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TGA Permits Hypertension Claims for AI Wearables: New Rules
Lifestyle Technology TheDayAfterAI News Lifestyle Technology TheDayAfterAI News

TGA Permits Hypertension Claims for AI Wearables: New Rules

The Therapeutic Goods Administration (TGA) has introduced a new legislative instrument permitting restricted advertising for software that detects hypertension patterns using wearable PPG data. This report outlines the specific regulatory conditions, including mandatory consumer advisories and prohibited accuracy claims, and examines how the framework aligns with broader AI medical device standards in Australia and overseas.

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