Tag: AI regulation

Takeda uses Weave Bio AI to draft drug filings 97% faster

Takeda runs Weave Bio's regulatory AI across 14 drug programs, cutting first-draft filing time by 97%.

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Medtech veteran tipped to lead AI oversight at FDA

HHS is standing up two new FDA deputy commissioner posts, with a medtech veteran tipped to oversee AI.

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Consumer chatbots are building a medical system outside hospitals

Two Harvard-affiliated physicians warn consumer chatbots are quietly building a parallel medical system.

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FDA and CMS court AI health startups in closed-door demo day

FDA and CMS hosted 10 AI health companies at a private demo day as they weigh clinical AI policy.

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EU AI Act high-risk rules now bind health AI developers

The EU AI Act's high-risk obligations took effect August 2, with AI medical software bound now and CE-marked devices getting…

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US medical boards say AI cannot hold a medical license

The Federation of State Medical Boards argues generative AI belongs inside existing physician oversight, not in a separate license.

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AI catches errors radiologists miss, then juries penalize the humans

A Brown University study finds radiologists face significantly higher jury liability when AI correctly identifies abnormalities they overlooked.

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OpenAI launches Health in ChatGPT day after lawsuit targets its safety

The feature lets US users connect medical records and Apple Health data, rolling out one day after a Florida pastor…

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