Ethical and legal challenges of cross-border health data sharing in Europe: A normative policy analysis of ICUData4EU.

BACKGROUND: Cross-border medical data sharing has become an important global practice. While it improves the efficiency of healthcare systems, it also raises significant concerns regarding patient privacy and data protection. How can healthcare data be used responsibly to advance medical technology while ensuring that electronic medical records are shared appropriately and privacy is safeguarded? METHODS: This paper adopts a normative policy analysis approach. It evaluates the programme's structure and governance model, examines its legal implications in light of the GDPR and EHDS, and analyses the potential benefits and risks of cross-border data sharing. RESULTS: The analysis shows that ICUData4EU provides a federated platform that enables intensive care unit (ICU) data to be analysed within local hospital environments while allowing researchers across the EU to access aggregated analytical results remotely. This model supports medical research while seeking to mitigate risks associated with cross-border data transfers. However, the programme may still face legal and ethical challenges, particularly regarding GDPR as well as EHDS compliance and patient privacy protection. DISCUSSION: The paper recommends linking HDAB authorisation to federated execution, assessment of unequal privacy risks, and benefit sharing for hospitals and institutions in low- and middle-income countries. Notably, given ongoing development, the analysis is precautionary. CONCLUSIONS: Cross-border health data platforms such as ICUData4EU have significant potential to advance medical research and improve ICU care. However, implementation requires strong legal safeguards and ethical governance frameworks to ensure data protection compliance and address unequal privacy risks, and benefit sharing mechanisms to protect patient confidentiality while producing public value.