Navigating European Healthcare Regulations Through a Historical Lens

This chapter draws comparisons between significant EU legal frameworks, such as the Medical Device Regulations and the General Data Protection Regulation, and the socio-economic challenges that Europeans have faced historically. It uses these comparisons to shed light on the motivations behind the policymakers’ decisions regarding upcoming regulations like the European Health Data Space and the AI Act. Additionally, the chapter outlines the similarities and differences between these regulations to assist scholars working with AI in healthcare in understanding the complex legal environment. The narrative begins with the establishment of the European Coal and Steel Community post-WWII, which was aimed at fostering Europe’s physical reconstruction and maintaining peace; without coal, steel could not be produced, and without joint control over steel production, it was impossible for individual nations to manufacture war weaponry. In today’s era, data is the new coal, and AI plays a vital role in driving European economic growth and competitiveness. It also holds the potential to become a formidable instrument of warfare. Therefore, ensuring equitable data sharing and ethical AI usage is essential for sustainable growth, peace, and democracy in Europe and beyond. The chapter concludes with a reflection on the inadequacy of existing regulations, particularly those in countries like the EU, USA, and China, to address low resource settings needs. It calls for future regulations to consider a more inclusive form of universalism.