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.

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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.