Smartphones with biometric sensors may be required to be labelled as medical devices in South Korea
The Korean Ministry of Food and Drug Safety and US Food and Drug Administration has ruled that any device that measures the amount of oxygen in the blood and UV radiation levels, such as the Samsung Galaxy Note 4, is required to be labeled as a medical device under the law, according to a report by Patently Apple.
Scheduled to be released in October, Samsung Galaxy Note 4 features an oxygen saturation sensor that measures the amount of oxygen in the blood and a sensor that measures UV radiation levels, which are designed to provide information about the surrounding environment to benefit asthma patients, smokers, and users with sensitive skin.
The legal issue is a considerable roadblock for Samsung and other smartphone manufacturers to provide smart healthcare or smart medical treatment functions by linking biometric data collected via smartphones with medical institutions.
Samsung is still in talks with the Korean Ministry of Food and Drug Safety and US Food and Drug Administration to convince them that a device with a built-in oxygen saturation sensor should not be labelled as a medical device.
Samsung didn’t announce more details on the oxygen saturation sensor, but the company said the sensor can be disabled if needed in certain markets.
Meanwhile, Apple has filed trademarks for Apple Watch under “International Class” which encompasses “Health, fitness, exercise, and wellness sensors, monitors and displays; medical apparatus and devices.” It is unclear at this time whether the biometric sensor on the iPhone 6’s has the same “International Class” coverage and protections or if Apple will be required to carry a sticker on it stating that it’s a “medical device” in certain countries, like South Korea.