NICE updated the Evidence standards framework for digital health technologies

On August 09, 2022, NICE updated the Evidence standards framework (ESF) for digital health technologies (DHT), initially published in 2018. The framework has the following objectives:

• To make it easier for innovators and commissioners to understand what good levels of evidence for DHT look like;
• To help innovators understand how to demonstrate the effectiveness and value of a DHT when submitting their technology for NICE evaluation or selling directly to the NHS;
• To help commissioners to make more informed and consistent decisions when purchasing DHT.

The following changes were made in the updated version of August 2022:

• Evidence requirements are included for artificial intelligence (AI) and data-driven technologies with adaptive algorithms
• Digital health technology classifications were aligned with regulatory requirements;
• ESF became easier to use;
• NICE introduced a subset of early deployment (ED) standards that could be used to evaluate the suitability of DHTs for inclusion in evidence-generation programs. The ED subset includes 16 standards related to design factors, describing value, demonstrating performance, and deployment considerations.

See the full details here.

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