NICE publishes new standards to develop digital health technology

new standards to develop digital health technologies

New standards, published today, set out the requirements needed to develop digital health technologies for the NHS and speed uptake of products like healthcare apps and wearable devices.

The digital revolution is rapidly evolving and new technologies such as apps and wearable devices are emerging at a fast pace. NICE has created a set of standards to help developers and investors understand what evidence is required to introduce their product for use in the NHS.

Working collaboratively NHS England, NICE, NHS Digital, MedCity, Public Health England and Digital Health London have been engaging with industry, commissioners and innovators to understand what is required for health technology to thrive in the UK. The resulting standards have been developed to support digital health technology development and provide guidance on what evidence is needed when innovators present their products to NHS commissioners.

Digital technology increasingly plays a key part in everyday life and with people regularly relying on digital products to manage aspects their life, they are now using these services to help diagnose, treat and monitor their health. This has the potential to radically change the way care is planned, provided and received but the uptake of innovations can be slow.

It is vital, therefore, to make sure that the appropriate standards and guidance are in place to ensure digital innovators are given the support they need.

Split into two, the new standards address both clinical and economic impact and what evidence is needed to develop a case for use in the NHS. They also equip commissioners so they know what information to ask for from technology developers and understand what to expect in return. This will enable the health and care system to identify which products show promise, which ones need further development and which ones are unsuitable.

The evidence required is measured against the risk of a new technology. Therefore embedded in the standards is a way of classifying and categorising digital health products, against any potential risks they may have in how they work or for their use with patients. This ranges between a scale of 1 and 3b, the latter being the highest category. Lower categories focus on apps that provide information and advice on healthy lifestyles or collect information for personal health diaries. Higher categories can include technologies that perform clinical calculations or use data to diagnose a condition to inform decisions made by healthcare professionals.

Alexia Tonnel, NICE Evidence Resources Director, said: “The new standards will make it easier for innovators and service commissioners to understand what a good level of evidence for new digital products looks like. This will enhance understanding between innovators and healthcare commissioners; supporting the way in which promising, value driven technologies are introduced into the NHS for the benefit of clinicians and patients.”

Dr Indra Joshi, Digital Programme Clinical Lead at NHS England, said:“The NHS needs to be sure any new digital tools are backed by appropriate evidence and these new standards, developed in partnership with NHS bodies, industry and academia, will be the start of that dialogue of defining what “good” looks like in digital health technologies.”