Section C: Evidence standards tables

Corporate document

Summary of NICE ESF standards

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:

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.
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.
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.
Delivering value: The 2 standards apply to DHTs in all tiers and show how DHTs should demonstrate their value for money.
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.

Figure 2 The 5 groups of evidence standards relating to different aspects of the product life cycle

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.

**Table 3 Design factors**
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
3: consider environmental sustainability	A, B and C
4: consider health and care inequalities and bias mitigation	A, B and C
5: embed good data practices in the design of the DHT	A, B and C
6: define the level of professional oversight	A, B and C
7: show processes for creating reliable health information	B and C
8: show that the DHT is credible with UK professionals	B and C
9: provide safeguarding assurances for DHTs where users are considered to be in vulnerable groups, or where peer-to-peer interaction is enabled	B and C