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, launching on 11 December, will support digital health innovators, grant funders and investors, and commissioners to understand what ‘good’ 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.

NICE Evidence Standards Framework for Digital Health Technologies

Following a series of workshops, case studies and meetings with key stakeholders including companies, commissioners, academics and clinicians, NHS England commissioned NICE to develop the Standards Framework.

The evidence standards are split into 2 evidence frameworks describing:

  • Evidence for effectiveness for intended use.
  • Evidence for economic impact.

Both evidence frameworks have a proportional approach to defining evidence standards. This recognises the generally lower levels of available evidence for digital health technologies (DHT) 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.

You can find a copy of these Standards from Tuesday 11 December on the NICE website and MedCity’s website here.