The European Health Data Space 

The European Union established a new law called the European Health Data Space (EHDS). This is a set of common rules between European countries to make better use of health data while protecting citizens' privacy. The aim is to improve patient care, promote research and help organise public health more effectively.

1. Access to data for health care (primary use)

A doctor can access certain medical information about you - such as your tests, allergies or medical history - to treat you more quickly and safely.

For example, if you fall ill in another EU country, a doctor can, with your consent, access a summary of your medical record. This makes treatment easier, avoids mistakes and improves the quality of care.

Marie, a Belgian citizen, was on holiday in Italy. One day, she experienced severe abdominal pain and went to the emergency room. She didn't speak Italian very well and didn't have her medical documents with her.

Before EHDS

The Italian doctors didn't know her medical history. They have to check everything themselves: allergies, current treatments, previous operations, etc. This takes time, increases the risk of error, and Marie may receive treatment that is not the most appropriate.

With EHDS

Thanks to the new European system:

• With Marie's consent, the Italian doctor can access her medical summary in just a few clicks: current treatments, allergies, important antecedents.
• He immediately understands that Marie is allergic to certain antibiotics, which avoids a serious mistake.
• He also sees that she has already had an operation for appendicitis. He could therefore look for another cause of her pain.
• Marie was quickly taken into care, given the appropriate treatment and returned home in great shape.

2. To promote public health (secondary use)

Health data can also be used for other purposes: scientific research, disease prevention, or improving health care and health policies.

It can come from a variety of sources, such as hospitals, clinical trials or medical records. It is always shared in a safe way, only when justified and without the possibility of identifying the individuals concerned.

In Belgium, the Health Data Agency (HDA) is in charge of secondary use. It acts as a trusted intermediary between those who need the data (such as a researcher or health authority) and those who hold it (such as a hospital or care provider).

In practice, the HDA :

• Helps organisations such as governments, hospitals, universities, companies and research institutions formulate their requests for access to data;
• Ensures that each request complies with security, confidentiality and ethical rules;
• Ensures that the data is of high quality and well standardised;
• Provide advice on regulatory issues;
• Informs and trains stakeholders, in particular through the Health Data Academy.

The aim is to make the use of health data easier, safer and more useful for society as a whole.

The European Health Data Space (EHDS) aims to improve healthcare systems in Europe. By sharing data more effectively, healthcare will become more efficient, medical research will advance and innovation will benefit everyone.

The goal?

To ensure that health data is used for the common good, with full respect for privacy and in complete security.

Anyone carrying out a research project can connect to the central 'HealthData@EU' platform. This platform shows what data is available in each country of the European Union. If you are interested in specific data, you can submit a request directly through the platform. The request will then be sent to the Health Data Access Bodies in the countries concerned, who will check it and respond.

It's a bit like a safe digital marketplace where health professionals and researchers from across the European Union can share data in a controlled way. Imagine a big shared library where, instead of borrowing books, people can consult data useful for research, care or health policy.

1. In March 2025, the European Health Data Space (EHDS) Regulation will enter into force, marking the start of a transitional period. This period will allow the European Commission to prepare and adopt, by March 2027, several implementing acts detailing the practical arrangements for the implementation of the Regulation.

2. From March 2029, the first key provisions will apply: Member States will have to allow the exchange of certain priority categories of health data for healthcare purposes (such as patient summaries and electronic prescriptions), while the secondary use of data (for research, health policy purposes, etc.) will begin to apply to most types of data.

3. By March 2031, the exchange of the second set of priority data (medical images, laboratory results, hospital discharge reports) should be operational in all Member States, and secondary use will be extended to other types of data, such as genomic data.

4. Finally, from March 2034, third countries and international organisations will be able to apply to join the HealthData@EU platform to access health data for secondary purposes.

Researchers in Belgium want to understand why more and more young adults are developing type 2 diabetes. They wonder whether factors such as diet, stress or lack of physical activity play an important role.

Before EHDS

Researchers had to contact several hospitals, go through very long procedures and often only had access to a small part of the data. This made the results less reliable or too limited to draw any real conclusions.

With EHDS

Thanks to the new European system:

• Researchers can request access to health data from across Europe, such as age, weight, lifestyle habits and medical history.
• This data is anonymous: no surname, first name or identification number is visible. There is no way of knowing who owns the data.
• The health data access authorities in each Member State ensure that the study is useful, well supervised and respects privacy. 

What does it mean?

The results will allow authorities to target prevention campaigns, such as more sport in schools or information campaigns in certain regions.

Other situations also demonstrate the value of sharing data at European level. Whether it's better understanding rare diseases or analysing the impact of the environment on our health. Having access to more data allows researchers to produce more reliable results that are useful for the population as a whole.

Take rare diseases, for example. In Belgium, a disease may only affect about ten people. In this case, Belgian researchers have very little data with which to do their analyses. But if these data could be pooled with those of patients with the same disease in other European countries, they would have access to a much larger set of data. This would enable them to obtain more solid and useful results for improving diagnosis, treatment or prevention.

Another example is public health and the impact of our environment. By linking data on air quality, heatwaves and living conditions with health data, researchers can better understand the links between pollution, climate and disease. They can show that high levels of pollution in cities increase the risk of respiratory disease. With this information, authorities can make targeted decisions, such as creating more green spaces in cities or launching prevention campaigns for those most at risk.

One of the long-term benefits of the European Health Data Space is the opportunity to improve the quality of care across Europe. Through secondary use of the data, researchers can identify best practices in certain countries or regions for the treatment of certain diseases. These best practices can then be shared across Europe. Regions facing more difficulties can draw inspiration from these practices and adopt proven approaches from elsewhere. Ultimately, this will help make healthcare more effective, better organised and more equitable for all.