anonymization, the roles of project partners as data controllers or processors, and the selection of appropriate legal bases for data processing. The authors emphasize the need for clear guidelines and regulatory science to balance patient

Author
Maryam Taki
Language
EN