Healthcare and medicine
This standard defines terms related to artificial intelligence and associated technologies in health care including assistive intelligence, synthetic data, remote…
This voluntary standard identifies types of bias, sources of bias, and bias management practices for health care applications of Artificial…
What is BS AAMI 34971 – Application of ISO 14971 to machine learning in artificial intelligence – Guide about? Artificial…
What is this standard about? It supplies the latest guidelines and specifications to ensure the safe design and use of…
Strategies and roadmaps
Roadmap towards the future regulatory framework for medical devices
This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…
Regulation and official guidance
Guidance on GxP data integrity
The guidance is intended to be a useful resource on the core elements of a compliant data governance system across…
Regulation and official guidance
Software and artificial intelligence (AI) as a medical device
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are…
Frameworks and principles
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…
Research and analysis item
Accelerating effective and safe adoption of artificial intelligence in the healthcare system
Artificial intelligence (AI) – algorithms with the ability to perform tasks that would normally require human intelligence – has great…
Research and analysis item
Better, broader, safer: using health data for research and analysis
Professor Ben Goldacre’s review into how the efficient and safe use of health data for research and analysis can benefit…
Research and analysis item
Better, broader, safer: using health data for research and analysis
Professor Ben Goldacre’s review into how the efficient and safe use of health data for research and analysis can benefit…
