The European Health Data Space (EHDS) represents one of the central building blocks of the European Health Union and a milestone in the EU’s digital transformation. Also, it represents one of those few pieces of legislation where we create something new on the European level and can be considered a ground-breaking proposal.
Ensuring the availability and accessibility of relevant and high-quality data is crucial for EU’s healthcare systems. However, currently there are variations in data collection methods, formats, and systems across different Member States and even within national healthcare systems. Timely access to up-to-date data is essential for effective decision-making, especially during public health emergencies or outbreaks. The COVID-19 pandemic has clearly demonstrated the importance of digital services in the health area. The uptake of digital tools increased significantly during this time. However, the complexity of rules, structures and processes across Member States makes it difficult to access and share health data, especially cross-border. With the EHDS, EU is changing this.
EHDS proposal envisages two types of data usage. Primary use of electronic health data enhances healthcare on a national and cross-border level.
Normally, medical information is stored in electronic health records, which encompass segments of a patient’s medical background, whether centralized or involving multiple healthcare providers.
The EHDS aims to enable individuals to access their health data and share it with their preferred healthcare professional, even when they are in a different Member State and using a different language. Consequently, patients can receive more accurate diagnoses and treatment, minimizing medical errors and avoiding unnecessary tests. Clearly, a regulatory framework specifically focusing on individual rights, reducing fragmentation in the digital single market, and facilitating secure data utilization is undeniably required. On the other hand, secondary use of electronic health data takes place when health data is analysed to inform public health policies or to facilitate research. A more direct method of acquiring data access within a reliable and secure framework will be advantageous for R&D in Europe. This practice has the potential to improve patient safety, advance the creation of new medicinal products and medical devices, and contribute to the development of personalized medicine. It is crucial for researchers, innovators, and policymakers to have more effective access to high-quality data while ensuring its security. EU-wide action is necessary and appropriate therefore, to promote the free, cross-border flows of personal health data and to foster a genuine internal market for personal health data and digital health products and services. In short, it will help deal with problems that would otherwise persist.
Negotiations between political groups are currently in progress in the European Parliament, and I believe that the main points of contention will be about the secondary use of health data.
The main challenge is to strike the right balance between enabling the utilization of health data and safeguarding privacy and data protection. To achieve this balance, my approach is to uphold the basic principles of the Commission’s proposal, which involves adopting a comprehensive approach that facilitates data use and fosters interoperability while ensuring the highest degree of data protection. Furthermore, it is imperative to strike a delicate balance between sharing data and protecting intellectual property (IP) rights, which are crucial for promoting research and innovation within the EU. Therefore, it is essential to find a solution that effectively safeguards these IP rights while facilitating the secondary use of data.
Last but not least, the question of patients’ decision making in the secondary use of health data will also be challenging, but I believe that a compromise will be reached among political groups.
`I would also like to add that the present Commission proposal lacks the provision for active stakeholders’ engagement in governance bodies, including patients’ organizations, healthcare professionals, and industry representatives. As a result, I have proposed in the Draft Report the participation of different stakeholders in the EHDS Board, Health Data Access Bodies, and Digital Health Authorities. Furthermore, funding remains a major challenge as the EHDS is proposed to be financed using existing financial instruments available to Member States, such as the Recovery and Resilience Facility. However, additional centralized funding from the EU is necessary to make EHDS operational, given that the current financial instruments were devised before the EHDS proposal and prioritize other health-related projects. To overcome this, we need a significant boost in EU-level funding for the EHDS, which I believe will gain strong support in the Parliament.
The EHDS should be a ‘new era for the EU’s digital health policy. By facilitating the secure and responsible sharing of health data across Member States, the EHDS can contribute to a deeper understanding of diseases, medicinal products and real-world outcomes. The EHDS can put Europe at the forefront of health data usage.