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EHDS Regulation provides a framework to address fragmented infrastructure in European public health surveillanceNew European rules could improve public health tracking and safety

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Key Takeaway
Note the EHDS as a proposed framework to address fragmented infrastructure in European public health surveillance.

This scoping literature review analyzes 35 scientific studies and six grey literature documents to evaluate the role of the European Health Data Space (EHDS) Regulation in strengthening public health surveillance and emergency preparedness across Europe. The review identifies several critical barriers to current public health intelligence, including fragmented infrastructures, distributed health data, limited interoperability, and unclear legal and governance mechanisms.

The authors synthesize the potential of the EHDS to address these challenges by establishing common governance rules, secure processing conditions, and federated access mechanisms. The review also proposes a conceptual European public health intelligence ecosystem to modernize surveillance capabilities. However, the authors note that the proposed ecosystem is a conceptual framework and has not been validated in practice.

Practical application of these findings is currently limited by the fact that future EU initiatives and implementation pilots are required to test and translate the vision into practice. The study serves as a regulatory and conceptual analysis rather than a clinical evaluation. The findings highlight the EHDS as a potential enabling framework for modernizing infrastructure, but its real-world efficacy remains to be determined through future implementation.

Tracking health trends and preparing for emergencies is difficult when data is scattered across different systems. Currently, public health officials in Europe face hurdles like fragmented infrastructure and a lack of shared rules for handling health information. These gaps make it harder to respond quickly when a health crisis hits.

A new regulation called the European Health Data Space (EHDS) aims to change this. By creating common rules for data governance and secure processing, the framework seeks to connect these pieces. It provides a way for different regions to share information more easily while keeping data secure.

While this framework offers a path toward a more unified system, it is still a conceptual model. It has not been fully tested in practice yet. Future pilot programs will be necessary to see how these rules work in the real world and to ensure they can successfully modernize how we track public health.

What this means for you:
New European regulations aim to unify fragmented health data to improve emergency preparedness and public health tracking.

Common questions

What problems currently exist in public health tracking?

Current systems are often limited by fragmented infrastructures and data that is spread out across different locations. It is also difficult because there is a lack of shared rules for how to handle data and a lack of systems that can talk to each other easily.

How does the European Health Data Space help?

The European Health Data Space (EHDS) works by establishing common rules for governance and secure ways to process information. It also creates ways for different systems to access data together, which helps overcome current barriers in public health intelligence.

Is this new system already in use?

The system is currently a conceptual framework rather than a finished tool. It will need future initiatives and pilot programs to be tested and proven in the real world before it can be fully used to manage public health.

Study Details

Study typeSystematic review
EvidenceLevel 1
PublishedOct 2026
View Original Abstract ↓
Public health surveillance in Europe is facing increasingly complex cross-border threats. Although digital health investments and EU-level initiatives have expanded the amount of health data available for surveillance purposes, the generation of timely and actionable public health intelligence remains constrained by disease-specific reporting systems and systemic technical and governance barriers. The European Health Data Space (EHDS) Regulation provides a new opportunity for the use and exchange of routinely electronic health data to improve public health surveillance and emergency preparedness, but its effective contribution remains insufficiently explored. Through a scoping literature review and regulatory analysis, this study examines the role of the EHDS in strengthening public health surveillance and emergency preparedness in Europe. This review followed the PRISMA-ScR guidelines. Multiple bibliographic databases were searched for studies published between 2016 and 2026, complemented by an analysis of grey regulatory literature. Eligible studies included publications addressing the EHDS or secondary use of health data and public health surveillance or emergency preparedness. The scoping review included 35 scientific studies and six grey literature documents. Our findings suggest that health system digitalisation, Electronic Health Records (EHR) implementation and the COVID-19 pandemic have reshaped surveillance and preparedness needs in Europe, which remain limited by fragmented infrastructures, distributed health data, limited interoperability, and unclear legal and governance mechanisms. Our regulatory analysis indicates that the EHDS could help address several of these challenges by establishing common governance rules, secure processing conditions, and federated access mechanisms. We further propose a conceptual European public health intelligence ecosystem, positioning the EHDS as an enabling layer for converting distributed health data into actionable intelligence. Three non-exclusive governance options illustrate how this model could be operationalised across national and European levels. This study establishes the EHDS as an important enabling framework for modernising public health surveillance in Europe. The conceptual framework proposed in this study establishes a foundation for future research on the development of an EHDS-enabled European public health intelligence ecosystem to strengthen surveillance, preparedness, and coordinated emergency response. Future EU initiatives and implementation pilots will be essential to test, validate, and translate this vision into practice.
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