Managing Risk and Quality of AI in Healthcare

Artificial intelligence (AI) provides a unique opportunity to help meet the demands of the future healthcare system. However, hospitals may not be well equipped to handle safe and effective development and/or procurement of AI systems.

This paper discusses challenges in AI implementation, particularly potential gaps in current management systems (MS), by reviewing the harmonized standard for AI MS, ISO 42001, as part of a gap analysis of a tertiary acute hospital with ongoing AI activities. From a quality assurance perspective, there is a need for emphasis on the foundation and structure of the healthcare organizations, including both workforce and data infrastructure.