LAUSR

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. OBJECTIVE To interpret published guidance and policy related to AI and justify clinical safety assurance of DHIs. METHOD Assessment of UK health regulation policy, standards, and AI institution insights, utilizing a published Hazard Assessment framework, to structure safety justifications, and articulate hazards relating to AI-based DHIs. RESULTS AI enabled DHI hazard identification, relating to implementation and use within healthcare delivery organizations. CONCLUSION By application of the method, we postulate that UK research of AI DHIs highlighted issues that may affect safety, in need of consideration to justify safety of a DHI.