The Newcomer’s guide to Digital Health

So, it’s 2020 and we’ve been thrust into a brave new world — one which is already affecting each of us and has changed all walks of life, not least that of digital health. But what exactly is digital health, where are the pitfalls and how might it fundamentally change the patients are treated?

Put simply, digital health is the use of technology to improve health. Specifically, it is a term which focuses on data-driven technologies, including data from sensors, from cameras, and from mobile devices; and the ability to converge the available data into meaningful, reliable medical insights that can be used to improve and sustain health.

Three technology forces have come together to make digital health possible: (1) the generation of new data streams from smartphone and wearable sensors, (2) super-fast data transfer across WiFi and 4G/5G networks, and (3) today’s powerful computing ability that allows the analysis of vast datasets and the convergence of the data into something clinically meaningful.

Digital health comes in many forms: the basics cover the utilisation of software for online appointment booking and hospital staff shift scheduling, through to online symptom checkers and symptom trackers available as apps. In clinics, the adoption of electronic patient records not only means an end to deciphering handwriting, but a means to ensure that various professionals can connect on an individual patient, and are kept up to date with patients’ progress. Natural Language Processing (NLP) software can capture a patient-doctor conversation and write it down in the patient notes, like a well-trained assistant, freeing up valuable time and energy. Clinical decision support software (CDS) provides a ‘second look’ over doctor’s decisions, checking for prescribing errors and providing peace of the mind in a busy clinic.

Until now, digital health held promising efficiencies for making hospital clinics run more smoothly, and more safely. But, in a COVID-19 world, digital health has suddenly moved from a ‘nice-to-have’ to a daily essential: the use of video calls has sky-rocketed, enabling crucial medical consultations to continue remotely, and even by doctors who themselves are self-isolating and who aren’t able to come in to the hospital. Chat bots are now able to reliably triage individuals as their augmented intelligence improves with feedback loops.

Digital health is about to get much, much more exciting than a video call.

The step-change in digital health ability is because we’re now living in a world where we can begin to connect up data: both an individual’s data, and crucially data between large groups of individuals. The emerging ability to connect up all the dots will lead to a much earlier diagnosis and more personalised treatment planning, using evidence that is based on the treatment responses of others who share the same demographic background.

Within 10 years, a complaint of persistent fatigue and digestive upset for example will be assessed by a family doctor using genome sequencing to identify rare disease that would otherwise have taken, on average, 7 years to diagnose. Historically, this type of medicine was confined to research labs, but the cost of testing has plummeted in recent years and the processing power required to search the genome is now available commercially. Sounds a little sci-fi? The team at Genomics England are already working to make that a reality, so watch this space.

2020 is the year that will define digital health. Put simply, this year, we didn’t have a choice: social distancing meant that like any successful species, we have had to adapt to survive. Now that pace of adaption is strong, and the benefits clearly visible, it will not stop anytime soon. Whilst ICU is battling the horrors of COVID-19, the rest of the hospital is bracing for the avalanche of waiting lists that will inevitably come after the majority of out-patient appointments and routine surgeries have been (and are still being) cancelled. Tele-medicine using video calls has been better than not seeing a patient at all. Even if social distancing were to remain only until the autumn, the 6-month suspension of normal activities will take most hospital waiting lists at least 2 years to recover from. The long-term impacts are here to stay: the avoidance of hospitals when possible, the patient expectation of remote care, the desire of patients to self-treat, taking more responsibility on themselves, to preserve the health system as a whole.

Moving from reactive to proactive care

Specialised sensors and high-resolution cameras on everyday mobile devices can now mimic specialist medical kit, and the digital biomarkers derived from smartphones and wearable device data will one day become as accepted and reliable as their original counterparts. Today, these technologies are being trialled by forward-thinking doctors to provide additional clinical data during video consultations. Tomorrow, the same technologies will be used between doctor appointments, permitting for real-time monitoring of high-risk individuals, and a true shot at early treatment intervention while the individual is still relatively healthy.

Digital health will have become embedded in our everyday living, and become a continuum between wellness and health. Imagine this: your digital devices prompting you to plan ahead for a meal containing the vitamins it reckons that you’re deficient in, or to adjust your meetings to give you the time to rest up since it knows your blood pressure has been rising this week, or to book in for an eye check because you seemed to have been needing much more light to read in the evenings lately. All of this will come, and if well designed and engineered, has the potential to keep us living better for longer.

