Read article-health ai for good rather than evil

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Reference no: EM133670614

Assignment:

Read Sara Gerke's article, "Health AI for Good Rather Than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices" (and/or or this less dense think piece on the same subject "Is Your Phone a Medical Device?") advocating for a new framework specifically for AI-based medical devices (specifically that Congress should amend its definition of a medical device to include clinical decision-making tools that are intended for the "prediction or prognosis of disease or other conditions or mortality."). Why did a clinical decision software (CDS) like "Watson for Oncology," described in Gerke's piece, which assesses medical information and provides treatment recommendations, not undergo FDA review? Do you find Gerke's argument for regulating such devices persuasive? If so, do you believe her proposed amendment is sufficient?

Reference no: EM133670614

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