NICE ESF: The what, when and how?
This month, the UK's National Institute for Health and Care Excellence (NICE) released the latest evidence standards framework (ESF) for digital health technologies (DHTs).
It was in collaboration with NHS England, Public Health England, MedCity and public consultation (and as an expert in digital health, I was involved too). It's easy to see how standards updates can be confusing, however this update is an important one, and benefits everyone across the industry, from developers, through to healthcare services and patients.
What is NICE ESF?
The NICE ESF is the evidence standards framework that we at Hardian recommend to digital health manufacturers. It consists of 24 standards collated into five groups, and provides clear guidance on the evidence needed for a NICE health technology assessment (HTA). Not only is it an important resource for digital health and healthtech companies, it can also used by NHS health and care services to help commissioners evaluate and inform DHT commissioning and purchasing decisions.
Why does it matter?
Digital platforms, software, and apps are intended to measurably improve people's health or the overall health and care system, fall under the regulatory category of DHTs. The recent surge of the solutions presents both opportunities and challenges to healthcare systems looking for new ways to facilitate efficient, low-cost, patient-centered care at scale. Due to the rapid pace of development, any DHTs destined for use in the NHS MUST be subjected to rigorous and consistent evaluation of, not only security and privacy, but clinical efficiency and cost effectiveness too.
Regulation can often be seen as a stifler of innovation, when in fact, the reverse is true; neatly summarised by The Lancet: “Without a clear framework to differentiate efficacious digital products from commercial opportunism, companies, clinicians, and policy makers will struggle to provide the required level of evidence to realise the potential of digital medicine.”
There are lots of factors that might make bringing a healthtech solution to market difficult, but regulatory and evidence frameworks don’t need to be one. Whether you consider frameworks like ESF to be a barrier to innovation or not, they’re necessary to protect patients, clinicians and the NHS, so demonstrating adherence and compliance to the necessary standards, sets your healthtech solution, and your company up for success too. To be frank, if you are attempting to enter the market without adhering to these standards, you’re setting yourself up to fail.
Some companies walk the fine line between a wellness DHTs and a medical device, to avoid regulation as it is perceived to be too complex - however, this update gives explicit guidance on how to ensure any given DHT has the best possible chance of success in the NHS market. Not only that, Hardian Health has a wealth of experience in guiding companies through the process and meeting the standards.
The NICE ESF update made simple
Helpfully, the update has mapped out the most up-to-date regulatory framework based on a solution’s classified risk (see figure 1), including internationally recognised standards. For example, DHTs in tier C are divided into four classification groups to align with the Software as a Medical Device (SaMD) classification framework proposed by the International Medical Device Regulators Forum (IMDRF). Each ESF standard applies to some or all of the groups depending on a DHTs tier classification; as it stands, most Class I medical devices will likely fall into tier two, and any devices Class II and above will fall into tier 3. The Medicines and Healthcare products Regulatory Agency (MHRA) has a helpful guide that explains medical device classifications. If you’re not sure where your DHT fits, it's a good place to start. If you’re still not sure, get in touch with us - we live and breathe intended use and risk classification!
So what does each group of standards actually mean? Let’s break it down.
Design factors: Key aspects of the design process that impact a DHT's value to the health and care system, including ensuring appropriate technical standards for safety and reliability (quality management and cyber security).
Describing value: The information required to demonstrate a DHT value proposition (claims and benefits).
Demonstrating performance: Meeting performance expectations and demonstrating that a DHT can achieve the efficacy and efficiency benefits it is purported to (via clinical investigations).
Delivering value: Money. Evidence of economic impact and financial value for care services (also known as health economics).
Deployment considerations: Demonstrating that a DHT can actually work in practice alongside or integrating with existing systems, services, processes and workflows (usability, software deployment).
Companies need a deep understanding of the regulatory pathway in the context of the solution they provide. It is also important to be able to demonstrate how the DHT changes a clinical care pathway - including an in-depth analysis of the impact on clinical performance and the economic value proposition. Without this, it will not be able to enter the NHS and social care markets.
Here’s the TLDR: Demonstrating real-world clinical evidence, economic evidence, and understanding of the regulatory pathway of your DHT is incredibly important!
How can healthtech meet NICE ESF?
We’re specialists in protecting, regulating and validating healthtech solutions and have been working with regulatory frameworks for a longtime. Our multidisciplinary team understands these frameworks and standards, and has extensive expertise in working with companies to develop the real world clinical and economic evidence to meet them.
There are many ways we can and do support our clients, so here are just a few examples of how we can help you navigate the NICE ESF:
Development of the intended use statement and purpose, which is a cornerstone regulatory document required to fully evidence the value proposition.
Strategic support for clinical investigations, literature research, and monitoring, to generate the substantial clinical evidence required to fulfill the standards set by NICE ESF.
Budget impact analysis and creation of economic models for specific DHTs to help companies better understand, and define the exact economic value proposition for the NHS.
Creating a cohesive go-to-market strategy incorporating sequencing and co-ordination of all the above, as well as identifying routes to market (including a submission for a NICE HTA).
Remember, getting healthtech to market doesn’t have to be difficult. We’re here to make it simple. So, if you want to find out more about how we can help your company, you know where to find us…
