Trust and Trade: Patient Perspectives on the Ethics of Real-World Data Monetisation

Real-world data (RWD) and real-world evidence (RWE) are now central to healthcare decision-making, supporting regulatory submissions, health technology assessments (HTA), and scientific communication. Yet patients whose data fuel these processes rarely see transparency or benefit when their information is commercialised. Governance frameworks from the European Medicines Agency (EMA), U. S. Food and Drug Administration (FDA), and other bodies emphasise methodological rigour and transparency, but they seldom address fairness, reciprocity, or perceptions of legitimacy from a patient perspective. This commentary argues that evidence integrity must extend beyond technical standards to encompass ethical stewardship. Drawing on case examples from the UK, EU, and North America, I show how opacity in consent processes, selective disclosure of data use, and absence of benefit-sharing widen the trust gap. Patients contribute information under the assumption it will improve care, not simply generate commercial value or institutional advantage. To address this, I propose five pragmatic safeguards: (i) transparent, plain-language consent; (ii) mandatory disclosure of monetisation models; (iii) governance boards with patient representation; (iv) reinvestment of commercial gains into patient support, public health, and digital tools; and (v) mandatory registration of non-interventional studies in public registries. Together, these measures extend evidence integrity to include fairness, reciprocity, and legitimacy. The future of RWE depends not only on scientific validity but also on whether patients trust that their data are handled responsibly and ethically. Perhaps it is time to move beyond passive consent and towards a new call for accountability—captured in a simple but powerful reminder: _“That is MY DATA. ”_