Q&A: REGULATION AND REIMBURSEMENT OF DIGITAL THERAPEUTICS (DTX) / France
- BioLawEurope
- Oct 13
- 12 min read
To enable a consistent comparison of the legal frameworks surrounding digital therapeutics (DTx) across different jurisdictions, we have developed this Q&A template. It serves as the basis for a blog series on the BLE website that explores how various countries regulate, clas- sify, and reimburse digital health applications. By answering the following questions, you con- tribute to an international understanding of how DTx are integrated into national healthcare systems. We appreciate your time and expertise in supporting this cross-border digital health initiative.
A. Contributor Information
Name: Ombeline Degrèze-Péchade
Law Firm / Organization: Schertenleib
City / Country: Paris, France
Email: odp@schertenleib-avocats.com
B. Introduction – Status and Definition of DTx
1. Does your country have any uniform or established regulations for digital therapeutics (DTx) which provides for a legal definition of DTx? If not, are there any soft law instruments, guidance documents, or working definitions used by authorities or HTA bodies?
However, two legal provisions apply to medical devices: EU Regulation n° 2017/745 and Article L. 5211-1 and following of the French Code of Public Health (“CPH”).
According to Article 2 of EU Regulation n° 2017/745 and Article L. 5211-1 II of the CPH, a medical device is defined as:
“(…) any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, (…)”
More in particular, article 2 of Annex VIII of the same Regulation gives a layered definition of medical devices, depending on their nature and purpose:
“(..)
2.2. ‘Surgically invasive device’ means:
(a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
(b) a device which produces penetration other than through a body orifice. (…)
2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.
2.5. ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. (…)”
Medical decision-support software may fall under both the Medical Devices Regulation (2017/745) and the AI Regulation (2024/1689). The qualifications are cumulative when the relevant conditions are met (Desmoulin, RDSS 2024, p.787).
C. Legal Classification of DTx in your Country
2. Under which legal framework do DTx fall in your country (e.g., medical devices, pharmaceuticals, others)?
In France, DTx fall under the legal framework applicable to medical devices.
When devices pursue a medical purpose, they are considered as medical devices, in accordance with the provisions:
of EU Regulation n°2017/745 on medical devices, particularly regarding certification and CE marking, and
of the French Public Health Code (article L.5211-1 and following).
Thus, in France, DTx are considered medical devices, with all the regulatory obligations that follow.
DTx incorporating AI are subject to the data governance requirements laid down by the AI Regulation (regulation 2024/1689), in addition to the medical device framework (Regulation 2017/745). The AI Regulation classifies certain medical devices incorporating AI as high-risk AI systems, insofar as they are subject to third-party conformity assessment, which increases the obligations of DTx manufacturers (AI Act, Art. 6). In practice, DTx may be simultaneously classified as medical devices and high-risk AI systems, which results in a cumulative set of requirements (CE marking, clinical evaluation, but also transparency, data governance, and human oversight) (RDSS).
3. What criteria determine whether a DTx is classified as a medical device or as a well-ness/lifestyle/other product?
In order to determine whether a DTx is a medical device, the dispositions of EU Regulation n° 2017/745 and of the French CPH must be applied, as detailed above.
If the product does not meet these criteria and has no medical purpose, it is considered a wellness or lifestyle product and thus falls outside the strict regulatory framework for medical devices.
If a device is considered as a medical device, EU Regulation n° 2017/745 requires the risk class of a medical device to be determined.
Medical devices are classified into four categories — Class I (lowest risk class), IIa (potential risk), IIb (high/major potential risk), and III (highest risk class) — depending on their level of risk. The criteria for determining a device’s class are set out in Annex VIII of the EU Regulation and take into account, among other factors, the duration of use, whether the device is invasive and the type of invasiveness, the possibility of re-use, the therapeutic or diagnostic purpose, and the part of the body concerned.
4. What are the regulatory requirements for market access (e.g., conformity assessment, CE marking, national registration)?
The main regulatory requirements for placing medical devices on the market are the following:
The product must fall within the definition of a medical device (Article 2 of EU Regulation n° 2017/745).
The device must be classified in accordance with the established rules (Article 51 and Annex VIII of EU Regulation n° 2017/745).
It must bear the CE marking (Article 52 of EU Regulation n° 2017/745 and article R.5211-12 of the CPH).
It must be identified by a Unique Device Identifier (UDI) (Annex VI, Part C, Article 27 of EU Regulation n° 2017/745).
A clinical evaluation must be carried out (Article 61 and Annex XIV of EU Regulation n° 2017/745 and article L.5211-3 of the CPH).
