The proliferation of Digital Health tools, including mobile health apps and wearable sensors, holds great promise for improving human health. As with other new health technologies, evidence of their effectiveness is a fundamental requirement of the health system and a limiting first step to adoption into clinical practice. Although analyses of the Digital Health landscape published by the IMS Institute for Healthcare Informatics in 2013 and 2015 found evidence still to be scarce and the value of Digital Health difficult to measure, this has now changed and the benefits to patients are becoming clearer. Efforts to incorporate these tools into practice in the United Kingdom are underway.
This report is adapted from the original IQVIA Institute report: The Growing Value of Digital Health — Evidence and Impact on Human Health and the Healthcare System, and focuses on the potential value of Digital Health in the United Kingdom. As digital tools focused on the detection, prevention and management of health conditions proliferate, this report explores the growing body of evidence that demonstrates their impact on human health and estimates the potential cost savings to the U.K. healthcare system. Trends in three areas — innovation, evidence and adoption — are examined.
This study was produced independently by the IQVIA Institute as a public service, without industry or government funding. The contributions to this report of Christine Lemke, President, Evidation Health; Dr. Michael Hodgkins, Vice President and Chief Medical Information Officer, American Medical Association; as well as Michael Krupnick, Hilary Armstrong, John Doyle, and dozens of others at IQVIA are gratefully acknowledged.
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Executive Summary of the Report
Over 318,000 health apps and 340 consumer wearable devices are now available worldwide. The value of these Digital Health tools to human health and the healthcare system is still evolving. There has been continued adoption by various stakeholders, exploration of innovative ways to apply these tools
to health and growing evidence of their impact on human health outcomes.
Since our study in 2015, over 153,000 new Digital Health apps were introduced to the Apple Store and Google Play, nearly doubling the number available, with more than 200 health apps being added each day. General wellness apps still account for the majority of health apps available to consumers, but those focused on health condition management — often associated with patient care — are growing and now account for 40% of all apps.
Although the range of health apps available present an overwhelming amount of options for consumers to choose from without guidance from their healthcare provider, there are now established leaders among apps for consumers to use. Just 41 apps with over ten million downloads each account for nearly half of all app downloads while over 85% of all health apps have fewer than 5,000 installs. There is now also at least one high-quality app for each step through the patient journey.
The importance of Digital Health to healthcare is defined by such apps that are the leaders in their respective use category, and the value they deliver, while the plethora of lesser apps have little impact. These leading apps may have high patient ratings, frequent updates, connectivity to sensors, inclusion in healthcare institutions’ app formularies, endorsements and promising clinical evidence.
The overall body of clinical evidence on app efficacy has grown substantially, including randomised controlled trials (RCTs) and meta-analysis studies. Particularly strong evidence now exists for use in diabetes, depression and anxiety, making these categories strong candidates for incorporation
into standard of care recommendations by clinical guideline writers. An additional 24 categories have one or more RCTs with positive results making associated apps strong candidates for adoption by healthcare stakeholders (e.g., provider organisations and payers).
The use of Digital Health apps in just five patient populations where they have provided some evidence of reductions in acute care utilisation (diabetes prevention, diabetes, asthma, cardiac rehabilitation and pulmonary rehabilitation) could save the U.K. healthcare system — including the public and private sector payers in England, Wales, Scotland and Northern Ireland — a conservatively estimated £170 million per year. This represents about 1.1% of total costs in these patient populations. If this level of savings could be extrapolated across total national health expenditure (not just these first five disease areas), annual cost savings of £2 billion could be achieved.
