The European Health Data Space is poised to play a transformative role in both the health care landscape and the broader competitiveness of the EU.
The September 2024 report on European competitiveness by former Italian Prime Minister and European Central Bank President Mario Draghi underscores the central importance of the EHDS in driving health care innovation, enhancing patient care and positioning Europe as a global leader in digital health.
However, realizing its full potential hinges on addressing a range of regulatory, technical and financial challenges that currently impede progress.
The promise of the EHDS: Revolutionizing European health care
At its core, the EHDS is envisioned as a secure, interoperable framework that enables the sharing and use of health data across borders within the EU. This data infrastructure would provide health care providers, researchers and policymakers the information needed to improve patient outcomes, accelerate medical research, and foster the development of personalized treatments and artificial intelligence-driven health care solutions.
Draghi's report identifies the EHDS as a cornerstone of Europe's broader digital transformation and highlights the significant competitive advantages it could deliver if implemented effectively.
However, progress has been slow, largely due to regulatory fragmentation across EU member states, particularly in relation to the EU General Data Protection Regulation. While the GDPR is crucial for protecting individual privacy, its complex and varied application across different jurisdictions has created barriers to the cross-border flow of health data, limiting the impact of the EHDS.
According to Draghi, harmonizing the interpretation and application of the GDPR is essential to unlocking health data's vast potential for innovation, research and health care delivery.
A fragmented landscape: Overcoming regulatory and technical barriers
One major obstacle to implementation of the EHDS is the lack of standardized electronic health records across EU member states. Draghi's report emphasizes the urgent need to harmonize EHR systems, allowing secure cross-border data sharing and overcoming current technical barriers.
Without interoperable EHRs, the EHDS risks becoming fragmented, limiting its impact on patient care and research. Draghi calls for immediate resource allocation to develop EU-wide standards, alongside investments in digital infrastructure, particularly in less-developed regions, to ensure all member states can fully integrate into the EHDS and drive both health care improvements and economic growth.
Enhancing data governance and access: Building public trust
Effective governance of health data is another critical factor in the success of the EHDS. In his report, Draghi emphasizes the need to strengthen national health data access bodies, which are responsible for managing and regulating the sharing of health data. These bodies must be equipped with the resources, expertise and legal frameworks necessary to balance the need for data access with the imperative to protect patient privacy.
Draghi argues, while the GDPR plays a crucial role in safeguarding personal data, it must be applied more consistently across the EU to avoid bottlenecks in data sharing. Currently, national interpretations of the GDPR vary, leading to confusion and inconsistency in how health data is shared and used for research, clinical trials and AI development. By streamlining and clarifying the GDPR, particularly related to health data, the EU can foster an environment where innovation can thrive without compromising individual privacy.
Building public trust is also essential to the widespread adoption of the EHDS. Public concerns about data security and the potential misuse of health information have led to high opt-out rates in several countries, limiting the availability of data for research and innovation. Draghi's report highlights the importance of a clear, coordinated approach to opt-out mechanisms, ensuring citizens understand how their data will be used and are confident in its protection. A transparent and harmonized opt-out system will encourage more individuals to contribute their health data, providing researchers with access to the comprehensive datasets needed to drive medical advances.
Driving innovation: Personalized medicine, AI and beyond
The EHDS is not just a data-sharing initiative, it is a vehicle for driving innovation in health care. The ability to access large-scale health data opens new possibilities for personalized medicine, where treatments can be tailored to individual patients based on their genetic profiles, medical histories and other factors. This approach promises to revolutionize health care by making treatments more effective and reducing the risk of adverse reactions.
In addition, access to rich datasets is critical for the development of AI tools in health care. Machine learning algorithms thrive on data. and the EHDS could provide the vast amounts of high-quality, standardized health data needed to train AI systems for a variety of applications, from diagnostics to treatment planning. AI-driven tools could help health care providers diagnose diseases earlier, predict patient outcomes with greater accuracy and optimize treatment plans in real time.
However, as Draghi notes, the development of these cutting-edge technologies depends on overcoming the regulatory and technical challenges that currently hinder data access. Without consistent, EU-wide frameworks for data sharing and governance, the potential of AI and personalized medicine will remain largely untapped.
Boosting EU competitiveness: A strategic opportunity
Beyond its impact on health care, the EHDS' successful implementation could significantly enhance the EU's global competitiveness. The digital transformation of health care is a key pillar of Europe's broader strategy for economic growth and innovation. By positioning itself as a leader in digital health, the EU can compete more effectively with the U.S. and China, both of which are making significant strides in AI and health tech.
The EHDS has the potential to spur innovation across the health care value chain, from pharmaceutical research to biotech startups. By making health data more accessible to researchers, startups and health care providers, the EHDS could accelerate the development of new therapies, medical devices and digital health solutions. This would not only improve patient outcomes but also create jobs and drive economic growth across the EU.
Moreover, the EHDS aligns with the EU's broader goals of achieving digital sovereignty and technological leadership. In an increasingly data-driven global economy, the ability to harness and analyze health data will be a key differentiator for countries and regions seeking to lead in this space. If properly implemented, the EHDS could give Europe a competitive edge in the global health care market, driving growth in the biotech, pharmaceutical and health tech sectors.
A vision for the future: EHDS as a pillar of Europe's digital strategy
Draghi makes a compelling case for the strategic importance of the EHDS in Europe's digital future. By addressing the regulatory, technical and financial challenges outlined in the report, the EU can ensure the EHDS becomes a powerful tool for health care innovation, economic growth and global competitiveness. The recommendations put forth in the report — from standardizing EHRs to enhancing national data access bodies — are essential to unlocking the full potential of the EHDS.
In the coming years, the successful implementation of the EHDS could transform not only European health care but also the EU's position in the global economy. As Draghi's report highlights, the EHDS is not just a health care initiative — it is a cornerstone of Europe's digital future with the potential to drive innovation, improve patient care and enhance the EU's competitiveness on the world stage.
Victoria Derumier is the data protection manager for MyData-Trust.
