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