Neelam Patel, Chief Operating Office, MedCity
Indra Joshi, Digital Health and AI Clinical Lead, NHS England
Have you ever woken up from a recurring dream? Your mind claws at the images of the dream and half asleep you try to guide them to the conclusion you desire, but the more you try to guide your thoughts, the more conscious you become. Eventually you wake with a feeling of something just beyond your reach, and you lie there pondering, if only you could fall into that dream again you might just reach a fitting end. When we think of evidence in digital health and innovation we are often left with this feeling. Is clarity on standards for evidence in digital health and innovation still a blur in our imagination or are we at the point that we are now visualising this dream and starting to realise it?
In a recent publication by the New Statesman, John Bell writes that the key challenge is obtaining sufficiently robust evidence of how innovative technologies work in the real world, he goes on to say that for them to be implemented effectively and to lead to genuine cost savings from the adoption of innovation we need to understand how these technologies can be used to change care pathways and significantly reduce cost across the system by working closely with healthcare systems such as the NHS.
He is not a lone voice, the digitalhealth.london programme, nearly three years ago, with their collaborative partners, including the heads of London’s Academic Health Science Networks (AHSNs), identified three areas that needed to be at the heart of the programme’s work: evidence, evidence, evidence.
As documented in a report published by BSI, DH.L and MedCity in 2017, the issue is not the lack of guidance, but making the large amount of published guidance out there relevant and accessible to innovators. The report noted the evidence themes that Stakeholders such NICE, MHRA, HRA, SMEs, AHSNs, NIHR, considered relevant to the deployment of digital health technologies, and at which point of the innovation journey these would need to be demonstrated.
We have made some positive steps in this space, last year NICE produced a sample of Health App Briefings, reporting on the evidence generated by medical technologies and their effectiveness in healthcare systems. Last year, digitalhealth.london published a blog on the work that the evidence workstream was undertaking to simplify the landscape and remove the barriers for faster innovation development. Since then, the work has moved forward and it is clear that in order to make these ambitious changes, we need a system-wide approach with organisations working collaboratively at national and regional level and including government and industry.
Work is underway across organisations to offer a tangible set of standards and guidance that takes into account what the innovative technology is, the risk it entails and accordingly what level of evidence would be suitable for a commissioner to be confident that is has reached the required mark.
The dream at the edge of our fingertips will become a reality. We will see innovators knowing the steps and standards they need to follow in order to properly test their technology and generate evidence that is relevant and evaluated consistently to support payer decision-making. We will see evidence that is generated through trials, pilots and evaluations based on RWD, both positive and negative, that is disseminated and available for shared learning and faster and more consistent adoption, and lastly we will see across the healthcare landscape informed clinicians having easy access to the right evidence-based technology tailored to their patient’s needs and users providing real world data to ensure ongoing surveillance of the technology and its safety and efficacy.
With technology changing at a fast pace, can we ever be definitive in setting evidence standards for digital health you may ask? Defining standards and guidance must be a process that is adaptive and agile. It requires connectivity between organisations and innovators to monitor and learn from successes and failures, it also requires a shift in culture and mindset to enable this collaborative approach. The fact that stakeholders such as NHS England, NHS Digital, NICE, BSI, Innovate UK, MedCity, DH.L and AHSNs are engaging in this topic together is a huge step forward.
By designing the solutions that solve a problem and collect the needed data sets that impact healthcare outcomes, we are one step closer to producing solutions needed by the healthcare system. The dream may yet end in way we desire.