25 June 2017
Liz Ashall-Payne, (our CEO), recently spoke (at the Women in Medical Technology event on 22 June) about the issues surrounding the global growth in the number of health and wellbeing apps and how the speed of development in the eHealth, mHealth and Telehealth industries is resulting in a less than rigorous data collection and regulatory system.
Liz asked how can patients and clinicians begin to use or prescribe these platforms to monitor diabetes, chronic obstructive pulmonary disease (COPD) or even depression, without the technology having been put through meticulous clinical trials and validation processes? Who has ultimate responsibility for patient safety? And what role can the engineering and software development communities play in addressing these issues to ensure that ‘Remote health monitoring’ technology such as apps and wearables, are fit for purpose?.
“If you can think of an ailment, concern, or any aspect of your health and wellbeing which you wish to monitor or improve, you can be certain there already exists an app for it. What is uncertain however, is whether such apps will work as advertised, and whether first and foremost, they will ‘ do no harm?’ .
In the wake of unprecedented National Health Service (NHS) efficiency savings, increasing waiting lists, and a looming shortage of trained medical professionals, those concerned with proactively managing their health and wellbeing are increasingly turning to mobile or ‘mhealth’, and the use of unregulated and largely un-validated ‘apps.’ This novel therapeutic medium is rapidly gaining momentum, and with an estimated 165,000 health apps available for download in 2015, the convenience and widespread availability of mhealth presents an accessible, affordable, and alluring opportunity to those looking to actively manage their health and wellbeing
As of 2015, it was estimated that 71% of Britons (45.5million in total) owned a smartphone, with 75% using smartphones or tablets to search for health information online, and over 90% revealing they would use mhealth services to engage with healthcare professionals, were such services available to them. By their very nature, apps provide the possibility of proactive health management from the comfort of your own home. Furthermore, while not confined by the constraints of appointment times, and waiting lists, the use of health apps may enable the treatment of thousands of individuals simultaneously.
The widely accessible nature of health apps also presents a flexible and pragmatic opportunity to empower patients, improve access, and extend the effective reach of healthcare services, especially for those who are not currently able to fully benefit from existing services. This may include the depressed armed forces serviceman for whom a desire for anonymity is paramount, or the knowingly overweight and pre-diabetic single-mother, who struggles to schedule a GP appointment around her childcare and work commitments
Yet despite the significant potential for health apps, there are currently numerous drawbacks when contemplating the use of these unregulated and largely un-validated technologies. Due to the rigorous processes involved in the evaluation of both safety and effectiveness, substandard pharmaceuticals and medical devices rarely make it to market, however the same cannot currently be said health apps. There exists a considerable gap between the potential benefits that apps could provide, and what they are currently likely delivering in practice. Recent reviews in the therapeutic areas of bulimia, asthma, PTSD, insulin dosing and suicide prevention, have yielded disturbing conclusions regarding the quality, scientific basis, and often blatant disregard for safety, that characterise a great number of health apps.
Even with respect to NHS accredited apps, recent research from the University of Liverpool demonstrated that just 15% of apps endorsed and recommended to patients for the treatment of depression and anxiety, could not provide evidence to corroborate claims of effectiveness made in the app store. This leads to the question of what, if anything, is the use of such apps likely to accomplish, and whether they should be viewed as a viable, effective, and a safe option for those in need of high quality healthcare services.
Of course this paucity of evidence is not a new phenomenon concerning electronic medical technologies, with the medical device industry historically suffering a similar shortage of evidence. This is because unlike pharmaceuticals, regulators are often evaluating medical devices and apps, at a very early stage of their market life cycle, and as such, the extent of product exposure, data collection and research is typically very sparse, especially considering any longer term outcomes and the sustainability of treatment effects.
Consequently, before blaming app developers for the prevailing lack of evidence, it is important to appreciate the barriers to evidence-generation currently faced by developers. While the burden of proof concerning app safety, clinical and cost-effectiveness ‘should’ ultimately lie with app developers, the fact that ‘acceptable evidence’ itself is largely open to interpretation, means that it may be folly to expect effective research to improve.
This is because unlike established therapeutic options including pharmaceuticals, there exists no clear guidance to app developers of what is expected, and what evidence should be collected, in order to demonstrate the efficacy and value of health apps. While some international ‘best-practice’ frameworks provide rudimentary recommendations, including the importance of both user feedback and user testing (PAS 277-2015), formal guidance is practically non-existent. Considering that 30% of app development companies have just a single employee, and 64% operate with less than nine employees most app development companies can be categorised as small and medium sized enterprises. App developers are faced with trade-offs and decisions regarding how best to allocate their limited resources. It is likely that the risks of committing limited funding to evidence generation efforts, currently outweigh the perceived benefits of doing so.
To reduce the divide between the number of app users and the number of evidence-based health apps, large-scale evaluative frameworks are required. An estimated 50% of health apps will receive fewer than 500 downloads across their entire product life cycle, as such, if left to market forces, the rate of app uptake (and subsequent collection of data for evaluation) are likely to be prohibitively slow. This limits the ability of developers, to detect meaningful treatment effects at conventional levels of statistical significance, further dis-incentivising developers to attempt to collect evidence.
It is clear that setting a high standard for health apps from the outset is vital to achieving long-term benefit to both patients and the NHS. Through identifying and actively promoting the most clinically effective, safe and beneficial apps earlier in an individual’s mhealth journey, the many potential benefits of health apps, including reducing treatment costs, extending the effective reach of healthcare, and improving NHS efficiency, are far more likely to be realised. In providing a clear means of navigating the seemingly never-ending pages of results when searching for a specific app, the ‘opportunity costs’ of not gaining access to the best app at the earliest possible time can be avoided. By informing the decisions of those who download such apps, the good can be sifted from the bad and even the dangerous. In doing so, the NHS and its patients can begin take full advantage of the apps revolution without the underlying threat of unknowingly inflicting harm on users. This in turn results in a more flexible, adaptive, and accessible healthcare system, and maximises the potential for large-scale improvements in population health.
But only by negating the fear that any evidence collected may be of poor quality and dispelling the ambiguity around what acceptable evidence can and should look like, can we begin to do so. By providing a much clearer path from development to reimbursement, and making it clear what is required, we can reincentivise developers to engage in evidence generation efforts. In doing so, we can maximise the likelihood of evidence-based decision making within the arena of mHealth taking a firm hold, and achieve the many benefits that this novel therapeutic approach can deliver”.
Liz Ashall-Payne – Founder & CEO ORCHA, is passionate about the opportunities that technology and particularly apps offer to improve health and care efficiencies and outcomes. She is determined to present a way to offer much needed guidance to app developers to help raise app quality, as well as helping the public and professionals to confidently find and apply apps that could genuinely improve public, patient and organisational outcomes.
Initially a Speech and Language Therapist, Liz has almost 20 years NHS experience. She has successfully led innovative change and service transformation in complex health economies. She has led regional, national and European change programmes and networks to deliver transformational shift and has experience of working collaboratively with Public Sector, Industry and Academia.
Co-Author: Simon Leigh BSc MSc (HECON) – Principal Consultant & Senior Health Economist at ORCHA