NICE has worked with partners to develop standards that ensure new technologies are clinically effective and offer economic value.
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.
NICE have created these standards as part of a working group led by NHS England. The group also includes Public Health England, MedCity and DigitalHealth.London.
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.