The French PECAN Framework at the Three Year Milestone
- Nelson Advisors
- Feb 17
- 13 min read
The French PECAN Framework at the Three-Year Milestone: A Structural Analysis of Market Access and Regulatory Transformation in European HealthTech
The European healthcare technology landscape entering the second half of the 2026 fiscal year is characterised by an unprecedented transition from the speculative fragmentation of the early 2020s to a disciplined era of industrial maturity.At the centre of this metamorphosis is the French Prise en Charge Anticipée Numérique (PECAN) framework, which has now completed its initial three year implementation cycle since its inception in early 2023.
Originally designed as a "fast-track" bridge to permanent reimbursement for digital medical devices (DMDs), PECAN was intended to catalyse the adoption of digital therapeutics (DTx) and remote patient monitoring (RPM) solutions by providing a one year window of derogatory funding while final clinical evidence was generated. Three years on, the impact of the PECAN model extends far beyond the borders of France, serving as both a blueprint and a cautionary tale for the broader European Union as it navigates the convergence of the Medical Device Regulation (MDR), the EU AI Act, and the implementation of the European Health Data Space (EHDS).
The year 2026 stands as a "clearing event" driven by what industry analysts term "Regulatory Darwinism," a structural filter that separates scalable, clinically validated innovators from ventures unable to withstand the rigorous evidence requirements of national payers. While the early promise of digital health was built on the ambitious verbs of the future reducing costs, improving access, and fixing outcomes, the current market has begun pricing these activities in the present tense, demanding durable adoption and measurable return on investment (ROI). The French model, alongside its German predecessor, the Digitale Gesundheitsanwendung (DiGA) framework, has fundamentally altered the valuation metrics for HealthTech startups, elevating regulatory status and reimbursement certainty above traditional software-as-a-service (SaaS) growth metrics.
Architectural Foundations: The PECAN Mechanism and Regulatory Integration
The PECAN framework was established under Decree No. 2023-232 on March 30, 2023, as a central pillar of the "France 2030" investment plan, aiming to accelerate market entry for innovative digital health solutions. Unlike permanent reimbursement pathways, which require a completed clinical dossier demonstrating significant benefit, PECAN provides a temporary, non-renewable twelve-month coverage based on a "presumption of innovation". This mechanism allows a developer to begin receiving revenue from the Assurance Maladie while finalizing the demonstration of clinical or organizational benefits.
The regulatory journey for a DMD candidate in 2026 involves a rigorous parallel evaluation by two primary authorities: the Agence du Numérique en Santé (ANS) and the Haute Autorité de Santé (HAS). The ANS serves as the technical gatekeeper, assessing the device's conformity with national interoperability and security standards via the "Convergence" platform. Simultaneously, the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) within the HAS evaluates the clinical and organisational claims of the device through the "Sésame" portal.
Cumulative Eligibility and Technical Prerequisites
For a device to be admitted into the PECAN program in 2026, it must satisfy a set of stringent, cumulative criteria that reflect the high standards of the French healthcare system. The technical requirements are particularly exhaustive, mandating standardised, interoperable data export and interfaces with devices recording vital parameters. Furthermore, the solution must comply with the French national health ID (INS) and data protection requirements, including the hosting of personal health data by cloud services possessing the French Health Data Hosting (HDS) certificate.
Eligibility Pillar | Requirement Description | Governing Body |
Regulatory | CE Marking according to MDR (Class I, IIa, IIb, or III) | ANS / HAS |
Innovation | Presumed clinical benefit or progress in care organization | CNEDiMTS |
Technical | Compliance with interoperability and IT security standards | ANS |
Evidence | Ongoing studies capable of supporting permanent listing | CNEDiMTS |
Exclusivity | No prior PECAN reimbursement for the same indication | HAS |
The inclusion of higher-risk classes (IIb and III) within the PECAN scope is a notable departure from the German DiGA model, which is restricted to Class I and IIa devices. This enables the French system to evaluate more complex interventions, though it simultaneously increases the burden of proof for the manufacturer.
Economic Logic and Reimbursement Tariffs
The financial structure of PECAN is designed to provide predictable compensation while preventing the price inflation initially observed in the early years of the German DiGA directory. For digital therapeutics (DTx) intended for individual use, the reimbursement is characterised by a front-loaded initial package followed by monthly fees, capped at a maximum annual amount.
