Regulation and official guidance
Healthcare and medicine
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
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
Regulation and official guidance
Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system
Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…
This British Standard specifies requirements for the development of safe, effective, and ethical healthcare AI products. This British Standard specifies…
Research and analysis item
Standardization empowering AI-enabled systems in healthcare – workshop report
Research and analysis item
Recent advancements in AI – implications for medical device technology and certification
Clearly, a system whose behaviour is impossible to guarantee seems unsatisfactory from a safety or regulatory perspective. To appreciate why…