Care, anywhere

The World Health Organisation states that, “Digital health will be valued and adopted if it supports equitable and universal access to quality health services; enhances health systems sustainability, accessibility and the affordability of care”.

There are legitimate concerns that only those with good internet access and the latest gadgets will receive better care, and that government and society must work hard to consider these “digital determinants of health” (availability of smartphones, wearables, and high-speed internet) in future service planning so that we reduce inequity rather than the very real risk of increasing it. Thankfully digital health is already being used to start balancing out care inequalities experienced at a geographical level, where clinicians in a rural clinic can simply dial in a expert from a specialist hospital that ordinarily only those in a capital city would receive.

Another huge contribution that digital health will have to medicine is driving up the efficiency of clinical trials — by devices capturing more data, and more often, away from traditional clinical trial centres. This will likely reduce both the cost and the duration of clinical trials, whilst opening them up to a wider demographic of people who live further from key hospital sites they would otherwise have had to regularly attend for data capture.

Tech is no longer just for the IT helpdesk!

Digital health is fundamentally about connecting up people, data and systems: it requires a whole-system approach.

Digital health is as much about a shift in attitudes and approaches to healthcare delivery as it is about the adoption of shiny new tech toys. It’s about the management of chronic conditions outside of a traditional care setting, and bringing that care much closer to the individual who needs it.

A whole-system approach starts with truly understanding the needs of the patient, the abilities and the constraints of clinical team and the supporting charity sector, the service manager, the finance team, information governance and the tech infrastructure team, to name a few! It’s rare to find an off-the-shelf solution in digital health that will perfectly fit the needs of a given service, so a significant investment of clinic time is required as well as finance.

This unique opportunity given to us by the heavy demands of COVID gives us the rare chance to pause and re-evaluate what our patients and clinical teams need in order to deliver a sustainable service with pride.

The gross imbalance of demand for healthcare services and our ability to meet that demand in a timely manner will only grow at a significant pace — it is now clear to everyone with their eyes open that the responsible implementation of technology to fill that gap is essential, and urgent. But crucially, the services that we design and build today and the technologies we choose will impact care delivery for many years to come. Having the right digital partners with the right approach is a cornerstone of future sucess.

Interoperability is another cornerstone: creating streams of data that can integrate with others to produce meaningful clinical insights for doctors and patients. This requires a forward-thinking approach from developers and clinicians who must work directly together so that developers intimately understand the medical problems within the speciality they’re engineering for and so that doctors understand the opportunities and the limitations of the code that is being developed. For hospital systems and medical devices to be able to connect, a common framework of coding standards and data-exchange interfaces (APIs) is essential, and are becoming standardised by great thinkers across the world.

The personalisation of healthcare

The most promising opportunity in digital health is the creation of the space and the information for medicine to suddenly become about the individual, rather than the protocol-based approach that young clinicians have become accustomed to. All healthcare staff, from receptionists to surgeons to cooks to pharmacists will have the opportunity to see data that represents the patient as an individual rather than as walking ailment fitting into a risk category. In practical terms, this means that data analytics will offer appointment scheduling based upon individual risk circumstances in a dynamic way that will adjust based on weekly progress; helping patients to avoid medical care when unnecessary. Personalised dosing will come, based on a real-time worldwide pull of scientific literature taking into account the patient’s ethnic background, gender and social influences as determined by streams of data from wearable devices, now connected in with the patient’s own record.

Already, groups of people living with diabetes have found insights by pulling off raw data from their continuous glucose monitors to help them self-manage their disease better. Such code is available on open-source platforms, enabling anyone to take advantage of it — and so we enter a rapid democratisation of healthcare (clearly, not without risks). It’s clear that researchers must also evolve and understand that a trial on several dozen subjects with controlled test conditions may be no match for a “real world evidence” (RWE) study on hundreds or thousands of people — the messiness of compounding variables is simply a fact of life, and the trends and intimate insights seen across large numbers of subjects are likely to more than mitigate for inevitable errors at the individual level.

