The European Health Data Space (EHDS), introduced on May 3, 2022, and approved by the European Parliament on April 24, 2024, marks a significant milestone in digital healthcare within the European Union. This initiative aims to transform health data management by creating a unified framework of rules, standards, infrastructure, and governance for primary (i.e., direct patient care) and secondary (i.e., research and policy) uses of health data. For primary use, the EHDS introduces the MyHealth@EU platform, a collaborative platform that enables individuals to access and share personal health data securely. In this context, a key objective is to give individuals greater digital control over their health data. For example, patients can restrict access to sensitive information so that specific healthcare providers can view it. As Croatian MEP Tomislav Sokol explained, "If you have some kind of mental health condition, you will be able to restrict access to these parts of the data so that your mental health data is only seen by your psychiatrist and not other doctors that treat you." This level of control ensures that personal privacy is upheld while facilitating better healthcare outcomes. For secondary data use, the EHDS includes the HealthData@EU infrastructure, which facilitates the use of anonymized health data for research and policymaking. "This data can lead, for example, to the development of new, revolutionary life-saving treatments, medicines, medical devices or next-generation antibiotics; and to make progress on personalized medicine," noted Commissioner Stella Kyriakides. This dual strategy improves personal health management and accelerates medical research, resulting in a more integrated and efficient healthcare system across Europe.

Challenges in Implementing the European Health Data Space

The EHDS framework introduces a federated data architecture, which aims to keep health data within national borders while enabling secure access across the European Union. This approach allows health data to be stored locally or regionally within each member state while adhering to national sovereignty and data protection requirements. Through standardized protocols and interoperability frameworks established by the EHDS, authorized entities can securely access and exchange health data across borders as needed. This system ensures that sensitive health information is protected according to local regulations while facilitating collaborative research, policymaking, and healthcare delivery throughout the European Union. However, safeguarding patient privacy through encryption, anonymization, and pseudonymization faces challenges due to overlapping EU regulations, such as the General Data Protection Regulation (GDPR), the Data Governance Act (DGA), the Data Act, the Network and Information Systems Directive (NIS2 Directive), and the Artificial Intelligence Act (AI Act). For instance, anonymization encounters complexities under regulations that hinder ensuring that the data does not allow the identification of individuals. Moreover, diverse national requirements and the administrative burden of compliance add further challenges in balancing innovative health data use with regulatory adherence. For example, some Member States enforce regulations that require data storage within their territories. These national data localization mandates may impede the broader availability and accessibility of health data.

Future Outlook on the European Health Data Space

The EHDS is anticipated to be fully operational by 2028, creating a timeline for individuals and businesses to adapt and leverage new opportunities in the new health data system. Nonetheless, to fully unlock its potential, the initiative requires greater clarity on its interpretation. For example, the term "interoperability," as defined in Article 2(2), describes the ability of organizations, software applications, or devices to interact towards mutually beneficial goals without altering the content of the data. While this inclusive approach ensures that various entities can engage with the regulation, it also means that the specifics, such as the types of organizations or the precise nature of the data exchanged, are not explicitly detailed. Addressing these nuances could be beneficial for harmonizing practices across member states and optimizing the EHDS's impact on healthcare innovation and data accessibility. Therefore, despite these areas needing attention, the EHDS is positioned to achieve its vision of a unified and secure health data space, fostering innovation and collaboration across the health data landscape. 

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This article reflects the personal opinions and views of the author. It does not necessarily represent the official stance or opinions of ECSO or The Cyberhive.