A refreshed evidence standards framework for digital health technologies

Updated NICE Evidence Standards Framework for Digital Health Technologies now available.

Earlier this month we released an updated version of the evidence standards framework for digital health technologies which includes several user-led improvements.

The evidence standards framework (ESF) is designed to be used for digital health technologies that are being considered for commissioning in the UK health and care system.

Digital health technologies have the potential to empower people, allow more convenient care, reduce numbers of appointments, and help people who may be isolated from standard care. They are often highly scalable with low costs.

The new version of evidence standards framework includes some important updates such as renaming the evidence tiers to avoid confusion with the MHRA classification system for medical devices, improving the clarity of advice on which digital health technologies belong in which category, and on the naming of the functional categories.

But we know there is a lot more work to do.

In fact, planning is already underway for the next update of the ESF, which we’re aiming to publish in Autumn 2022. We will seek to fully incorporate digital and data driven technologies with embedded artificial intelligence (AI), including those that utilise adaptive algorithms.  To achieve this, we’ll be working with stakeholders and partners from across the globe to inform our work and ensure our approach is both proportionate and pragmatic. 

So far, we’ve commissioned work on the classification of AI technologies so that we can begin to consider and describe the levels of evidence and types of studies that should be generated (and that the health system should be looking for), to demonstrate that these technologies work and offer real value to patients and the health and care system.  

New Office for Digital Health

The virtual door has swung open and NICE has launched its Office for Digital Health.

This new in-house team has been set up to help accelerate NICE’s efforts to deliver innovation to the health and care system faster, support the growing digital health sector, and closely monitor NICE’s evolving methods and processes to ensure they fully accommodate new and emerging digital health technologies.

The Office for Digital Health will provide a single point of contact for anyone who wishes to engage with NICE about digital health technology assessment, from our strategic partners to developers and adopters.

They will coordinate NICE’s digital health activities and strategic projects and help us to collaborate with external partners across government, Arm's-Length Bodies (ALBs), industry and academia on partnership projects. This dedicated resource will also lead digital health policy at NICE, developing and embedding NICE specific policy across our guidance development programmes and raising awareness of the broader policy landscape. 

The Office for Digital Health will also triage digital companies’ enquiries and appropriately direct them to the most suitable team within NICE or to our system partners who will provide appropriate support.

Hot off the starting line, the team will initially be focused on our next Evidence Standards Framework update, strengthening our digital health horizon scanning capabilities and working closely with the MHRA to explore the possibility of developing an innovative regulatory and access pathway for data driven technologies, where there is a critical patient and system need.

Through this office, we aim to improve patient access to the best digital health innovations, by providing leadership on assessing value, setting universal data and evidence standards for new and emerging digital health technologies. NICE’s new team will enable us to build on our existing expertise in health technology assessment and work towards our ambition of being at the forefront of anticipating and rapidly evaluating new and emerging technologies.

This is an exciting step forward for the organisation, and last year we completed a pilot project to test our methods for evaluating digital health technologies to ensure they were robust. This project was a success and resulted in the publication of MedTech guidance for the Zio XT Service, for detecting cardiac arrhythmias.

The Office for Digital Health team can be contacted via digitalhealth@nice.org.uk