Health data constitutes a major strategic asset for biomedical research, patient care, the monitoring and performance improvement of institutions, as well as medico-technological innovation. In France, its valorization relies on mechanisms that are currently being structured: hospital data warehouses (EDS), health cooperation groups (GCS), or national platforms.
However, there are numerous hurdles: fragmentation of access, heterogeneity of formats, long processing times, and legal complexity. These hurdles weigh particularly heavily on start-ups, industrial players, and innovative project leaders.
As the European Health Data Space (EHDS) begins its implementation in 2025, with an entry into force on March 26, the issues of readability, interoperability, and governance are becoming central. In this article, Alcimed explores the current barriers to data exploitation, the best practices already in place, and the levers to activate to simplify access, streamline collaborations, and accelerate valorization in France and Europe.
According to the CNIL (French Data Protection Authority), health data are personal data relating to the physical or mental health of a person, including data revealing information about their health status or resulting from care received. They are therefore highly sensitive, strictly regulated, and protected by the GDPR and the French Data Protection Act (Loi Informatique et Libertés).
Access to this data relies on Reference Methodologies (MR), validated by the CNIL. If a project falls outside this framework, specific authorization must be issued by the institution. The MRs thus impose a strict legal and ethical framework: explicit objectives, data minimization, pseudonymization, reinforced security measures, and limited retention periods.
While essential for protecting individuals, this framework often slows down data access. This is particularly the case for start-ups, industrial players, or clinical teams unfamiliar with the procedures, often lacking internal legal support.
Several structures are attempting to regulate and facilitate data access in France, each with a specific role:
Today, these different structures have a common objective: to simplify access to health data for all innovation actors, whether hospital-based, academic, or industrial. Furthermore, the challenge now goes beyond simple local structuring to move towards a true federation of data. Initiatives are emerging to break down silos, such as the FeData project, which aims to federate CHU warehouses to offer multicentric access (horizontal approach), or Unicancer, which centralizes data from Cancer Control Centers via its Harmonie project (vertical approach by specialty).
Access to health data therefore relies on a mosaic of actors and portals. Data are accessible via the Health Data Hub (HDH), local EDS and GCS, specific registries (e.g., the FRANCIM cancer registry network or the REIN registry in nephrology), or national cohorts (e.g., the generalist Constances cohort or the E3N-E4N study). For example, the G_NIUS portal, piloted by the Ministerial Delegation for Digital Health, offers a directory of access counters.
However, the diversity of governances, formats, and access conditions makes the landscape complex and difficult for project leaders to grasp. Beyond access, value lies in data linkage (chaining), i.e., the ability to cross-reference distinct sources for the same patient. Major advances are underway regarding National Research Organizations (ONR), notably with Inserm’s validation of linking its data with multicentric hospital initiatives, which constitutes a real “game changer”.
Legal access modalities vary according to use cases and the nature of the partners:
A national working group led by the Health Data Hub and the Strategic Committee for Health Data recently published a standard contract for the provision of data from EDS, in order to harmonize practices and reduce negotiation times.
On average, access to data via major national platforms and initiatives like EDS or GCS takes between 6 and 12 months. According to reports from the Senate (2023) and the Court of Auditors (2024), these delays can reach up to 18 months or more, depending on the complexity of the project and the origin of the data.
Three major hurdles explain these durations:
For start-ups and companies, these excessive delays constitute a major obstacle to the rapid deployment of proofs of concept.
Several initiatives illustrate emerging best practices.
These examples show that effective operational models are possible. However, not all initiatives are at the same level of maturity. Data quality, warehouse completeness, interoperability, and the availability of human resources to support projects remain very heterogeneous across regions or institutions. The absence of a clear business plan (costs, financing model, governance) sometimes limits their long-term impact, hence the crucial interest of a federated approach: by mutualizing resources and costs (the “Run”), it allows reaching a critical size and building a more robust and sustainable economic model.
Accelerating access to health data requires more agile experimentation environments.
Better cooperation between actors requires the standardization of tools and contractual practices.
The European Health Data Space (EHDS), whose entry into force is scheduled for 2025 with progressive implementation until 2029, opens up major perspectives at the European level:
To realize these ambitions, it will be necessary to anticipate technical interoperability, harmonization of standards, mutual recognition of authorizations, and legal protection of cross-border flows. French and European actors will then have to adapt their tools, simplify their processes via a multicentric approach, and evolve their governance models by integrating the imperative of digital sovereignty. This dimension, having become central in current structures, is now guiding choices towards European solutions and actors.
While France has a solid foundation to become a key player in health data in Europe, the construction phase (“Build”) is now over. To realize this potential, the urgency is to successfully navigate the shift to exploitation (“Run”) by acting now on several levers: clarifying access modalities with single windows capable of centralizing requests, stabilizing contractual frameworks to save time, strengthening support for project leaders, and mutualizing resources through federation logics.
In the longer term, the preparation for the EHDS imposes a change of scale: harmonization of standards, interconnection of platforms, adapted governance, and protection of cross-border exchanges. This requires strategic alignment between territories, public structures, and industrial partners.
Finally, the valorization of health data cannot be conceived sustainably without integrating ecological issues: the environmental impact of their collection, processing, and storage must be measured, regulated, and integrated into technical choices. It is about thinking of a valorization model that is responsible, useful, secure… and sustainable.
Alcimed accompanies General Management, IT Departments (DSI), and Clinical Research & Innovation Departments (DRCI) of hospitals, as well as medico-social establishments and Skills Operators (OPCO), to transform their digital initiatives into truly operational roadmaps. We intervene throughout the project lifecycle, from design (“Build”) to exploitation (“Run”) and scaling conditions, in order to secure appropriation, economic sustainability, and deployment. By combining strategic analysis, field feedback, multicentric benchmarks, and work on use cases, we structure sustainable, mutualizable, and sovereign models, adapted to the concrete challenges of healthcare actors. Don’t hesitate to contact our team.
About the author,
Alix, Consultant in Alcimed’s Innovation and Public Policy team in France
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