The European Union (EU) Artificial Intelligence (AI) Regulation is the world’s first comprehensive AI Regulation. It will take effect from mid-2025 onwards with most of its provisions taking effect in 2026. The new rules introduce obligations for both providers and users and are based on the level of risk from the application of AI. Additionally, Member State national regulators are not excluded by this Regulation and may impose stricter market-specific requirements alongside the EU AI Regulations.  Investors and providers of AI systems and technology who are well-versed on these changes and prepared to meet the new requirements will be better positioned in the market.

In this piece, Marwood analyses the upcoming regulatory changes affecting AI systems in the EU and the potential impact it may have on companies developing or promoting AI applications in healthcare, or investors with existing or potential investments in these companies.