Evidence Standards Framework for Digital Health Technologies
Sector insightsn evidence standards framework from NICE that explains what digital health technologies need to demonstrate on effectiveness and economic impact to support adoption in the UK health and care system.
Overview
The Evidence Standards Framework for Digital Health Technologies is a NICE guidance document, commissioned by NHS England and developed in collaboration with NHS England, Public Health England and MedCity. It describes the evidence that digital health technologies should provide to show their value in the UK health and care system, including evidence of effectiveness and of economic impact relative to financial risk. The framework introduces functional classifications and four cumulative evidence tiers, which align evidence expectations with the level of risk and intended use. It is designed for technology developers planning evidence strategies and for decision makers considering whether to commission a digital health technology. Alongside this document, NICE has published a user guide and case studies that show the framework in use.
Key takeaways
- Tiered standards matched to digital health riskThe framework classifies digital health technologies by function and places them into four cumulative evidence tiers, so that higher risk functions such as treatment, diagnosis and active monitoring must meet more demanding effectiveness standards as well as all lower tier requirements.
- Evidence for effectiveness and economic impactThe framework sets out what good evidence looks like for both clinical effectiveness and economic impact. It covers credibility with professionals, relevance to UK care pathways and user acceptability, and links these to economic information, appropriate analysis and clear reporting standards.
- A practical tool for developers and commissionersTechnology developers can use the framework to plan evidence generation that matches their product’s function and risk, while commissioners can use it to assess whether a technology’s evidence base is sufficient to support adoption, business cases and investment decisions.
