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Regulation and Machine Learning at the “Frontiers of Science”Arti K. Rai
Elvin R. Latty Professor; Faculty Director, Center for Innovation Policy; Duke Law School
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Case StudiesPatent Office FDA
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Themes•public and private capacity•secrecy and accountability
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What’s New with ML?•complexity
•synergy of complexity and secrecy
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Capacity and Secrecy at Patent Office
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Capacity at the Patent Office (2)
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FDA and 21st Century Cures ActExempts algorithms that acquire and analyze medical information to make recommendations so long as the algorithm
“enabl[es] such health care professional to independently review the basis for such recommendations that such software presents . . .”
FDA: regulate if software is proprietary or highly complex
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“Administrative support”
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Viz.AI ContaCT: triage based on signs of large vessel occlusion (LVO) in CT scan
Stroke Triage
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Diabetic Retinopathy Detection
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ContaCT De Novo Approval Summary
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Pre‐cert program
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