Accounting for EU external effects: from clinical trials to data colonialism to AI ethics dumping

Abstract Against a backdrop of rapidly expanding health artificial intelligence (AI) development, this paper examines how the European Union’s (EU) stringent digital regulations may incentivise the outsourcing of personal health data collection to low- and middle-income countries (LMICs), fuelling a new form of AI ethics dumping. Drawing on parallels with the historical offshoring of clinical trials, we argue that current EU instruments, such as the General Data Protection Regulation (GDPR), Artificial Intelligence Act (AI Act) and Medical Devices Regulation, impose robust internal safeguards but do not prevent the use of health data collected unethically beyond EU borders. This regulatory gap enables data colonialism, whereby commercial actors exploit weaker legal environments abroad without equitable benefit-sharing. Building on earlier EU responses to ethics dumping in clinical trials, we propose legal and policy pathways to prevent similar harms in the context of AI.