The path forward for real-world data and AI in Europe

Europe is pursuing a path similar to the one described for the U.S., leveraging real-world data (RWD) and artificial intelligence (AI) to advance healthcare research—but there are important distinctions shaped by the EU’s regulatory landscape. EU AI Regulations: Opportunity and Structure AI Act: The EU’s Artificial Intelligence Act (in force since August 2024) is the world’s first comprehensive AI law. It adopts a risk-based approach, placing the strongest requirements on “high-risk” systems, which include most of the AI used in healthcare and clinical research. High-risk AI must meet strict standards: High-quality, representative data sets, checking for bias Rigorous risk management and transparency Human oversight of AI systems Mandatory registration and ongoing monitoring Prohibited Uses: A small number of AI applications—primarily those that threaten fundamental rights—are banned entirely (e.g., social scoring, certain biometric uses, especially if they might introduce discrimination). Minimal & Limited Risk: Most AI tools fall into categories with fewer requirements but must still provide basic transparency...