By Sean Hilscher, Tanvi Mehta

Published in: Pharmaceutical Online Newsletter

Published on: December 14, 2023

In mid-October 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health,1 identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with WHO’s Working Group on Regulatory Considerations (WG-RC) on AI for Health, whose members include regulatory authorities, policy makers, academics, and representatives from industry. The document is intended to serve as a resource for regulators, providing a list of 18 regulatory considerations to address in their emerging regulatory frameworks. It should be noted that the scope of the document extends beyond medical product development and is also intended to inform healthcare delivery.

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