April 28, 2023

European Health Data Space: a milestone for patient empowerment

On Thursday, April 27, EU40 – the Network of Young MEPs, and MEP Sara Cerdas, hosted an event titled: “The European Health Data Space: a milestone for patient empowerment“. The debate aimed at discussing and providing different perspectives on the European Commission’s proposal for a regulation on the European Health Data Space, published on the 3rd of May 2022. The regulation is extremely relevant as it deals with a cross-sectoral topic: the EHDS represents a key pillar of the European Health Union and it builds further on the proposed Data Governance Act and Data Act, respectively the horizontal legislation on data governance and a recently presented EU law on data-sharing. Despite the initial decision to assign the European Health Data Space exclusively to the European Parliament’s civil liberties committee (LIBE), it has now been agreed that the Committee for Health (ENVI) will co-lead the file, which expands the EU data regulation. 

The major inter-institutional conference took place in the European Parliament, giving the opportunity to all major stakeholders to voice their concerns and to set out their own respective perspectives regarding how the legislative process should move forward.

Guest panellists included MEP Cerdas, Sandra Gallina – European Commission Director General for Health and Food Safety, Gözde Susuzlu – Data Saves Lives Coordinator, Agata Hidalgo – France Digitale European Affairs Manager, and Leyna Sultan – Arkhn Legal Counsel. The panel was moderated by Filip Karan – EPHA Digital Transformation. 

After the welcoming remarks by Karan, Leyna Sultan began her intervention by expressing some considerations from a legal point of view. She stated that, even if there is some work to be done to make the EHDS coherent with the GDPR regulation, overall this is a chance to improve alliances among different bodies. As she stated: “This is a chance to improve collaborative research, but it also means improvement in the legislation itself and in all the government’s structures”. 

Agata Hidalgo, from France Digitale, provided an overview of how digital startups can contribute to improving the healthcare ecosystem, and the existing obstacles faced by innovators: from the administrative and technical barriers to lack of interoperability among electronic health records, and the existing complex regulations.  The EHDS was very well received by the private community: “This regulation is answering real problems that we are facing”, at the same time, Hidalgo continued,  there are many implementation questions that arise, especially regarding the trust that exists in the healthcare ecosystem. She remarked: “For this regulation to succeed we need to involve the people that are on the ground implementing it: we should hear from patients organizations, healthcare professional organizations, startups, and other parties that are involved, creating a bottom-up conversation.” 

Sandra Gallina, European Commission Director General for Health and Food Safety, stressed the importance of this regulation to facilitate data-sharing among different healthcare structures: “We need to be looking at this primary data in the light that a doctor needs to understand the language. We are not going to impose a one size fits all”. According to Gallina, the EHDS will make the selected information available based on the concept that the empowerment of citizens lies at the root of the EHDS proposal. Gallina continued by saying that the EHDS aims at creating a dialogue for interoperability in order to reach some common standards. With this proposal: “We need to build trust among citizens and patients, making people understand why the EHDS is useful for them”. Gallina remarked how the proposal ensures strong data protection and security protection, however, investments are necessary. She continued: “Investing in digitalisation means investing in better healthcare.” 

Gözde Susuzlu, Data Saves Lives Coordinator, brought up how it is necessary that the creation of solid policy pillars goes hand in hand with education. She stressed how policymakers can have difficulties in educating common citizens on complex proposals such as the EHDS. This is why umbrella organizations such as DSL, can provide “training to trainers”: “Local patient organizations are the key players to reach the citizens, our members are aware of the EHDS but they don’t know what it will imply, so education is the key.”.

Finally, MEP Sara Cerdas reported again the benefits of the EHDS, bringing concrete examples of how this proposal will benefit the different players involved in the healthcare ecosystem. From carrying out a cross-sectional study on how many appendicitis there were in a certain year, to enabling a patient transferred from one hospital to another to share his personal medical file. This is what the EHDS aims to do at a bigger level. Indeed, Cerdas remarked on the importance of digital literacy and education, and her concerns regarding the well-being of healthcare professionals. She stated:” We don’t want this new system to be an extra burden for healthcare providers, and to impact the doctor-patient relationship. We need to guarantee that all questions are answered and all the worries are answered with concrete examples of what can be the benefits of the EHDS.”