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AI should not be used to predict the course of clinical depression if all it has to work with are new patients’ medical records of past diagnoses, medications, encounters and patient-reported outcomes.

Nearly 9,000 devices distributed in 2019 and 2020 are included in this Class 1 recall. 

The society said it has no plans, as of yet, to add new safeguards following the Biden administration's announcement on Monday.

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