Manifesto for the Ethical and Responsible Reuse of Health Data from Research

Foreword

The European Health Data Space (EHDS) is a new European framework intended, in particular, to facilitate the reuse of health data for research, public health, and health policymaking. The EHDS Regulation provides for the gradual implementation of the rules governing this reuse starting in 2029.

Accordingly, this manifesto was drafted at the initiative of researchers working in the field of public health, who seek to ensure that the reuse of health data within the EHDS framework complies with a number of essential principles, ensuring scientific integrity, transparency, stakeholder trust (patients, researchers, healthcare professionals, etc.), and the sustainability of the research infrastructures that generate these data.

This manifesto is endorsed by its signatories in their individual capacities. It does not in any way bind the institutions, organisations, or governing bodies with which they are affiliated. Each signature constitutes a personal commitment and binds only the signatory.

With the entry into force of the European Health Data Space (EHDS) Regulation, the large-scale reuse of health data becomes possible for a diverse range of academic, public, non-profit, and private actors. This represents an opportunity to expand knowledge, accelerate innovation, strengthen transparency, and promote reproducibility of research – provided, however, that it is governed by strong principles.

Indeed, health data – sociodemographic, clinical, biological, genetic, imaging, environmental, or behavioural – are not an ordinary resource.

They originate from individuals who entrust them to research teams within a relationship of trust, as part of research projects (clinical trials) or research infrastructures (cohorts, registries, and platforms), in order to generate knowledge for the public good.

They are the result of a considerable human, scientific, and financial investment: that of participants, who voluntarily give their time and experience – sometimes by completing questionnaires on multiple occasions, undergoing medical examinations, sample collection, imaging, or long-term follow-up – and that of the research teams who design, collect, document, audit, secure, and maintain these data over time.

Thus, we – patients, participants, researchers, healthcare professionals, and committed citizens – support the sharing of health data for responsible reuse. To this end, we call for compliance with ten essential principles:

1. Serve only the public interest and public health

2. Respect the relationship of trust established between participants and research teams

3. Safeguard scientific integrity in the presence of conflicts of interest

4. Make scientific transparency a condition for access to health data

5. Limit access to data to what is strictly necessary (data minimisation principle)

6. Evaluate data use to ensure that data sharing serves the public interest and public health

7. Recognise the scientific role of research teams that produce data, and support research infrastructures

8. Ensure pluralistic governance of decisions on access to health data

9. Provide the necessary resources to assess access requests and make data responsibly available

10. Guarantee a right of appeal and sanctions in cases of non-compliant use

We call on all those who agree with these ten essential principles to sign this manifesto and disseminate it.