In our position paper, we call for the European and national stakeholders to consider the impact of secondary legislation on data-sharing procedures. This includes the practical application for individual researchers and universities to ensure they are prepared for compliance and operational adjustments.
Below, we have outlined our key recommendations:
- Data sharing and consent: Member States should establish a structured engagement and guidance framework with health data holders and Health Data Access Bodies (HDABs) to ensure that EHDS data-sharing and pre-existing consent rules strengthen research, safeguard patients’ trust and researchers’ integrity.
- Opt-out mechanisms: Member States must balance citizens’ opt-out rights with the need for representative health data by ensuring clear communication, consistent implementation, and public trust, so that population-level research remains robust and aligned with societal values.
- Ethical approval process: Member States must ensure that HDABs have clear responsibilities, adequate ethical expertise, and coordinated cross‑country processes so that ethical review does not become a barrier to multi‑country health research under the EHDS.
- Third-country participation: The EHDS should facilitate existing and future international health research collaborations by providing clear, predictable pathways for third‑country participation, ensuring minimal added bureaucracy, regulatory continuity, and transparent guidance for how non‑EU partners can participate in the HealthData@EU infrastructure.
- Fees and costs: Clear, predictable guidance on data preparation, budgeting, and fee structures is needed to ensure that health data holders and users, especially researchers, can plan accurately, avoid cost disputes, and confidently meet EHDS requirements without discouraging participation in research projects.
- Compliance and enforcement: Member States must ensure proportionate enforcement and provide sustained technical, financial and institutional support so that universities and other health data holders can meet EHDS compliance obligations without undermining their public‑interest missions.
If the EHDS is to fulfil its transformative promise, patients and clinicians must be empowered to decide how their data is used, for the benefit of collaborative, ground-breaking research across borders. As the EHDS is rolled out across Member States, researchers and universities require practical guidance to navigate new data-sharing obligations while ensuring that trust with research participants and patients is preserved and scientific integrity remains intact. The EHDS is now a call to action to improve cross-border collaboration and increase the visibility of health research. To meet these expectations, the framework must be fit for purpose and effectively coordinated for implementation at all levels.
Secretary-General, Jan Palmowski