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28 June 2024

The regulation of artificial intelligence in healthcare: the AI Act but not only!

The Regulation on Artificial Intelligence (or IA Act) is on everyone's lips, following its adoption by the European Parliament on March 13 and its final adoption on April 22. However, when applied to the healthcare sector, does this text constitute the sole cornerstone of regulations governing the use of artificial intelligence by healthcare players? What if the real upheaval lay in the regulations governing the secondary use of data, and first and foremost, healthcare data?


An involuntary text Initiated in April 2021 and after several years of negotiations during which ChatGPT emerged, the European legislator has equipped itself with a regulation on artificial intelligence1. Concerned with the protection of fundamental rights, the European Union retains a broad definition of AI system2 (AIS) and enshrines a risk-based approach to the regulation of these AI systems: the higher the risk, the more the use of this system will be regulated. For AIS representing an...
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Author

Laurence Huin

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