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

Abstract

Many legal and regulatory requirements need to be considered in projects developing medical AI systems. Their implementation may be challenging as both AI technology and some of the regulations are new. This article examines the key legal challenges arising from the EU General Data Protection Regulation, Medical Devices Regulations, AI Act, as well as selected intellectual property issues in multi-partner projects developing medical AI systems, using an ongoing clinical validation study of such