For class III devices, a Summary of Safety and Clinical Performance (SSCP) is required (Article 32 of EU Regulation n° 2017/745).
Manufacturers, authorised representatives, and importers are required to register devices in the European Eudamed database (Article 29 of EU Regulation n° 2017/745).
Finally, the ANSM (French National Agency for Medicines and Health Products Safety) monitors the market and may carry out inspections of medical devices (Article 94 of EU Regulation n° 2017/745 and article L.5211-2 of the CPH).
While CE marking allows a device to be placed on the market, effective market access in France also requires compliance with national rules on reimbursement and pricing, set out in the French Code of the Social Security (“CSS”):
Listing and timing: inclusion on the Liste des Produits et Prestations Remboursables (LPPR) under Article L.165-1 CSS, with tariff fixation within 180 days (Article R.165-8 CSS).
Evaluation: the French National Authority for Health (HAS), through its CNEDiMTS committee, issues an opinion within 45 days (Article R.165-75 CSS), assessing both the “Service Attendu” (SA) and the “Amélioration du Service Attendu” (ASA).
Pricing: the Economic Committee for Health Products (CEPS) determines the reimbursement tariff/price, which may be modulated depending on use, while ensuring no increase in the insured person’s financial burden (Article L.165-3 CSS).
Early access mechanisms: several derogatory pathways allow temporary coverage prior to definitive LPPR listing, such as PECAN, PEC-T or forfait innovation.
Thus, in practice, market access for medical devices, including digital therapeutics (DTx), is a two-step process: regulatory conformity and CE marking under the MDR, and national evaluation and pricing under the CSS to secure reimbursement and widespread patient access.
5. Are there specific cybersecurity, interoperability, or data protection requirements that apply to DTx?
DTx generally involve the processing of personal data, which subjects them to EU Regulation n° 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data (GDPR).
Furthermore, as specified in articles L.1470-1 and L.1470-5 of the CPH, the health professional must comply with the principles of interoperability and security framework issued by the Digital Health Agency (Agence du Numérique en Santé – ANS), allowing the exchange, sharing, security and confidentiality of personal health data.
These principles notably include the protection of patient’s data following their identification to obtain a web appointment with a doctor, as well as the protection of data used by the health care professionals in “Pro Santé Connect” and the data that can be contained in a Medical Shared File, which has the objective to improve the coordination of health services for a patient.
In addition, the Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 may also apply to DTx in specific circumstances. While it does not create a regime dedicated to digital therapeutics, it covers them indirectly:
when a DTx qualifies as an “Electronic Health Record (EHR) system” and must integrate harmonised interoperability and logging modules with a CE “EEDS” mark,
when a DTx claims interoperability with EHR systems, in which case it must comply with EU common specifications,
when a DTx generates or holds health data that can be reused for secondary purposes (research, public health, innovation), making the manufacturer subject to the obligations applicable to data order.
This layered framework ensures not only cybersecurity and data protection, but also interoperability and controlled reuse of health data; importantly, it also expressly protects the confidentiality of manufacturers’ proprietary information, since Article 35(5) of Regulation 2025/327 prohibits that data access requests or interoperability obligations result in the disclosure of trade secrets or other sensitive business information protected under Directive (EU) 2016/943.
Finally, the AI Regulation (Regulation (EU) 2024/1689) imposes additional obligations on DTx incorporating AI, particularly when they qualify as high-risk AI systems. These include requirements of transparency, automatic logging of processing steps (Article 12), data quality (Article 10), and human oversight (Article 14). Such requirements complement those already set out under the Medical Devices Regulation (EU) 2017/745, thereby creating a cumulative compliance framework for DTx manufacturers.
6. Is there a specific regulatory pathway or fast-track available for digital health products or DTx (e.g., expedited review, sandbox programs)?
Yes. France has implemented several mechanisms to accelerate market access by providing reimbursement for innovative digital medical devices:
PECAN (Prise En Charge Anticipée Numérique i.e.: Early Access to Reimbursement for Digital Devices) (article L.162-1-23 of the French Code of Social Security);
PEC-T (Transitional Early Coverage) (article L.165-1-5 of the French Code of Social Security);
Innovation Package (article L.165-1-1 of the French Code of Social Security).
7. How is the legal distinction between DTx and other digital health applications handled (if any) in your jurisdiction?
Under the EU Regulation n° 2017/745, there is a legal distinction between DTx and other digital health applications, which is based on the medical purpose of the software, as specified by the ANSM.
DTx are considered medical devices when they have a medical purpose and generate individual medical information by processing data. They are thus subject to the regulations applicable to medical devices.
