Trust and trade: patient perspectives on the ethics of real-world data monetisation

Real-world data (RWD) and real-world evidence (RWE) are increasingly used to inform regulatory decisions, health technology assessment, and health system planning. However, patients whose data underpin these activities often experience limited transparency or benefit when their information is monetised. While regulatory and HTA frameworks emphasise methodological rigor and analytical transparency, they provide limited guidance on fairness, reciprocity, and legitimacy from a patient perspective. This Policy Brief examines this governance gap and argues that evidence integrity must extend beyond technical standards to include ethical stewardship and public trust. Drawing on policy contexts from UK, EU, and North America, it proposes five pragmatic safeguards to strengthen transparency, accountability, and patient-centred governance in secondary data use, supporting the sustainability and legitimacy of RWE infrastructures as data initiatives expand.