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First published on The European Union is advancing artificial intelligence regulations that could impact medical device and diagnostic companies around the world. Through the policy, the EU plans to impose additional requirements on the use of AI in medtech and issue fines for noncompliance that could total billions of dollars.  In a document setting out its plans, the European Commission states high-risk AI systems should only be placed on the EU market if they comply with certain mandatory requirements  that ensure they do not pose unacceptable risks to important public interests. Medical devices and in vitro diagnostics are on a long list of products that could be classed as high-risk.

Yiannos toliasBob carpenterMedtech europeEli lillyEuropean unionFlatiron institute centerEuropean commissionMedical device regulationFlatiron instituteComputational mathematicsGeneral data protection regulationUtech europeHealth itPolicy amp regulationHealthcare regulationPolicy amp reg