FDA Seeks More Resources to Oversee AI's Growing Role in Healthcare
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Doctors are already using unregulated AI tools like virtual assistants and diagnostic software to treat patients. This is a high-stakes experiment happening without government oversight.
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The FDA wants to monitor AI software over time since it changes constantly, but lacks the resources and authority to effectively regulate this fast-moving technology.
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The FDA says it needs Congressional approval for more staff and powers to request AI performance data and set stricter algorithm guardrails. But Congress has not prioritized AI regulation.
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The FDA proposed establishing public-private assurance labs at universities to validate AI systems, but smaller healthcare providers worry about conflicts of interest.
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Some experts say the FDA should be handling AI oversight itself and requiring systems to prove they improve patient outcomes, regardless of who does the validation.