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Home » Medical AI remains a high-risk product under updated AI Act
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Medical AI remains a high-risk product under updated AI Act

Dec. 12, 2023
By Mark McCarty

The European Union’s Artificial Intelligence Act (AI Act) is widely seen as a groundbreaking piece of legislative handiwork, but companies in the life sciences may see it as a groundbreaker with negative consequences. The latest edition of the AI Act continues to treat medical AI software as a high-risk product, which would make these products exceptionally expensive and burdensome to bring to market in the EU and convince some companies in the medical AI business to skip the European market altogether.

BioWorld MedTech Regulatory Artificial intelligence Europe

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