EU Regulation of Artificial Intelligence: Challenges for Patients’ Rights

In order to create a well-functioning internal market for Artificial Intelligence (AI)-systems, the European Commission recently proposed the Artificial Intelligence Act. However, this legislative proposal pays limited attention to the health-specific risks the use of AI poses to patients’ rights. This article outlines that fundamental rights impacts associated with AI such as discrimination, diminished privacy and opaque decision-making are exacerbated in the context of health and may threaten the protection of foundational values and core patients’ rights. However, while the EU is facilitating and promoting the use and availability of AI in the health sector in Europe via the Digital Single Market, it is unclear whether it can provide the concomitant patients’ rights protection. This article theorises the Europeanisation of health AI by exploring legal challenges through a patients’ rights lens in order to determine if the European regulatory approach for AI provides for sufficient protection to patients’ rights.