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.
The aim of these standards is to make it easier for innovators and commissioners to understand what good levels of evidence for digital healthcare technologies look like, while meeting the needs of the health and care system, patients, and users.
We've created these standards as part of a working group led by NHS England. The group also includes:
- Public Health England
The evidence standards framework is made up of 2 sections:
- Evidence for effectiveness for intended use.
- Evidence for economic impact.
Both parts of the framework have a proportional approach to defining evidence standards. This recognises:
- the sparsity of available evidence in the field of digital healthcare
- the challenges of developing traditional clinical trials for digital health technologies
- the significant opportunities offered by digital health technologies to collect real world data to inform effectiveness judgements.
This work directly supports the relevant principles of the Department of Health and Social Care code of conduct for data-driven health and care technology. We welcome comment and feedback on the standards framework - find out how to do this in the 'tell us what you think' section below.
Frequently asked questions
For more background information on the standards, take a look at our frequently asked questions. We'll update these based on any feedback we receive.
Budget impact template
We’ve developed a budget impact template to support digital health innovators in using the economic impact standards. Use of the template is optional. It contains detailed guidance on its use.
Budget impact template (Excel)
The aim of the standards
Provide advice to digital health innovators:
- about how the NHS makes decisions
- about the standards of evidence they will be expected to produce for different types of digital 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 truly collaborative, bringing key parties together including innovators, commissioners, clinicians, academics and other stakeholders to better understand their needs, experiences and perspectives.
Together we have produced a set of standards that attempt to strike the right balance between supporting innovation and ensuring an appropriate level of rigour and assurance for the health and care system.