Maksymilian Aleksander Brzezicki, Przemysław Temistokles Zakowicz
The heterogeneous landscape reflects the challenge of balancing technological advancement with patient safety. Harmonised national ethical guidelines and closer collaboration between medical regulatory bodies are needed to support responsible AI adoption while preserving ethical practice across the EU.
OBJECTIVE: Regulatory frameworks governing artificial intelligence (AI) in medical practice vary widely across European Union (EU) member states. We assessed the extent to which national medical bodies' codes of conduct address the clinical use of AI.
METHODS: Codes of conduct issued by national medical regulatory bodies in EU member states were analysed and rated for AI-specific content using a four-point scoring system.
RESULTS: Six countries (Belgium, France, Germany, Lithuania, Poland and Spain) had established AI-specific guidance within their medical ethical frameworks, with scores of 3 to 4; the remaining member states had none. France and Belgium showed the most progressive approaches, emphasising innovation while maintaining ethical standards, whereas Germany and Poland were more conservative, imposing stringent requirements for AI deployment in clinical settings. EU-wide instruments such as the AI Act and the High-Level Expert Group (HLEG) guidelines provide overarching frameworks but do not address the codes of medical practice that govern day-to-day clinical decision-making in member states.
CONCLUSION: The heterogeneous landscape reflects the challenge of balancing technological advancement with patient safety. Harmonised national ethical guidelines and closer collaboration between medical regulatory bodies are needed to support responsible AI adoption while preserving ethical practice across the EU.