DTx (digital therapeutics): definition, regulation in France and uses

Software that treats. DTx, short for digital therapeutics, refers to health software designed to treat or alleviate a disease, disorder or condition by delivering an intervention with a demonstrated positive impact on health. This is the definition used by the Digital Therapeutics Alliance, the sector's professional organization[1].

In French, you will encounter several equivalent terms: thérapie numérique, thérapie digitale or, in regulatory terminology, dispositif médical numérique à visée thérapeutique[5]. The wording changes, but the requirement remains the same: the software does more than inform or monitor; it treats.

However, the definition is not yet settled. According to an analysis published in npj Digital Medicine, the use of DTx remains ambiguous in practice because of a lack of international consensus on their definition, as well as regulatory frameworks that still vary from country to country[6].

Their form also varies. A DTx can take the form of a mobile app, web software, a virtual reality program or a video game, and can be used on its own or alongside conventional treatment[4].

This is the most common source of confusion. Not all health-related apps are digital therapeutics: DTx are only a subset of digital health technologies, defined by their therapeutic purpose and supporting evidence[1].

When a tool is presented to you as therapeutic, one criterion is often enough to decide: does the software claim to provide treatment, and has it proven that it does? If the answer is no, it is not a DTx.

Digital therapeutics mainly target situations in which treatment involves exercises, habits or repeated learning.

Mental health, addictions and chronic diseases

Mental health is a natural field of application. HAS cites cognitive behavioral therapy apps as an example of digital medical devices for therapeutic purposes[5]. Anxiety and depressive disorders, addictions and insomnia lend themselves well to structured programs that patients follow between consultations.

Chronic diseases follow the same logic. Diabetes, chronic pain and rehabilitation rely heavily on establishing behaviors over time. The software guides, measures and adjusts. The uses of medical virtual reality for pain, phobias and rehabilitation reflect this same approach to guided training.

Virtual reality among digital therapeutics

Virtual reality is one of the forms a DTx can take, alongside mobile apps and video games[4]. However, one distinction matters for your practice.

A DTx delivers the intervention itself and must demonstrate its effect as a medical device. Other virtual reality solutions work differently: they are tools used by the practitioner, who leads the session and adjusts the exposure. C2Care follows this second approach. The practitioner selects immersive, realistic and controlled environments and controls them in real time to retain control over the course of the session. Virtual reality exposure therapies thus allow the professional to guide every stage of the session.

In France, the term DTx has no legal status of its own. The term used is digital medical device (DMN) for therapeutic purposes, with two reimbursement pathways that you will encounter in product information sheets.

The standard pathway: LPPR listing

A CE-marked therapeutic DMN can be assessed by HAS's specialist committee, CNEDiMTS, for inclusion in the liste des produits et prestations remboursables (LPPR). In September 2025, HAS clarified its assessment principles[5]. It emphasizes the quality of ongoing studies and clinical benefit. It also notes that the impact on the organization of care, often claimed by manufacturers, remains poorly documented.

PECAN early reimbursement

The second pathway is an exceptional arrangement. Established by the Social Security Financing Act for 2022 and detailed in a decree of March 31, 2023, early reimbursement for digital medical devices (PECAN) provides reimbursement for a non-renewable period of 12 months[2]. It is intended for DMN presumed to be innovative, whether through their clinical benefit or the improvements they bring to the organization of care. The device must be CE-marked and comply with the interoperability and security standards of the Agence du numérique en santé. The manufacturer of a therapeutic DMN must then submit an application for standard reimbursement within 6 months[2].

Good to know: PECAN is not a certification of efficacy. HAS describes it as a bet on a technology while awaiting additional data[5]. It is temporary reimbursement that gives the manufacturer time to provide evidence.

Germany has taken the lead, and its experience gives you an idea of what lies ahead for France. Its 2019 digital healthcare law created DiGAs, health applications that doctors can prescribe and that health insurance reimburses. An analysis published in the Journal of Medical Internet Research provides a quantitative overview: as of July 1, 2024, 56 applications were listed, including 35 permanently and 21 provisionally[3].

Provisional listing allows one year to demonstrate the application's effect. In practice, most DiGAs exceed this period before obtaining permanent listing, reflecting the effort required to demonstrate clinical effectiveness[3]. Prices, meanwhile, fall substantially after negotiation.

France and Germany also signed an agreement on digital medical devices in June 2025, according to HAS[5].

There is no universal answer. Effectiveness must be demonstrated for each product, and this is itself a condition of DTx status.

Research is active: more than 300 clinical trials are underway worldwide[4]. But the German experience shows that gathering this evidence takes time, as most applications exceed the allotted year[3]. The authors in npj Digital Medicine call for stronger validation through real-world data, beyond trials alone[6].

Before recommending a DTx to a patient, four questions can help you assess it:

• Study: is there a published controlled trial, and which patients did it involve?
• Comparator: has the software been compared with a standard treatment or only with no treatment?
• Status: is the software CE-marked as a medical device, and for which indication?
• Coverage: is it listed on the LPPR or covered through early access reimbursement?

The first barrier is conceptual. As long as the definition varies across countries and stakeholders, professionals and patients struggle to distinguish a DTx from a simple application[6]. Next comes patient engagement: software only works if it is used over time, and the authors in npj Digital Medicine identify this as a technological and regulatory challenge in its own right[6].

Evidence itself slows adoption. It takes time to gather, as the German case shows[3], and its impact on the organization of care remains poorly documented according to HAS[5]. Then there is integration into your care pathway: who prescribes it, who supports the patient, and how the software fits with existing follow-up. These questions also arise for artificial intelligence tools in mental health, which raise the same issues of evidence and integration into care.

A DTx is defined by evidence and status, not by technology. In France, PECAN opens the door to reimbursement, provided evidence is demonstrated within a short timeframe. For you as a practitioner, the useful question remains the same for every digital tool: what evidence, for which patient, and with what support?