Artificial Intelligence refers to the application of a broad range of computing techniques, from neural networks to machine learning, which are designed to mimic human behaviour.
In the context of medical devices, AI is being used to gather and analyse vast quantities of data to provide outputs to clinicians and assist them in the medical diagnosis process and provide better care to patients. Some key characteristics of artificial intelligence such as autonomy, opacity, and data dependency, can give rise to unwanted outcomes.
This raises multiple questions:
- Who is liable when a diagnosis suggested by an AI-powered device differs from a clinician’s diagnosis?
- How rigorous is the testing and auditing of the device?
- Can the existing regulatory framework for medical devices adapt to the new technology?
We answer these questions in an article on our Life Sciences microsite, On the Pulse.