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Samsung Learns that Smartphones with Biometric Sensors have to be labelled as Medical Devices & Drops the new Sensor

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In a new business report that was published in South Korea earlier this week we've learned that Samsung Electronics' smartphone sensor technology has been dragged down by technological and legal problems. The legal issue revolves around smartphones integrating biometric sensors have to be clearly labelled as medical devices. Whether this problem could spill over to the iPhone 6 being sold in certain countries like South Korea is unknown at this time.


Samsung Unexpectedly Drops their Smart Scroll Feature


According to Samsung on Sept. 15, the Smart Scroll feature was eliminated in its major smartphones released this year, including the Galaxy S5 and the Galaxy Alpha. The feature automatically scrolls the screen by detecting the location of a user's eyeballs or the face of the user through the front camera.


To my surprisethe report stated that "Samsung's technology to recognize eyeballs is a method in the early stage for iris recognition," though they admitted that manysmartphone manufacturers are conducting such research.


An industry source explained, "I think that the Smart Scroll feature had to be removed while the new Android operating system was optimized." In fact, Samsung's facial recognition technology has been rarely mentioned since its initial application in the Galaxy S4 and the Galaxy Note 3 last year.


Smartphones with Biometric Sensors Must be labelled as Medical Devices (in South Korea)


In addition to technical defects, Samsung's new sensors have been mired in legal issues. Specifically, the Galaxy Note 4, which will roll out in October is equipped with an oxygen saturation sensor that measures the amount of oxygen in the blood and a sensor that measures UV radiation levels. These sensors are aimed at giving information about the surrounding environment to asthma patients, smokers, or those with a sensitive skin.


However, any device that measures this kind of information must be labeled as a medical device under the law. This legal matter hinders the company's strategy to overcome the limits of hardware with sensors.


Samsung and other smartphone manufacturers are apparently trying to expand the role of the smartphone as a biometric device through a variety of biometrics sensors. Smartphone makers are aiming at strengthening the role of the smartphone with smart healthcare or smart medical treatment functions by linking information collected via smartphones with medical institutions. The mere mention of biometric sensors in context with this issue is troubling. If it's on the same list for oxygen saturation sensors it could cause problems for many smartphone OEM's rushing to include biometric sensors like Apple.


Currently, Samsung is reportedly continuing its discussion with the Korean Ministry of Food and Drug Safety and US Food and Drug Administration to exclude devices with a built-in oxygen saturation sensor from the list of medical devices. Yet Samsung's decision to remove the sensors prior to shipment is admitting at the very least that the problem is real and damaging.


Currently Apple has filed for Apple Watch under International Class which covers "Health, fitness, exercise, and wellness sensors, monitors and displays; medical apparatus and devices." Yet it's not clear if Apple's new iPhone 6 introducing a new biometric sensor carries the same International Class coverage and protections. Whether Apple's packaging will be required to carry a sticker on it stating that it's a "medical device" in certain countries, like South Korea, is unknown at this time.


For now it's an open question with very few answers. Yet if it's affecting Samsung, it could very well affect Apple. If this issue is as real as Samsung is reportely stating, then it's bound to surface somewhere in the US mainstream press over the course of the next quarter. For now, only Samsung is admitting to it being a definite problem.


As far as Samsung dropping their Smart Scroll feature, well, that's another matter. More than likely it wasn't that smart of a feature to begin with. The new report squarely called it a "technical defect." In the end, that great innovative feature that Samsung loudly touted when introducing the Galaxy S4, just bit the dust.


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