Digital therapeutics – or digital therapies – are not mere tele-monitoring initiatives, nor simple applications concerning health: they are actual curative interventions, capable of affecting the clinical outcomes, exactly like a pharmacological treatment.
While a drug interacts with the patient’s biology, digital therapies interact with the thoughts and behaviours of the users. The treatment with digital therapies is based on changes in behaviour or lifestyle, as well as on the application of cognitive-behavioral interventions through the implementation of digital guidelines and programs.
As their pharmacological counterparts, digital therapies – which are considered to all intents and purposes like a medical device – also require a basis of scientific evidence, and they should be tested through clinical studies, approved by regulatory authorities, and followed by post-marketing studies.
Furthermore, in the same way as the traditional ones, digital therapies are also composed of an active ingredient and a series of excipients: the active ingredient is the therapeutic algorithm; the excipients – which are also digital – are all the services integrated into the platform, such as reminders and motivational messages.