Digital Therapeutics: Reflections on going beyond the pill and the limitations of current practices

By Teresa Murray, Giant Health Conference Team Writer

At this year’s Giant Health conference, there is a focus on digital solutions that go beyond the pill with several sessions discussing Digital Therapeutics and virtual solutions as well as innovator pitching sessions and of course our exhibitors. 

The Covid 19 crisis forced healthcare regulators and clinical practitioners to adopt a different modus operandi to cope. In companies, employers were forced to yield on pre-pandemic resistances to staff working from home. Locked down, socially distanced humans were forced to interact with each other, and with organisations, in different ways. Different digital and telecom solutions resolved problems and facilitated human ability to function despite it all. 

Digital health and wellness applications and digital therapeutics experienced increased adoption as clinicians found themselves dealing with patients remotely and isolated people sought ways to satisfy their socio-emotional needs.

This situation brought about adaptive behavioural and attitudinal change. Practices and habits that would been unacceptable to many before the pandemic became almost the norm. Few in pre-pandemic times would have accepted substituting their regular visits to their doctors or specialists with a phone call. In the same vein, most people would not have engaged in therapy over zoom or similar.  

Fear of the virus and state enforced virus related restrictions were the main drivers of adaptive behavioural change, but importantly digital innovation was ready, primed for increased levels of adoption too. It is hard to imagine having come through the Covid pandemic without technology, though many living in less privileged countries had to do exactly that.  

The resulting societal mind-set shifts will make it easier to continue and accelerate these trends, not only to go beyond the pill, but also to go beyond the limitations of pre-pandemic practices in improving the provision of medical and mental health care. Digital solutions transcend geographical and scale limitations. Doctors had been coming under increasing pressure to see more patients in less time, with decreased patient satisfaction levels as the feeling of being ushered quickly out prescription in hand was taking the human out of the doctor-patient relationship. 

Digital therapeutics have for the most part focused on chronic illnesses and mental health issues though some inroads into acute illness has begun. Again, we note that DTx are framed for the most part as medical devices and must comply to the same standards. This means that they must pass clinical evaluation, are subject to regulatory oversight and regulations governing real world data collection. Digital therapeutics are used to prevent, manage or treat a medical disease or disorder and cannot be just downloaded from an app store. A clinician will grant access via prescription or authorization. (Digital Therapeutics Alliance) 

The amount of regulation and trial rigour required is usually directly proportional to the level of perceived risk associated with the DTx ‘s particular goal. It would be logical to assume that there will be more implicit risk when there is a treatment component than where there is a prevention one.  

The types of trials that DTx tend to undergo range from Randomised Clinical Trails (RCT), Real World Evidence (RWE) and what is known as Health Economics and Outcomes Research. (HEOR) and must adhere to industry best practices and ethical standards. Dtx Alliance

Digital therapeutics offer the promise of home-based monitoring of chronic illnesses thus reducing the visit & testing burden on already stretched healthcare systems and thus reducing costs too. But DTx home-monitoring and illness management benefits go beyond mere cost-effectiveness. There are also risk reduction benefits linked to social distancing and contagion reduction, and not just Covid! 

There are benefits too in home-based monitoring and management potential to alleviate the problem of staffing shortages in health care as software brings better data and analytics providing advantages to clinicians in coping better with scale.  

Of great importance as well is digital therapeutics' potential to reduce mortality and morbidly, particularly when it comes to under-served population segments. A stark example of this can be seen in the Healthy People 2020 study in USA showing higher levels of mortality in 7 major morbidities in rural areas. Lack of quality care in rural, less densely populated areas and inequalities in health care provision due to income differences or access discrimination are major issues that digital therapeutics can realistically tackle.

This is particularly true when it comes to mental health care delivery where quality of care access constraints and problems in health seeking behaviours are numerous due to poor coverage, inadequate psycho-social education, high levels of pervading stigma, long waiting lists, insurer reticence to pay up over time, as well the high prohibitive costs of private access to quality psychiatrists and psychologists. 

The pandemic has merely shone a stronger light on this poor coverage in mental health as the social drama, tragedies and anxieties caused or exacerbated by the crisis have become harder to ignore. 

As calls for increased oversight and regulation gain traction and discussions over ethical issues emerge as digital solutions uptake increases,  one can only think that it would be a shame if policy makers and regulators mapped the same limitations that govern traditional clinical practices onto digital therapeutics, particularly in terms of demonstrating efficacy. 

This is not a minor point, particularly when we are talking about conditions with a large behavioural component. At the end of the day behaviour is multifactorial and notoriously hard to change and demonstrating cause and effect in trials practically impossible.

It would be a pity to require of digital therapeutic solutions what is not today required of psychiatrists or therapists when it comes to demonstrating that what they do in the privacy of their consultation rooms is effective. The same probably applies to GPs.

It is also worth noting that Randomised Clinical Trials are not without controversy nor is Cognitive Based Therapy without its critics as more integrative, humanistic approaches gain in both credibility and traction.

Digital therapeutics can not only reach where today’s healthcare cannot but perhaps can also pave the way for a different approach to how efficacy can be demonstrated using more Real World Evidence from direct patient feedback and monitoring systems. 

It goes without saying that we must be mindful of the cybersecurity and data privacy concerns that must of course be managed, the Finnish psychotherapy company Vastaamo 2020 ransom private data hack being a dark, cautionary tale. Wired Article

However, with advances in AI and the amount of useful data harvesting that digital solutions can do, the potential to produce more insights from aggregated population data surely more than outweighs the risks. Ultimately these faster acquired insights can improve medical and mental health knowledge and care more quickly than the cumbersome clinical trials required of the pill. 

After all, hundreds of thousands of doctors, nurses, psychiatrists and therapists do not analyse their patient data longitudinally across life-spans or populations segments. Therapists cannot analyse their reams of therapy session notes for patterns over time on what works and what doesn’t. 

The hundreds of thousands of healthcare professionals in practice are not mined collectively for their knowledge accumulated over decades of patient management to provide insights and innovations in patient care.  Such valuable experience and knowledge remains for the most part untapped into.

There is surely only room for improvement and perhaps DTx and quantitative and qualitative data collection and analysis will nudge in a new and better informed era.