NICE have published their ‘Evidence Standards Framework for Digital Health Technologies’. These new standards aim to assist people in the industry in understanding what evidence is required in introducing their product to the NHS.
The standards were the product of a collaborative industry engagement conducted by NHS England, NICE, MedCity, Public Health England and DigitalHealth.London. Th report is split into two sections which regard:
- Evidence for effectiveness for intended use
- Evidence for economic impact
NICE say that both of these sections take a proportional approach in defining evidence standards. This approach 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 cite the growing influence that digital technology is having in everyday life and also its uses in the diagnosis, treatment and monitoring of health as the rationale for their development.
“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.” – Alexia Tonnel, Evidence Resources Director NICE