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White House orders HHS to collect reports on healthcare AI safety

November 1, 2023

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Regulatory scrutiny of AI has increased over the past year. The European Union is developing the AI Act, legislation that it claims will be the first comprehensive AI law, and the FDA is drafting guidance on AI-enabled device software functions. Now, the White House has set out its stance on AI in an executive order.

The order gives the HHS 365 days to establish an AI safety program. The program should create a “common framework” for approaches to identifying and capturing clinical errors resulting from AI, as well as specifications for a central tracking repository for “incidents that cause harm, including through bias or discrimination, to patients, caregivers or other parties.”

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