France has emerged as one of the most promising health tech markets in Europe, especially for international innovators. Recent developments have created funding opportunities, streamlined the regulatory process for digital health solutions, and shone a spotlight on France as a receptive environment for modern, technology-driven healthcare.
If your company is exploring international expansion, understanding the French model—and how to plug in—is essential.
This post unpacks everything health tech and digital health innovators need to know to break into France, drawing directly on the latest market insights and regulatory changes.
Why France Is Now a Top Health Tech Destination
France isn’t just large—with over 68 million residents and one of the biggest economies in Europe—it’s now on a mission to modernize its healthcare system.
Despite already spending a similar share of GDP on health as Denmark, the reality is France’s hospitals and clinics have lagged behind in digitalization and structural reform. This delay has turned into an urgent opportunity.
Billions of euros are now flowing into the sector. Through programs like “France 2030”, France has committed major investments to everything from telemonitoring to digital therapeutics, health workforce retention, and upgraded infrastructure.
For international companies, this means an active search for innovative solutions—especially those with a proven impact on chronic diseases, elderly care, and workflow efficiency.
Regulatory Pathways: PECAN Fast Track and Beyond
At the heart of market access in France is a new approach to reimbursement.
France recently launched the “PECAN” initiative—a fast-track route for getting digital medical devices, digital therapeutics, and remote monitoring applications reimbursed by the French Social Security system.
What Is PECAN and How It Works
The PECAN process offers up to one year of coverage to solutions that are already marked with a CE, are judged innovative, and have started gathering credible evidence of benefit. Companies can apply directly, or work through local partners or distributors. While most of the application must be in French, supporting scientific material can be in English.
A unique advantage of PECAN is the structured feedback and support during the process. Applicants receive targeted advice at key stages, and can consult with authorities both before and just ahead of their submission, ensuring potential gaps or misunderstandings are quickly dealt with.
Reimbursement Model Explained
During the fast-track year, the French Social Security typically reimburses 60% of the device/app cost (for example, approximately €41 per patient in remote monitoring cases as a benchmark), with the remainder often covered by private insurance. The model also provides additional fees for healthcare professionals who prescribe or monitor the solution, ensuring broad support among clinicians.
After the fast-tracked year, products transition to a standard five-year reimbursement process—provided ongoing data continues to demonstrate value and safety.
Standard Reimbursement in French Health System: Long-Term Play
After the PECAN track, or if the PECAN isn’t available, solutions enter a more rigorous and longer approval process—the standard procedure. This allows for five years of reimbursement—essential for commercial sustainability.
There are two paths:
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Generic Fast Track: For remote monitoring solutions that are substantially similar to ones already approved through pilot programs. This approach cuts down on application time and evidence-gathering.
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Full Brand Review: For truly new or innovative solutions that don’t match previous categories, requiring in-depth clinical, economic, and organizational data.
Pricing and reimbursement rates are set through negotiation based on the product’s proven value: how much improvement it delivers compared to existing solutions and their cost.
Healthcare Market Entry: Lessons from the Field
One of the central messages is that entering France—like any major European healthcare market—requires planning, partnership, and deep local engagement.
Key Principles for Success:
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Do a gap analysis: Map the requirements of the French regulatory and reimbursement system to your product. Are you missing local health economic data, testimonials from French clinicians, or French-language market materials? Identify these early.
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Leverage public support: Institutions like trade councils and embassies can provide initial market scoping, guidance on application processes, and introductions to local stakeholders. They’re invaluable for navigating the first steps. However, some aspects of the process will require local experts or specialized partners once you move beyond preliminary research.
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Prioritize finding a local partner: Having a French organization—or even a French distributor—on your side can help you build brand recognition, access networks of clinicians able to prescribe your solution, and gather the local data regulators are looking for.
Do you need a hand in finding a partner or distributor in France? This is what we do for our clients. -
Invest in localization: Don’t underestimate the need for a fully localized product. This doesn’t just mean translation, but also meeting technical integration standards, complying with French regulations (such as GDPR and ANS interoperability standards), and tailoring support materials and onboarding for French users.
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Be realistic about timelines: Large organizations and healthcare systems move at a very different pace from agile startups. Plan for longer decision cycles, and don’t be discouraged by initial delays or the bureaucracy of new processes.
France vs. Germany: PECAN vs. DiGA Explained
Germany’s DiGA process for digital therapeutics was a first in Europe and has inspired much of what France is doing. However, Germany’s system has been slowed down by friction between digital health companies and the country’s many health insurers, some of whom have resisted paying even after regulatory approval.
France has designed the PECAN and standard reimbursement routes to sidestep this challenge. With a unified national payer (Social Security) and a clear, central approval process, the risk of payment disputes is lower and timelines are more predictable. France has also widened the scope to include higher-risk devices and more complex telemonitoring use cases.
Next Steps for Health Tech and Digital Health Innovators
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Research and Prepare: Review the Genius platform (available in French and English) for up-to-date guidelines, application templates, and technical checklists related to PECAN and standard procedures.
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Consider a Joint Program: Sector organizations and trade bodies may offer group entry programs, tailored workshops, or partnering tours in Paris for companies ready to dive in together.
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Engage a Local Partner: Search for a distributor, hospital network, or health system willing to pilot or co-brand your solution—this step makes clinical and real-world data collection much easier and speeds trust-building with regulators.
Do you need a hand in finding a partner or distributor in France? This is what we do for our clients. -
Invest in Application Support: Plan to have your application thoroughly reviewed and translated—this is not the place to cut corners.
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Commit to the Long Game: French market entry is not “set and forget.” Ongoing engagement with clinicians, continuous improvement based on user and regulator feedback, and marketing efforts are all crucial for sustainable success.
Conclusion: Why Now is the Time to Enter France
With billions in funding, long-term political commitment, and a regulatory system tailored for digital innovation, France is now the most promising entry point for international health tech and digital health in Europe. Successfully navigating the process requires strategic preparation, genuine partnerships, and solid investment in localization—yet the rewards for first movers are significant.
Whether you’re developing remote monitoring systems, digital therapeutic apps, or AI-powered clinical tools, the regulatory pathways are in place and the demand has never been greater.
Stay tuned for more detailed guides, useful links, and invitations to join collaborative entry programs. The French health tech revolution is underway—are you ready to join?
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Disclaimer: We aren't a legal or regulatory affairs firm. We are not specialists in this matter; therefore, we cannot be sued for wrongful information or harm. Please check with experts and local authorities for up-to-date information.
FAQ - Entering the French Digital Health Market
Can non-French clinical data be used for PECAN and reimbursement?
Yes. Clinical data from European countries is typically accepted as long as it is robust. English-language scientific documentation is welcome in the application package.
Is reimbursement available for hybrid digital/human solutions?
Yes, as long as the coaching or clinical follow-up is provided by the same healthcare professional who prescribes the app/device. Additional operator fees for doctors or nurses are built into the reimbursement.
Are there technical requirements unique to France?
While Europe-wide CE-marking is essential, France has specific technical and interoperability requirements, particularly for integrating with French electronic health record systems and patient data privacy regulations.
How does the PECAN application process differ from German DiGA process?
France offers a wider scope (including higher-risk devices and telemonitoring), and the main payer is the national social security system, reducing insurance-level friction that has affected German digital health roll-out.
What happens if your application is rejected in the PECAN process?
The standard five-year reimbursement process is always available—even if your solution isn’t deemed “innovative enough” for PECAN. Initial rejection need not be a setback.
Disclaimer: We aren't a legal or regulatory affairs firm. We are not specialists in this matter; therefore, we cannot be sued for wrongful information or harm. Please check with experts and local authorities for up-to-date information.
