Corporate document
Section C: Evidence standards tables
The NICE evidence standards framework (ESF) has been designed to inform the evaluation of digital health technologies (DHTs) for use in the NHS and social care system. The standards are presented in groups related to phases of the DHT product life cycle. There are 21 standards arranged in 5 groups:
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Design factors: The 9 standards identify key aspects of the design process that impact the DHT's value to the health and care system, including ensuring the technology has the appropriate technical standards for safety and reliability. Standards 1 to 6 apply to tier A, B and C DHTs. Standards 7 to 9 do not apply to tier A DHTs.
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Describing value: The 4 standards apply across all tiers and provide information to build the value proposition of the DHT. Standards 10 to 13 apply to tier A, B and C DHTs.
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Demonstrating performance: Standards 14 to 16 are designed to help ensure that the DHT meets its performance expectations. Standard 14 only applies to tier C DHTs. Standards 15 and 16 apply to tier A, B and C DHTs.
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Delivering value: The 2 standards apply to DHTs in all tiers and show how DHTs should demonstrate their value for money.
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Deployment considerations: The 3 standards help to ensure that the claimed benefits of the DHT can be realised in practice, and apply to all 3 tiers.
Summary of NICE ESF standards
Tables 3 to 7 summarise the 21 standards and specify the classification tiers to which each standard applies. Additional information is provided in the section on how to meet the standards, to explain the kind of information that a company needs to show in order for a DHT to meet each standard.
Standard |
Tiers to which the evidence standard applies |
---|---|
1: the DHT should comply with relevant safety and quality standards |
A, B and C |
2: incorporate intended user group acceptability in the design of the DHT |
A, B and C |
A, B and C |
|
4: consider health and care inequalities and bias mitigation |
A, B and C |
A, B and C |
|
A, B and C |
|
B and C |
|
B and C |
|
B and C |
Table abbreviation: DHT, digital health technology.
Standard |
DHTs it applies in |
---|---|
A, B and C |
|
A, B and C |
|
12: describe the proposed pathway or system process using the DHT |
A, B and C |
A, B and C |
Table abbreviation: DHT, digital health technology.
Standard |
DHTs it applies in |
---|---|
14: provide evidence of the DHT's effectiveness to support its claimed benefits |
C |
15: show real-world evidence that the claimed benefits can be realised in practice |
A, B and C |
A, B and C |
Table abbreviation: DHT, digital health technology.
Standard |
DHTs it applies in |
---|---|
A, B and C |
|
18: for DHTs with higher financial risk, provide a cost-effectiveness analysis |
A, B and C |
Table abbreviation: DHT, digital health technology.
Standard |
DHTs it applies in |
---|---|
A, B and C |
|
A, B and C |
|
A, B and C |
Table abbreviation: DHT, digital health technology.