The aim of these standards is to make it easier for innovators and commissioners to understand what good levels of evidence for digital healthcare technologies look like, while meeting the needs of the health and care system, patients, and users. The standards also improve the approach to developing and commissioning digital health technologies, by making it more dynamic and value driven, with a focus on offering real value to patients. NICE have created the standards as part of a working group led by NHS England.
“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,” says Alexia Tonnel, Evidence Resources Director, NICE.
The evidence standards framework is made up of 2 sections:
- Evidence for effectiveness for intended use
- Evidence for economic impact
Both parts of the framework have a proportional approach to defining evidence standards. This recognises:
- the sparsity of available evidence in the field of digital healthcare
- the challenges of developing traditional clinical trials for digital health technologies
- the significant opportunities offered by digital health technologies to collect real world data to inform effectiveness judgements.
NICE has also published a budget impact template to support digital health innovators in using the economic impact standards.