EHDS Promises & Pitfalls: The Case of Genomic Data Integration in Personalised Medicines
Human Colossus Foundation co-organised the NextGen Pre-event at MyData 2025: Genomic Data and the Future of the European Health Data Space
Helsinki, 24 September 2025 — The European Health Data Space (EHDS) is set to redefine digital health across Europe. With the potential to benefit more than 250 million citizens, it promises to transform clinical research, innovation, and patient care. But can it truly deliver?
A successful rollout of EHDS would restore trust—an essential prerequisite for unlocking the value of health data not only for medical purposes but for the entire health economy. Driven by the AI revolution, new revenue opportunities for European innovators could reach billions of euros. Done right, EHDS could become a flagship success story, showcasing the competitive edge of well-organised data ecosystems.
If it fails, however, the consequences would be so severe that its absence of success could only be described as a doomsday scenario.
Meeting this challenge requires a clear understanding of the barriers to building a health data ecosystem at a continental scale.
The NextGen EU Horizon project tackles some of the most complex data challenges in cardiovascular personalised medicine. Serving as a kind of “mini-EHDS,” NextGen acts as a testing ground for digital tools that enable the creation of interoperable data spaces.
Against this backdrop, the high-level pre-conference event at MyData 2025—titled “EHDS Promises & Pitfalls: The Case of Genomic Data Integration in Personalised Medicines”—took place on Tuesday, September 23. Over three and a half hours, the session addressed topics for researchers, clinicians, regulators, policymakers, and all those who recognise that maintaining the status quo is the simpler—but ultimately false—choice.
The central question was clear: How can genomic data—among the most sensitive and valuable forms of health data—be safely and effectively integrated into EHDS for the benefit of all?
A distinguished panel of experts shared their insights:
The fundamentals of EHDS — Mikael Rinnetmäki, Finnish Innovation Fund Sitra, introduced EHDS and explored the challenges posed by both the primary and secondary use of health data in Europe.
The legal dimension and the Finnish approach — Sofia Kuitunen, Senior Legal Counsel, FinnGen, examined the secondary use of health and genomic data in Finland.
Overcoming implementation barriers in the Netherlands — Johan Bokslag, Programme Manager, Health Data Space Utrecht, addressed the practical challenges of building an EHDS-compliant infrastructure in the Netherlands and how these can be turned into opportunities for transformation.
End-user expectations — Dr. Petra Ijäs, Head Physician at Helsinki University Hospital, presented a clinical case highlighting how EHDS could help overcome barriers in cardiovascular risk prediction for carotid artery stenosis.
Moderated by Philippe Page (NextGen & Human Colossus Foundation), the session illuminated both the opportunities and the serious pitfalls of Europe’s flagship health data initiative.
The key conclusions were:
EHDS implementation offers a historic opportunity to bring Europe’s healthcare system into the digital era.
Major pitfalls exist, with the restoration of trust and confidence standing as the most critical.
If EHDS fails to deliver a secure and efficient data space, global competition risks driving Europe’s health innovation elsewhere.
A detailed summary of the discussions and participant takeaways is in preparation and will provide further insights.
From the Human Colossus Foundation’s perspective
The EHDS vision responds to the urgent need to unlock the value of health data. It aims to build a human-centred data ecosystem, where “human” encompasses patients, healthcare professionals, public health authorities, private actors, regulators, and policymakers. Creating such an ecosystem requires three conditions:
Distributed governance — Governance must be shared across legitimate authorities representing regions, communities, professionals, and individuals. This requires a federated digital design that builds upon existing frameworks while advancing them into the digital era.
Respect for Europe’s diversity — Diversity is a source of creativity; complexity is merely an implementation challenge to be overcome. EHDS should prioritise harmonisation, not standardisation, especially in data models. The semantics—the meaning of data—should remain as close as possible to the collection point. Mechanisms must ensure data is structured and its integrity preserved before it reaches AI tools, training datasets, or other uses.
True digital identity — Both individuals and organisations need digital identities that uphold privacy and fundamental rights as protected by EU and Member State ethical, regulatory, and governance frameworks. Achieving this requires a truly decentralised authentication architecture capable of accommodating Europe’s diverse sovereignties.
Together, these requirements form the foundation for introducing sovereignty in the digital era. Regaining control over our data demands governance, integrity, and authenticity in every data exchange.