What started in Germany at the end of 2019 is now also being adopted by neighboring France: The “app on prescription,” the Digital Health Application (DiGA) is becoming an export hit – including a French equivalent to the Fast Track procedure. This provides a uniform framework for new and existing providers to be reimbursed by French health insurers for digital medical devices with direct patient benefit. We summarize for you what France requires and how to bring a DiGA to the new market. Recommendations for the approval and implementation of a DiGA in Germany can be found in this blog article.
Overview
- Background
- DMD and PECAN – at a glance
- Regulatory framework
- Actors
- Register and framework
- Procedure
- Conclusion – the DMD framework as DiGA with additions
Background
Since 2019, Germany has had a uniform framework for the commonly referred to “app on prescription” in the form of the “Digital Health Application” (DiGA). In neighboring France, clear regulations for the reimbursement of such applications are still lacking.
Of course, it was already possible to have software approved as a medical device along European regulatory lines in France. However, a framework for the reimbursability of digital applications comparable to Germany’s and a uniform process on the way there did not exist until now.
Now France – following Germany and a few other European countries – is also taking the path of creating uniform procedures for the recognition and reimbursement of digital health applications. In the future, software medical devices may be reimbursed by health insurers under certain conditions. Along the way, France is taking its cue from the German fast-track process.
DMD and PECAN – at a glance
On March 31, 2023, the French Ministry of Health published a new regulatory framework for the approval process for digital health applications reimbursable by French health insurers. In Germany, such applications are referred to as DiGA for short, while official bodies in France use the analogous term Digital Medical Device, or DMD for short.
A central part of the new regulation is the introduction of a fast-track procedure, which has recognizable analogies to the German “DiGA Fast Track”, and is called “PECAN“. It allows early reimbursement by health insurers for one year already without conclusive clinical evidence on the effects of the application (apart from the mandatory clinical evaluation according to MDR). At the same time, France is opening up the market to Germany for digital medical devices in risk classes IIb and III, while in this country the limit is IIa (note: DiGAs in risk class IIb are soon to be approvable in Germany under the MDR).
This makes France an interesting market in two respects: on the one hand as an export market for DiGA already listed in Germany, and on the other hand as a market for digital medical devices that would not be certifiable in Germany due to their risk class.
Regulatory framework
Basically, similar to Germany, not every medical device is a DMD, but every DMD is a medical device. Basically, similar to Germany, not every medical device is a DMD, but every DMD is a medical device.
In principle, approval as a Digital Medical Device (DMD) in France requires the presence of a European CE certification, which refers to the Medical Device Regulation (MDR). For more information, see our blog article on MDR approval & certification.
Innovative clinical or organizational benefit
The central requirement for recognition is an innovative component either in terms of clinical benefit for the patient or in terms of organizational improvements for the healthcare system.
Interoperability
Equally comparable to the German requirements is the obligation to meet the interoperability and safety standards that the French government lists here. Among other things, this places demands on the portability of health data, the identification of users and special data protection. A key component is the embedding in the “French National eHealth ID” (INS), which enables uniform identification and management of personal master and health data.
Risk classes
Probably one of the most central differences between the German DiGA and the French DMD regulatory regime is the opening to higher risk classes. Only products in the lower risk classes I to IIa can be listed as German DiGA (as of July 24, 2023), while in France risk classes IIb and III are also included.
Personal data protection and data security
A DMD in France must comply with national and international data protection law. Nationally, the authoritative legal standard is Act 78-17; internationally, it is the European data protection standard DSGVO. In addition, it is mandatory that all providers hosting personal health data – i.e., in the case of a DMD, the corresponding cloud service provider – have undergone “Hébergeurs de Données de Santé (HDS)” certification; Microsoft offers this, for example.
Proof of actual usage
It also calls for using an individual activation code to prove that the prescription was actually filled, so that DMD providers receive their reimbursement from French health insurers based on actual usage.
DiGA Fasttrack vs. DMD and PECAN: Differences
The following chart presents the key differences between the DiGA Fast Track and DMD with the PECAN process in France. An important difference here is primarily that DiGA can currently only be medical devices of risk classes I and IIa according to MDR (in future possibly also IIb), while France also allows risk classes IIb and III for DMD in the PECAN process.
Actors
Four main actors, hierarchically subdivided, play a role in DMD approval in France:
• The Ministry of Health and Prevention, as the highest authority, is responsible for setting the general regulatory framework. In addition, it is responsible for the final decision on the approval of a DMD.
• The Agence Nationale de Sécurité du Médicament et des produits de santé is responsible for the final approval of medical devices in France.
• The Agence du Numérique en Santé (ANS) is the executive body on behalf of the Ministry of Health specifically responsible for Digital Health. Fast track DMD testing is the responsibility of the SNE.
• The Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMtS) is responsible for the testing and evaluation of medical devices and applications, including digital health applications. Their assessment is the primary basis for the SNE’s review. The main pillar of their review is the technical specification of the software and an estimate of how large the number of potential users for the respective indication is most likely to be.