Digital health ultimately holds promise for catching disease before symptoms begin, particularly in the cardiac and mental health space. This blurs the line between who’s a patient and who’s not, blurring consumer and medical products: pulling together social media data and wearable sensor data to make a fairly reasonable assumption of when someone needs to seek medical help.

Senior doctors such as Eric Topol and Atul Gawande tell us of the need to use technology to re-humanise medicine, creating space for the conversations that really matter and the data for the decisions that really matter (you ought to read their books if you work in health or if you would like to segue in!).

In tech we trust?

Fundamentally, both the public and clinicians should be able to trust what’s on offer in the digital health market. But in reality, most professionals and patients are struggling to know what’s legitimate and what’s not, particularly in the case of apps, where consumer wellness tech sits side-by-side to medical grade health tech.

After a hairy couple of years in which digital health felt uncomfortably sandwiched between a ‘free-for-all’ consumer software culture and an innovation-stifling prescription drug framework, digital health is emergine into it’s own and specific discipline: frameworks are now emerging, across regulatory legislation, healthcare systems and in data governance and security.

In Europe, the landscape is rapidly changing to adopt the Medical Device Regulation (EU) 2017/745 in May 2021, widening the scope of software/apps that are considered a medical device and increasing most from a basic Class I to a more heavily regulated Class IIa. The regulatory change requires medical app developers to have a qualified quality manager, central product registration on the EUDAMED database and a continued quality review when the software is launched and in use — forcing the less serious to exit the market.

It is important to recognise that software medical device products are a (reasonably sized) subset of digital health, but those which are, and therefore must carry the accompanying CE mark are: “software intended to be used with: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.” (a wide scope!)

The FDA rightly recommends that the first step to evaluating the value of a digital health tool is to look at the company that produces it. The software developers should “reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards”. In Europe, software medical device companies will undergo ISO:13485 certification by an external auditor. But it is important to realise that ISO:13485 and CE-marking denote quality and safety, and do not claim either clinical efficacy nor value-for-money. Software medical device companies should be upfront about their intended use and provide the clinical evidence to support the implementation in a clinical setting.

The importance of data security can’t be overstated. You should be looking for a company who has (or is working towards) ISO:27001 and Cyber Essentials so that you can be assured strong security processes are in place and constantly being evaluated. These go above basic GDPR standards.

Rise of the prescribed app

2020 is such an important year for digital health because it is finally gaining appropriate reimbursement models that will allow clinics to both pilot and expand its use. Germany’s Digital Supply Act will allow doctors to prescribe digital apps with health benefits, which can be reimbursed by the country’s health insurance system. In the UK, NHSx are committed to creating digital tariffs for central reimbursement of the services that use software medical devices, such that digital health becomes an integral part of NHS service delivery and future sustainability.

We’re also going to see ‘companion apps’ to drugs, that provide information and monitoring support, and which feed in to personalised dosing and appointmenting.

Digital therapeutics is the hot new Silicon Valley buzzword. While I consider this the adjunct of digital to actually treat disease, others consider this more widely to encompass the pipeline of digital health from diagnosis through to monitoring. In the US, the FDA has approved numerous digital therapeutics, particularly in mental health, as an alternative to traditional dug therapy.

In many markets, we’re going to see most evidence coming post-launch: with the provisional release of medical devices under license to collect real world evidence, that will then be used to affirm regulatory status.

It’s important to balance tech innovation with clinical accuracy, and the best digital health companies will have systems and R&D pipelines in place to get this balance right.

Will digital health reduce costs?

Digital health will save duplication, time and enhance patient safety with more accurate and faster diagnosis. It will mean that individuals will visit hospital less often, and perhaps doctors too — being able to provide more care via tele-medicine from home. We’re seeing a move toward “value-based healthcare”, the wise use of resources, proactive healthcare, with more front-loaded investment to prevent disease or deterioration. However, demographics of our populations: ageing, obesity and population growth generally, mean that demand for healthcare won’t reduce anytime soon — there won’t be an overall reduction in the cost of delivering healthcare. Drugs will become available to treat more niche diseases — and those won’t come cheap. The best that we can hope for is to drive effeciency: seeing more patients with the same number of resources, and to make them better more quickly (or even better, help them prevent getting ill in the first place).

