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AI built into a medical device generally falls under high-risk systems. Here are the three workstreams to start now.
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Healthcare is one of the critical sectors covered by the NIS2 directive. First steps for the providers, laboratories and manufacturers concerned.
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An AI in healthcare faces risks that traditional systems do not. The four checkpoints to verify before going live.
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Quantum computers threaten today’s encryption. For health data that must stay confidential for decades, the topic needs preparing now.
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For a manufacturer, cybersecurity is no longer an after-sales topic: it conditions CE marking as well as access to the US market.
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An AI model that evolves is hard to freeze, yet computerised system validation assumes a controlled system. How to reconcile the two.
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