Hazards for the Implementation and Use of Artificial Intelligence Enabled Digital Health Interventions, a UK Perspective.
Journal:
Studies in health technology and informatics
PMID:
35062080
Abstract
BACKGROUND: Artificial Intelligence (AI) has seen an increased application within digital healthcare interventions (DHIs). DHIs use entails challenges about their safety assurance. Exacerbated by regulatory requirements, in the UK, this places the onus of safety assurance not only on the manufacturer, but also on the operator of a DHI. Clinical Safety claims and evidencing safe implementation and use of AI-based DHIs require expertise, to understand and act to control or mitigate risk. Current health software standards, regulation, and guidance do not provide the insight necessary for safer implementation.