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AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence     The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices. AAMI Technical Information Report (TIR)34971:2023, Application of ISO 14971 to machine …

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FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing     On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers, Patrizia Cavazzoni, M.D., Director of the FDA Center …

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White Houses Releases AI Bill of Rights Blueprint

White Houses Releases AI Bill of Rights Blueprint     Against a backdrop of growing concern surrounding biased data and rights to privacy and informed consent, the White House has released the “Blueprint for an AI Bill of Rights” that lays out five principles and associated practices to protect the American public against potential harm. “Among …

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