New changes to Evidence Standards Framework and Digital Health Technologies - what might they mean for your organisation?
The National Institute for Health and Care Excellence (NICE) has published new Evidence Standards Framework for Digital Health Technologies following an open consultation. Here, Fieldfisher solicitor apprentice, Megan Ford, outlines the changes and what you need to be aware of.
The National Institute for Health and Care Excellence (NICE) has recently published changes to its evidence standards framework (ESF) for digital health technologies (DHTs). The changes follow hot on the heels of updates to the ESF in August this year, that were made to include artificial intelligence (AI), data-driven technologies with adaptive algorithms, associate design factors and deployment considerations within the framework.
The ESF was introduced in 2019 (and amended in 2021) as a tool to drive innovation within the UK healthcare industry, whilst reducing the cost burden on the NHS. The ESF sets out a non-mandatory set of standards to be used by the NHS and care system in the evaluation and commission of DHTs. It is a key framework to consider when developing digital health technology intended for adoption within the NHS.
The ESF can be used by DHTs to demonstrate how they are expected to perform and provide good value for money to the health and care systems. However it's worth noting that meeting the standard does not mean that a technology has been assessed or endorsed by NICE for re-imbursement from the NHS but it should help to make the regulatory approval journey smoother.
Who does the ESF apply to?
The ESF applies to DHTs such as smartphone apps, standalone software, online tools for treating/diagnosing conditions and programmes that can be used to analyse data from medical devices such as scanners.
However, it does not apply to software that is integral to a medical device or in vitro diagnostic (IVD) and DHTs that are designed for providing training to health care professionals or which facilitate data collection in research studies.
The ESF distinguishes between three tiers of DHTs according to the risk they pose to the public and the healthcare system:
- Tier A DHTs are those which have no direct outcome on the patient, but which are intended to save costs or staff time (e.g. electronic prescribing systems that do not provide advice to patients, complex scheduling software)
- Tier B DHTs are those that assist the public to manage their own health (e.g. instant messaging apps for healthcare, symptom or mood diaries and programmes to aid weight-loss or better sleep)
- Tier C DHTs are those used for treating and diagnosing medical conditions, with direct health outcomes, and which are likely to be regulated medical devices (e.g. symptom monitors which share data with care teams, triaging systems that use patient health data to assist with care decisions and devices that perform diagnostic image analysis for making treatment decisions). Tier C DHTs are further split into four sub-groups, in line with the 'Software as a Medical Device Framework' issued by the International Medical Device Regulators Forum, namely those which: inform clinical management, drive clinical management, diagnose a condition and treat a condition.
The potential risk to service users varies according to which tier the DHT falls into; with Tier A DHTs posing the lowest risk to users and Tier C DHTs posing the highest. Accordingly, the evidence standards required for each tier varies proportionately to the potential risk.
What are the evidence standards?
There are 21 evidence standards which are divided into five categories, with the ESF setting out the details of the various standards and examples of how DHTs can evidence that they have met the standards.
- Design factors (standards 1 – 9);
- Describing value (standards 10 – 13);
- Demonstrating performance (standards 14 – 16);
- Delivering value (standards 17 – 18); and
- Deployment considerations (standards 19 – 21).
The 2022 amendments to the ESF
The most recent amendments to the ESF include the additions of design factors and deployment consideration standards. Design factor standards that a DHT may now be required to meet include;
- compliance with relevant safety and quality guidelines (Tiers A, B & C),
- consideration of environmental sustainability (Tiers A, B & C),
- the embedding of good data practices in the design of the DHT (Tiers A, B & C)
- showing that the DHT is credible with UK professionals (Tiers B & C).
Deployment consideration standards that DHTs may be evaluated against include ensuring transparency about requirements for deployment (Tiers A, B & C), describing strategies for communication, consent and training processes to allow the DHT to be understood by end users (Tiers A, B & C) and ensuring appropriate scalability (Tiers A, B & C).
The NHS AI Lab also funded NICE to update the ESF to include evidence requirements for AI and data-driven technologies with adaptive algorithms.
What's next?
The ESF is likely to develop in tandem with the changing landscape of DHTs and it is anticipated that the ESF will be reviewed annually to keep up with these changes. The next update to the ESF is anticipated to follow the Medicines and Healthcare Products Regulatory Agency's implementation of the 'Software and AI as a Medical Device Change Programme'.
It's important that DHTs keep up-to-date with amendments to the ESF in order to remain competitive when being evaluated by the health and care systems prior to commissioning.
You can find more information on the recent changes to the ESF and how these could affect your business on NICE's website (Overview | Evidence standards framework for digital health technologies | Guidance | NICE).
How we can help – and a note for your diary!
We plan to host a unique event in early 2023 bringing together key opinion leaders and decision makers from the world of digital health to explore the practicalities of deploying artificial intelligence in healthcare. If you would like to attend this event please let us know.
Register: Event - The Future of Public Procurement in the UK
We support many businesses with navigating the NICE Medical Technologies Evaluation programme. We work with those delivering diagnostic assessment, medical devices, screening tools and highly specialised technologies to understand how medical technologies will be appraised and evaluated, including attending NICE Committee meetings and appealing decisions where appropriate.
This article was authored by Solicitor Apprentice, Megan Ford.