Evidence standards framework for digital health technologies

Introduction

The NICE evidence standards framework (ESF) for digital health technologies (DHTs) describes standards for the evidence that should be available or developed for DHTs to demonstrate their value in the UK health and social care system. The ESF encompasses evidence of performance relevant to the purpose of the technology and evidence of economic impact relative to the financial risk. The ESF has been updated in 2022 to also include associated design factors and deployment considerations.

The ESF can be used by evaluators and innovation teams in the NHS and care system when they are evaluating a DHT for a commissioning or purchasing decision. This will enable high-quality innovation to be identified and used in the UK. The ESF is not mandated, so it is not compulsory for the ESF to be used in commissioning DHTs.

The ESF can also be used by DHT companies to understand how the UK health and care system evaluates DHTs, and what kinds of evidence should be shown to facilitate commissioning or purchasing decisions in the NHS and care system.

The ESF has been designed to complement the existing regulatory and technical standards that apply to DHTs. The ESF focuses on evaluating DHTs to ensure they are likely to perform as expected and represent good value for money to the health and care system. The standards to demonstrate evidence for performance have been set at levels that are intended to be realistic and achievable for DHT companies, while being of a sufficiently high standard to give the health and social care system confidence in the DHT. This balance is intended to encourage the confident use of innovative, effective DHTs in the health and social care system. The standards on delivering value are based on the guidance evaluation methods used at NICE, and are designed to assess the likely economic impact of a DHT. We have designed the ESF within the context of a health and social care system that is seeking innovative ways to improve care while reducing cost burden on the system.

The development of the medical device regulatory framework and evaluation methods for DHTs, particularly those with adaptive algorithms, is progressing rapidly and we expect that the ESF will be updated to reflect the changes in the health technology assessment landscape for these technologies. We anticipate that the ESF will be reviewed annually to ensure that it remains up to date with other regulatory and assurance guidance. We expect the next update to the ESF to follow the Medicines and Healthcare products Regulatory Agency (MHRA) implementation of the Software and AI as a Medical Device Change Programme.

NICE is grateful to the wide range of stakeholders who helped develop the concepts and content, and to all those who have provided feedback on the ESF since it first published in December 2018.

Find out more details about the development and use of the ESF in the ESF user guide.

The ESF is presented here in 4 sections: