The number of approvals for “U-healthcare gateway” needed for conducting telemedicine increased sharply last year.
U-healthcare gateway is a device or software that collects biological information measured in U-healthcare medical equipment (that measures and collects personal medical information gathered outside of medical institutions, and transfers to and stores them at medical institutions) and transfers them, through wired and wireless technology, to a server to conduct telemedicine.
The Ministry of Food and Drug Safety식품의약품안전처(MFDS) said in a report Friday that the primary cause of the steep rise in approvals resulted from the revision of its rules on medical equipment items and itemized classes, in August 2016. At that time, the ministry subdivided the U-healthcare gateway, which had thus far been in the second class in uniform, into the first and second classes.
The ministry divides medical equipment into four classes by the risks on the human body. Class-4 equipment has the highest level of risks while Class 1 device has almost no potential risks. The medical industry had called for readjusting the class of U-healthcare gateway, claiming it performs the simple function of transferring medical data.
U-healthcare gateway turned out to be the U-healthcare equipment most approved and recorded last year. In 2016, the ministry approved or received the report of four U-healthcare gateway devices, making it account for about 71 percent of the total seven approved or reported.
In 2016, among the companies whose U-healthcare gateway were approved were Medtronic Korea메드트로닉코리아, BITcomputer비트컴퓨터, U-SHIN C&C유신씨앤씨, HOOH Healthcare후헬스케어, Health Connect헬스커넥트, and National Health Insurance Service국민건강보험공단(NHIS). Except for BITcomputer, all of them received approvals as the first class.
And the approved items of Medtronic Korea, HOOH Healthcare, and Health Connect are equipment or software, which collects biological information measured for telemedicine in U-healthcare medical equipment through wired or wireless technology, and transmits the collected biological information to medical institutions after codifying them.
NHIS won the approval to use for sending, automatically or manually, data of chronic patients (hypertension and diabetic diseases) of through a mobile app (M health insurance). BITcomputer turned out to be the software which collects, through wired technology, blood pressure information measured in U-healthcare blood pressure gauge and sends the blood pressure information to medical institutions. U-SHIN C&C is a software, which receives blood sugar and blood pressure information earned through U-healthcare medical equipment and provides them for users and medical staff in the form of alarms, for conducting telemedicine.
<© Korea Biomedical Review, All rights reserved.>