The EHDS Is Ready for the Green Light

The European Health Data Space (EHDS) will benefit European patients and healthcare professionals, according to Mor Dickman MD, PhD.

The EHDS was proposed by the European Commission in 2022 as part of the European Data Strategy, and it aims to facilitate the exchange of healthcare data within the European Union. “It is part of the Commission’s efforts to tap into the potential of health data to get the best social benefit from it,” Professor Dickman said. He observed this opportunity marks an exciting moment where technology and science finally come together.

The Commission, the Parliament, and the Council tried to find common ground during trilogue negotiations over the last three years. Despite some interoperability, data protection, and safety concerns, a provisional agreement addressing these challenges was reached on 15 March 2024. The new EHDS regulation will enable the exchange and access of health data across the EU and make certain anonymized data available for research and innovation.

For instance, the EHDS will allow a doctor in the Netherlands to access the medical records of a Spanish citizen who fell ill while on vacation in Amsterdam. German patients will also be able to buy medicines prescribed by their regular doctor in a Polish pharmacy. This initiative will also benefit the research community and policymakers: Certain anonymized health data will be made available to scientists for research and innovation to improve treatments and patient care and for policymakers to improve informed decision-making.

Especially in ophthalmology, it might be a life-changing moment. “With ESCRS, we already have registries containing data from 5 million records around Europe, and it is one of the biggest IT projects in ophthalmology,” Prof Dickman explained. “We recognize the importance of digital health, and we are committed to making it interoperable and harmonized for our community and the patients. The EHDS brings additional legal clarity, which is welcomed.”

Ophthalmology heavily relies on imaging and technology, making EHDS a landmark event. “For us specialists, such a framework makes our lives and work easier: we can make better diagnoses, prescribe better treatments, and have a lower administrative

burden,” Prof Dickman said. A lesson learned from the COVID-19 pandemic is the importance of having this data available in the interest of public health.

Also, patients would have access to their data everywhere within the EU and free of charge. Finally, researchers in ophthalmology would have access to standardized and harmonized data, which can help R&D develop at an extraordinary pace. This is particularly important for rare diseases. “There are 30 million patients with rare diseases across Europe, and healthcare is really fragmented in this field,” he remarked. “So having a harmonized system is very beneficial.”

Issues and concerns

However, several issues have raised concerns in the past few months. In a statement coordinated by Digital Europe signed by 35 stakeholders, including the ESCRS, there was deep concern about some security aspects of this data possibly being overlooked due to the urgency of approving the regulation before the EU elections. The stakeholders highlighted the lack of clarity and coherence in the definitions and their scope. They advocated for consistency with existing EU data protection legislation, such as the GDPR. They also called against international health data transfer restrictions going beyond the existing EU legal framework to incentivize the free circulation of data within EHDS.

Concerns about data privacy have been the biggest mountain to climb. Led by the European Commission’s health division (DG Sante), the EHDS original text offered no option for patients to opt out of the system. “We need to establish a secure and trustworthy environment for handling this highly confidential data,” Prof Dickman said. “It is crucial to ensure that the data does not get into the wrong hands while simultaneously making it accessible to researchers to gain insights and find cures for diseases.”

Stakeholders were worried about the possibility that this information could lead to forms of discrimination for patients according to their health condition. In the agreed proposal, the EHDS prohibits the usage of health data for advertising or assessing insurance requests, as well as job offers or lending conditions.

The crucial point was the extent to which patients should opt out of the use of their data.

“Finally, it was agreed that EU countries would allow all patients to opt out of the system’s secondary use, except for public interest research,” Prof Dickman remarked. “It means patients will be able to opt out of their anonymized or pseudonymized data being used by private companies.”

Each EU member state would also establish national health data access services and monitor data safety, enforcing sanctions in the event of violations.

“Like everything in society, it is a question of balancing the different interests,” he concluded. “I think part of creating trust in this big change process is really ensuring that all stakeholders are involved.”

Mor Dickman MD, PhD is Professor of Ophthalmology, University Eye Clinic, Maastricht UMC, Netherlands. m.dickman@maastrichtuniversity.nl