In the digital age, health data are central to advancing care and medical innovation. They encompass all information related to an individual’s physical or mental health, derived from medical care, clinical trials, test results, or connected devices.
These data can be used in two ways. On the one hand, their primary use is limited to care management, enabling healthcare professionals to monitor patients through analyses, prescriptions, or medical imaging. On the other hand, their secondary use extends beyond the immediate clinical setting. In this case, once anonymized[1] or pseudonymized[2], the data become valuable sources for public policy development, scientific research, and technological innovation.
The stakes are considerable. According to the European Commission, the value generated by the secondary use of health data in Europe is expected to increase from €25 billion in 2022 to €43 billion in 2028, representing growth of 70% over six years. In Europe, this use represents a major strategic opportunity to drive innovation and strengthen the sector’s competitiveness. However, despite market growth and increasing political willingness to capitalize on it, challenges remain. Governance and the regulatory framework still need to be structured appropriately in order to fully unlock this potential.
In this article, Alcimed explores the different uses of secondary health data, provides an overview of their development in Europe, and outlines the main challenges that must be addressed.
While the secondary use of health data represents a major growth driver, its realization in continental Europe remains well below expectations. Innovation is largely driven by the United States. As early as 2022, the dynamism of its ecosystem had already enabled the emergence of six unicorns[3] specializing in the valorization and exploitation of these data. Among them are pioneers such as Komodo Health, which provides its clients with a comprehensive view of the care pathways of millions of American patients, and Innovaccer, which facilitates the transition to a value-based care model through predictive analytics.
By comparison, Europe is struggling to turn this potential into tangible success. With the exception of the United Kingdom—where, in 2022, two companies secured over €100 million in funding—the continent is significantly lagging behind in the creation of health data champions.
France has structured its approach around an ecosystem of key stakeholders, governed by a rigorous legislative framework. Data producers are at the source of the data, generating information (such as electronic health records, genomic data, or test results) within healthcare institutions and research laboratories.
These data are then centralized, prepared, and made available by the access platform, the Health Data Hub (HDH), in a secure environment after pseudonymization, thereby facilitating research. Finally, users—primarily pharmaceutical companies, medical device manufacturers, and academic researchers—leverage this data repository to drive innovation. Regulation is ensured by two pillars: the French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés, CNIL), which guarantees data protection, and the Ethics and Scientific Committee for Research, Studies, and Evaluations in the Health Sector (CESREES), which reviews access requests.
While this organizational model is robust, it raises the critical question of financing. As highlighted in the recommendations of the Strategic Contract for the Health Industries and Technologies Sector (Contrat Stratégique de Filière des Industries et Technologies de Santé, CST-ITS), as early as 2020 it was proposed to structure a model based on pricing access to data. This mechanism would aim to enhance the value of secondary data use by ensuring financial compensation for the entities that produce and prepare the data. However, the issue of data pricing remains sensitive and fuels debates about the very legitimacy of commercializing health information, leading to difficulties in implementing this type of system.
Europe, benefiting from a strong innovation ecosystem and the rigorous framework of the GDPR, is seeking to scale up in order to catch up with leaders in health data exploitation. The European Health Data Space (EHDS) is no longer just a project: this regulation was formally adopted at the beginning of 2025, marking a turning point in the management and use of health data at the European level. Supported by initiatives such as TEHDas (Towards the European Health Data Space), this framework will facilitate the secure exchange of data between Member States, strengthening both primary and secondary uses of health data while ensuring a high level of transparency and harmonization. For companies and researchers, this offers a unique opportunity to innovate while complying with data protection standards, thereby creating a favorable environment for new public health and research solutions.
Despite these advances—whose implementation is scheduled for March 2027—several key obstacles have been identified and will need to be overcome. The lack of automation in data collection, interoperability issues, and the absence of unified pricing continue to slow down the exploitation of health data. These challenges, combined with slow negotiations and fragmented regulation across countries, are prompting some industry players to seek data abroad, particularly in the United States and Canada. This raises questions of sovereignty and hampers local innovation.
The exploitation of secondary health data is experiencing strong momentum, with rapid changes in regulations and practices. This transformation is opening up new opportunities for companies and startups, fostering collaborations and innovations around the secondary use of health data. In the years ahead, this sector will become increasingly strategic. At Alcimed, we can support you in navigating this fast-evolving landscape by helping you understand the challenges, define the types of data to leverage, and anticipate future developments. Do not hesitate to contact our team!
About the author,
Virgile, Consultant in Alcimed’s Life Sciences team in France
[1] Anonymization: Processing that involves using a set of techniques to make it practically impossible to identify an individual by any means, in an irreversible manner.
[2] Pseudonymization: Replacement of directly identifying data (last name, first name, etc.) in a dataset with indirectly identifying data (alias, sequential number, etc.).
[3] A unicorn: A private startup valued at more than one billion dollars. A term coined by venture capitalist Aileen Lee in 2013.
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