Skip to content
Generic filters
Exact matches only
Search in title
Search in content
Search in excerpt

Jelena Malinina: Assessing the pulse of the European Health Data Space proposal

December 2023

Every person living with a rare disease knows well the benefits of data sharing for diagnosis, treatment, care, and research. Following the COVID-19 pandemic, the needs for data sharing and the value of it became apparent to the whole world. The European Union (EU) was not an exception, and in May 2022 the European Commission announced the launch of the European Health Data Space (EHDS).

The key goal of the EHDS is to make data more accessible by creating common standards, infrastructures, and a governance framework for health data use in healthcare settings, research, innovation, statistics, patient safety, and other regulatory purposes.

It has been around 18 months since the proposal was introduced, and currently, debates on the EHDS are intensifying both in the European Parliament and the European Council. If an agreement is not reached by early 2024, it is most likely that the finalisation of negotiations will be delayed by at least a year.

However, let’s take a closer look at what is going on and what it could mean for rare diseases.

Opt-in or opt-out?

Consent management for secondary health data use has become the hottest topic during the political debates on the file. Opt-in consent demands patients explicitly agree to data processing, while opt-out consent assumes patient consent unless they act to withdraw it.

What system is the best? It depends.

On one hand, opt-in is more user-centric, stricter, and aimed at empowering individual choice and control over the data. However, the implementation of an opt-in system might equally mean that many individuals could decide not to share the data, and thus it would mean that there will not be enough representative, good quality data. For rare diseases, it could mean that the current situation of data scarcity will not be improved at all.

Both systems have pros and cons, and in the end, they are just two sides of the same coin: consent-based data sharing. What is more important is how such systems are organised, whether they reflect the needs of a certain context, and whether they have enough other safeguards to protect a patient. There are many more layers of complexity to this question of whether it is opt-in or opt-out or nothing at all. Different contexts might need different solutions and certainly more safeguards than consent. This seems to be missing in the current debates.

Diverse national systems

It is key to remember that the EHDS may not dramatically change national healthcare systems, especially when it comes to secondary health data uses. It is still the competence of the Member States, and the EU can influence it only to a certain extent. A wish to preserve the national rules is also reflected in the current debates in the EU’s Council: the Member States would like to harmonise the approach to health data without necessarily sacrificing their existing national systems. This may seem to be a contradictory wish.

The risks of rushing

All in all, the EHDS proposal is highly ambitious and much-needed. However, it is important to make it right. Policymakers should not rush the text just because the institutional term is coming to an end; it should be thoroughly managed and matched not only with a higher vision but the actual reality of the Member States and available resources.


Read our resources on the European Health Data Space (EHDS):

Jelena Malinina, Data Director, EURORDIS-Rare Diseases Europe 

Disclaimer: As a Staff Blog, the opinions – including possible policy recommendations – expressed in this article are those of the author and do not necessarily represent the views or opinions of EURORDIS. The publication of this article on the EURORDIS website does not equate to endorsement.