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AIと法律
AI health products: when do they count as medical devices
Once a health AI feature is deemed a medical device, the compliance bar and market path change completely.
AI offering diagnosis, treatment suggestions, or disease-risk assessment may be classified as medical-device software in some markets, requiring registration, clinical validation, and post-market surveillance.
The line between a 'wellness tip' and 'medical advice' often decides which regime a product falls under.
Judge intended use and marketing framing at kickoff to avoid inadvertently triggering device regulation, or plan the compliance path early where it is genuinely needed.