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Clinical Evidence Requirements For AI Must Be Based On Purpose, EU Expert Group Says

 
• By Eliza Slawther

EU guidance on clinical evidence requirements for medical device software does not yet include AI-specific information. An expert group explains how regulators can determine how much evidence is needed for AI-based devices and why common standards should be utilized.

AI Evidence

Artificial intelligence (AI) technology is widely used in the medical sector, but regulators in the EU and beyond are yet to reach a definitive decision on the best way to regulate this type of software. Indeed, the European Commission has faced much criticism for its proposed AI Act, which is set to be a landmark piece of legislation that sets out sector-agnostic rules for AI products.

But what actually is AI, and how should it be regulated in a medical context? In an 8 May

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