Abstract Digital transformations are reshaping public health across Europe and globally, presenting both opportunities and challenges. The increasing reliance on digital tools and data-driven health interventions necessitates robust regulatory guidance, standardization, FAIRification, and harmonization across sectors and jurisdictions to ensure security, transparency, and ethical use. The European Union (EU) has introduced key legislation, including the General Data Protection Regulation (GDPR), the EU Cybersecurity Act, the EU Artificial Intelligence (AI) Act, the EU Data Act, and the European Health Data Space (EHDS) Regulation. These regulations aim to strengthen health system resilience, promote the safe and ethical use of AI in healthcare, and enable timely, secure, and harmonized health data exchange across the EU. However, the readiness of health systems to implement these regulations varies widely due to differences in national governance, infrastructure, workforce capacity, and digital health maturity. This variability influences the complex and unequal implementation of EU regulations at the national level, as s
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