The European Health Data Space Regulation: opportunities and challenges

The European Health Data Space Regulation is the first domain-specific common European data space established under the European Union’s data strategy [Li, Wenkai, and Paul Quinn, "The European Health Data Space: An expanded right to data portability?", Computer Law & Security Review 52 (2024); Marcus, J.S. et al., "The European Health Data Space", Policy Department for Economic, Scientific and Quality of Life Policies, European Parliament, December 2022].

Its principal aim is to improve individuals' access and control over their electronic health data (primary use) and increase data availability for secondary use purposes such as research, innovation, and policymaking [Li, Wenkai, and Paul Quinn, "The European Health Data Space: An expanded right to data portability?", Computer Law & Security Review 52 (2024); Fåhraeus, E., Reichel, J., and Slokenberga, S., "The European Health Data Space: Challenges and Opportunities", European Policy Analysis, February 2024:2epa; Marcus, J.S. et al., "The European Health Data Space", Policy Department for Economic, Scientific and Quality of Life Policies, European Parliament, December 2022].

The EHDS is designed to establish a common framework, standards, infrastructures, and governance for the use and exchange of electronic health data across the EU [Li, Wenkai, and Paul Quinn, "The European Health Data Space: An expanded right to data portability?", Computer Law & Security Review 52 (2024); Marcus, J.S. et al., "The European Health Data Space", Policy Department for Economic, Scientific and Quality of Life Policies, European Parliament, December 2022].

The EHDS presents significant opportunities by:

• Empowering individuals with increased access and control over their electronic health data (primary use), enabling them to obtain better care and make informed choices by reducing information asymmetries between healthcare providers [Marcus, J.S. et al., "The European Health Data Space", Policy Department for Economic, Scientific and Quality of Life Policies, European Parliament, December 2022; Fåhraeus, E., Reichel, J., and Slokenberga, S., "The European Health Data Space: Challenges and Opportunities", European Policy Analysis, February 2024].

The Regulation reinforces patients’ rights to access their data immediately and free of charge, eliminating previous challenges like providing data in paper form or charging fees for access [Fåhraeus, E., Reichel, J., and Slokenberga, S., "The European Health Data Space: Challenges and Opportunities", European Policy Analysis, February 2024].

• Expanding the scope of the General Data Protection Regulation (GDPR) by mandating strong interoperability requirements and extending the right to data portability to cover inferred data, which is excluded under GDPR Article 20 [Li, Wenkai, and Paul Quinn, "The European Health Data Space: An expanded right to data portability?", Computer Law & Security Review 52 (2024)].

• Driving substantial economic and societal benefits for secondary use, including faster and more cost-effective development of new drugs, medical procedures, and AI systems, and supporting evidence-based public health decisions [Marcus, J.S. et al., "The European Health Data Space", Policy Department for Economic, Scientific and Quality of Life Policies, European Parliament, December 2022].

However, the EHDS implementation faces numerous challenges, including:

• High costs and complexity associated with the mandatory implementation of interoperable Electronic Health Record systems, placing a financial burden on constrained national healthcare budgets [Fåhraeus, E., Reichel, J., and Slokenberga, S., "The European Health Data Space: Challenges and Opportunities", European Policy Analysis, February 2024].

• Regulatory incoherence and fragmentation due to overlaps with the GDPR, the Data Act, and the Data Governance Act, compounded by significant variances in national rules concerning data protection and health policies across Member States [Kiseleva, Anastasiya, and Paul de Hert, "Creating a European Health Data Space. Obstacles in Four Key Legal Areas" (undated preprint, SSRN: 3846781); Fåhraeus, E., Reichel, J., and Slokenberga, S., "The European Health Data Space: Challenges and Opportunities", European Policy Analysis, February 2024].

• Risk of decreasing legitimacy and trust due to the limited role of the individual in exercising control over their data for secondary use purposes [Fåhraeus, E., Reichel, J., and Slokenberga, S., "The European Health Data Space: Challenges and Opportunities", European Policy Analysis, February 2024].

• The persistence of legal ambiguities regarding intellectual property protection and the duty to disclose research outputs ("giving back to the commons"), which could deter innovative commercial actors from participating in secondary use [Ramozzi, Francesco, "Data Solidarity in the Health Sector: The challenges of 'giving back to the commons' under the Health Data Space Regulation" (undated preprint, SSRN: 5727225)].

Conclusion

The EHDS establishes a foundational framework intended to transform healthcare data governance in the EU, leveraging data as a source of innovation and public good [Marcus, J.S. et al., 2022].

Its success hinges on the delicate process of implementation, which must resolve the structural tension between harmonizing data flow across borders and respecting the existing fragmentation of national health systems and legal traditions [Fåhraeus, E., Reichel, J., and Slokenberga, S., 2024; Kiseleva, Anastasiya, and Paul de Hert, undated preprint].

Achieving the ambitious goal of making health data seamlessly accessible requires not only political will, but also the successful, technically sound application of the mandatory interoperability standards and administrative procedures that are intended to foster trust while maximizing economic and societal gains [Li, Wenkai, and Paul Quinn, 2024].

* CEO and Co-Founder Techno Polis