26th July 2023
In the age of digitalization and data-driven advancements, the healthcare sector is experiencing a significant transformation. At the heart of this revolution lies the European Health Data Space (EHDS), an initiative introduced by the European Commission. Unveiled through a legislative proposal on 3 May 2022, the primary objective of EHDS is to facilitate the secure and responsible exchange of health information across borders,
Andrzej Rys, the Principal Scientific Advisor at the European Commission’s Directorate-General for Health and Food Safety (SANTE), offers some valuable insights into the significance, challenges, and potential benefits of the EHDS.
Can you elaborate on the significance and revolutionary nature of health data sharing?
In 2018, health data sharing was still seen as a complex and far-reaching approach. However, the European Commission made it clear in its policy that the willingness of patients and stakeholders to share and make health data available are needed for different purposes. The outbreak of COVID-19 dramatically changed the landscape. The urgent need for data during the pandemic highlighted the importance of efficient data management and decision-making. The development of the digital COVID-19 certificate demonstrated that European countries can collaborate and propose solutions that gain acceptance globally. Collaboration with stakeholders and Member States was crucial in the development of the proposal, and the European Commission hopes negotiations will be finalised by the European Parliament and Council in the coming months.
And what is your role in this?
Throughout my 17 years of work as a director in different health departments of the European Commission, I have been involved in creating concrete legislations and regulations in health. I have worked closely with my team, Commission colleagues, Member States experts and stakeholders to develop the EHDS proposal. As the Principal Scientific Advisor, my role is to stimulate collaboration with stakeholders, including academia and life science sector and EIT Health. To achieve this, we have created the EHDS roundtables and meetings in various countries to understand the diverse needs and contexts across Europe.
In terms of the next steps or obstacles, what can you tell us about what you foresee and how they might be overcome?
There are several types of obstacles that need to be addressed. Firstly, the challenges arising from complex European legislation and its implementation at the national level. Different countries have varying cultures, capacity, administrative systems, and policy-making approaches. Tailoring the implementation to fit these diverse contexts is crucial. Secondly, technical challenges related to building the necessary infrastructure for the EHDS. While digital solutions have been implemented in various sectors, healthcare presents unique complexities. Interoperability and ensuring access to data are key technical aspects that need to be addressed. Thirdly, ensuring that end-users, including patients and healthcare professionals, understand and embrace the regulations and their rights regarding health data access and collection. This requires clear communication and education. Lastly, fostering a data culture where healthcare professionals actively use data for improving practices and making informed decisions is essential. Learning from each other’s experiences and sharing knowledge between Member States can greatly contribute to overcoming these challenges. Adequate resources and funding from both the EU and Member States are also crucial for the successful digitalisation of healthcare.
How would you assess the preparedness of Member States? Are there any differences that you observe in terms of digitalisation and health data gathering across Europe? What challenges do you see, and what are your hopes?
The level of development in digital health and health data gathering varies across European Member States. Different countries have different approaches and levels of digitalisation. Each country has its own unique challenges and strengths due to differences in administrative systems, cultural norms, and policy-making approaches. The situation is complex, and progress is not uniform across Europe. However, based on my experience and observations, I believe that all Member States are willing to adapt and prepare for the future. It is important for countries to build upon their strengths and work together to address the challenges. The EHDS provides an opportunity to create a common framework for data sharing and collaboration, and I am optimistic about its potential impact on patient care and health outcomes across Europe.
Finally, how do you believe the European Health Data Space will impact patient care, and what benefits do you see emerging from this initiative?
The European Health Data Space has the potential to revolutionise patient care and healthcare outcomes. By enabling the secure and responsible sharing of health data across borders, the EHDS can facilitate the identification of patterns, trends, and best practices in healthcare. This can lead to improved decision-making, personalised treatments, and better patient outcomes. For example, EMA and the European pharmacovigilance system demonstrates how data gathering and digitalisation can enhance patient care. By quickly identifying and addressing issues related to medication side effects, patient safety can be significantly improved. The EHDS can enable healthcare providers to access comprehensive and up-to-date information about patients. Additionally, the EHDS can facilitate research and innovation by providing researchers with access to large-scale, diverse datasets. This can accelerate the development of new treatments, therapies, and interventions. It is crucial for all stakeholders to work together to maximise its potential and ensure the successful implementation of EHDS.
On 30 May 2023, EIT Health Ireland-UK, in partnership with the Irish Medtech Association at its Meeting of Minds event, brought together key opinion leaders and stakeholders to assess Ireland’s preparedness during a 90-minute roundtable discussion. Read our latest instalment of the Creating Impact series for more information.
Our comprehensive whitepaper report summarizing the key findings from the roundtable discussion will be shared soon. Sign up to our newsletter to be the first to receive the report.