Tools for building or evaluating an evidence base

Real-world evidence (RWE) framework

We developed our real-world evidence framework to help us use real-world data to resolve gaps in knowledge and drive forward access to innovations for patients.

The framework advances the use of real-world evidence in our guidance by:

• identifying when we can use real-world data to reduce uncertainties and improve guidance
• describing best-practices for developers when planning, conducting, and reporting real-world evidence studies.

Evidence standards framework (ESF) for digital health technologies

We worked with key stakeholders, system partners and thought leaders to develop our evidence standards framework. It aims to ensure new digital health technologies are clinically effective and offer value to the health and care system. The framework guides developers through how to generate high quality evidence.

Evaluators and decision-makers in the health and care system can use it to make informed and consistent decisions when buying digital health technologies.

Having an evidence standards framework that's regularly refreshed will help to ensure that the evidence we generate today will meet the system requirements of tomorrow.

AI and digital regulations service

Our AI and digital regulations service supports the development and widespread adoption of safe, innovative, value-adding technologies in health and social care. The service maps out the regulatory and health technology assessment pathway. This helps developers progress their technology in line with legal requirements and best practice principles. 

The service is a multi-agency collaboration between NICE, the Care Quality Commission, the Health Research Authority and the Medicines and Healthcare products Regulatory Agency.