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European Health Data Space: Advancing Healthcare through Unified Data Access

In a significant stride toward a more connected and efficient healthcare ecosystem across the European Union (EU), member state ambassadors have unanimously agreed upon the Council’s mandate for a pioneering law. This law intends to streamline the exchange and accessibility of health data at the EU level, ushering in the era of the European Health Data Space (EHDS).

The proposed regulation of EHDS stands as a monumental effort aimed at empowering individuals with more accessible and controlled avenues to their personal electronic health data. Simultaneously, it fosters the reuse of specific data segments for groundbreaking research and innovation purposes. At its core, EHDS constructs a health-centric data environment poised to cultivate a unified marketplace for digital health services and products within the EU.

Presently, the accessibility to health data fluctuates across the EU’s borders, presenting hurdles for seamless healthcare delivery. EHDS endeavors to eliminate these barriers, envisioning scenarios where a Spanish tourist can effortlessly collect a prescription from a German pharmacy or where doctors can securely access health information pertaining to a Belgian patient undergoing treatment in Italy.

Mónica García, the Spanish Minister for Health, emphasized the potential of digitizing health data within the EU. “The digitization of health data in the EU carries potentially vast benefits for patients, medical professionals, and the research community, yet so far this potential has not been realized. The mandate agreed on today provides for an EU-wide data space that will enable us to share and access health data safely and efficiently,” said García.

Enhanced Access and Control

EHDS marks a watershed moment by granting individuals faster and simpler access to their electronic health data, regardless of their location within the EU. This empowerment translates to better-informed decisions and safer healthcare provision across borders. Moreover, individuals gain amplified control over the utilization of their health data. The expansion of the existing infrastructure, MyHealth@EU, will play a pivotal role in facilitating cross-border data exchange. EU member states will also establish digital health authorities to implement these novel provisions.

Catalyzing Research Potential

Beyond individual access, EHDS serves as a treasure trove for researchers and policymakers, offering access to specific anonymized and secure health data. This access enables groundbreaking scientific research, the development of enhanced treatments, and an overall improvement in patient care. The establishment of HealthData@EU will serve as a dedicated platform supporting cross-border data access, complemented by health data access bodies (HDABs) at the national level to review and authorize data access requests.

Ensuring Interoperability

The variation in digitalization levels of health data among EU member states has been a stumbling block for seamless data sharing. EHDS addresses this challenge by mandating that all electronic health record (EHR) systems comply with EU-level specifications for interoperability, thus facilitating smoother data exchange across borders.

Key Elements of the Council’s Mandate

The Council’s mandate significantly refines the Commission’s proposal in various pivotal aspects:

  • Clarity: Providing lucidity on the regulation's scope, alignment with GDPR, and criteria for electronic health data access.

  • Steering Groups: Advocating the establishment of steering groups to oversee MyHealth@EU and HealthData@EU, ensuring stakeholder representation.

  • Governance: Expanding member states' roles in the EHDS governing board and requiring regular activity reports from national digital health authorities.

  • EHRs: Offering flexibility by potentially allowing separate national and cross-border profiles for the European electronic health record exchange format.

  • Opt-Out: Allowing member states discretion in permitting patients to opt out of the new data-sharing system.

The application of the regulation is slated to commence two years following its entry into force.

Next Steps and Background

The EU Council presidency is now equipped to commence negotiations with the European Parliament, aiming to reach a provisional agreement on the proposed regulation. The Parliament is anticipated to finalize its stance on December 13, 2023.

The EHDS proposal, published by the European Commission in May 2022, aligns with the broader vision outlined in the 2020 communication, ‘A European strategy for data,’ aiming to establish nine European sector-specific data spaces. EHDS, considered a foundational element of the European Health Union, strives to simplify cross-border health data access and exchange, supporting both primary and secondary uses of data in healthcare delivery and research.

In summary, the EHDS initiative stands as a testament to the EU’s commitment to harnessing the potential of data for the collective benefit of its citizens, healthcare professionals, and the research community, envisaging a future where health data seamlessly transcends borders, fostering innovation and improved healthcare outcomes.

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