In contrast, other health applications without a medical purpose (such as wellness, sports, administrative management, etc.) are not considered medical devices and do not fall within the scope of this regulation.
D. Reimbursement According to your Jurisdiction
8. Is there a legal basis for the reimbursement of DTx in your healthcare system?
Yes. First of all, a “general law” reimbursement scheme is provided in the French Code of Social Security.
This scheme involves registration on one of the following lists: the list of Reimbursable Products and Services (LPPR) for devices used in the diagnosis and treatment of disease and injuries (article L.165-1 of the French Code of Social Security), and the List of Telemonitoring Medical Activities (LATM) for remote controlling devices (article L.162-52 of the French Code of Social Security). Inclusion on these lists allows the product or service to be reimbursed directly by the Health Insurance Fund.
9. Under what conditions can DTx be eligible for reimbursement (e.g., prescription require- ment, evidence of efficacy, medical benefit)?
Under the “general law”, to be eligible for reimbursement in France, a medical device must meet several criteria:
the device must have obtained CE marking in accordance with EU Regulation n° 2017/745;
it must undergo a medico-technical assessment by the CNEDiMTS (Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé) to demonstrate its clinical benefit (Article R.165-2 of the French Code of Social Security) and, where applicable, its level of improvement in expected service (the Amélioration du Service Attendu - ASA) compared to existing alternatives (Article R.165-11 of the French Code of Social Security);
if necessary, it must also undergo a health economic evaluation by the CEESP (Commission for Economic Evaluation and Public Health), when a significant level of ASA (levels I to III) is claimed and the device is likely to have a significant impact on National Health Insurance expenditures (Décret n° 2012-1116 du 2 octobre 2012).
10. How is reimbursement of DTx practically carried out – through catalogs, individual agreements, or direct claims to insurers?
Once a medical device has met all regulatory requirements (CE marking) and demonstrated its clinical efficacy, it may benefit from the general reimbursement scheme provided under French law by being listed on the the list of Reimbursable Products and Services (LPPR) (Article L. 165-1 of the French Social Security Code). The price is then set by agreement between the Economic Committee for Health Products (Comité économique des Produits de santé – CEPS) and the companies (Article L. 165-2 of the French Social Security Code).
For therapeutic digital medical devices, manufacturers have six months starting from the granting of the PECAN (see below) to apply for registration on the list of Reimbursable Products and Services and qualify for a reimbursement. Prices are negotiated with the Economic Committee for Health Products (Comité économique des Produits de santé – CEPS), as indicated by article L.165-1-5, IV of French Code of Social Security.
For remote monitoring activity, manufacturers have nine months to apply for registration on the List of Telemonitoring Medical Activities as a generic or brand name. Reimbursement levels have been set by the Ministry of Health and Social Security.
11. What role do health technology assessment (HTA) bodies or evidence evaluation procedures play in this process?
In France, in accordance with Decree No. 2023-232 of 30 March 2023 and Articles L.165-1, L.165-1-5, L.165-11, R.165-1 et seq. of the French Code of Social Security, the CNEDiMTS (Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé), within the Health Authority (Haute Autorité de Santé – HAS), plays a central role in the assessment of digital medical devices, with a view to their reimbursement and appropriate use within the healthcare system.
Its missions include:
Issuing opinions and recommendations: It prepares reports and formal opinions that inform public authorities (such as the Ministry of Health or the National Health Insurance) in decisions concerning reimbursement, price setting, and conditions of use.
Periodic reassessment: It also conducts regular reassessments of technologies already listed for reimbursement, in order to ensure their continued relevance and economic efficiency over time.
The CNEDiMTS (Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé) issues its opinion within 60 days after receiving a dossier.
12. What limitations or uncertainties currently exist regarding the reimbursement of DTx in your country (e.g., missing lists, lack of contracts, definitional issues)?
Limitations mainly consist in a limited number of DTx currently reimbursed.
13. Is temporary or conditional reimbursement (e.g., while real-world evidence is collected) possible in your jurisdiction?
The derogatory framework temporarily funds and facilitates market access for innovative devices that are still under development or clinical evaluation. The derogatory framework system notably includes
PECAN (Prise En Charge Anticipée Numérique i.e. : Early Access to Reimbursement for Digital Devices);
PEC-T (Transitional Early Coverage) ;
Innovation Package.
“Innovation Package”, as provided by article L.165-1-1 of the French Code of Social Security, is a temporary funding mechanism conditional on the completion of a clinical trial. It aims to finance clinical trials for digital medical devices in the early development phase.
