Secondary use of health data
Whether you're an innovator, a start-up or a researcher, the European Health Data Space is for you!
Getting started
By March 2029, the European Health Data Regulation (EEDS ) will come into force for the secondary use of health data.
In particular, it provides for a one-stop-shop mechanism for making health data available for specific purposes, such as :
- scientific research
- innovation activities
- and algorithm testing and evaluation.
In practice
Am I concerned?
As an innovator, you may have several roles that give you rights and obligations:
- Data holder: if you hold data for which you are data controller. In this case:
- You must share information relating to your databases in the Répertoire national des ensembles de données (RED)
- You must make the data available to any authorized user who requests it for their project
- You can collect royalties on the provision of your data and benefit from guarantees for data protected by intellectual property and business secret rights
- Data user: if you wish to carry out processing on data and purposes listed in the regulation. In this case:
- You can find out about all the data available through the RED
- You can request that data be made available via the one-stop shop.
When ?
2027: designation of the Body or Bodies responsible for access to health data
2029: implementation of most of the provisions relating to secondary use of health data
2031: implementation of the provisions relating to secondary use for certain data: environmental determinants, "omics" data, data from clinical trials, studies and research, registry and cohort data.
Does this apply to me?
As an innovator, you may have several roles that give you rights and obligations:
Data holder: if you hold data for which you are responsible for processing. In this case:
- You must share information about your databases in the National Directory of Datasets (RED).
- You must make the data available to any authorized user who requests it for their project.
- You can collect royalties for making your data available, and benefit from guarantees for data protected by intellectual property rights and business secrecy.
Data user : if you wish to carry out processing on data and purposes listed in the regulation. In this case:
- You can find out about all the data available thanks to RED.
- You can request that data be made available via the one-stop shop.
When?
-
2027
Designation of the organization(s) responsible for access to health data
-
2029
Most provisions on secondary use of health data come into force
-
2031
Implementation of secondary use provisions for certain data: environmental determinants, "omics" data, data from clinical trials, studies and research, registry and cohort data.
Experts
Secondary use of healthcare data: a revolution for innovation and research in France
The secondary use of healthcare data today represents a major challenge for medical innovation and scientific research. With the forthcoming entry into force of the European Health Data Space (EHDS) regulation by March 2029, France is positioning itself as a key player in this digital transformation.
The European regulatory framework: EEDS and national strategy
The European Health Data Regulation (EEDS) forms the legal basis for this development. In France, this regulation is accompanied by an interministerial strategy launched in 2025, structured around four priorities:
- Promoting transparency and public confidence
- Create reusable databases of interest
- Creating the right conditions for sharing and reusing healthcare data
- Facilitating and simplifying the use of healthcare data
The latter aims to optimize the reuse of health data, while preparing for the implementation of the EEDS regulation. This coordinated approach involves a number of players: the DNS, the CNIL, the Health Data Hub and the CNAM.
Obligations of health data holders within the European framework of data reuse
Health data holders will be required to share information about their databases in the Répertoire national des ensembles de données (RED). This is in line with the European regulation on data re-use. They will have to allow secondary use of health data to any user who requests it for their research, care or digital development projects. These holders will become key players in the national and European strategy for making the most of health data, in line with CNIL recommendations and the objectives of the European Health Data Area.
Accessing, processing and reusing health data: a digital strategy for research, innovation and personalized care
The secondary use of healthcare data represents a major opportunity for innovation players, researchers and healthcare professionals. Users wishing to process personal health data can consult the data available via the RED and apply for access via the one-stop shop.
This data, essential for processing and analysis, can be reused in research projects, for innovation in digital health or to improve patient care. The European Health Data Space facilitates cross-border collaboration, particularly in research into rare diseases, and reinforces France's global and European strategy for quality reporting and analysis.
The exploitation of vast volumes of data health enables the development of artificial intelligence algorithms, promoting more accurate diagnoses and personalized patient treatment. Making data available in this way opens up new perspectives for innovation, while guaranteeing a secure and ethical framework.
Making the most of healthcare data: balancing innovation, the European framework and patients' rights
The valorization of health data for secondary use is based on an essential balance between digital innovation and the protection of patients' rights. The European regulation provides for a fee system for data holders, recognizing the value of making data available within a secure framework. These data can be reused to fuel research projects, health innovation initiatives, or evaluative studies, contributing to the improvement of care and the construction of a national and European digital health strategy.