2024
DOI: 10.31219/osf.io/5ks37
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The Emerging Role of ISO 42001 Certification in Fostering the Deployment of Responsible Generative AI Healthcare Solutions

Fabio A. Thiers, MD PhD,
Zach Harned

Abstract: The growing excitement about the potential positive impact of generative AI (GenAI) solutions in healthcare has been tempered by uncertainty on how to ensure that such solutions are deployed safely and effectively. A core issue is that the current product-centric regulatory oversight model does not apply well to a technology that adapts to the operating environment and becomes enmeshed with medical practice in a non-deterministic manner. This difficulty has led to the development of alternate approaches to fos… Show more

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