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AI-ready · Governance Risk

A third-party AI writing tool would speed up drafting sections of a PMA submission, but doing so means pasting unpublished preclinical study data into it. How do you evaluate whether that's acceptable?

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I start from the assumption that unpublished preclinical data doesn't leave our controlled systems by default, and the burden is on the tool to earn an exception, not on me to find a reason to allow it.…

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