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 have a proven clinical benefit. For example, Digital Therapeutics can support patients with the self-management of their symptoms, and thereby improve their quality of life and other clinical endpoints. DTx uses digital implements, like mobile devices, apps, sensors, 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. Considered one of the most innovative areas within digital health, DTx ecosystem has experienced an accelerated period of progress over the last two years.  

DTx can be used as a standalone therapy or in conjunction with more conventional treatments like pharmacological or in-person therapy, and 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 European level, the European Medicines Agency and the European Commission are starting to explore these solutions. At national level, the new German Digital Healthcare Act regulates specific requirements for the use of DTx. In the USA, the Food and Drug Administration has an active pre-certification program on DTx in place since 2017. 

Positive foreseen impacts on data protection:

  • No positive impacts on data protection have been identified for the moment: taking into consideration the current design of this technology, there are no specific positive outcomes in relation to 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: given the particularly sensitive nature and amount of personal data processed within DTx applications, a potential data breach can be a major threat 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 of unlawful access across devices and providers due to possible security flaws.


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Tech Champion: Dina Kampouraki