While the quality and clinical value of a leading group of Digital Health apps is becoming clear on a global basis, challenges remain in terms of how this value is realised in the United Kingdom. While the NHS Apps Library (Beta) has now listed 42 apps that have successfully navigated the new Digital Assessment Questions (DAQs), thereby endorsing them for use by patients and clinicians, this list only includes 2/26 Top Apps identified in this report (MyCOPD for pulmonary rehabilitation and OWise for breast cancer). While there are many anecdotal reports of pilots of Digital Health apps within the NHS, a minority of worldwide Digital Health efficacy studies have taken place in the United Kingdom. These figures indicate that while the United Kingdom — and specifically the NHS — have growing enthusiasm for Digital Health apps, routes to improve access to high-quality apps and facilitate more local studies of their benefit may be needed.
Despite progress to date, a number of barriers still exist to widespread adoption by patient care institutions, and only a limited level of adoption has yet occurred. Barriers to further use by physicians surround app selection, concerns around privacy and security, malpractice liability, financial incentives and workflow integration. Few condition management apps — which offer the greatest potential impact
on human health care and healthcare costs — have reached the level of workflow integration necessary to gain widespread physician adoption.
Before healthcare can be more fully supported by apps and sensors, a new fit-for-purpose infrastructure must evolve to support their delivery and incorporation into the standard health toolkit, similar to the type of ecosystem that exists to disseminate safe therapeutics. A variety of industry and policy initiatives have now emerged to address these barriers and accelerate the ongoing adoption of Digital Health tools by care facilities. Critically, app curation initiatives are facilitating the creation of formularies of high-quality apps; privacy and security guidelines are being published; patient access is being addressed by programmes such as the NHS England Innovation and Technology Tariff, efforts are underway to align Digital Health programmes with providers’ existing and emerging incentive structure; and interoperability initiatives create the potential for streamlined integration of Digital Health apps into physician workflow.
Digital Health Tools
While “Digital Health” is defined in varying ways, the term is used throughout this report as meaning the use of connected mobile devices — including, but not limited to, mobile phones, tablets, consumer wearables, connected biosensors and in-home virtual assistants — to improve health (see Exhibit 1). The value of these tools typically derives from abilities to communicate information through the internet, web or text messaging, to provide continuous monitoring of human health metrics or display health data more clearly.
Over 318,000 health apps and over 340 consumer wearable devices are now available worldwide, with over 200 health apps being added each day.
General wellness apps still account for the majority of health apps, but the number of apps focused
on health condition management — those often associated with patient care — are increasing faster and now account for 40% of all apps.
Apps that provide disease-specific support and management have grown from 10% to 16% of all apps; the top five therapy areas they focus on are all chronic conditions.
Very few apps account for the majority of downloads; just 41 apps with over 10 million installs each account for nearly half of all app downloads.
Wearable BioSensors and other Connected Devices
Many apps also connect to sensors. Biosensors, as an overall category of devices, collect information on a variety of health parameters and vital signs by reading or measuring energies from a person — e.g., pressure, temperature, light, etc. — and transmit that data via electric signals to be interpreted. Among these, activity monitors measure consumer motion patterns (e.g., movement, rotation and position) and translate them into measures of routine activity like sleep, steps and exercise, among others. Since the release of Fitbit to the market in 2007, a growing number of individuals have adopted wrist-worn wearables like fitness trackers and smartwatches to help track their activity levels, and provide real-time feedback to aid in motivation.
Based on analysis of the AppScript Device database, 344 consumer wearable biosensors are now available worldwide, with fitness trackers and smartwatches accounting for 47% and 13% of these devices, respectively. Although activity monitors have Exhibit 6: Examples of Connected Biosensors been among the most popular, there are now a vast range of connected biosensors that transmit health information wirelessly to mobile apps (see Exhibit 6). Users can interact with a biosensor briefly, such as a glucometer, or wear them for continuous data collection.
Delivering Value to Patients and the Health System
High-quality apps — those with characteristics such as high patient ratings, frequent updates, connectivity to sensors, inclusion in Digital Health formularies, endorsements, and promising clinical evidence — now exist for each major type of healthcare use.
The overall body of clinical evidence on app efficacy has grown substantially and now includes 571 studies, including 234 randomised controlled trials and 20 meta-analysis studies.
