Policy database

Artificial Intelligence is developing fast. It will change our lives by improving healthcare (e.g. making diagnosis more precise, enabling better prevention of diseases), increasing the efficiency of farming, contributing to climate change mitigation and adaptation, improving the efficiency of production…

Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices (or as in vitro diagnostic medical devices (IVDs). This guidance provides access to important Software Group…

This report provides a holistic approach for a common, long-term position that highlights the EU’s key values and objectives relating to AI in the digital age that ensures that the digital transition is human-centric and consistent with the Charter of…

Our exit from the EU provides us with the opportunity to think boldly about how we regulate and for the first time in a generation, we have the freedom to conceive and implement rules that put the UK first. We…

This report was presented by Sir Patrick Vallance, the Government Chief Scientific Adviser, to the Chancellor of the Exchequer and to HM Government, as part of the Pro-innovation Regulation of Technologies Review. Scope of the review We have engaged extensively…

These principles aim to be wide reaching and applicable to anyone developing, deploying or operating a system with a machine learning (ML) component. They are not a comprehensive assurance framework to grade a system or workflow, and do not provide…

In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance…

Building on the broader Life Sciences Vision, this high-level document reviews the current UK medtech landscape and identifies and prioritises the areas for action. This strategy will form the basis of future implementation plans that will set out in detail…

Increasingly, we are seeing an uptake in applications of artificial intelligence (AI). The use of AI has the potential to make a significant difference to society. However, to realise the benefits, there needs to be confidence that AI is being…

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