NICE Evidence Standards Framework for Digital Health Technologies

Commissioned by NHS England, the National Institute for Health and Care Excellence (NICE) has developed the Standards Evidence Framework using a co-design approach, with extensive input and case studies from stakeholders including companies, commissioners, academics and clinicians

The evidence standards are split into 2 evidence frameworks describing:

  • Evidence for effectiveness (EfE) for intended use
  • 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 at