28 May 2021
Earlier this month, the National Institute for Health and Care Excellence (NICE) made two welcome and forward-thinking announcements, some might say, not before time.
Firstly, they released an updated version of the evidence standards framework (ESF) which is designed to be used for digital health technologies being considered for the UK health and care system.
Covid has massively accelerated the take-up of digital health technologies, particularly Telehealth, but other patient facing digital products as well. The application of digital health has a huge potential to streamline processes, provide access to people who may be isolated from regular access to healthcare and provide a more convenient and scalable solution to patient/clinician appointments.
The new ESF will (finally) differentiate between digital health and medical devices, as well as improving the clarity of advice regarding classification and categorisation.
This will be an interim measure – a further clarification will be published in the third quarter of 2022, to take into account the digital and data driven technologies with embedded artificial intelligence (AI), including those that utilise adaptive algorithms.
The second innovation is the introduction of the NICE office for Digital Health, with an in-house team to help accelerate the adoption of digital technologies and the growing digital health sector as a whole.
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 explore the possibility of developing an innovative regulatory and access pathway for data driven technologies, where there is a critical patient and system need.
Although discussions of digital technologies and artificial intelligence (AI) are not new, the vague and often burdensome evidentiary framework means that many AI and algorithm-powered tools that can, for example, triage patients and diagnose conditions are not commercially available. However, many are now at the planning and development stage. NICE is looking to get ahead of the curve by taking a more innovative approach to assessing new technologies and guiding manufacturers about the data requirements. Other countries are likely to follow, or at least refer to, the models it is setting up.