Particularly strong evidence now exists for diabetes, depression and anxiety that may be considered
by clinical guideline writers for incorporation into standard of care recommendations.
The strengthening maturity of clinical evidence in diabetes, cancer, post-traumatic stress disorder (PTSD), arthritis, stroke, genitourinary conditions, pulmonary rehabilitation and dental uses has been significant over the past three years, with new studies showing significant benefits vs. controls; however, exercise, autism and bipolar disorder experienced disappointing study results.
Of the top 26 apps, 80% have at least one positive observational study demonstrating clinical efficacy, over half connect to an external sensor, one quarter are not publicly available to patients and one-fifth are cleared by the U.S. FDA.
The use of Digital Health apps in five patient populations where they have proven reductions in acute care utilisation (diabetes prevention, diabetes, asthma, cardiac rehabilitation and pulmonary rehabilitation) would save the NHS £170 million per year and provide tangible health outcomes improvements.
Extrapolating this level of cost savings — approximately 1.1% — to total U.K. national health expenditures indicates the NHS may experience total cost savings of ~£2 billion per year
“Top Apps” list
To generate a “Top Apps” list, a top-rated free and publicly available app as well as a top clinical rating app (regardless of business model) was selected across 16 high-priority Digital Health app categories with high app demand and app quality. This yielded 26 Top Apps within top “Free and Publicly Available” apps and top “Clinical Rating” app classifications (see Exhibit 14). This number is less than the 32 that might be expected because certain Digital Health app categories did not have any high-quality free and publicly available apps (e.g., Diabetes Prevention, Atrial Fibrillation Screening, Cardiac Rehabilitation, Pulmonary Rehabilitation) or had a Free and Publicly Available app that also happened to be the top Clinical Rating app (e.g., the Walgreens app in the Prescription Refills category).
Certain characteristics of the Top Apps are descriptive of the current state of the art in Digital Health. The vast majority of Top Apps have at least one positive observational study demonstrating clinical efficacy (21/26; 81%). The majority of Top Apps are iOS apps (17/26; 65%), however most of these apps have Android versions with similar features, endorsements and clinical evidence. More than half (14/26; 54%) connect to an external sensor directly or via a hub such as Apple HealthKit. About one quarter (7/26; 27%) — including about half of the Top Clinical Rating apps — are not publicly available to patients and instead require a payer or provider organisation to contract with the developer. About one-fifth (5/26; 19%) are cleared by the U.S. FDA (MySugr, Kardia by AliveCor, BlueStar Diabetes by WellDoc, Propeller Health and reSET by Pear Therapeutics), but more (e.g., MoovCare by Sivan Innovation) may seek FDA clearance in the near future. A minority (3/26; 12%) have a proprietary device required to use the app (FitBit, Kardia by AliveCor and Propeller Health).
No Top Apps were originally developed by pharma. One of the 26 (MySugr) is currently owned by a pharma (Roche), however Propeller Health and BlueStar Diabetes have announced substantive partnerships with specific pharma companies and others including Medisafe have product offerings for pharma partners. Notably, only a small minority of these very high- quality apps (2/26; 8%) have been included in the NHS Apps Library (Beta), namely the OWise breast cancer app and the MyCOPD pulmonary rehabilitation app. These observations point to an increasingly clinically validated and sophisticated set of apps, but also incredible diversity in terms of business models that is likely to create significant procurement challenges for healthcare providers and payers for the foreseeable future. App accessibility and procurement by U.K. institutions and patients is further complicated by the fact that the majority of these leading apps have initially been built for a global or U.S. audience.
Adoption of Digital Health
Adoption of Digital Health by clinicians is increasing but is far from mainstream.
A variety of industry and policy initiatives have emerged to address barriers to adoption of Digital Health tools.
App curation initiatives, including the NHS Apps Library (Beta), are facilitating the creation of formularies of high-quality apps that meet quality guidelines.