For remote patient monitoring (RPM) activities, the pricing logic is bifurcated between a technical fee paid to the platform operator and a medical fee paid to the care team. The technical fee is tiered based on the specific type of benefit demonstrated by the device:
The Three Year Reality: Trends and the Evidence Gap
As the French healthcare system reaches the end of the first three years of the PECAN experiment, the data reveals a significant gap between policy ambitions and market reality. The Digital Health Roadmap 2023–2027 set a target of 50 PECAN applications by the end of 2026. However, as of early 2025, the actual adoption rate has remained markedly lower. Only at least 11 dossiers had been submitted for the PECAN pathway, comprising seven applications for telemonitoring solutions and four for digital therapeutics.
The success rate of these applications further highlights the rigorous scrutiny applied by the HAS. Out of the 11 submissions, only seven opinions had been issued by early 2025, with just three receiving a favorable outcome. These figures suggest that the "fast-track" is not an easy route; rather, it is a highly selective filter. The HAS has identified several recurring challenges that lead to negative opinions, including inconsistencies between the manufacturer's clinical claims and the supporting evidence, incomplete administrative documentation, and a lack of clarity in defining the target population and relevant comparators.
The Transition Crisis: The Bridge to Permanent Reimbursement
The most critical test for the PECAN model in 2026 is the ability of solutions to transition from temporary funding to permanent listing on the Liste des Produits et Prestations Remboursables (LPPR) or the Liste des Activités de Télésurveillance Médicale (LATM). The PECAN pathway is strictly non-renewable, lasting only 12 months.Manufacturers of DTx must submit their permanent reimbursement application within six months of the PECAN decision, while RPM operators have a nine-month window.
The experience of Cureety TechCare, a telemonitoring solution for oncology patients, serves as a high-profile case study of the "transition crisis". Although Cureety successfully entered the PECAN program in 2023, it initially failed to secure a transition to the permanent LATM list. The HAS cited insufficiently reliable evidence of long-term clinical benefits and organizational added value as the primary reasons for the rejection. This failure highlights the "evidence cliff" that startups face: the PECAN year provides immediate cash flow, but it also places the company on a rigid regulatory clock. If the ongoing studies required for the permanent dossier do not yield statistically significant results within the allotted timeframe, the solution faces de-listing, leading to a collapse in market credibility and potential financial distress for the venture.
Comparative Market Maturity: PECAN versus DiGA
The contrast between the French PECAN and the German DiGA market in 2026 is stark, reflecting the different speeds of institutional maturation and market acceptance. After nearly four years of implementation, the German DiGA directory has established itself as the "gold standard" for DTx reimbursement in Europe. As of early 2026, there are 52 solutions listed in the DiGA directory, compared to the single-digit successes in France.
Market Metric | Germany (DiGA) | France (PECAN) |
Directory Size (2026) | 52 Solutions | < 5 Solutions |
Median Initial Price | €547 (2024 data) | €435 (Fixed package) |
Median Negotiated Price | €232 (2023 data) | Negotiated via CEPS |
Total Prescriptions | ~375,000 (Top 15 apps) | Data not publicly aggregated |
Feedback Loop | Deficiency letters and dialogue | No appeal/additional info |
The German model's higher success rate is often attributed to its more collaborative evaluation process, which allows for "deficiency letters" and ongoing exchanges between the manufacturer and the regulator. In contrast, the French PECAN process is described as less flexible, with no option for appeals or the submission of additional information once a negative opinion is issued. For developers, this means that the "first shot" at PECAN must be nearly perfect, requiring a clinical dossier that is already robust before the "anticipated" phase even begins.
The Economic Moat: Funding and Valuation in the PECAN Era
The influence of the PECAN model on the French HealthTech ecosystem in 2026 is perhaps most visible in the capital markets. The regulatory status of a digital health startup has ascended to become the single most critical metric for valuation, surpassing traditional SaaS metrics like Annual Recurring Revenue (ARR) growth. This shift is driven by a structural transformation of the asset class from speculative fragmentation to "Industrial Maturity".
In 2025, the French tech ecosystem recorded 686 funding rounds, raising a total of €8.2 billion. While AI and Machine Learning dominated the landscape, accounting for 62.5% of total funding, the HealthTech and BioTech sector completed 56 funding rounds totaling €496.9 million. The average round size in HealthTech stood at €8.9 million, suggesting that investors are willing to commit significant capital to companies that can demonstrate a clear path to reimbursement through national fast-tracks.
The "Dry Powder Paradox" and US Investor Influence
The year 2026 is defined by a "Dry Powder Paradox": while private equity and venture capital funds hold nearly $2.5 trillion in unallocated capital, deployment is highly selective, favoring platforms that demonstrate industrial logic over theoretical potential. Investors are rigorously avoiding "Black Box" AI models, instead rewarding companies that have engineered "Glass Box" transparency into their algorithms to satisfy the requirements of the EU AI Act and national HTA bodies.
