Citation and selected extracts below. Full text here: https://doi.org/10.1016/S0140-6736(18)33129-5
CITATION: Felix Greaves et al. What is an appropriate level of evidence for a digital health intervention?
The Lancet 2018; Comment| volume 392, issue 10165, p2665-2667, december 22, 2018
'Digital technologies — eg, apps, wearables, and software algorithms — have the potential to support a technology-enabled health system in which care interactions are moved away from formal settings and citizens are encouraged to manage their own health and illness', but they should be subject to the same rigour as is already held for other interventions such as medicines and medical devices, say the authors of this Comment in The Lancet...
The authors, from NHS England, National Institute for Health and Care Excellence, Public Health England, and Med City, have developed and launched an Evidence Standards Framework for Digital Health Technologies This framework 'provides standards for the evidence of effectiveness and economic impact for digital health interventions'...
'The framework is founded on a proportionate approach to risk, determined by the functionality of the digital tool. A hierarchical classification identifies the level of evidence appropriate for the intervention. For example, digital tools that provide diagnosis or treatment are in the highest level... Support services and technologies designed to simply communicate information are lower in the hierarchy and the requirements are therefore designed around the credibility and accuracy of the content, including whether they meet established standards for the quality of the information provided...
'While the focus is on the UK, the authors note that 'Regulators and health systems around the world are facing similar challenges, and looking to create proportionate and dynamic solutions. The proposed approach in the Evidence Standards Framework for Digital Health Technologies should have relevance for other jurisdictions that are also facing the dilemma of how to balance rigour and innovation. These two attributes need not stand in tension.'
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Coordinator, HIFA Project on Evaluating the Impact of Healthcare Information
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