The AI Act and patient’s rights
The EU AI Act is part of the European Union’s efforts to establish a comprehensive regulatory framework for artificial intelligence systems. The legislation aims to set clear rules for AI development, deployment, and use within the EU, addressing concerns related to ethics, accountability, transparency, and fundamental rights. The AI Act was adopted in June 2024, and certain prohibitions came into force early 2025. There is still much to be done to ensure that the AI Act protects health and patient’s rights. HAI will continue to engage with standards development processes and monitor the policy decisions that are made as we move towards implementation of the Act. We will continue our advocacy to ensure that AI in healthcare is trustworthy, fair, equitable and contributes to patient outcomes and wellbeing.
A collection of our outputs on the AI Act can be found here:
- Why the EU AI Act falls short on preserving what matters in health (June 2025)
- Unpacking the AI Act: Gains and Gaps in the Protection of Health (April 2024)
- Inside AI Policy article: European analyst identifies gaps in the AI Act for addressing risks in the health sector (December 2023)
- Voting Advice: European Parliament Plenary Vote on the AI Act (June 2023)
- Blog: Five “Big MedTech” myths about medical AI debunked (April 2023)
- Blog: AI can threaten health equity for marginalised populations: The EU must act now (June 2023)
- Blog: When the AI team went to Brussels (October 2023)
- Blog: Health protection in non-negotiable in the AI Act negotiations (August 2022)
- Recommendations hand out: Addressing risks and harms from health-related AI (February 2022)
- Report: Interpreting the EU AI Act for the health sector (February 2022)

