On 26 March 2025, the European Health Data Space (EHDS) Regulation officially became EU law. This is a major step forward for building a European Health Union that works for patients. The EHDS offers more than just technical solutions. It marks a turning point in how Europeans can access their own health data directly, choose sharing options and improve allergy, asthma and COPD disease management.
The European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) has followed and informed the development of the EU EHDS from the beginning. Since 2020, we have been calling for a data framework that puts patients at the center, protecting their rights and focusing in improving care.
As the EU now moves to implement the EHDS, Member States and stakeholders are designing the complex and robust data systems, rules, and digital infrastructure needed to bring this health data space to life.
A framework to improve care and enable innovation
The EHDS introduces a shared European framework to help health data flow safely between patients and healthcare providers, and meaningfully across borders. It gives people access to their health data and allows them to share it with healthcare professionals throughout the EU. This makes it easier to understand own care pathway and receive care in another country. Importantly, as it is digital and always at hand, it improves continuity between healthcare services and helps clinical information follow the patient.
At the same time, the EHDS will serve to break EU silos, as it regulates how individual patients’ anonymised or pseudonymised data can be used for research, innovation, public health, and policymaking at EU level, helping Europe build smarter, evidence-based systems for the future.
Making digital health work for patients
EFA welcomes the EHDS as an opportunity to re-center healthcare around patients. By improving access to data, this information system can support better self-management and more appropriate care. It also brings Europe closer to a health system that is connected, inclusive and ready for the challenges of chronic diseases.
But to deliver on its promises, implementation must centre on patient rights and trust. People need to be informed clearly about how their data is used and have tangible opportunities to interact and get active on their health. One of the most important objectives in the EHDS is the requirement for countries to improve digital health literacy.
Also, patients are the engine for knowledge development through patient reported outcomes and clinical trial participation, but we welcome the right to opt out from sharing data for research (secondary data use), as well as.
Yet, important gaps remain. The regulation does not provide patients with a clear path to justice if their data rights are violated. And despite the EHDS being built to serve people, patient organisations are not guaranteed a place in its core governance. Without structured representation, key decisions risk being taken without the input of those most affected.
What happens next
The EHDS will be rolled out over the next decade. In 2027, the first detailed rules will be adopted. By 2029, patients should be able to access and share core health data across Member States. More data types, including imaging and hospital reports, will follow by 2031. From 2034, international partners may be able to join the system for secondary data use.
This long timeline reflects the scale of the change ahead. But the direction is clear: a more connected Europe that uses data to support better care, research, and decision-making.
EFA will continue advocating for patients throughout the implementation. We are observers in the European Commission eHealth Stakeholder Group since 2024. We will work to ensure the EHDS is transparent, secure, and inclusive helping it become a tool that delivers not only innovation, but dignity and support for every person living with allergy or respiratory disease.
The EHDS is a chance to make care smarter, fairer, and more accessible. To achieve that, patients must remain at the centre, every step of the way.
Learn more about EFA’s work on EHDS:
EFA response to the public consultation on a European Health Data Space (EHDS)
Refer to the European Commission's FAQ for more info