Digital Therapeutics (DTx)


Digital Therapeutics (DTx) are evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease. In other words, DTx are patient-facing software applications that help patients treat, prevent, or manage a disease and that have a proven clinical benefit. For example, Digital Therapeutics can support patients in self-managing symptoms and thereby improve their quality of life and other clinical endpoints. DTx uses digital implements like mobile devices, apps, sensors, virtual reality, the Internet of Things, and other tools to spur behavioural changes in patients. DTx development can have a positive impact on providing well customised health services as their design is tailored to fit patient’s needs. Considered one of the most innovative areas within digital health, DTx ecosystem has experienced an accelerated period of progress over the past two years.  

DTx can be used as a standalone therapy or in conjunction with more conventional treatments like pharmacological or in-person therapy or also with certain hardware or other sensory or mechanic devices. The treatment depends on the collection and processing of digital measurements. Because of the digital nature of the methodology, data can be collected and analysed as both a progress report and a preventative measure. Currently, treatments are being developed for the prevention and management of a wide variety of diseases and conditions, such as type II diabetes, congestive heart failure, Alzheimer's disease, anxiety, depression, and several others. 

At the European level, the Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. No specific legal regulation exists on DTx while the European Medicines Agency and the European Commission are starting exploring these solutions. On national level, the new German Digital Healthcare Act (DiGA) regulates specific requirements for the use of DTx. A list of requirements defines which features any DTx application must have. Important factors such as quality, security and data protection must be proven with scientific evaluation. France is moving forward to implement a similar legal act like Germany. In the USA, the Food and Drug Administration has an active pre-certification program in place since 2017 on DTx.

Positive foreseen impacts on data protection:

  • No positive impacts upon data protection have been identified for the moment: taking into consideration the current design of this technology developed in the market, there are no specific positive outcomes toward data protection. The situation may change in the case of a different design and configuration of the technology embedding privacy enhancing features.

Negative foreseen impacts on data protection:

  • Constant observation and profiling of the patient: a vast amount of personal data is collected directly from the patient and processed in a complex digital ecosystem. In most cases, accurate health and/or behavioural profile of the person are created for the functioning of the solution. This practice might entail risks of being constantly observed or the possibility of repurposing patients’ profiles.
  • High impact of personal data breaches: as the particular sensitivity and amount of personal data processed within DTx applications, a potential data breach can be a major threat against for the person concerned.
  • Complexity might generate security flaws: the fact that the processing is done via numerous OSs and application providers might create risks on unlawful access across devices and providers due to possible security flaws.


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Tech Champion: Dina Kampouraki