This standard defines terms related to artificial intelligence and associated technologies in health care including assistive intelligence, synthetic data, remote…
Healthcare and medicine
BS 10102-2:2020
Big data. Guidance on data-intensive projects
This part of BS 10102 provides guidance on good practice for implementing data-intensive projects to realize value, including: a) defining…
BS 34971/AAMI CR 34971
Application of ISO 14971 to machine learning in artificial intelligence. Guide
What is BS AAMI 34971 – Application of ISO 14971 to machine learning in artificial intelligence – Guide about? Artificial…
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…
Strategies and roadmaps
Medical technology strategy
Building on the broader Life Sciences Vision, this high-level document reviews the current UK medtech landscape and identifies and prioritises…
Regulation and official guidance
Clinical decision support software: Guidance for industry and Food and Drug Administration staff
Research and analysis item
Accelerating effective and safe adoption of artificial intelligence in the healthcare system
Artificial intelligence (AI) ā algorithms with the ability to perform tasks that would normally require human intelligence ā has great…
Research and analysis item
Accelerating effective and safe adoption of artificial intelligence in the healthcare system
Artificial intelligence (AI) ā algorithms with the ability to perform tasks that would normally require human intelligence ā has great…
Research and analysis item