On 26 June 2025, this webinar was hosted in the context of the xShare project and the EHTEL “Imagining 2029” work programme. It gathered together leading experts to explore how to better connect the primary use of health data for patient care with the secondary use of the data for purposes of public health, research, and policy. The event had three aims: to address the persistent fragmentation in Europe’s health data ecosystem, offer insights from pioneering countries, and discuss concrete use cases and tools (such as the International Patient Summary + Research (IPS+R)). The overarching goal was to suggest how to maximise societal value from health data. As a result, a number of recommendations and priorities have been developed which list three levels of potential activity which are directed towards European Member States; various European bodies; and projects and/or standards bodies.

Take-aways

• Together both the primary use and secondary use of health data can produce societal value.
• Among the approaches to be used, a “once-only” approach to data entry and use can be extremely helpful.
• European Member States can already share important lessons learned on how they have implemented once only-approaches.
  • Four potential steps to implementation have emerged.
• Key enablers exist to increased societal value exist:
  • The expansion/extension of the International Patient Summary (IPS) (or IPS+ or IPS+R).
  • Two critical areas of importance are the EEHRxF and the xShare yellow button.
  • A focus on specific disease or condition-specific use cases (e.g., infection surveillance; anti-microbial resistance (AMR); intensive care-related infections; long COVID; and cancer survival).
• Both action plans and sets of recommendations/priorities should be formulated.
  • Orientations could include the following domains and levels:
    • Legal and organisational; technical and semantic; and change management.
    • Member States; European Union (EU) and European Health Data Space (EHDS) bodies; projects and standards bodies.
  • Important fields for improving the societal value of health data range over more responsive public health initiatives to accelerated clinical research.

The speakers

Five speakers offered core insights into how both the primary use and secondary use of health data can lead to producing societal value from data.

Fidelia Cascini - Università de Sacro Cuore, Italy

Fidelia Cascini drew on the content of her 2025 book on the secondary use of electronic health data. She put forward the following three points:

• As background: there are three essential messages – there are multiple “data families”; real-world data has a definite role; emerging applications strengthen evidence.
• The use of real-world data has both benefits and limitations.
• The effective use of secondary data is based on four key premises: they relate to robust data models; data quality frameworks; semantic interoperability; and mapping tools.

Luc Nicolas - EHTEL, Belgium

Luc Nicolas extracted what can be learned from only once (“once-only) public implementations in the health sector. He offered three insights:

• Differences approaches can be used to implementing health data strategies.
• It is possible to compare lessons learned from Member States. Example countries include e.g., Belgium, Denmark, and Finland, which have each taken distinctive routes towards “only once” (once-only) data strategies.
• A first set of cross-country lessons can be identified that highlight a number of potential steps to implementation. Four steps include:
  • start with practical use cases;
  • invest in usability, automation, and tools;
  • align standards with international models;
  • provide tangible returns to data providers.

Rebecca Kush and Rebecca Baker - CDISC & University of Missouri-Columbia, USA

Rebecca Kush and Rebecca Baker proposed that leveraging international standards can enable efficient reuse of data. They cited past gathering of evidence from projects/studies and argued how today it is possible to be more optimistic about the usefulness of international standards than in the past. They cited concrete evidence especially related to time savings, dealing with adverse events, and patient safety. While no new standards are needed, work has been conducted to show how the International Patient Summary (IPS) can be extended (e.g., to the IPS+R) to support richer use cases. A spring 2025 CDISC working paper has been published which outlines a core data set that could cover both primary and secondary use of health data.

Eugenia Rinaldi - Charité, Germany

Eugenia Rinaldi emphasised how the xShare project team has associated various versions of EEHRxF formats with tangible public health priorities. The project has explored several public health use cases related to specific disease-related challenges. Examples include: infection surveillance; anti-microbial resistance (AMR); intensive care-based infections; long COVID; and cancer survival. It also points to how eventual use of the xShare yellow button may enable easier patient sharing of their own primary health data for secondary use that can have public health benefits.

Panellists

Four panellists – Sierk Marbus; Luis Alves de Sousa; Christos Schizas; and Beatriz Barros emphasised public health messages on e.g.:

• The work of several useful European-wide projects and initiatives.
• Infectious disease surveillance, AMR, and cancer survival.

Discussions led to the identification of three chief possible levels at which a number of action plans could be formulated to achieve these aspirations:

• On the legal and organisational side.
• On the technical and semantic side.
• On the change management side.

A set of potential recommendations/priorities emerged for three different sets of stakeholders. They relate to European Member States; the European Union (EU) and European Health Data Space (EHDS)-related bodies; and projects and standards bodies. There were plentiful mentions of e.g., governance models and investments; cross-standard alignment and the showcasing of real-world pilots; and inventories, servers, tools, training and user-centred design.

Conclusions

In conclusion, Europe can unlock vast new societal value from such developments, which would range from more responsive public health initiatives to accelerated clinical research. The xShare project, along with initiatives like TeHDAS2, United4Surveillance, and the evolving implementation of the EHDS, sets the stage for these ambitions to materialise.

Follow-ups from this 26 June 2025 co-organised webinar will be made public.