The Digital Technology Assessment Criteria for health and social care (DTAC) gives staff, patients and citizens confidence that the digital health tools they use meet our clinical safety, data protection, technical security, interoperability and usability and accessibility standards.
It is the new national baseline criteria for digital health technologies into the NHS and social care. It is designed to be used by suppliers to build technology and healthcare organisations to build and to buy technologies that meet our minimum baseline standards.
The DTAC is available as a document (ODT, 132KB) that you can download and print.
Please download the assessment criteria at the point of use, to make sure you’re using the most up to date version.
Why are we introducing the DTAC?
The DTAC was developed in response to developers and those making buying and commissioning decisions looking to NHSX for clear direction on how to build and buy good digital health technologies. We listened to innovators who are seeking to understand what the NHS is looking for when it buys technologies to enable them to build it into their product development ‘by design’. Those buying technologies told us they wanted a proportionate and tangible criteria that was simple to apply and assess against, encompassing all digital health technologies, to ensure that the products they select are safe and built well.
By setting a national baseline, the intention is now to smooth the path between development and procurement so that the NHS and social care may realise the benefits that digital technologies can bring.
What is included in the assessment criteria?
The assessment criteria is focused on 5 core areas. Sections 1-4 form the assessed criteria, with a separate conformity rating provided around usability and accessibility:
- Clinical safety: assessed to ensure that baseline clinical safety measures are in place and that organisations undertake clinical risk management activities to manage this risk
- Data protection: assessed to ensure that data protection and privacy is ‘by design’ and the rights of individuals are protected
- Technical assurance: assessed to ensure that products are secure and stable.
- Interoperability: assessed to ensure that data is communicated accurately and quickly whilst staying safe and secure.
- Usability and accessibility: products are allocated a conformity rating having been benchmarked against good practice and the NHS service standard.
Responding to feedback from beta
Between October 2020 and January 2021, DTAC was in beta launch. During that period we engaged with over 800 developers, innovators, trade and membership organisations, digital technology assessors, buyers and commissioners, clinicians and other interested parties and continued to pilot products through the process. Feedback from this engagement and refinement through testing is reflected in version 1.
In summary, the changes are:
- additional questions created by splitting our some of the beta questions for efficiency during the assessment process
- more detail as to what constitutes a pass or a fail for the assessed sections
- accessibility and usability broken down into individual questions to better support developers
- removal of IS0:27001 as part of the version 1 baseline to support earlier stage innovations
- additional information on clinical safety and the addition of a professional registration check for the nominated Clinical Safety Officer
- more specific requirements for Technical Security relating to penetration and load testing
- context on interoperability added and opportunity for developers to provide more rationale on connectivity.
NHSX would like to thank everyone that provided feedback on the question set and programme of work.
DTAC will naturally iterate as legislation and standards change. We will update on changes through our Digital Transformation bulletin. Please register to keep up to date.
Evidence standards framework for digital health technologies
We continue to work alongside other key stakeholders including the Accelerated Access Collaborative (AAC) to support innovators, the Medicines and Healthcare products Regulatory Agency (MHRA) and NICE to build on the Evidence Standards Framework for digital health technologies. This is a framework that describes the level of evidence needed to demonstrate effectiveness and value for digital technologies that have different functions and risks.