1.E. Scientific session: EU regulations with impact on digital public health: A Roadmap to navigate the evolving landscape

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 some are immediately applicable, others require adaptation, and some are ignored altogether. To address this challenge, structured guidance for systematically assessing national preparedness is urgently needed, but currently lacking. This workshop aims to fill that gap by introducing and discussing an innovative checklist tool that includes core indicators for assessing national preparedness for digital public health regulation across EU member states. The checklist supports policymakers, practitioners, and researchers in evaluating critical areas such as infrastructure, interoperability, workforce development, trust, and regulatory alignment with EU legislation. The session will begin with two framing presentations: one outlining the impact of EU legislation and its national implications for the digitalization of public health, and the other introducing the checklist as a practical assessment framework for national preparedness. These will be followed by two case studies from Norway and Malta, illustrating how national-level strategies, focused on AI governance and digital health education, are shaping the path to compliance and transformation. A moderated discussion will engage participants in identifying best practices, common barriers, and future needs, helping to inform policy dialogue and action on digital public health regulation adaptation across EU Member States. Key messages • By equipping policymakers, public health professionals, and researchers with a practical checklist, this workshop supports evidence-informed decision-making in digital public health governance. • The checklist provides a platform for cross-country learning, fostering international collaboration, and promoting regulatory preparedness as a key investment in public health sustainability.