Domain 2: safety, acceptability and credibility

Evidence framework for the assessment of health technologies
Healthcare Improvement Scotland

What do we need to see? 

  • A description of how the technology complies with relevant regulatory standards.
  • A description of any safety considerations.
  • A description of how intended service user groups were involved in the development of the technology.
  • A description of inequalities.
  • A description of the environmental sustainability considerations
  • A description of the credibility of the technology with UK health and care professionals

Open the accordions sections to see descriptions of the domain elements. 

A description of how the technology complies with relevant regulatory standards

  • Does the technology have regulatory approval (that is, UKCA or CE marking)?
  • Is documentation that all safety and quality standards (relevant to the device classification) have been met provided?

A description of any safety considerations

What are the safety concerns?

  • Related to the technology or comparator.
  • How do these safety concerns compare with current practice?
  • Does the frequency or severity of harms change over time or in different settings?
  • What are the risks for the public and the environment when using the technology?
  • Are there any harms related to dosage or frequency of applying the technology?

Managing the risks.

  • How can the safety risks for service users, professionals and the environment be reduced?
  • Are there any service user groups that are more likely to be harmed through the use of the technology?
  • Are there any safety risks to staff when using the technology compared with current practice

Screening and diagnosis technologies.

  • What is the impact of false positive, false negative and incidental findings, from the viewpoint of service user safety?

A description of how intended service user groups were involved in the development of the technology

How were representatives from intended service user groups involved in the design, development or testing of the technology?

A description of inequalities

How have health inequalities been considered in the design of the technology?

Does the technology have any impact on health inequalities?

  • Is there evidence that the technology positively or negatively impacts health inequalities in the UK health and social care system?
  • Is there evidence that the technology improves access to care among hard-to-reach populations?
  • Is there evidence that the technology promotes equality and eliminates unlawful discrimination?
  • Is there evidence that the technology fosters good relations between people with protected characteristics (as described in the Equalities Act 2010) and others?
  • Are there any efforts to reduce the negative impacts of the technology on health inequalities?

A description of the environmental sustainability considerations

  • What are the expected environmental sustainability benefits and negative impacts from using the technology?
  • Is an analysis of the environmental outcomes available (for example, comparative CO2e estimates)?

A description of the credibility of the technology with UK health and care professionals

  • Is there evidence that relevant health or care professional(s) working in the UK health and social care system have been involved in designing, developing or testing the technology, or given their support to the deployment of the technology?
  • Is there evidence that the technology is viewed as useful by professional experts or expert groups?