At this year's CES exhibition, the US Food and Drug Administration announced that it will relax regulations on "low-risk" health devices, including smart scales, heart rate monitors, electric wheelchairs, and more. This move is seen as the latest move by the Trump administration to promote the development of the AI industry. Previously, the White House had revoked the Biden administration's executive order on ethical protection of AI, and the Department of Health and Human Services had also released a strategic blueprint to expand the application of AI in healthcare.
Regulatory easing means that more innovative products can be quickly launched, but it also opens up a Pandora's box.
Cohen pointed out that the existing bill only protects patient data within medical institutions, and information collected by consumer grade health devices is not covered by it. This means that manufacturers can legally use sensitive data such as users' hormone levels, sleep quality, and emotional fluctuations for AI training, and even sell it to third parties.
Some companies insist that user privacy is strictly protected. Mira founder Coman introduced that its flagship product, the "Egg shaped Hormone Tracker," is known as the "world's smallest hormone laboratory. Users can immerse the test paper in urine and insert it into the device to view changes in indicators such as estrogen and progesterone in the app. She stated that all data is encrypted and stored in the cloud, and will never be shared or sold.
