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Digital therapeutics: Navigating the ‘wild west’ of digital health

Dr Charlotte Lee, UK Director, Big Health, on what digital therapeutics are and why they matter

I believe there is significant confusion in buyers, prescribers, and users, around what constitutes a digital therapeutic and why this matters.

A question I often get asked is how people can differentiate a digital therapeutic from, well, everything else claiming to digitally manage health. I set out a few thoughts below on definition, why digital therapeutics matters and what people should be asking of digital health apps.

The purpose of this blog is to engage with patients, industry and clinicians to gain a better understanding of alternative perspectives, so send us your reactions, and do sign up for our upcoming webinar on Navigating the ‘wild west’ of digital health on 30 June 12:30 – 13:30, where I’ll be joined by Jessica Shull, European Lead for the Digital Therapeutics Alliance, Paul Wicks, independent consultant in digital health, clinical trials, rare disease and patient centricity, and Hugh Harvey, Managing Director of Hardian Health, to discuss and debate the importance of clinical evidence in digital health.

We’re in an exciting era where the rapid digitisation of healthcare has catalysed delivery of the NHS Long Term Plan. Many policy makers are thinking about what next for the healthcare system, and it’s largely acknowledged that we will not return wholesale to the mainly analogue system we operated in before. I’m interested in what happens next now that healthcare delivery has gone virtual. Is this the moment digital therapeutics become embedded or are there just too many systematic gaps to do this meaningfully?

Before we get there, let’s get the basics right.

Defining digital therapeutics

Digital therapeutics are clinically evidenced software programmes to prevent, manage or treat health conditions. The way that it is delivered is comparable to a drug, but the potential of a digital therapeutic is more akin to a healthcare service.

Like a drug, they are highly scalable and can be prescribed across any pathway. Unlike a drug, they have remarkably few side effects, no major contra-indications, and can be taken alongside other treatments, with no adverse interactions.

Like a healthcare service, it is reliable, safe, and guarantees clinically evidenced treatment. It uses data to improve performance, and can integrate into other services. Unlike a healthcare service, it has no waiting times, doesn’t require you to take hours out of your day to get to the appointment and offers personalised treatment. It also runs no risk of inter-clinician bias.

Most importantly, they are defined by the clinical evidence to demonstrate treatment efficacy, not the software they are developed in. You may have a set of apps, but only a few of these with robust clinical evidence can be termed a digital therapeutic.

The best examples of digital therapeutics are in effect digital cognitive behavioural therapy (CBT), that is evidence-based psychological therapies that have been demonstrated in trials to be effective when delivered on web/ mobile platforms.

Why digital therapeutics matter

I have two perspectives, firstly, why this is important in the history of medicine, and secondly, why this is important in the history of digital health.

Historically, clinicians have been limited by drugs or invasive interventions as definitive treatments for diseases. Even though we were taught to provide patient education and promote behavioural change, that approach wasn’t feasible in the often time-pressured and resource poor healthcare environment. We resorted to prescribing drugs, even though for certain conditions the side effects for some patients outweighed the benefits.

Even when we do manage to provide behavioural intervention, the problem is that it is very hard to sustain in the real world. In the field of mental health, a growing problem with significant treatment gaps, the NHS has invested a significant amount into accessible CBT through the Increasing Access to Psychological Therapies (IAPT) service. However, it is limited in scope to anxiety and depression, there are waiting times and the pressure to maintain high caseloads has led to high attrition rates for psychological practitioners.

We find that access to evidence-based behavioural therapy is limited either through lack of trained staff or long waiting times. Outcomes are marred by poor adherence, or the service is very expensive due to the number of check-ins needed to keep someone on track. There is variation in delivery and a lack of personalisation. However, in a world where we regularly use technology to influence behaviour change (detrimentally, or to our benefit) there lies an opportunity in using technology to deliver sustainable behavioural change.

Digital therapeutics help us move towards the holy grail of delivering cognitive-behavioural interventions with a workforce that never tires, in a consistent manner, driven by data to enable personalisation, giving people immediate access to gold standard treatment with one click.

Secondly, I’ve heard the digital health market in the 21st century be described as the “wild west”. As a consumer or prescriber, you are baffled, overwhelmed, excited by the number of options available. With no clear standards, you will veer towards who has the best claims and the loudest voice, or to the favoured tactic of marketing teams, ‘anecdotal evidence’. There is a very low barrier to entry for new apps with healthcare claims, and as healthcare becomes more digital, this barrier is expected to drop even lower. This is simply not acceptable considering some of these apps are being used, promoted or prescribed in healthcare systems.

Whilst all digital software is essentially safe, i.e. no immediate life-threatening harm will come to people who do or do not use a digital app for behavioural intervention, prescribing apps that haven’t been evidenced pose a different kind of harm. It prevents people from getting the help they need, at the earliest opportunity, essentially distracting them from evidence-based treatment with digital homeopathy. There is a big difference in how high the barrier to entry should be for apps that do not claim a healthcare benefit but provide harmless entertainment versus those that claim to prevent, manage or treat a health condition.

There have been many calls to differentiate apps across literature. This is only going to increase as healthcare becomes more digital. Clinicians have a duty to practice evidence-based medicine, and this becomes even more important when approaching digital health. Digital therapeutics is a much needed early definition to help those responsible for healthcare delivery sort out which apps are treatments, and by definition, should be prescribed.

What questions should you be asking of digital health products to test whether they’re a digital therapeutic?

If you’re left wondering what to do with this information, here are a few suggestions. The next time you come across an app that claims to manage or treat health, ask:

  1. What evidence does it have to demonstrate that it works for a given condition? Are these results consistent across a representative population, and are they unlikely to be down to chance?
  2. If you’re a clinician, is this level of evidence acceptable to you in general for your prescribing practice?
  3. What evidence does it have for how safe it is? Whether that is about keeping your data safe, or that it’s studies show there were no adverse events?

I’m interested in your thoughts! This is an emerging area and it’s important we open up a dialogue around what actually matters. Do you agree that clinical evidence is the most important attribute of a digital therapeutic? How do we maintain this standard when clinical evidence is so expensive and difficult to attain?

Join the conversation on 30 June

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During the COVID-19 public health emergency, Sleepio and Daylight are being made available as treatments for insomnia disorder and generalized anxiety disorder (GAD), respectively, without a prescription. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia disorder and GAD, respectively.

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