Trust and Trade: Ethical Reflections on Patient Trust and the Monetisation of Real-World Data

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 do not directly adjudicate questions of fairness, reciprocity, or perceived legitimacy from a patient perspective, which largely fall outside their formal remits. For clarity of scope, this commentary focuses specifically on patient perceptions of fairness, reciprocity, and legitimacy in the monetisation of secondary-use health data; it does not examine urgency-of-use questions, direct clinical benefits, or broader societal goals of data-driven healthcare. This article is a normative commentary informed by published patient surveys, governance case studies, and regulatory experience. It does not present original patient research but synthesises recurring patient-relevant concerns regarding trust, fairness, and public value in the secondary use of health data. 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, it shows how opacity in consent processes, selective disclosure of data use, and the 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, five pragmatic safeguards are proposed: i. transparent, plain-language consent; ii. mandatory disclosure of monetisation models; iii. governance boards with patient representation; While many national and international data governance bodies now include patient or public representatives, the depth of their influence varies considerably. In several early national data initiatives, patient involvement was limited to advisory or consultative roles without formal voting rights, agenda-setting authority, or oversight of commercial access decisions. Such structures risk being perceived as symbolic rather than substantive participation, reinforcing concerns about tokenism when representation is not matched by real decision power. iv. reinvestment of commercial gains into patient support, public health, and digital tools; Benefit sharing should not be interpreted as direct financial remuneration to individual patients, which is neither feasible nor desirable in most regulatory and research contexts. Rather, it refers to structured reinvestment of value generated from secondary data use into patient-relevant public goods, such as disease registries, patient organisations (including umbrella and European-level federations for rare diseases), digital infrastructure, education, and support services. In this way, reciprocity is achieved at community and system level, even when data originate from multiple countries and fragmented patient populations. v. mandatory registration of non-interventional studies in public registries. Together, these measures extend evidence integrity to include fairness, reciprocity, and legitimacy. 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.”_ This commentary is informed by principles of relational ethics and the _social responsibility of science_, framing data monetisation as both a technical and moral question of reciprocity and legitimacy. These safeguards are grounded in emerging international experience with data transparency and patient governance, though practical challenges and alternative frameworks are discussed.