Artificial intelligence, or AI, has the ability to process large sets of data. The term “AI” describes algorithms that can be taught to identify patterns or predict outcomes. If the algorithm is primed with a teaching set of data, then it can evaluate new sets of data based on the desired outcome. AI has been
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FDA revamps cybersecurity guidance for marketed medical devices
The Food and Drug Administration (FDA) published a draft update to its premarket cybersecurity guidance for device makers on October 18, 2018. The expanded draft guidance includes recommendations on tiered classification of cybersecurity risk, trustworthiness, cybersecurity bill materials, and device cybersecurity labeling that are specific enough to be helpful to manufacturers while at the same…