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Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in

Emilia Niemiec1, Timo Minssen1, Patrick A Boland2

  • 1Centre for Advanced Studies in Bioscience Innovation Law (CeBIL), Faculty of Law University of Copenhagen, København S, Denmark.

Expert Review of Medical Devices
|July 7, 2025
PubMed
Abstract

Keywords:
AI ActGeneral Data Protection RegulationMedical Devices Regulationclinical investigationdata sharingintellectual property rightsmedical AImedical device software

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