What is the EU AI Act's approach to medical AI?

The EU AI Act (2024) classifies medical AI as ‘high-risk’ and mandates bias testing, data governance, and human oversight prior to market entry. This means AI systems used in healthcare must demonstrate fairness, transparency, and accountability before deployment. In contrast, the US FDA has issued guidance on diversity in clinical validation datasets, and a 2023 Executive Order requires federal agencies to address algorithmic discrimination.