Furthermore, the funding dynamics of European HealthTech have taken on an "American accent". In 2025, U.S. investors participated in 62% of late-stage European digital health deals, triple the rate seen in 2023. These investors are increasingly identifying best-in-class European technologies, particularly those that arrive with the deeper clinical validation required by frameworks like PECAN and DiGA, and funding them specifically to scale on American soil. This "evidence-first" culture, once viewed as a drag on speed, has become a defensive moat and an offensive weapon for U.S. market entry.
The Evolution of the Rule of 40
In previous market cycles, a digital health company could satisfy investors by adhering to the "Rule of 40" (Growth Rate + Profit Margin) with high growth offsetting significant losses. In 2026, the weight has shifted heavily toward the profit component. High-growth, high-burn companies are seeing their multiples compressed to 3x–4x revenue, whereas profitable, moderate-growth platforms with secured reimbursement command 10x–14x EBITDA.
Investor Metric (2026) | Strategic Requirement | Impact of PECAN/DiGA |
Valuation Multiple | Shift from Revenue to EBITDA | Reimbursement provides recurring EBITDA |
Compliance Moat | MDR Certificate & HTA Opinion | Binary filter for "investable" vs "distressed" |
Clinical Validity | Robust RCTs or high-quality RWE | Defensive moat against U.S. competitors |
Exit Window | Alignment with PE liquidity cycle | Secured reimbursement facilitates M&A |
This shift necessitates a rigorous review of the P&L for French startups, focusing on high-margin product lines and cutting non-essential R&D that does not contribute directly to clinical validation or reimbursement milestones.
Continental Ripples: The PECAN Influence on EU Member States
The French PECAN model has acted as a catalyst for a wave of regulatory innovation across the European Union. By 2026, several member states have either implemented or are piloting fast-track reimbursement schemes modelled on the Franco-German approach.
Italy: The National HTA Program for Medical Devices
Italy has entered the operational phase of its 2026–2028 National Health Technology Assessment Program for Medical Devices (PNHTA-DM). This program is supported by approximately €13 million from the national medical device governance fund, signalling a shift toward centralised evaluation for innovative technologies. Furthermore, Italy's 2026 Budget Law (Law 199/2025) reintroduced enhanced depreciation to support productive and sustainable investments, including the digitisation of the healthcare system.
The Italian Medicines Agency (AIFA) has also updated its criteria for "therapeutic innovation status," prioritising medicines and high-risk medical devices that address serious conditions lacking valid alternatives. This status unlocks immediate reimbursement and fast-track hospital access, utilising a €1.3 billion Innovation Fund. While the Italian system remains decentralised through its 125 local health agencies (ASLs), there is a clear trend toward aligning national assessment parameters with those seen in France and Germany to improve the governance of public spending and ensure equitable access.
Spain: Regional Innovation and Private Sector Strength
In Spain, the 17 autonomous communities remain responsible for defining their own health and innovation policies, leading to a landscape characterized by regional disparity and inequality. As of 2026, Spain does not have a single national "fast-track" equivalent to PECAN; instead, national reimbursement through the "basic services portfolio" must be followed by regional assessment by the autonomous communities (ACs).
However, the Spanish private sector occupies a dominant position in healthcare innovation, often serving as the primary testbed for digital therapeutics before they seek public reimbursement. Furthermore, regional governments such as Andalusia, Catalonia, and Navarre are active participants in European joint transnational calls, such as the CARMEN2026 initiative for personalised medicine, suggesting that the drive for harmonisation is occurring from the bottom up.
Finland: The Digi-HTA and the Nordic Evidence Advantage
Finland has positioned itself as the "premier testbed" for digital health evidence generation. By late 2025 and early 2026, Finland launched a national reimbursement pilot for digital therapies modeled on the DiGA and PECAN frameworks. The Finnish Digi-HTA framework is notably comprehensive, assessing products not only for clinical benefit but also for robotics, AI-specific components, and adherence to cybersecurity standards.
The Finnish model's advantage lies in the country's longitudinal patient registries and unique personal identification numbers, which allow for long-term outcome tracking that is often impossible in more fragmented systems. This has led to a surge in investment, with Finland raising $1.16 billion in digital health funding in 2025, outpacing larger markets like Germany and France on a per-capita basis.
Regulatory Convergence: AI, EHDS and the Future of the MDR
The three-year milestone of PECAN coincides with a period of intense regulatory overhaul at the European level. The implementation of the European Health Data Space (EHDS) and the looming deadlines of the EU AI Act are reshaping the "technical plumbing" that digital medical devices must navigate to remain competitive.