PEC-T, as provided by article L.165-1-5 of the French Code of Social Security, is intended for digital medical devices that have progressed through the clinical process and are about to be marketed, offering a gateway to the final list of Reimbursable Products and Services (LPPR).
These mechanisms provide temporary funding prior to the inclusion of said digital medical devices on reimbursement lists, thus supporting breakthrough innovations and the continuation of clinical trials.
The most detailed system, containing the greater number of conditions, is the PECAN system.
PECAN (article L.162-1-23 of the French Code of Social Security) applies exclusively to digital medical devices for the diagnosis and treatment of disease and digital medical devices and services for remote monitoring.
PECAN allows a one-year (non-renewable) reimbursement period prior to registration on a reimbursement list. This early reimbursement supports the final demonstration of clinical or organisational benefits.
To be eligible for PECAN, digital devices must meet four criteria assessed by the Health Authority (Haute Autorité de Santé – HAS) and the Digital Health Agency (Agence du Numérique en Santé – ANS) as detailed in article L.162-1-23 of the French Code of Social Security:
the device must be deemed innovative (and thus provide clinical or organizational benefit, such as giving an impact on the quality of life of the patient, impact on morbidity and mortality),
the device must have obtained CE marking,
the device must have initiated clinical trials,
and meet the safety and interoperability standards set by the Digital Health Agency (Agence du Numérique en Santé – ANS).
The reimbursement of these digital medical devices varies.
For therapeutic digital medical devices, the initial flat-rate reimbursement is €435/month incl. tax for one quarter, then €38.3/month/patient incl. tax, up to a maximum of €780/patient incl. tax for one year, as established by Order of 22 April 2024.
For digital medical devices and services for remote monitoring, the flat reimbursement values depend on several criteria: the number of patients treated, and the organizational or clinical benefit (impact on quality of life, morbidity, mortality) expected from this type of medical device as established by legislative decree of 16 May 2023.
To benefit from the PECAN coverage, manufacturers are required to apply for inclusion on a reimbursement list as provided by French general law, and to guarantee continuous treatment or medical follow-up with the patients.
The granting of PECAN is summarized here below:
Manufacturers who fail to meet these obligations can be considered liable and might incur financial penalties.
The different derogatory systems can be summarized as follows:
| Innovation Package (L.165-1-1 of the French Code of Social Security) | PECAN (L.162-1-23 of the French Code of Social Security) | PEC-T (L.165-1-5 of the French Code of Social Security) |
Eligibility | Digital medical devices under development deemed innovative | Digital medical devices or remote monitoring activities deemed innovative | Medical devices deemed innovative and that can be registered on the LPPR |
Duration | Duration of the study | 1 year (non-renewable) | 1 year (non-renewable) |
Benefits |
| Early availability to patients
| Early availability to patients
|
E. Practical barriers
14. Have manufacturers of DTx in your country faced specific practical barriers (e.g., delays in evaluations, inconsistent insurer decisions, lack of digital infrastructure)?
Yes. Manufacturers of DTx in France continue to face significant practical barriers, as the administrative burden, the complexity of procedures, and the multiplicity of verification steps still weigh heavily on market access.
However, the situation is gradually improving. An increasing number of digital medical devices are now certified as compliant with the interoperability and security framework of the Agence du Numérique en Santé and, more importantly, more and more of them are reaching reimbursement. While only a handful of solutions such as Axomove, Cureety, Résilience and Continuum+ were reimbursed initially, the number of reimbursed devices is steadily expanding, reflecting a positive trend even though reimbursement remains the main bottleneck.
F. Perspectives – Future Outlook
15. Are there any ongoing initiatives or legislative efforts in your country to further develop or reform the legal and reimbursement framework for DTx?
Currently, there is no legislative reform underway regarding the reimbursement of DTx. However, the EU Regulation n° 2021/ 2282 on Health Technology Assessment (ETS), which is being progressively implemented (until 2028), requires:
harmonisation of the clinical data to be provided at the European level,
greater transparency through the publication of joint assessment reports.
As a result, even though the HTA Regulation does not directly determine reimbursement decisions in France, the evaluations of DTx by the Health Authority (Haute Autorité de Santé – HAS) will have to take into account the conclusions of the European joint clinical assessments. This could change the evaluations issued by the HAS and thus have an impact on the reimbursement of DTx.
16. Do these efforts include stakeholder consultations or pilot programs that manufacturers can engage with?
We assume that there is collaboration between manufacturers, healthcare professionals, and regulatory authorities. The CNEDiMTS (Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé) calls on external experts when issuing opinions on DTx, but there are no specific guidelines on this matter.
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