As digital health technologies develop at an increasing pace, we've worked with partners to develop standards that ensure new technologies are clinically effective and offer economic value.
We created the standards as part of a working group led by NHS England. It also includes Public Health England, MedCity and DigitalHealth.London.
About the standards
The evidence standards framework for digital health technologies is made up of effectiveness standards and economic impact standards.
It supports the relevant principles of the Department of Health and Social Care code of conduct for data-driven health and care technologies.
The user guide covers:
- the background of the standards
- their development and use
- future priorities identified by stakeholders.
The aim of the standards
We want to make it easier for innovators and commissioners to understand what good levels of evidence for digital health technologies look like. These technologies must also meet the needs of the health and care system, patients, and users.
- Provide advice to digital health innovators about how the NHS makes decisions, and the standards of evidence they will be expected to produce for different types of digital health technologies.
- Help NHS commissioners to make more informed and consistent decisions by providing a framework for the levels of evidence they should expect to see presented to them.
- Improve the approach to developing and commissioning digital health technologies by making it more dynamic and value driven, with a focus on offering real value to patients.
How we developed the framework
The project to develop the standards has been collaborative, bringing together innovators, commissioners, clinicians, academics and other stakeholders. This approach has helped us to better understand their needs, experiences and perspectives.
Together we have produced a set of standards that support innovation while ensuring an appropriate level of rigour and assurance for the health and care system.
We collected feedback on the first version of the evidence standards framework. The feedback period ran from 12 December 2018 to 14 January 2019. We made minor changes to the framework and published them in March 2019.
At the end of 2019, we did a survey about people’s experiences of using the evidence standards framework. The feedback helped us to make further improvements to the framework and supporting documents.
Read our feedback report (Word) to find out more about the feedback we received and the changes we've made to the framework.
We’d like to thank everyone who took part in the development and review of the evidence standards framework.
How to apply the framework
Information to help you match digital health technologies to the appropriate evidence for effectiveness tier.
1. Select the functional classifications
Choose the functional classification that best describes the main function of the digital health technology.
For technologies with more than one function, use the function in the highest applicable evidence tier.
2. Find the highest evidence tier for those functions
Identify the relevant evidence tier based on the highest functional classification:
- Tier C: interventions
- Tier B: understanding and communicating
- Tier A: system impact.
There is an evidence table for each evidence tier.
3. Identify any specific risks
Use the contextual questions to identify any potential specific risks associated with the technology:
- Are the users in vulnerable groups?
- What are the consequences of technology failure?
- Is there professional oversight?
- Is artificial intelligence used?
- Is a very high cost expected?
If there are no specific risks, use the minimum evidence standards.
If specific risks are identified, use the best practice standards.
We commissioned 2 of our external assessment centres, Newcastle upon Tyne Hospitals NHS Foundation Trust and York Health Economic Consortium, to develop supporting resources.
- Medical Device Regulation mapping document (Word)
How the evidence requirements for Medical Device Regulation can be used by developers to meet the evidence standards framework evidence requirements.
- Budget impact template (Excel)
To help digital health innovators use the economic impact standards.
- Budget impact guide (PDF)
Information on budget impact and cost consequences analysis.
- Functional classification case studies (PDF)
Examples of how digital health technologies are classified for the effectiveness standards.
- Effectiveness and economic impact case studies (PDF)
Examples of the available evidence for some digital health technologies.
- The names of the evidence tiers have been changed to avoid any confusion with CE marking categories:
- Tier 1 is now Tier A: system impact
- Tier 2 is now Tier B: understanding and communicating
- Tier 3a and 3b are now Tier C: interventions.
- We have improved Table 1 to make it easier to understand which technologies fit into each functional classification.
- 'Simple monitoring' classification in Tier B is now 'Health diaries'.