Abstract 

The rapid advancement of digital health innovation, including Artificial Intelligence (AI), is transforming healthcare. The growing role the European Union (EU) plays in regulating the use of AI in healthcare renders national laws insufficient to safeguard patients from unique AI-related risks. This underscores the urgent need for the recognition of a canon of patients’ rights in the scope of EU law. This paper proposes the blueprint for an EU Charter for Digital Patients’ Rights, consolidating and adapting existing rights for patients to address these specific challenges. Traditional patients’ rights such as the right to privacy and the right to informed consent are interpreted in light of the challenges posed by AI. It also proposes novel rights for patients, such as the right not to be subject to automated medical decision-making and the right to meaningful human contact. This paper highlights the EU’s central role in protecting patients’ rights and outlines strategies for effective implementation. This comprehensive approach aims to address the current shortcomings and enhance the legal framework governing digital health in Europe.