Out-Law News 1 min. read

New evidence standards set for digital health tech

New evidence standards have been developed to help inform investment in new digital health technologies by NHS bodies in England.

The standards have been published by National Institute for Health and Care Excellence (NICE), which worked in partnership on their development with NHS England, Public Health England, MedCity and DigitalHealth.London.

The development of the standards was welcomed by Louise Fullwood, a specialist in digital health at Pinsent Masons, the law firm behind Out-Law.com.

"At present there are a large, and increasing, number of digital technologies available or being developed, but with variable levels of evidence as to their usefulness or accuracy" Fullwood said. "The introduction of standards will put digital technologies on a footing more akin to medicinal products and medical devices, particularly for the higher tier digital technologies where comparative studies, similar to clinical trials in some respects, will help to develop evidence of effectiveness."

"This can only be helpful in providing evidence to encourage healthcare providers to make more use of digital technologies – and to prevent resources being wasted on technologies which are unable to demonstrate a genuine benefit to patients," she said.

There are two elements to the standards framework. The first element is aimed at ensuring digital health technologies are assessed for effectiveness, while the second element is designed to ensure their use delivers economic impact.

In a blog, Dr Indra Joshi, clinical lead for NHS England’s digital experience programme, said: "Developing new standards for health technologies like apps and wearables devices in the dynamic, fast-paced world of digital health was always an exciting challenge for us. Today we have published the NICE Evidence Standards Framework supporting digital health innovators, grant funders, investors and commissioners to understand what a ‘good’ level of evidence looks like."

"Enabling the categorisation of digital health technologies by functional classification helps ensure that evidence is both relevant and proportionate. Our new framework 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, by examining both evidence of clinical effectiveness and economic impact," she said.

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