What are digital therapeutics?
Digital therapeutics is a new concept in healthcare in which digital technologies change patient’s behaviour and treat medical conditions. Whereas ‘digital therapeutics’ are often wrongly described as a digitized version of traditional therapeutics (which we would rather like to call ‘digital health’ or ‘digital medicine’), the revolutionary idea of digital therapeutics is that the digital technology by itself can impact a mechanism of action of disease. It thereby classifies as digital drug replacement and the highest clinical claim. Digital therapeutics can monitor and predict an individual’s symptoms in an adaptive and clinical feedback loop via digital biomarkers. As such, digital therapeutics can provide patient-tailored therapy, also known as ‘precision medicine’ that is adjusted to a patient’s individual need.
A video-game to treat ADHD
An interesting example of a recently approved digital therapeutic is a game for children with ADHD. EndeavorRx, developed by Alkili Interactive, received De Novo* Marketing authorization for its video-game digital therapeutic. The software treatment is indicated by the FDA to improve the symptoms of ADHD in children aged 8 to 12. In the game, the users must navigate an alien avatar through a course while they respond to on-screen prompts. The user’s behaviour is monitored by the app by tracking movements, upon which the player rapidly adapts. The video game showed to improve attention in patients that played the game 5 times a week for 30 mins for one month. A major advantage of this therapy is that the drug-adherence to traditional medication is very low in this group (both due to concerns of parents as well as reluctancy patients) and that no serious adverse events were reported. Whereas EndavorRx’s technology uses adaptive algorithms, it is not fully relying on AI. Introducing more AI features into the game may further improve its personalisation, but with the current approval standards this it is very challenging for its developers to introduce them as such. (*Novel devices of low to moderate risk that do not have a valid predicate device.)
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