Register and framework
Depending on the type of DMD, it is assigned to one of two registers, both of which were newly created with the introduction of the PECAN procedure.
• LATM includes all digital medical devices whose main component is the monitoring of health data. This is a key difference to the German DiGA, which excludes (tele)monitoring and data collection/processing as the primary purpose of the app.
• LPPR is the list of all approved DMDs for therapeutic purposes, comparable to the current German DiGA directory.
The division into two different registers is a central difference to the German model, which has only one central register for all DiGA.
Excursus:
Mon Espace Santé: In addition, as early as 2022, the Republic of France created “Mon Espace Santé”, a one-stop digital shop that allows all citizens to securely manage their health data digitally, and also opens a way to share it with doctors, clinics, practices – but also with listed digital services, which may include DMD providers.
This database includes, among other things, medical history, current health data (such as weight, blood pressure…) and important health documents.
Particularly interesting: A listing in this catalog as an eHealth provider enables, in addition to visibility for patients and the “soft factor” of gaining trust, above all the use of the health data deposited by the patient, provided that the patient has given their consent.
Procedure
The path to reimbursable DMD can be taken in two stages using the fast-track process, but theoretically the direct path to permanent approval is also conceivable.
Das Fast-Track-Verfahren (PECAN) ist der Einstieg in die Anerkennung als DMD, und lehnt sich stark an das deutsche Fast-Track-Modell an. Within only two months, the CNEDiMTS issues a statement on the basis of which the French Ministry of Health decides on “early reimbursement” and its framework conditions – this still without the existence of a study and thus proven clinical evidence (however, at least “initial clinical evidence” seems to be required here as well). The trial period cannot be extended, so full recognition under the regular procedure is required after one year at the latest. By then, therefore, there must be sufficient clinical evidence of the positive effect of the application.
In the first step of the PECAN process, the application is sent to the French Ministry of Health and, as a copy, also to CNEDiMTS. The proof of compliance is obtained by the ANS.
In the second step, the CNEDiMTS provides its assessment of whether and to what extent DMD provides health and/or organizational benefits to the health care system. It is important to note that this is indeed “only” an assessment (albeit a very weighty one). This assessment is also accompanied by the Certificate of Compliance from the ANS, provided that the ANS has determined that the requirements in terms of interoperability and safety have been met.
Based on both assessments or findings, the French Ministry of Health and Social Affairs ultimately makes a decision. If the outcome is positive, the DMD is reimbursable for one year (non-renewable) at a set price. This completes the fast track process.
Regular testing of DMD by CNEDiMTS lasts either six months (for a therapeutic use) or three months (for a monitoring use). The reimbursability established in the case of successful validation then applies permanently.
PECAN as admission on trial
On the application side, there are differences in terms of time requirements and complexity. Permanent reimbursement already requires that scientific evidence (in the form of one or more studies) on the medical and/or organizational benefit to the health care system (cf. “positive health care effect” in Germany) is already available and submitted, whereas the PECAN process replaces this requirement with the assessment of the CNEDiMTS.
The application is thus considerably simplified in the first step, and the processing times are correspondingly greatly reduced – instead of six (for a therapeutic product) or nine (for a telemonitoring product) months, the opinion of CNEDiMTS in the PECAN procedure takes merely two months.
Under the simplified and expedited PECAN process, admission is temporary for one year, which cannot be renewed – while subsequent admission for permanent admission is for several years, and can be renewed.
PECAN should therefore be seen as a bridge to the actual, permanent approval. The PECAN process provides DMD startups with time, financial flexibility, and the opportunity to produce evidence during the “pilot” phase.
Conclusion – the DMD framework as DiGA with additions
France is adopting large parts of the German DiGA concept, including Fast Track, enabling accelerated and simplified market entry for reimbursable digital medical devices (DMDs). The requirements for qualifying a medical device for DMD are largely the same as those for the German market.
Due to the early stage, there are also still some uncertainties (as of July 24, 2023): It is not officially known which exact study forms are required, nor along which guard rails the prices will be set or negotiated; the law remains unclear at this point and refers to ministerial decisions yet to come.
Nevertheless, one thing is already clear: with the introduction of the legal framework for a uniform handling of reimbursable DMD in France a wide field for German providers and providers operating in Germany opens up, who can take their DiGA, already established in this country, to another market with a population of around 67 million – an interesting way to diversify development costs.
In addition, the more liberal handling of risk classes offers yet another opportunity. Digital medical devices, which are currently excluded from the DiGA definition in Germany due to risk classes IIb and III, are being given an opportunity in France. Thus, the new regulation in our neighboring country enables the establishment of products and ultimately business models that are currently unthinkable in this country under DiGA regulation.
This and the general fact that France is recognizably showing great ambition in the further development of the framework for digital health makes it seem worthwhile for DiGA providers or aspirants to look beyond the western German border.
QuickBird Medical is happy to advise and assist you in the implementation of your DMD for the French market.
