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Autonomous AI systems are rapidly making their way into the health care system, presenting regulators with thorny questions about how to protect data, prevent bias, and make sure constantly evolving machines can operate safely in clinical practice.

The urgency of those inquiries will be on display Thursday during a key meeting hosted by the Food and Drug Administration, which is convening patients to collect their perspectives on AI development and regulation. The gathering of the Patient Engagement Advisory Committee comes as the agency considers crossing a crucial threshold: the approval of the first adaptive AI product, in which a system’s performance changes based on its use in the real world. To date, the FDA has only approved locked systems that produce the same result based on the same input.

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