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

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.