Last year a working group led by NHS England, with NICE, MedCity, Public Health England and DigitalHealth.London formed to develop a set of standards to ensure new digital health technologies are both clinically effective and offer economic value, while meeting the needs of the health and care system, patients and users. The first version was launched in December 2018, followed by an updated edition in March this year.
As with all medical innovations, health tech products need to demonstrate evidence of clinical effectiveness and value. This is essential for patients, who deserve to receive only those technologies that have proven safety and clinical benefits. It is also important for healthcare systems, which need to know that their limited resources are being spent on new medical technologies that work and deliver economic value.
A collaborative working group consisting of NHS England, NICE, Public Health England, MedCity and Digital Health.London came together to look at how to make it easier for innovators and commissioners to understand what ‘good’ evidence for digital innovations looks like, while meeting the needs of the NHS and patients. The aim was to enable better NHS commissioning, as well as understanding of how the NHS makes decisions and the standards expected of SMEs. It would facilitate a dynamic, value driven market.
The evidence standards framework was developed over a six-month period through an agile, user-centric process. This included robust evidence-based framework development by the NICE team, refined iteratively through multiple stakeholder workshops, roundtables and meetings.
Innovation development is fast-moving by nature, and the resulting framework has been designed to be pragmatic and flexible rather than ‘perfect’.
Since the first publication of the standards in December, the NICE team has incorporated feedback from over 200 survey responses and published a second, updated version.
Members of the working group have been active in presenting the standards at industry, investor and NHS events, delivering hands-on seminars to accelerator cohort companies. The team have been invited to present the work overseas to the WHO, as well as to countries looking to England’s example in setting the direction for the evaluation and adoption of quality digital health technologies. This raises the prospect of the creation of harmonised evidence standards for digital health technologies, which would be invaluable to companies looking for a global market.
Application in practice
It’s a common misconception that the hard work ends once guidance, regulation or policies are published. In reality, the work is only beginning at this stage, as it’s then that we begin to measure impact through adoption and outcomes.
Embedding the standards is a shared responsibility and a continuous process, involving a digital ecosystem with multiple players. As with the collaborative development approach, this needs to involve industry, commissioners, AHSNs, academic researchers and regulators that are using the framework and can keep refining it.
Having accelerators, in particular, the DigitalHealth.London Accelerator and the NHS Innovation Accelerator use the standards framework to support and guide their cohort of companies in evidence generation has been an important tactic to gain early adoption of the standards within the SME base. The Generator, for example, is an initiative enable companies within the DHL Accelerator to evidence their products through partnerships with the academic research community. The DHLA programme assigns NHS navigators to each company and with support from partners including HIN and MedCity, has been using the evidence standards framework to support cohort companies develop evidence generation plans for their products to aid adoption. This has been done on a 1:1 basis as well as through workshops. In addition to this, the generator supports development of the appropriate research methodologies for products that align with the standards.
There are currently inconsistent approaches to the evaluation and take-up of digital healthcare products across the UK. The NICE evidence standards for digital health technologies provide an optional framework for manufacturers, research funders, investors and commissioners to use to assess new technologies, providing an authoritative and trusted point of reference and helping to encourage a better dialogue between the developers of technologies and the decision makers.
What the users are saying
“For all our projects, including our student projects and those we will do with industry partners, we are developing a scoring and categorisation system. In this way any project can be mapped to our priorities, the WHO digital intervention categories, and the evidence standards framework to determine what level of evidence would be required for potential clinical use.
The idea of this is to make it easy for us to report on the various different types of activities that we are doing and also so we can provide evidence where we are on the pathway for the various projects, in terms of how close or far away they are from being potentially usable. We are also trying to map any appropriate project to the NHSE guidance on best practice for AI, to demonstrate how the project meets all of the appropriate criteria. This is the approach being incorporated into everything from the planning phase forward. Of course, lots of the student projects are never destined to themselves end up as products for clinical use but are often explorations of early principles so not all of these elements would be applicable to every project.”
Prof Neil Sebire, DRIVE unit, Great Ormond Street
“Transforming Systems worked closely with YHEC and NICE on the evidence case for the Digital Health Technology Standards for WaitLess. It was a very well thought through process which drew our data sources together in a concise way. This has helped us to improve our presentation to Commissioners and providers. Having gone through the process of using the NICE framework has helped to give commissioners confidence about WaitLess’ impact. This has opened up several new opportunities for Transforming Systems. As it helps to remove barriers to sale, I believe it should be a key objective for SME’s to go through this process”.
Alistair Martin, Chief Commercial Officer, Transforming Systems
“As Digital Innovation Lead for an STP that has a 1/4 of all Londoners within the area to support for health, it has been difficult to encourage digital innovation, know what apps to recommend to patients and know what to commission. The financial climate for the NHS is constrained and each CCG has previously done its own commissioning, sometimes swayed by the promises from suppliers without being able to have a clear, robust and dependable ‘measuring stick’ to assess whether this is a good tool.
The evidence standards framework is the document that has enabled me to develop a framework where each digital tool we engage/procure we use the framework to localise our own processes which have enabled me to create a Digital App/Tool Board which has membership from the CCGs, Acutes, Councils to robustly assess effectiveness and economic impact. The framework and guide has given me the ability to use this board to filter through all proposals, which ensure that we are doing things ‘once and for all NWL’.
Those that are sceptical or find that the guide is ambiguous need to appreciate that this is a framework which is supposed to be localised and built upon. The framework delivers on its objective of providing a solid methodology to leverage the best in digital health for our population.”
Kwesi Afful, Digital Citizen and Innovation Lead, North West London CC
“The Generator is an initiative arising from a partnership with DH.L and its founding members to enable companies within the DHL Accelerator to evidence their products through partnerships with academic research community. The DHLA programme assigns NHS navigators to each company and with support from partners including HIN and MedCity, has been using the evidence standards framework to support cohort companies develop evidence generation plans for their products to aid adoption. This has been done on a 1:1 basis as well as through workshops. In addition to this, the generator supports development of the appropriate research methodologies for products that align with the standards.”
Paul Wallace, Clinical Director Digital, South London HIN, UCL Emeritus Professor of Primary Care and CEO FIDFMP