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A video-game as digital therapeutic

August 26 2020

In our series of blogs about AI in healthcare we discuss the innovation opportunities and challenges of AI in both the pre- and clinical setting. Recently, the first video game-based therapeutic has received regulatory authorization. We also see numerous peer-reviewed studies showing improved outcomes using AI as therapeutics for a broad range of indications. Digital therapeutics can be added to the growing list of algorithm-based applications in healthcare. In this blog we discuss what digital therapeutics is, how it is regulated and how we think it will impact our society.

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.

Do digital therapeutics require clinical validation?

Yes, they do. Digital therapeutics are evidence-based, clinically validated therapeutic interventions for patients, driven by advanced technology and high-quality software programs to prevent, manage or treat a medical disorder or disease. Furthermore, during development of digital therapeutics, it is key that safety and efficacy protocols are followed in randomized clinical trials. It is also required to protect patient privacy and security and publish clinical outcomes in peer-reviewed journals. It is typically harder to receive permission for a clinical claim when more AI and machine learning is involved.

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.)

What are the limitations of digital therapeutics?

As with traditional drugs and therapies, adhering to guidelines, and demonstrating accuracy, reliability and validity by scientific research is a big hurdle to take. An extra complication for digital therapeutics is that the research itself is had to conduct. In a computerized setting, using double-blind placebo-control is not always feasible. Also, the adoption of healthcare providers and patients to these therapeutics may not be self-evident. Another difficulty lies in the accountability; who is ultimately responsible for the therapy?

At ttopstart we believe that AI in healthcare will impact on the lives of everyone. Our advisors can assist developing the right strategy to overcome the hurdles that come with building AI solutions in healthcare. 

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