The recent COVID-19 pandemic showed the importance of better health data sharing and collaboration within the EU, and the potential this can bring in terms of monitoring and prevention, and research and development of treatments and, in this case, vaccines. The EU COVID-19 digital certificate and the EU Vaccines Strategy already showed Europe’s capacity to act and come with innovative solutions.  

As a response to the pandemic, the European Commission launched the European Health Union Project in 2020. The project has the aim to better protect the health of all Europeans and equip the EU and its members states to respond collectively better to (potential) cross-border health crises. ¹ Through a number of key initiatives, including among others the pharmaceutical strategy, Europe’s Beating Cancer Plan, and the European Health Data Space, the European Commission wants to build this European Health Union. In this blog post we zoom in on the latter, the European Health Data Space, and the many opportunities it can bring to improve health for all.

A European initiative to the advantage of patients and public health
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In May 2022, the European Commission announced “the launch of the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union. The EHDS will help the EU to achieve a quantum leap forward in the way healthcare is provided to people across Europe. It will empower people to control and utilize their health data in their home country or in other Member States. It fosters a genuine single market for digital health services and products. And it offers a consistent, trustworthy, and efficient framework to use health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with the EU's high data protection standards.”²

The EHDS proposal represents a major opportunity for unlocking the full potential of health data, both serving the individual patient and public health. As such, it aims to

• provide the patient with more control over its health data as well as support the free movement of health data, making sure the data can follow the patient efficiently within the EU to ensure a continuum of care;  
• enable the use of healthcare and real-world evidence (RWE) data of a higher data quality and level of FAIR-ness for research, innovation, and policymaking at EU-level, while ensuring a uniform and efficient way in accessing health data across Europe;
• improve patient care. Hospitals can use the EHDS to access and exchange health data with other healthcare providers and organizations, which can improve the quality of patient care; and
• better clinical research. The EHDS can enable hospitals to share data for clinical research purposes, which can help improve the understanding of diseases and develop more effective treatments.

This could in turn facilitate improved diagnosis and treatment of diseases, more and faster research and innovation at a European scale, facilitate benchmarking of data and patient outcomes, increased healthcare efficiency, and better quality of care for all.

Protecting data while fostering innovation and research
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For the EHDS to be able to live up to its full potential, certain challenges need to be overcome. Crucial factors that will determine the success of the EHDS are:  

• the establishment of a harmonized governance and infrastructure model promoting the interoperability of health data across Europe (including ensuring the validity and trustworthiness of the data); and
• the striking of the right balance between the (competing) needs of the various stakeholders, where both the individual is protected, and public health is promoted.

While “insufficient protection could damage the flow of data at its source, cutting off invaluable resources; data protection that is so complete that it prevents the acquisition and effective use of data could damage the flow of innovation.”³

How LynxCare’s technology contributes to the European Health Data Space

International interoperability data standards as an enabler for efficient exchange between healthcare providers in the EU.

LynxCare helps hospitals set up health data warehouses according to OHDSI’s international standards, an open-source software portfolio and methods for data standardization and analysis (including the OMOP CDM). As such, LynxCare loads, processes, extracts, and structures all incoming data from hospitals in the OMOP format adhering to the FAIR data principle. The created OMOP databases allow efficient large-scale analysis of health data. It can help develop innovative solutions and products. This can promote the development of new diagnostic tools, treatments, and medical devices.

With the hospital remaining in control of the data, it can be made available for research collaborations - without transfer of data ownership. This is the concept of a federated approach, as shared by the European Health Data and Evidence Network (EHDEN).

As science develops, so does technology. High quality and transparent data generating RWE.

Through Artificial Intelligence and Natural Language Processing, LynxCare helps hospitals unlock the 80% of its data that is siloed in unstructured data sources (i.e. clinical notes). LynxCare’s context-specific NLP as well as elaborate data quality checks ensure that the high granularity and complexity of the data in EHRs does not go lost. By harmonizing and aggregating this data in OMOP CDM, hospitals and researchers can gain access to previously unavailable clinical (real-world) insights. The EHDS can promote the development of interoperable data standards and platforms, which can facilitate data exchange and integration. This can help to break down data silos and enable the integration of diverse data sources.

Creating a climate of trust based on a regulatory and ethical approved framework.

All stakeholders have a role to play to ensure a climate of trust can be established. With LynxCare founded from an individual patient's need, securing patient's interest is at our core. We are equally convinced data should serve a bigger scientific purpose so it can help new treatments and other patients, however never purely commercial interests.

As such, LynxCare advocates for clear data governance structures (i.e., ethical and data committees) that safeguard public and patient's interests. This requires that data is used for legitimate purposes and that data users adhere to ethical principles. This includes ensuring that data is used in a way that is fair, transparent, and accountable. With proper data governance in place, trust in data can be ensured, so stakeholders can collaborate efficiently. This includes setting clear rules and standards for data use, establishing appropriate oversight and accountability mechanisms

This blog post is intended to merely highlight certain key concepts around the EHDS and not to be comprehensive, nor to provide any type of advice. If you have any questions, do not hesitate to reach out.

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