Not up to standard: healthcare apps & the NHS
Healthcare app review company Orcha has found that the majority of healthcare apps used by NHS trusts do not meet the necessary standards, in part due to insufficient awareness of regulatory requirements. Abi Millar explores the challenges around regulating these apps and what can be done to ensure the NHS is only using the safest and most effective healthcare apps.
ver the last few years, the healthcare app market has taken off in a big way. According to health app review company Orcha, there are over 327,000 health apps currently available to download, ranging from those targeted at particular conditions to general fitness apps. You can download an app to track your weight loss, monitor your diabetes, share parenting advice, or even remind you to do your pelvic floor exercises.
Not all these apps are equally popular. Orcha notes that just 43 apps account for 83% of all health app downloads. Most of the rest have been downloaded less than 5,000 times – and many have been neglected. Almost two-thirds haven’t been updated in the last 18 months, and just 15% of those reviewed by Orcha meet minimum standards.
Arguably, the app market finds itself in a Wild West type situation – a new, exciting and fast-changing landscape, in which regulatory oversight hasn’t kept pace with innovation.
“Innovators can get a bad reputation and that can be unfair,” Liz Ashall-Payne, CEO of Orcha, told the BBC. “Imagine if you have experienced a challenge with your health or that of a loved one and you just want to help others. You’re coming at it with good intentions, but you wouldn’t necessarily know which regulation your product needs.”
At the moment, any app that purports to diagnose conditions or calculate medicine doses is classified as a medical device and requires a CE quality mark. Some other health apps (but not all) need to be registered with the national regulator, like the Care Quality Commission (CQC) in England. This can paint a confusing picture for developers.
What’s more, there are real issues associated with targeting apps towards those most in need. Orcha found that, while 240 different conditions are supported by health apps, less than 7% of diabetes sufferers use an app designed for their condition, dropping to less than 2% of COPD sufferers.
While general health and wellbeing apps are registering significant growth, there seems to be an impasse when it comes to viewing apps as a therapeutic option.
Digital health during the pandemic
The situation, however, may be about to change. The NHS has committed investment towards digital technologies like healthcare apps, with a view to reducing pressure on frontline workers while continuing to meet the needs of patients.
This has proven particularly salient during the pandemic. Over the last year, the adoption of digital health services has accelerated as face-to-face care has come to a standstill. According to Orcha’s latest report, there was particular demand for mental health apps, such as Wysa, Calm and Headspace, as well as digital triage services relating to Covid.
“Primary Care has faced unprecedented challenge through the pandemic, driving the ambition for every patient to have access to digital-first primary care by 2023-24,” says Suzanne Ash, head of governance and medical devices lead at Doctorlink (part of HealthHero).
Healthcare apps are able to respond readily to the changing demands, guidance and models of delivery.
“Where there is funding and a perceived gap in the market, digital start-ups have flourished. Healthcare apps can offer ready access to care at a time and place convenient to patients, saving time and money, and helping those who need to stay at home and stay safe.”
Doctorlink is an online service that helps people check their symptoms, and then guides them towards the appropriate care (whether that’s caring for yourself at home, visiting a pharmacy, or booking a visit to the GP).
In common with other digital services and health apps, it has the advantage of being highly responsive. Updates can be designed, tested and safely released within hours, not weeks – ideal for a fast-changing situation like a pandemic.
“Healthcare apps are able to respond readily to the changing demands, guidance and models of delivery,” says Ash. “For example, Doctorlink had its first product update to support the national Covid-19 response safely implemented within hours of the first change to Public Health England guidance. It continued to track and respond throughout the pandemic.”
How regulation might improve
Ash doesn’t think the health apps market is poorly regulated, per se. But she does think the existing standards and regulation are lagging behind the pace of app development. For that reason, Doctorlink has been working with the CQC to shape future policy guidelines for digital health products.
Specifically, the CQC is developing a ‘regulatory sandbox’ for digital triage. Here the word ‘sandbox’ refers to a collaborative approach, in which care providers, service users, tech developers and the regulator come together to develop ideas. Doctorlink was one of six organisations chosen to join the project.
“We were thrilled to be selected for the regulatory sandbox,” says Ash. “For us, this offered a unique space where commercial interests could be put to one side. We could be open about the challenges new models of care bring and focus on what really matters – how we can continue to innovate to achieve the best possible outcomes for patients.”
Currently, there are examples where initiatives, working groups and frameworks can seem repetitive and bewildering.
The resulting report found a high level of variation among digital triage apps. It emphasised that national bodies, like the National Institute for Health and Care Excellence and the The Medicines and Healthcare products Regulatory Agency, should be involved in commissioning digital triage tools, and it advocated for bridging the gaps between regulators and tech developers.
“Currently, there are examples where initiatives, working groups and frameworks can seem repetitive and bewildering to promising digital startups, and it is important that those areas are addressed,” says Ash.
“Healthcare apps have great potential to improve access to care, save resources and offer a positive and safe user experience for patients and clinicians, but only if they are designed and implemented in the right way.”
A template to follow
Throughout its reviewing process, Orcha found many apps that were getting it wrong – not least a diabetes management app with no input from experts, and a smoking cessation app that hadn’t received security updates in two years.
Ultimately, this can lead to problems for the users, as well as for the healthcare professionals who want to recommend tools to help them.
However, this is not to say that no apps are getting it right. Perhaps one of the hallmarks of a good healthcare app is its patient-centricity. Ideally, its developers will have engaged with the appropriate patient population and taken their experiences onboard.
There are fantastic examples of responsive, innovative suppliers working well with providers.
The NHS has a public-facing app library, containing apps that it has vetted, which may serve as a good template for others to follow. Orcha has played an important role in helping the NHS sort the wheat from the chaff.
“There are fantastic examples of responsive, innovative suppliers working well with providers to implement safe, clinically effective health apps for the benefit of patients,” says Ash. “We can bank and shop 24/7 on our apps, so why should patients expect any less when accessing reliable healthcare advice and signposting?”