It is the European Union’s landmark, comprehensive legal framework designed to regulate the development, deployment, and use of AI systems based on a risk-based approach.
The AI Act protects clinical research by classifying most AI applications in this sector as “high-risk,” mandating strict compliance with data governance, human oversight, and safety standards to protect research participants.
Entered into force on August 1, 2024, it aims to foster “trustworthy AI” by ensuring that AI systems used in the EU are safe, ethical, and transparent, with significant penalties for non-compliance.
- EU Digital strategy https://digital-strategy.ec.europa.eu/en/policies/regulatory–frameworkai#:~:text=The%20AI%20Act%20is%20the,in%20AI%20across%20the%20EU
More resources
- Bignami EG et al. JMIR AI. 2025 Oct 30;4:e75527 Balancing Innovation and Control: The European Union AI Act in an Era of Global Uncertainty https://pmc.ncbi.nlm.nih.gov/articles/PMC12574960/
