From 2 billion in 2019, Juniper Research has estimated the market for digital therapies at 32 billion in 2024. The advent of Digital Therapeutics (DTx) marks a revolution in the medical field, where innovative digital solutions now complement traditional treatments. These 2.0 therapies, based on solid scientific evidence and validated by clinical trials, bring a new dimension to patient care, from chronic diseases to mental disorders. What is the definition of a DTx, what are these tools used for in healthcare and what is the regulation in France? We explore all the uses and regulation of digital therapies before focusing on the unique proposition of Healthy Mind.
What’s behind the term Digital Therapeutics (DTx)?
Definition of digital therapies
The use of digital solutions is nothing new. These tools have been an integral part of the healthcare pathway for several years, simplifying the management for caregivers and the comfort for patients. However, digital therapies are distinct from e-health and digital medicine.
The Digital Therapeutics Alliance offers a definition of DTx that sheds light on its categorisation and acts as a consensus in the sector:
“DTx (or Digital Therapeutics) provide medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage and prevent a wide range of diseases and disorders.”
| E-health | Digital medicine | Digital Therapeutics | |
| Definition |
Technologies, platforms and systems that :
|
Includes evidence-based software and/or hardware products that measure and/or intervene in the service of human health. | Proposes evidence-based therapeutic interventions to prevent, manage or treat a medical condition or disease. |
| Clinical evidence | Not required. | Required. | Required, in addition to expected real-world outcomes. |
| Regulatory oversight | Not required. | Products with medical classification or used in the development of other tools and products require approval. | Requirement for review, validation or certification by regulatory bodies. |
Summary table of the differences between digital health, digital medicine and digital therapy – Source: DTx Alliance
Unlike traditional health applications that often focus on general well-being or data collection, Digital Therapeutics are specifically designed to treat medical conditions. They rely primarily on rigorous scientific evidence and are subjected to clinical trials to demonstrate their efficacy and safety.
These digital therapeutic solutions encompass a variety of tools, which may include :
- interactive software ;
- mobile applications
- online platforms;
- connected devices.
The goals of Digital Therapeutics range from modifying patient behaviour to managing the symptoms of chronic diseases, as well as monitoring and improving medication adherence.
The principles that qualify a product as DTx
Digital therapies provide invaluable, evolving tools for patients, clinicians and all health actors. DTx products thus address a wide range of disorders and pathologies while meeting the following criteria:
- accessible via smartphones, tablets, virtual reality headsets or other devices ;
- personalised medical interventions
- available with and without a prescription;
- reliable and meaningful information on patient engagement and outcomes;
- facilitates access to healthcare.
According to the DTx Alliance, all products that fall under the definition of Digital Therapeutics adhere to these principles:
- Incorporate best practices in design, manufacture and quality.
- Involve end-users in product and process development.
- Implement privacy and patient security protection measures.
- Apply best practices in product deployment, management and maintenance.
- Publish trial results, including clinically significant results, in peer-reviewed journals.
- Be reviewed and approved or certified by regulatory authorities as required to support claims of risk, efficacy and intended use of the product.
- Formulate claims appropriate to clinical evaluation and regulatory status.
- Collect, analyse and apply real-world evidence and/or product performance data.
DTx are responsible for delivering an intervention to the patient through a technological platform, medical device, pharmaceutical product, etc. To verify whether a product meets these requirements, DTx Alliance offers the “Is this a DTx product?” flowchart.
Digital therapies: what for in the care pathway?
DTx fit into the treatment process in a variety of ways, bringing innovative solutions to complex medical issues. Digital therapies shows its full potential in disorders involving behavioural, cognitive, sensory and emotional signals. The most common cases involve :
- the management of chronic illnesses;
- treatment of mental disorders;
- re-education and rehabilitation;
- prevention and well-being.
Digital therapies are proving particularly effective in helping patients manage chronic conditions such as diabetes, hypertension and asthma. For example, applications provide medication reminders, personalised advice on diet and exercise, and even alerts if risky behaviour is detected.
Moreover, digital therapies are increasingly popular for managing conditions such as anxiety, depression and post-traumatic stress. Online cognitive-behavioural therapy programs, supported by healthcare professionals, enable patients to access psychological care flexibly and often at a lower cost.
In the context of post-accident or post-surgery rehabilitation, Digital Therapeutics offer guided exercise programs, remote monitoring by therapists and real-time feedback. This design contributes to the gradual evolution of patients while benefiting from personalised follow-up.
Regulation of digital therapies in France
In France, DTx are assessed by the French National Authority for Health (HAS) and must obtain a CE mark, indicating their compliance with European standards. Products are subject to the medical device evaluation framework drawn up by the French National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). This includes clinical tests demonstrating their efficacy and safety.
Digital Therapeutics often handle sensitive data. French regulation imposes strict data protection standards, in line with the General Data Protection Regulation (RGPD), to ensure the confidentiality and security of patient information.
In addition to this provision, products must comply with the requirements of the Healthcare Data Host (HDS) regarding patient confidentiality and product security.
As part of a digital advance care programme (PECAN), some DTx products with recognised therapeutic value may be reimbursed by the French National Health Insurance. This financial contribution encourages the adoption of these technologies by patients and healthcare professionals.
Healthy Mind: an innovative DTx device
Healthy Mind’s therapeutic virtual reality solution was designed in close collaboration with doctors and neuroscience experts. With a 4K, wireless, off-network headset that can be deployed in 2 minutes, along with a specific medical application, the device can be integrated quickly and easily into the medical workflow.
Proven by clinical studies, our immersions draw on the brain’s cognitive abilities to modulate pain and anxiety responses through distraction techniques.
Protected by a patent from the French National Institute of Intellectual Property, our unique system of immersion therapy in a virtual environment and its control process are classified as a medical device (CE class 1). At the heart of our development, we are actively contributing to clinical research on therapeutic virtual reality.
More than 300 healthcare establishments in a dozen countries use the Healthy Mind tool daily in one of its many applications. As a digital therapy, our virtual reality headsets provide proven relief from anxiety and pain.
Digital Therapeutics (DTx) are based on concrete evidence to offer solutions that are as innovative as they are effective in the healthcare field. The use of digital therapies in the care pathway, supported by rigorous regulation, promises a close collaboration between technology and medicine to improve patients’ quality of life. In this perspective, Healthy Mind’s therapeutic virtual reality offers a high-performance DTx product to reduce pain and anxiety. To witness the benefits and advantages of such a device, don’t hesitate to request a demonstration.
