In this new digitalised and patient-centred era, robust real world data and evidence will be vital to maximise the potential of revolutionary digital innovations for the benefit of patients and healthcare providers. As specialists in real world data and evidence, pH Associates welcomes the developments in Digital Health. Senior Analyst and Scientific Consultant at pH, Fiona Glen discusses this further in this article.
Despite being one of the largest and most rapidly growing sectors in the world, the healthcare industry has generally stuck stringently to a reactive, treatment-focused model.
However, with many services close to breaking point, and power shifting rapidly towards technology and the patient themselves, there is heightening pressure on the industry to capitalise on other forms of innovation in order to offer a more proactive, personalised, and cost-effective approach to disease prevention and management.
A key factor in enabling this transformation will likely lie within the digital health sector. The global market for digital health is expected to reach almost £43billion in 2018 and £408billion by 2025, with research suggesting that mobile and digitally enabled technology has the potential to substantially improve patient outcomes and reduce healthcare costs.1-2
The new opportunities offered by digital health are bountiful, with a variety of uses ranging from disease detection and diagnosis, self-management of chronic conditions, psychological support and clinical decision-making.
For example, some of the current offerings available on the market include:
- Smartphone apps that encourage users to record data in order to self-monitor and self-manage their conditions e.g. Sleepio; My COPD
- Applications that use social networks for support and encouragement e.g. HealthUnlocked; PatientsLikeMe.
- Technology that links to healthcare systems, using apps/devices to monitor conditions in real-time e.g. AliveCor; Dexcom G5® or to enable more efficient diagnosis and access to care e.g. Peek; DrDoctor.
- The application of predictive analytics to complex datasets for optimisation of diagnosis or management e.g. Babylon Health, DeepMind.
This new, person-centred and technology-driven approach has also created openings for new players to break into the market.
While the pharmaceutical industry has traditionally stood at the forefront of the healthcare industry, the recent shift towards digitalisation has meant that giants such as Google, Apple and Amazon have begun to diversify into the healthcare arena. Many investors are also keen to support start-ups and SMEs who apply AI and technological approaches within a healthcare environment, with non-profit companies also keen to harness technology to solve problems and improve access to care.
In this busy space, there is therefore an increasing need for standardised, evidence-based approaches in order to encourage the implementation of the most innovative and effective innovations within healthcare services.
Changing UK and European priorities
In their recent report, the European Commission recognised the potential of digital technology for tackling some of the key health-related challenges currently being faced across Europe, such as the increasing burden on healthcare systems due to the rapidly ageing population, staff shortages, as well as inequalities in access to care. The Commission also responded to the findings of a recent public consultation, which highlighted a desire amongst members of the public to be able to securely access and share their health data, and to be able to provide feedback on their care and treatment.
One of the priority areas set out in the report was to support the development and uptake of innovative digital-based healthcare solutions across borders, by introducing common principles and certifications, exchanging knowledge and technical assistance, and mobilising public funding.
The commission also recognised the need to harness real world data ‘to ensure that healthcare products, innovative technologies and therapies meet patients’ needs and lead to favourable health outcomes’.
Similarly in the UK, a number of initiatives have been introduced within the NHS in order to encourage the development of revolutionary health technologies and to facilitate their implementation within healthcare services.
In their Five Year Forward View, the NHS committed to ‘leverag the potential of technology and innovation, enabling patients to take a more active role in their own health and care while also enabling NHS staff and their care colleagues to do their jobs’.
This ambitious goal will require not only the development of innovative solutions to address current barriers within the system, but also the engagement and support of those working within the NHS to routinely implement these solutions and maximise their potential within clinical practice.
One method of engaging stakeholders will be to provide robust evidence that demonstrates that a new approach is effective and that it will improve patient outcomes and save costs- a stance that is becoming increasingly common within the NHS.
For example, in order to help encourage the adoption of digital solutions, the NHS has identified a number of “Digital exemplars”- organisations that will act as world class exemplars for the rest of the NHS to learn from, in the hope that this will help reduce the time and cost needed for further adoption of new approaches.
The NHS Innovation Accelerator, a national programme committed to facilitating the uptake and spread of high impact, evidence-based healthcare solutions, was also recently introduced. A total of 37 innovations have been supported since the launch of the programme in 2015, which have since been implemented in over 1000 NHS and international organisations for the benefit of patients, staff and the wider population.
Similarly the Innovation and Technology Tariff (ITT) was introduced in 2017 to incentivise the adoption and spread of transformational innovation, including those technologies supported by the Innovation Accelerator. Previously, there was no clear way for the NHS to purchase digital solutions, as opposed to the systems in place for accessing new equipment or drugs. The new ITT will enable NHS Trusts and CCGs in England to use evidence-backed innovations either for free or to claim a charge per use.
NHS Digital also recently relaunched their NHS apps library. Listing only a specially selected cohort of apps which are supported by a solid evidence-base demonstrating their value and effectiveness, the library will enable patients and healthcare professionals to seek out the best option to fit their needs.
Moreover, the National Institute of Health and Care Excellence (NICE) have been commissioned by NHS England to publish Medtech Innovation Briefings, which outline relevant published evidence and costs associated with new medical technologies. Unlike the NICE HTA programme, these briefings are optional, but provide commissioners and staff with the relevant information they may need to make a decision as to whether or not to adopt a new innovation locally.
What is “good” data and evidence?
Despite these positive steps, the next stage will be to support stakeholders with this decision-making process, by providing guidance as to what “good” evidence actually looks like. As an increasing number of patients begin to engage with technology to take control of their medical conditions, it will also be important to harness these data in a safe and robust manner, in order to continuously improve patient outcomes and wider clinical care.
In order to help tackle this challenge, the Clinical Digital Council (CDC)1 was set up in 2017. The CDC consists of senior clinical digital health leaders from key healthcare bodies such as the MHRA, NICE, Care Quality Commission, Public Health England, NHS England, NHS Digital and the Department of Health.
A key aim of the CDC will be to develop new standards and frameworks in relation to digital health, which will include providing guidance on how to design and appraise real world evidence studies to inform the effectiveness of new innovations, and how best to utilise real world data generated from digital technology on a wider scale.
As specialists in real world data and evidence, pH Associates welcomes these developments. In this new digitalised and patient-centred era, robust real world data and evidence will be vital to maximise the potential of revolutionary digital innovations for the benefit of patients and healthcare providers.
If you would like to discuss anything in this article, or to have a conversation about your specific real world evidence needs, then please contact Amanda Pulfer or Sam Oliver, Joint Managing Directors at pH Associates Ltd.