Beware the free apps

The lure of free software is appealing to healthcare teams, particularly during COVID, a unique opportunity with relaxed regulatory and governance frameworks to allow rapid adoption of pragmatic digital health technologies. Since it takes tens of thousands and many, many months of work to build the quality systems around any stable and scalable app technologies, healthcare providers must resist the temptation to take ‘free’ offers in the absence of knowing the company is well financially backed, with the team and the capacity to support the app when it’s in the hands of patients, deal with the inevitable bugs that will arise, and to do so very quickly.

The post COVID patient

COVID has given doctors the mandate to freeze usual protocols, to center care back around the patient, making pragmatic decisions based upon individual risks and wishes. In short, doctors are now flexing their natural innovative instincts, in the absence of the comfort of usual information from face-to-face consultations. Doctors are readily adopting new ways of doing old things, and most are more excited and empowered than they’ve been in years.

The post-COVID era is likely to bring a replenished respect for our scientists and healthcare staff, their work now more valued as populations tune in for every latest update about infection rates, antibody testing and vaccine developments, knowing that the reinstatement of our normal lives rests upon it. Healthcare staff are looking forward to a restart where they aren’t expected to be running at full capacity all of the time, since the government and the public now see the need to have some slack in the system for unexpected events.

One thing is for sure: social distancing measures mean that there’s much less capacity in hospitals (busy waiting rooms will be a thing of the past). And as much as hospitals can’t accommodate usual numbers of patients, it’s becoming abundantly clear that individuals want to avoid hospitals anyway. This rapid practical and societal shift will result in fewer face-to-face appointments, and digital health could mean fewer appointments full stop.

And perhaps the biggest change will be seen in the post-COVID patient. The last few months have taught us that any single one of us could be hours away from being a patient ourselves. In the last weeks and months, I’ve been blown away by my family and friends taking responsibility for their own health, knowing that their actions have a forceful impact on their safety and wellbeing. If it wasn’t before, protecting one’s mental health has gone fully mainstream. While it’s yet to be seen if wearables do really lead to behaviour change, it’s clear that lifestyle medicine (eating well, staying active, sleeping well and mindfulness) is much more powerful when it’s personal; post-COVID this will be the next digital health to slip into each of our lives.

It’s strikingly clear that the empowered patient will make better and more informed decisions about their own care, and we should strive to put only the most reliable and the most useful data in the hands of those patients.

The tech giants are here — healthcare will never look the same

There is absolutely no doubt that Google, Amazon, Apple, Microsoft and Facebook could re-engineer healthcare, and they are moving in quickly. The ambition of these companies and their ability to push change at scale is incredible, not to mention their software infrastructures which are crucial for much of what already goes on within healthcare (the NHS already use Amazon Web Services to store health data securely on the cloud). But of course, there is a concern about what happens when the attitudes of stereotypical techies in hoodies start colliding with the front line medical clinicians, building the healthcare systems of the future that we will directly interact with.

Digital health is the coming together of the tech tribe and the medical system. Early collaborations led by tech giants haven’t always been successful in a PR context, with health data being ‘sold’ on both sides of the Atlantic without patient consent. But medicine is learning quickly, and fresh blood is necessary in the medical field to spark innovative change. Each partner has so much to learn from one another. We simply must work together to make great healthcare possible. The future of digital health looks like a combination of start-up companies, with large digital health giants working symbiotically.

The role that pharmaceutical companies will play in digital health is emerging, a potentially very exciting one — most are dipping their toes in, running accelerator programmes and investing in the companies they feel are most promising. License deals are being made within a disease area in specific country territories, building cautious but meaningful relationships while protecting their reputation. Who will become the prominent pharma player in digital health remains to be seen.

We’ve already seen some interesting acquisitions of start-ups by both pharma and by tech giants, across a wide variety of spaces such as medical education, online pharmacy, mental health and eye care.

What should you be doing today to transform healthcare?

Healthcare is in a state of change and redesign. If you’re a patient, think about what great healthcare would look and feel like, if you could redesign it from scratch. Where would you get your information, how would you want to access it? How much information would you want? How quickly would you want a diagnosis, and how would you want to receive it? How would you want to monitor your condition, how would you like to visualise your data and how would you like to communicate with those who care for you? If you’re in healthcare, start by asking your patients these questions, and you won’t go far wrong!

Want to suggest an edit or addition to this article? Drop me a line at stephanie@okkohealth.com