The Value from Nordic Health Data (VALO2) pilot study demonstrated how a real-world oncology study can be delivered across Finland, Norway and Denmark using a common protocol and analytical approach, despite different national approval pathways, secure environments, and operating models. Patient-level data remained under local control throughout. Analyses were completed, and results were released in accordance with each country’s local review and approval arrangements. The pilot showed that countries do not need identical technologies or operating models, but they do need clear approval pathways, research-ready data and workflows, local expertise and dependable support. These lessons provide practical guidance for organisations preparing to implement the European Health Data Space (EHDS) and scale cross-border health data research.

Introduction

The VALO2 Pilot study went beyond demonstrating secure remote data access. It examined whether a Danish research team could use data from Finland, Norway, and Denmark to conduct a real-world study of first-line immunotherapy treatments for metastatic non-small cell lung cancer. The researchers followed a common protocol and analytical approach across the three national environments.

The analyses were completed using data from all three countries, with results reviewed and released through the relevant national arrangements. Permission to use the data was only the first step. The Danish researchers also had to verify their identities and gain access to the secure environments in Finland and Norway, where approved users could analyse the data without it leaving local control. They then needed the right data, software, and support in place before analysis could begin. Drawing on lessons from the VALO2 Pilot, this blog explores how organisations preparing for EHDS can make those steps easier to plan, quicker to complete and simpler to repeat, helping to make cross-border research routine rather than exceptional.

The VALO2 Pilot was coordinated by Sitra, the Finnish Innovation Fund, and funded by the Nordic Council of Ministers. IQVIA Nordics led the pilot study and produced the main research report. IQVIA’s Privacy Analytics led the data governance workstream and worked with project partners to produce a separate Lessons Learned Report examining the practical experience of delivering the research across multiple Nordic secure environments.

Moving from EHDS ambition to practical delivery

From March 2029, key EHDS rules will begin to apply to the secondary use of health data. This means using health data beyond direct patient care for purposes such as research, innovation, and public health. By then, data access bodies and secure environments will need to give researchers a clear, dependable route from approval of their request to use the data through to usable results. The VALO2 Pilot showed that this route can already work, even when each step is handled by a different national organisation using its own technology and processes.

Unlike traditional federated approaches, where analyses are run locally and only combined results are shared, the VALO2 Pilot allowed the Danish research team to work directly inside secure processing environments (SPEs) in Finland and Norway. SPEs are controlled environments where approved researchers can analyse data without it leaving local control. Finnish and Norwegian patient-level data stayed in those environments, so each country kept its own oversight and accountability. Working directly with the data gave researchers a clearer view of what data was available, which patients met the study criteria and how their analyses were running.

For EHDS, the opportunity is not to make every country's environment identical. It is to make each one clear and dependable enough that researchers can plan and complete cross-border studies with confidence.

Successful research depends on the complete journey

SPEs provided the essential controlled setting for the study. Completing the research, however, depended on the services, data, workflows, and expertise around those environments. Four practical lessons from the VALO2 Pilot stood out.

1. Approval did not mean analysis could begin - permission, identity verification, and analysis readiness were separate milestones. Researchers still needed the right workspace, data connections, software, permissions, and support before analysis could start.
2. Shared standards did not guarantee comparable data - a common protocol and data model supported a consistent analytical approach, but researchers still needed to confirm that important variables were available, appropriately mapped and sufficiently comparable across participating environments.
3. Local expertise remained essential - direct access gave researchers valuable visibility of the data, but local clinical, data and operational expertise remained important for interpreting variables, completing approvals and preparing analytical workspaces.
4. Results release required early planning - each country applied its own arrangements for reviewing and releasing results. Agreeing permitted outputs, formats, review responsibilities, and expected timelines early helped avoid delays later in the study.

Together, these lessons show why successful cross-border research depends on the complete journey, from approval and onboarding through analysis and the release of results. The next opportunity is to make that journey clearer, more consistent, and easier to repeat under EHDS.

Fine tuning the researcher journey

Building on the VALO2 Pilot experience, the focus now shifts to making that journey easier to repeat. Countries and organisations do not need identical platforms, but researchers should encounter sufficiently clear and dependable services wherever the data are held.

Researchers need clarity and consistency to understand what happens next, who owns each step, what information is required, how long it should normally take and where to go when something does not work.

To capture what worked, what proved challenging and what should be improved for future EHDS-style research, IQVIA's Privacy Analytics worked with the project partners to produce a dedicated VALO2 Pilot Lessons Learned Report. The VALO2 Pilot Lessons Learned Report groups the findings into three priorities for organisations implementing EHDS:

a. Research-ready services - clear approvals, onboarding processes and access arrangements that help researchers move efficiently from application to analysis.

b. Research-ready environments - data, tools and tested analytical workflows that allow research to be conducted consistently and confidently.

c. Research-ready operations - support, result-release processes and continuous improvement mechanisms that help services become more effective over time.

These are refinements to a model that the Pilot has already shown to be feasible. Together, they can help future studies plan more confidently and complete analysis with fewer avoidable delays.