Legal and Ethical Considerations in the Use of Emergency Department Electronic Health Records for Research and Quality Improvement in Emergency Care: An EU Project Perspective

Mihaela Matei^1*Rita Banzi²Maria Alexandra Rujano¹Sergio Contrino¹Giulia Irene Ghilardi³Chiara Pandolfini³Sergej Černčič⁴Klara Mihaldinec⁴Isaac John^5,6Jacques Demotes¹Guido Bertolini³

• ¹European Clinical Research Infrastructure Network, Paris, France
• ²Department of Health Policy, Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
• ³Department of Medical Epidemiology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy
• ⁴Univerzitetni Klinicni Center Maribor, Maribor, Slovenia
• ⁵St Peter’s Hospital, Chertsey, United Kingdom
• ⁶Forman Christian College, Lahore, Pakistan

The eCREAM project seeks to enhance emergency department (ED) care quality and research capacity by developing tools to extract and analyse electronic health record (EHR) data using artificial intelligence-based natural language processing. This involves creating interoperable databases for research and quality-of-care improvements across multiple European countries, which presents significant legal and ethical challenges due to the cross-jurisdictional processing of sensitive health information. A dedicated legal and regulatory task force was established to address these challenges. The methodological approach included the development of an ethical, legal, and social implications (ELSI) document, a legal and operational survey to map data flows and identify regulatory requirements, the creation of template documents for regulatory submissions, and multidisciplinary consultations with national experts. The main challenge was the legal classification of studies that did not fit the conventional clinical study categories. The data reuse was confirmed to rely on consent, but obtaining fresh consent was impracticable and incompatible with the study design. Varying national interpretations of the GDPR necessitated case-by-case analyses. Regulatory pathways primarily involved submissions to local ethics committees, which subsequently approved the approach under strict safeguards. This experience demonstrates that multinational ED research using EHR data can be conducted in a legally and ethically compliant manner through a proactive, tailored strategy to navigate the legal and regulatory landscape. Early engagement of a multidisciplinary legal and regulatory task force is critical. The framework developed provides a replicable model for future large-scale emergency care research initiatives within the EU while respecting patient privacy and regulatory requirements.