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

• DOI: 10.1007/s12553-024-00878-z
• Publication Date: 2024-05-04T01:01:40Z
• Authors: Leandro Pecchia; A. Maccaro; M. A. G. Matarrese; F. Folkvord; G. Fico
• Keywords: Data Sharing; Enabling

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