Evidence standards framework for digital health technologies

Why the framework was developed

Evaluating digital health technologies (DHTs) in terms of their potential user and system benefits is challenging.

DHTs are rapidly developed and updated, with new versions being regularly released. There is generally less or lower quality evidence for DHTs compared with the evidence available for drugs or devices. This is because of how quickly they are developed, and the challenges faced by smaller technology companies in accessing clinical trial expertise and research funding.

Also, there are specific issues with DHTs around data security, privacy and confidentiality, which are difficult to assess by non-specialists. More and more DHTs also incorporate machine learning (a form of artificial intelligence [AI]), which poses additional challenges such as model adaptiveness, device autonomy, limited output explainability and the consequences of human–technology interaction in clinical settings.

These challenges have created barriers to DHTs being commissioned and inconsistencies across the UK in how these commissioning decisions are made.

The framework was developed to provide a set of evidence standards that should be used to show the value of DHTs in the UK health and social care system.

The evidence standard supports principle 11 of the Department of Health and Social Care's guide to good practice for digital and data-driven health technologies, which states that the companies should generate evidence that the product achieves clinical, social economic or behavioural benefits, and may also be relevant for other principles.