The European Health Data Space (EHDS)
The EHDS Regulation (EU) 2025/327 came into force on May 26, 2025, establishing an EU-wide framework for the primary and secondary use of electronic health data. For DMD manufacturers, the EHDS is transformative:
Primary Use: All Electronic Health Record (EHR) systems in the EU must interoperate by including a European interoperability software component. This aligns with PECAN's technical requirements for interoperable data export and standardised interfaces.
Secondary Use: Health data holders are required to make extensive categories of health data available for research, innovation, and the training of algorithms. This provides a massive, high-quality data set for the development of next-generation AI-enabled DMDs.
The EU hope is that by March 2029, when most secondary use provisions become mandatory, the EHDS will have created a unified market for health data, reducing the cost of clinical validation for European startups. In the context of 2026, the EHDS infrastructure (MyHealth@EU) already enables citizens from 14 member states to redeem e-prescriptions across borders, paving the way for the cross-border prescription of digital therapeutics.
The Decisive Shift: The EU AI Act and MDR Simplification
The EU AI Act introduces a binary filter for HealthTech investment, with key obligations for high-risk systems effective from August 2, 2026. Most diagnostic and therapeutic AI tools are classified as high-risk under this regime. However, in a major move to preserve innovation, the European Commission published proposals on December 16, 2025, to simplify the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Key proposed changes to the MDR in 2026 include:
Abolition of Certificate Validity Caps: The fixed five-year validity of certificates would be removed, replaced by risk-based periodic reviews by Notified Bodies.
Software Classification Revisions: Changes to Rule 11 are intended to allow more software to fall within Class I, reversing the widespread "up-classification" that occurred during the initial MDR rollout.
AI Act Harmonisation: Specify that most high-risk AI system requirements will not apply to medical device manufacturers if they are already covered by the MDR, avoiding duplicative compliance.
Regulatory Sandboxes: The establishment of "sandboxes" for emerging technologies to fast-track innovation from research to market.
These simplifications respond to the "certification bottlenecks" and "reduced innovation" that have hammered the European MedTech industry since 2021. For companies in the PECAN pathway, these changes could significantly reduce the administrative burden and costs of maintaining market access.
Institutional Harmonisation: The European Taskforce for DMDs
One of the most significant second-order effects of the French and German fast-track programs has been the creation of the European Taskforce for Harmonised Evaluation of Digital Medical Devices (DMDs). Launched in 2022 by the French Digital Health Delegation (DNS), the task force aims to provide a European-level blueprint for DMD assessment procedures.
By 2026, the task force has worked on three primary "work packages":
Harmonised Taxonomy: Defining different types of DMDs based on their application scope and risk level.
Clinical Evidence Standards: Reaching consensus on the quantity, quality, and type of evidence needed for assessing DMDs
Socio-Economic Framework: Developing evaluation criteria that include value elements beyond clinical outcomes, such as operational efficiency, personalised care, and patient empowerment.
This movement toward a unified European evaluation framework is viewed as essential for the "Technological Sovereignty" of the EU. Without common criteria, European startups face local fragmentation that prevents them from scaling cross-border, leaving them vulnerable to U.S. and Asian competitors. The task force's goal is to ensure that a favourable HTA in one member state can be recognised or easily adapted in another, effectively creating a "Single Market for Digital Health".
Conclusion: The Structural Legacy of PECAN
Three years on, the French PECAN model has transitioned from a novel experiment to a foundational element of the European healthcare technology architecture. Its impact is characterised by a "Great Rationalisation" of the HealthTech sector, where the exuberance of early-stage software development has been replaced by the discipline of clinical-grade data and operational AI.
While the actual number of successfully reimbursed solutions in France has not yet met the ambitious targets of the 2023 roadmap, the mechanism itself has successfully shifted the focus of the entire ecosystem. Startups are no longer "logo hunting" for pilots; they are engineering for durable adoption and permanent reimbursement. The "Compliance Moat" has become the defining feature of successful ventures, and the convergence of national fast-tracks with the EHDS and the simplified MDR promises a more predictable, if more rigorous, future for European innovation.
For the broader European market, the PECAN experiment confirms that "fast-track" is a misnomer, it is a "structured track". Success in this environment requires a longitudinal evidence strategy that begins years before the first application is filed. As Europe enters the second half of 2026, the question is no longer whether digital health can deliver value, but which companies possess the clinical and operational durability to prove it under the most exacting regulatory standards in the world.
Nelson Advisors > European MedTech and HealthTech Investment Banking
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