NICE publishes evidence standards for digital health technologies

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As digital health innovations develop at an increasing rate, it is important that they are clinically effective and offer economic value. NICE has published evidence standards for digital health technologies. These standards have been developed to make it easier for digital health innovators and commisioners to understand what a ‘good’ level of evidence looks like, whilst meeting the needs of the NHS and patients.

The intention is to provide organisations with a consistent framework to support their evaluations. Whilst both national and local organisations will be encouraged to adopt these standards when appropriate, they will not be mandated.

The evidence standards framework is made up of two sections:

  1. Evidence for effectiveness for intended use; and
  2. evidence for economic impact.

Both parts of the framework are intended to have a proportional approach to defining evidence standards. This is designed to recognise:

  • the sparsity of available evidence in the field of digital healthcare;
  • the challenges of developing traditional clinical trials for digital health technologies; and
  • the significant opportunities offered by digital health technologies to collect real world data to inform effectiveness judgments.

These standards are intended to directly support the relevant principles of the Department of Health and Social Care code of conduct for data-driven health and care technology.

The standards were developed by NICE between June and December 2018, in collaboration with various organisations including NHS England, Public Health England and MedCity. The work was commissioned by NHS England.

These standards will be further developed over time and a new iteration is planned for the end of January. In the meantime they are interested in feedback by 7th January, which can be provided via this survey.