Building Trust in Artificial Intelligence in Medicine: A European Union Legal Perspective

Artificial Intelligence (AI) is slowly transforming the healthcare sector in the European Union. In order to speed up innovation while minimizing risks and protecting fundamental values and rights, the European Commission proposed a new legal framework for AI. Its main objective is to create an ‘ecosystem of trust’. Patients may benefit from a regulatory approach to AI that centres on building trust. Trust is considered crucial for the doctor-patient relationship, and far-reaching technological changes in the healthcare system may undermine trust. Achieving trust in new technologies is vital for society in general and patients in specific. The use of trust as a regulatory objective for AI raises three crucial questions: 1) What does the European Commission mean with ‘trust’ and ‘trustworthiness’? 2) To what extent does AI as such has the capacity to be trusted? And 3) How can trust in AI be achieved through legal regulation? Because of these uncertainties, it is unclear whether ‘trustworthy AI’ as a foundational policy ambition also enhances the protection of patients’ rights, despite the shared value of trust. In light of the common foundational value of trust, this article analyses the role of the notion of trust in the legal Europeanisation of health AI through a patients’ rights lens. The primary aim of this study is to evaluate the consequences of the EU policy objective of trust for AI used in the health sector. It aims to answer the following research question: does the focus on trust in the EU legal framework on AI provide for stronger protection of patients’ rights in the Member States? The outcome of this article will permit to shed light on shortcomings in the current legal framework on health AI and patients’ rights in Europe in view of the algorithmic turn in healthcare.