From the Perspective of Fatima HENICHE

La French Care is a movement initiated three years ago by Bpifrance with the support of the association Les Acteurs de la French Care. The goal of this movement is to bring together private, public, and institutional health stakeholders to develop a sector of excellence serving patients, healthcare professionals, and care organizations. To achieve this ambitious goal, La French Care regularly organizes events and meetings to create synergies and collaboration opportunities between startups, companies, investors, research institutes, and healthcare institutions. As a co-founding member of this state-supported association, Bpifrance supports young health entrepreneurs at different stages of their journey by providing them with financing tailored to each stage of their development: creation, growth, innovation, and export. Thus, La French Care plays a key role in supporting health startups by offering them an environment conducive to innovation and financial solutions adapted to their development.

As the main operator of the France 2030 plan, a large-scale investment program of €54 billion, with €7.5 billion specifically allocated to the health sector*, Bpifrance supports health innovations by ensuring a continuum of funding covering all stages of the value chain for health services or products. This includes the feasibility exploration phase, research and development, industrialization, and market entry. The available funding through national calls for projects covers both structural and targeted components: Structural component: This includes innovation competitions such as i-Lab, i-Nov, i-PhD, as well as the i-Démo and Première Usine schemes. Targeted component: This is implemented through acceleration strategies, including the Digital Health Acceleration Strategy (SA SN). Finally, some dedicated programs, such as French Tech/Emergence, a program designed to support innovative startups in their early stages, or ADD (Deeptech Development Aid), are managed by Bpifrance's regional branches. In 2024, Bpifrance allocated €160 million in funding to support 180 digital health projects. These grants involve nearly 250 partners, including 150 SMEs. The funded digital solutions/services are distributed into several categories: therapeutic strategy support (28%), diagnostic and screening assistance (27%), care coordination and workflow optimization (25%), telehealth (9%), research (8%), training (2%), and drug discovery (1%). (*) Since the deployment of France 2030 in 2021, €2.3 billion in health has been managed by Bpifrance to fund 1,800 projects

Beyond the technical performance of digital solutions, particularly those integrating artificial intelligence, it is crucial to demonstrate that these solutions provide concrete benefits for healthcare professionals and patients while respecting ethical issues, especially concerning data usage. These must be of impeccable quality and accessible in compliance with current regulations. In other words, to successfully scale in healthcare and/or medical institutions, solutions must prove and demonstrate, through evaluation studies, their impact on optimizing care organizations as well as patient and resource flow management.

Bpifrance plans to invest €10 billion in AI startups in France. This investment aims to directly support some of these companies through equity financing, particularly those developing foundational models. Startups specializing in AI infrastructure or designing AI components and chips will also receive support from Bpifrance. All these initiatives could also benefit the e-health sector. Between 2015 and mid-2024, Bpifrance has already invested over €1 billion in AI startups, supporting more than 150 companies, including Mistral AI, Bioptimus, and Aqemia.

Healthcare companies, particularly in digital health, are subject to increasingly stringent European regulations aimed at ensuring the safe deployment of solutions and services. To support these companies in their market access efforts, Bpifrance offers not only R&D funding but also downstream phases through the Digital Health Acceleration Strategy (France 2030 plan). As part of this, Bpifrance operates the "Evaluation of Digital Medical Devices" call for projects, which supports SMEs in assessing their innovative solutions. The objective is to showcase emerging solutions and support the demonstration of their value before evaluation by other funding schemes or temporary derogatory articles. The evidence provided in the submitted protocols helps justify the chosen economic model (reimbursement, hospital procurement, etc.) and prove its viability. Since its launch in 2019, this call for projects has funded 20 winning projects. It is closely linked to the Diagnostic Medical Device (Diag DM) funding scheme, which helps businesses obtain certification for their medical devices. Finally, this market access support reassures even the most cautious investors, encouraging them to take risks to support companies in their riskiest phases.

According to a recent analysis by MindHealth media, current trends in e-health funding for 2025 show a recovery in growth after a period of uncertainty in 2023. In 2024, fundraising in France reached €654 million. Investments are now focused on high-maturity projects and solid companies. Major digital health firms dominate the market, while emerging startups face greater difficulties. E-health entrepreneurs must navigate a constantly evolving landscape and tackle several major technical challenges. First, they must adapt to recent advancements in artificial intelligence (AI) by integrating generative AI into their service offerings to improve diagnostics, treatments, and patient pathways while ensuring data security, ethics, and sovereignty. Attracting and retaining AI specialists is also crucial. Next, they must protect patient data from cyberattacks by implementing reliable cybersecurity solutions, a critical issue given the rise of digital solutions. Finally, they must ensure interoperability by guaranteeing compatibility between different healthcare systems for better care coordination and efficient information sharing. This must align with efforts to simplify, harmonize, and comply with international standards (SNOMED CT). Recognizing these challenges, initiatives such as the Diagnostic Medical Device scheme have been expanded to support entrepreneurs in cybersecurity, interoperability, and other critical areas.

In digital health, market access can be particularly complex due to strict regulations and the need for sustainable business models. Digital therapeutics (DTx) solutions, for example, are growing continuously. However, their economic model remains a major challenge. No DTx solutions are currently reimbursed in France, unlike in Germany, where regulations and market access are more advanced. Bpifrance supports companies by helping them define their strategy, validate their business model, and identify their competitors. Understanding buyers, prescribers, and users is essential in this evolving landscape.