Objectives

NICE’s evidence standards framework (ESF) was published in 2019 to help innovators and commissioners understand what good levels of evidence for digital health technologies (DHTs) look like. Since then, these technologies have evolved with many now utilising artificial intelligence. Also, regulators have started to develop clearer regulation criteria for medical device software. NICE therefore is updating the ESF to reflect these developments and improve its useability. Here we present the foundations of the updated framework.

Methods

We used an agile and iterative methodology to revise the structure and content of the ESF. This involved a review of the regulatory and HTA landscape for DHTs; iterative engagement with stakeholders through feedback on earlier ESF versions and a series of workshops followed by a public consultation on the draft standards

Results

We updated the ESF classification system from a function-based taxonomy to an intended-use classification consisting of 9 categories that are grouped in 3 tiers based on risk to the end user. The highest tier is designed to align with the regulatory framework so most DHTs in this tier will be medical devices, In the revised ESF we integrated the effectiveness and economic standards into one set of standards and restructured the evidence domains and contextual questions using a modular approach. We simplified the structure of the ESF to include a single level instead of minimum and best practice levels. Additional questions are integrated in specific evidence domains to identify technologies which need to meet a higher evidence standard. The modular structure of the framework should improve the usability of the ESF and allow it to be used as an interactive tool.

Conclusions

The updated ESF is a comprehensive tool for developers and evaluators to assess the value of digital health technologies for health and care providers.