Artificial Intelligence, data protection and medical device regulations: squaring the circle with a historical perspective in Europe

Abstract

Abstract Purpose This manuscript presents a parallel among important EU legal frameworks, such as the Medical Device Regulations and General Data Protection Regulation and economic-historical challenges faced by European citizens. This parallel offers a prospective for understanding the direction taken by policymakers for forthcoming regulations, such as the European Health Data Space and the AI-Act. Method The paper describes key commonalities and differences among those regulations, which may help scholars working with AI in medicine, navigating this articulated legal framework. Results The European Union journey started with the European Coal and Steel Community, enforced after the WWII for nurturing European physical reconstruction and as a mean for peacekeeping: without coil it was not possible to transform steel, and with shared control of steel it was not possible for individual member states to build war weapons. Conclusions In this century, modern coal are data and modern steel is the AI, which is a crucial enabler for European economy growth and competitiveness, and, potentially, a powerful war weapon. Ensuring a fair data-sharing and correct use of AI is crucial for sustainable development, peace, and democracy in Europe and beyond.