Wearable medical device earns gov't's 1st regulatory waiver

Wearable medical device earns gov’t’s 1st regulatory waiver

Memowatch, a wearable electrocardiogram measurement device developed by the Korean company Huinno, has received Korea’s first waiver under the government’s regulatory sandbox program in the information and communication technology (ICT) sector. (Huinno)

Memowatch, a wearable electrocardiogram measurement device developed by the Korean company Huinno, has received Korea's first waiver under the government's regulatory sandbox program in the information and communication technology (ICT) sector. (Huinno)

A wearable electrocardiogram measuring device that sends a patient's data to his or her doctor is Korea's first product exempt from regulations under the government's regulatory sandbox program.

Developed by the Korean startup Huinno, the Memowatch was one of several items included in a regulatory sandbox approved by the Ministry of Science and ICT on Feb. 14 in the first meeting of a national committee on new technologies and services.

Huinno had developed the Memowatch in 2015 ahead of Apple but could not release the product on the market because of regulatory issues. The Korean company plans to commercialize the device in Korea after receiving medical equipment certification from the Ministry of Food and Drug Safety next month.

Memowatch sends electrocardiogram data from the wearer to a doctor. If an abnormal symptom is detected, the smart device relays the information to the doctor, who then instructs the user to come to the hospital for medical assistance.

The device enables doctors to collect electrocardiogram data on their patients without the latter needing to visit the hospital.

Other items selected for regulatory exemption included a mobile e-billing system for paying public fees and an online bridging service that remotely accepts applications for clinical tests.

Minister of Science and ICT Yoo Young Min said, "We will actively look for more cases to grant regulatory sandbox waivers to as long as they don’t hamper public safety and daily life," adding, "I hope the regulatory sandbox can serve as a stepping stone for innovation in ICT and related services."

The regulatory sandbox exempts or postpones the enforcement of regulations on new technologies or products for a designated time to expedite their launch. The system grants a waiver for a product or service during testing from regulations governing a designated region or grants temporary market access.

Minister of Science and ICT Yoo Young Min on Feb. 14 chairs the first meeting of a national committee on new technologies and services at Government Complex-Gwacheon, Gyeonggi-do Province.

Minister of Science and ICT Yoo Young Min on Feb. 14 chairs the first meeting of a national committee on new technologies and services at Government Complex-Gwacheon, Gyeonggi-do Province. (Yonhap News)

SOURCE: KOREA.NET

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