AI & Cyber Awareness
AI threats, deepfakes, and awareness for regulated healthcare teams.
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How to Threat Model an AI-Enabled Medical Device
Article 15(5) of the EU AI Act requires high risk systems to resist attacks on the model itself, and FDA's draft guidance asks sponsors to submit whatever they added to the threat model for AI, but the threats, the assets and the right framework all change depending on whether your device runs a model that is fixed at release, a model that keeps changing, or a language model feature.
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