NICE Evidence Standards Framework for Digital Health Technologies

As digital health innovations have developed at an increasing pace, it has been a challenge to identify which are clinically effective and offer economic value.

The Digital Health Evidence project, led by NHS England, NICE, Public Health England, MedCity and DigitalHealth.London, aimed to develop digital evidence standards to address and streamline support on this issue.

The NICE Evidence Standards Framework launched on Monday 10th December and will support digital health innovators, grant funders, investors, and commissioners to understand what a ‘good’ level of evidence looks like. The framework, aimed at supporting evidence of effectiveness and economic impact, is intended to support evidence generation plans for digital health innovations and to help inform the judgement of evaluators about the quality and relevance of the evidence base.

The evidence standards are split into 2 evidence frameworks describing:

  1. Evidence for effectiveness (EfE) for intended use.
  2. Evidence for economic impact (Ei).

Both evidence frameworks have a proportional approach to defining evidence standards. This recognises the generally lower levels of available evidence for DHTs and the challenges of developing traditional clinical trials, but also the significant opportunities for collecting real world data to inform effectiveness judgements.

The framework has been designed with a range of intended users in mind:

  • Technology developers, including commercial organisations of any size, when considering the appropriate evidence generation plan for an individual DHT;
  • Grant funders and investors who are considering funding the development of DHTs
  • Evaluators and others, including commissioners, to help reach a judgement on the evidence requirements for DHTs as a group, and individual DHTs being considered to be commissioned at public expense.

The Standards Framework are now live here

Find out more by reading this presentation.

Watch the video about the project and the potential impact of the standards here.

For enquiries or feedback on the Standards, please contact Phil Boorman, External Communications Manager at phil.boorman@nice.org.uk

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