High-quality Digital Health apps are now available for nearly every conceivable use along the patient journey. The value of many of these apps are now supported by compelling clinical studies that have shown the ability to improve human health and outcomes through the prevention and management of chronic disease. These outcomes benefits potentially create a new and significant opportunity for healthcare systems globally to reduce their costs, including the NHS.
Despite this promise, the adoption of Digital Health apps across the NHS is currently limited. While there are many anecdotal reports of pilot studies of Digital Health apps within the NHS, only a small fraction of published worldwide Digital Health efficacy studies have taken place in the United Kingdom. Separately, clinicians continue to see challenges to leveraging Digital Health apps in their practice. Common concerns include patient privacy and security, concerns around clinical value, concerns around malpractice liability, the lack of financial incentives, and lack of workflow integration. While Top Apps often address the usability and clinical value requirements
of healthcare providers, even these do not consistently meet the privacy & security, risk mitigation, financial incentives and workflow requirements of a typical NHS clinician (see Exhibit 18). To fully realise the value of Digital Health to the NHS, these provider requirements will need to be addressed.
Before healthcare can be more fully supported by apps and sensors, a new fit-for-purpose infrastructure must evolve to support their delivery and incorporation into the standard health toolkit, similar to the type of ecosystem that exists to disseminate safe therapeutics. Emerging accelerators of Digital Health adoption — including app curation platforms, privacy & security guidelines, inclusion in clinical guidelines, merit-based incentives associated with health outcomes improvements, and new interoperability standards — are beginning to create such an ecosystem.
Critically, app curation initiatives are facilitating the creation of formularies of high-quality apps that meet quality guidelines. One such set of guidelines is the Digital Assessment Questions (DAQs) developed
by the NHS, which provides guidance on required app parameters like clinical effectiveness, safety, privacy, security, usability, interoperability, technical stability, appropriate regulatory clearance and change management.
The NHS Apps Library, a library of apps that have successfully been vetted using the DAQs, helps by endorsing vetted apps for use by patients and clinicians. To the extent that the NHS Apps Library creates confidence in the listed apps, patients’ and clinicians’ apprehensions around app privacy, security and overall usefulness may be addressed. While the NHS Apps Library is new — only 2/26 of the identified Top Apps have been included Library to-date — evaluation and inclusion of such Top Apps is likely to continue, increasing the opportunity for the NHS to realise the value of Digital Health.
Perhaps one of the most vexing challenges to the adoption of Digital Health in the United Kingdom, and elsewhere, will be the careful management of how clinical evidence should be developed and reviewed. Historically, NHS institutions including NICE have shown a strong preference for clinical data derived from studies within the NHS itself. However, in the case of Digital Health, significant clinical evidence has been established outside of the NHS, but little internally. NHS England and NICE have presented a model which addresses this tension in their Improving Access to Psychological Therapies (IPAT) programme. This programme, which will assess 14 digital therapy products by 2020, identifies apps for the treatment of mental health conditions that have at least one positive RCT regardless of the geographic location of the underlying app and its studies. If initial assessments — which are based on the DAQs as well as NICE’s own clinical assessments — are positive, apps are matched with relevant IPAT service providers to test their real world effectiveness in the NHS. To assist with bringing apps into compliance with NHS requirements (e.g., the DAQs), NHS England provides some funding to app developers to support further technology development (e.g., new security features). If successful, this model could serve as a scalable template for how the NHS matches the world’s best apps with its local healthcare system and patient needs.
The NHS — given its long-time horizons in areas like chronic disease prevention — may be uniquely well positioned to realise the significant potential of Digital Health. In the past few years, this potential has moved from intangible claims to tangible benefits that can be calculated based on examples from an ever- expanding base of clinical literature and increasingly real world effectiveness data. To the extent that key policy setters are able to navigate a long list of potential market failures surrounding issues such as physician incentives and workflow integration, the use of Digital Health tools within the NHS is likely to accelerate, creating a bright future for NHS patients.
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