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Brussels, |
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European Health Data Space: A Unifying Leap for Health Data in the EU
After the EP first reading last December, EP and Council negotiators agreed on a compromise text of the EU Regulation on the creation of a European Health Data Space, to ease access to personal health data and to boost secure sharing for the public interest.
Bridging Borders: The Dawn of Enhanced Health Data Accessibility and Privacy - On the journey to harmonize healthcare throughout the European Union, the Council of the EU and the European Parliament have reached a provisional agreement on the European Health Data Space (EHDS). This pioneering regulation aims to transform the way health data is exchanged and accessed within the EU, offering individuals greater control over their health information and enabling the smooth transfer of health data across borders for the purposes of public interest and scientific research.
The Journey to a Digital Health Revolution
The EHDS initiative stems from the European Commission's proposal on 3 May 2022, marking the first of nine sector- and domain-specific data spaces envisioned in the Commission's 2020 'A European strategy for data'. Its conception is a testament to the EU's commitment to fostering a single market for digital health services and products, deemed a cornerstone of the European Health Union.
On 13 December 2023, the European Parliament voted on its first reading and agreed to start negotiations with the EU Council.
After many meeting, on 15 March 2024 the EU legislators reached a compromise on a final text of the new Regulation.
In April 2024, this compromise will be submitted to the vote of the Health Committee of the European Parliament and later to the Plenary's vote.
The agreement reached is more than a legislative milestone; it's a beacon of hope for patients, healthcare professionals, and researchers alike. Envisioning scenarios where a Spanish tourist could effortlessly pick up a prescription in Germany or a Belgian patient receives care in Italy with no hitches in data access underscores the transformative potential of the EHDS.
On 13 December 2023, the European Parliament voted on its first reading and agreed to start negotiations with the EU Council.
After many meeting, on 15 March 2024 the EU legislators reached a compromise on a final text of the new Regulation.
In April 2024, this compromise will be submitted to the vote of the Health Committee of the European Parliament and later to the Plenary's vote.
The agreement reached is more than a legislative milestone; it's a beacon of hope for patients, healthcare professionals, and researchers alike. Envisioning scenarios where a Spanish tourist could effortlessly pick up a prescription in Germany or a Belgian patient receives care in Italy with no hitches in data access underscores the transformative potential of the EHDS.
Key Features and Innovations of the EHDS
Enhanced Accessibility and Control
Under the new regulation, individuals will gain unprecedented access to their electronic health data, irrespective of their location within the EU. This facilitation extends beyond mere access, empowering individuals with greater authority over the use of their data. National digital health authorities, mandated by the regulation, will play a pivotal role in implementing these provisions, ensuring that every EU country aligns with the envisioned digital health landscape.
Fostering Research and Policy-making
The EHDS is not just about individual health data; it's a catalyst for broader societal benefits. By providing secure access to specific kinds of health data, the regulation opens new avenues for research and policy-making. This access will enable stakeholders to leverage the wealth of health data within the EU, driving advancements in public health initiatives, scientific discovery, and the formulation of robust health policies.
Interoperability
The Key to UnityOne of the EHDS's core objectives is to address the disparities in the digitalization of health data across member states. By mandating compliance with the European electronic health record exchange format, the regulation ensures that EHR systems across the EU can communicate seamlessly. This interoperability is crucial for the cross-border exchange of health data, paving the way for a truly integrated European health data network.
Amendments and Safeguards
The provisional agreement introduces several amendments to the Commission's original proposal, focusing on privacy and data protection. These include options for patients to opt-out of data sharing, both for primary healthcare use and secondary uses such as research, under strict conditions. Additional safeguards are proposed for sensitive data like genetic information, and the establishment of trusted data holders aims to streamline the administrative process related to health data access.
- Citizens will be able to access prescriptions, imagery and lab tests electronically, also from different EU countries
- Aggregated health data can be shared for research purposes e.g. into cancer and rare diseases
- Strong privacy safeguards on the manner and the purpose of the sharing of sensitive data
With the provisional agreement in place, the next steps involve formal endorsement by both the Council and the Parliament, followed by legal-linguistic revisions before the regulation's official adoption. This legislation is poised to enter into force 20 days after its publication in the EU's Official Journal, marking a significant leap towards a unified health data space that respects individual privacy while enhancing healthcare delivery and research across the European Union.
In the words of Frank Vandenbroucke, Belgian Deputy Prime-Minister and Minister of Social Affairs and Public Health, this deal represents a significant leap forward in patient care and scientific research across the EU. As Europe embarks on this journey towards a digital health revolution, the EHDS stands as a beacon of innovation, privacy, and collaboration in the quest for a healthier European Union.
In the words of Frank Vandenbroucke, Belgian Deputy Prime-Minister and Minister of Social Affairs and Public Health, this deal represents a significant leap forward in patient care and scientific research across the EU. As Europe embarks on this journey towards a digital health revolution, the EHDS stands as a beacon of innovation, privacy, and collaboration in the quest for a healthier European Union.
