S. Korea is trying to decide whether the Galaxy S5 is a medical device

The Galaxy S5 smartphone--Courtesy of Samsung

The Galaxy S5 is soon to be the first smartphone on the market with a built-in heart rate monitor. The monitor is designed for fitness use, but according to South Korea's health agency, its inclusion may subject the highly anticipated new phone to med tech-level regulation before its maker, Samsung, can sell the phone in its own home country.

By South Korean law, any equipment used to diagnose, treat or prevent diseases must be approved by Seoul's Ministry of Food and Drug Safety before it's marketed. The ministry is looking into whether the S5 meets that threshold for regulation, Korea's Yonhap News Agency reports. 

The S5 is set for an April 11 launch in 150 countries, alongside the company's Gear Fit, a wearable, wristwatch-sized device that also monitors heart rate and can link to the phone wirelessly. 

The Gear Fit smartwatch also includes a heart rate monitor.--Courtesy of Samsung

Regulators say whatever happens, they won't delay the South Korean portion of the S5's planned global launch. "Even if it is designated as a medical device, the procedure for testing its safety and functions is not complicated," an unnamed ministry official told Yonhap.

South Korea is a smaller market than the U.S. or Europe, but it means more to Samsung than just hometown pride. In the past two years smartphone adoption there has tripled, giving South Korea the highest per capita ownership of the devices in the world. Some 73% of South Koreans own smartphones, market tracker Ipsos reported last July, putting smartphone ownership there somewhere north of 30 million. By comparison, about 150 million Americans own smartphones, according to comScore's October 2013 report

A schematic drawing from Apple's heart monitor patent. Numbers indicate areas that could house ECG sensors.

Seoul's move to regulate the S5 may also have implications for Apple ($AAPL), which is developing its own technology for a heart monitor inside a mobile device. In December, Apple won a patent detailing how the company might install electrocardiogram (ECG) sensors at multiple locations in conductive surfaces along the phone's casing.

Apple's patent application details how the ECG sensors might be used for biometric identification. It makes no mention of health or wellness applications, an omission that may indicate Cupertino is well aware of the potential for costly FDA oversight. Apple executives--including a recent hire, Dr. Michael O'Reilly, former chief medical officer at Masimo--met with FDA med tech regulators in December. Days later, a Google R&D team met with some of the same officials, apparently to discuss the company's plans for a glucose-monitoring contact lens.

- read the Yonhap report
- here's Samsung's page describing the Galaxy S5's features

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