The digital health landscape in the UK is complex and evolving, with many organisations involved it its regulation and functioning. Andrew Davies, digital health lead at the Association of British HealthTech Industries (ABHI) gives an overview of some of the key organisations and initiatives.

It is perhaps a fitting time to take a stock take of where we are on the journey to deliver digital heath solutions in the NHS. It was a decade ago, in 2011, that the National Programme for IT (NPfIT) was abandoned, arguably the low point in the NHS journey to digitisation. However, since then we have been on an upward trajectory, with some substantive policy work such as the Five Year Forward View setting out the (unrealised) ambition for paperless 2020, the Wachter review in 2016 crucially setting the tone for the further work, and the Future of Healthcare from the Department for Health and Social Care in 2018 getting more into the practical aspects, whilst the 2019 Long Term Plan built further on Wachter.

This has led to some important programmes such as the Global Digital Exemplars (GDEs), which have created just that, some world leading digital centres. However, as is often the case in the NHS, the consistent adoption of best practice, as highlighted in the GDEs, is still lagging, leading to a switch in emphasis from investing in the best, to supporting the next wave to improve their digital maturity through the Digital Aspirants programme.

A 2019 study by Bertelsmann Stiftung placed England sixth, compared to 16 other comparator countries. Those countries performing better than England, such as Israel, Estonia and those in the Nordics, tended to have a much smaller population, arguably making national programmes and adoption easier. The UK is still well placed when compared to most similarly sized countries, but I would say that some are closing, and fast.

Digital health in the post-pandemic world

So how is the UK faring today as we start to get our house in order post-EU exit and post-pandemic? At a recent ABHI Digital Health conference a wide range of organisations central to delivering digital programmes across the UK outlined the current state of play.

The regulatory system for HealthTech is in for a period of change, with proposed changes partly due to the need to create new UK legislation post-EU exit, whilst others are shaped by the evolving needs of the system in response to new innovations that offer systemic benefit, but often come with systemic risk. This was a key point raised by Johan Ordish, Deputy Director, Software as a Medical Device at MHRA, as he outlined to delegates the shifting legislative landscape as we transition from the European CE mark to a new UKCA mark. The systemic nature of the digital implementations also highlights a key challenge that digital health poses, that they fall into no one regulator’s domain, but several regulatory domains. This will require differing regulators to work tighter. The need to align the work of the different regulators is one that ABHI has been pressing Government to address so we are pleased to see the formation of the Multi Agency Advisory Service.

A number of speakers also expressed the desire to avoid “AI exceptionalism” and to handle AI in-line with other Software as a Medical Device (SaMD) on a risk-based approach. We can probably expect to see greater use of standards and guidance in this area, rather than legislation.

Updating processes 

Other regulators at the conference, including Health Research Authority (HRA) and NICE, outlined how they are aiming to update their processes and some common themes emerged with transparency and trustworthiness central to much of the thinking, but also how processes could be improved to streamline assessment and approvals.

These themes also carried through to the presentation from HDRUK where they outlined how, through their portal, they are surfacing the data resources available to health data researchers, as well as providing support for innovative uses of data and supporting with data analytic skills.

Building a high quality, accessible dataset and analytics capability in the UK is a critical element of the Life Science Vision. The UK has some inherent advantages within its system that we need to build on to maintain our international lead. It has been much touted that we have an unrivalled dataset, and whilst this is true, it is not the complete picture. We have the data, but it is not always well curated, or indeed easily accessible, particularly for industry. Access for industry to high quality data has been a continuing theme in ABHI responses to reviews by the Government such as the Goldacre review and the TIGRR review. The need to invest in our data assets has been recognised and we will be following the announcements in the upcoming spending review with interest to see if funding has been made available to support these efforts.

Creating the right ecosystem

However, it is not just the data assets that could set the UK apart, in fact there are a number of countries where certain data types are much easier to access than the UK, what we can do is combine that data resource with the skills of leading clinical and academic centres. And it is that combination that can set us apart on an international stage.

The ABHI conference also heard from organisations representing Wales, Scotland and England on the work being undertaken to create the right ecosytem for digital service delivery. Of course, data was central to this and included investment in infrastructure, curation governance processes and interoperability.

From a policy perspective, from a process perspective and from the great strides the NHS has made in implementing digital health technologies we can see a positive trajectory in realising the Life Science Vision: to make the UK the home for health innovation. But there are several elements that are not yet in place that need to be to realise this ambition. Key amongst these is funding, reimbursement and incentives which will be critical for both front line organisations to be able to ‘pull through’ the required technologies, and to ensure innovators have a receptive market to support adoption. There should be appropriate transparent, streamlined and risk-based assessment processes to access this funding.

I look forward to returning to these pages to go into more depth on the topics that I have outlined and how the system can support development and deployment of digital heath technologies to deliver improved system efficiency, better patient outcomes and experiences, and create the ecosystems that will enable companies to invest and grow in the UK.