How often do we hear about privacy, transparency and data sharing?
In the era of Real-World Evidence (RWE), Real-World Data (RWD) come from a variety of sources and tell the story of patients' health beyond clinical trials, with the awareness that behind every single data point is a person who lives, feels and hopes. That’s why it’s essential to view RWD not as mere numbers, but as entrusted confidences that must be handled with care and responsibility.
Privacy takes on an essential meaning in this context: it is both a legal requirement and a necessary condition for patients to maintain control over their healthcare experience.
The GDPR (Regulation (EU) 2016/679 of 27 April 2016) and similar regulations consider not only the masking or removal of identifying information, but also the relationships between variables that could make the data re-identifiable.
A crucial issue is re-identification: even apparently de-identified data can become traceable if combined with other sources, especially in the context of RWD, where the merging of multiple datasets is common. Ensuring that this information remains unrecognizable to third parties requires rigorous technical solutions.
The essential premise is that every data project must be based on an ethical choice: the patient as a person remains the owner of his/her experience.
Therefore, transparency, equity, and specific consent are essential. Consent may also be dynamic, meaning a consent that evolves over time and respects the patient’s will.
In Europe, initiatives like the European Health Data Space (Regulation (EU) 2025/327of 11 February 2025) are already setting clear rules on access, interoperability, consent withdrawal and transparency regarding who can access the data and for what purposes.
These rules can only be truly effective if they are built on trust between those who collect the data and those who generate it. Patient organizations have the important task of ensuring this trust.
In this process, Patient Associations play a central role: they can facilitate dialogue, demand guarantees and clarity about the purposes of research, orient the priorities, and amplify the voices of those who are too often left out.
Because trust doesn’t arise on its own, it is built over time, through listening, explaining and respect.
Privacy is not just a prerequisite for data collection and quality research, nor is it merely protection, it's the foundation of a genuine relationship with patients: a clear, respectful and shared exchange, where data becomes truly useful when it relies on a pact of trust.
Valuing RWE means recognizing that every care journey has meaning and can contribute to the common good, but only if that value is safeguarded responsibly.
We expect every project based on real-world data to recognize patients not as sources of information, but as true partners in the co-creation of science and shared knowledge.