Insung Home Healthcare u-Device Gets KFDA Approval
– HiCare HX-461 to be the world’s first VoIP-based “health gateway”
– The device to be distributed to 4,000 homes participating in MKE’s Smart Care project
– The company preparing to get an international approval in 2011 for global distribution
November 11, 2010, SEOUL
Insung Information, Co., Ltd., (www.insunginfo.co.kr) an IT total solutions and u-health solutions provider, announced today that the company’s HiCare HX-461 has been approved by KFDA (Korea Food and Drug Administration) as a “home healthcare device.” The device is the first of its kind to get a KFDA approval.
Compared to HiCare Dr-U (HX-554), a health gateway device for healthcare professionals, HiCare HX-461 is a VoIP and multimedia-based health gateway device for home use. It is also the world’s first VoIP-based home health gateway device.
Developed as a part of Korea’s UCN (ubiquitous computing and network) technology project, HiCare HX-461 is the country’s first medical device based on ISO/IEEE11073, HL7, an international standard for device middleware connector technology.
HiCare HX-461 has been tested for device compatibility during CHA(Continua Health Alliance) Plugfest and IHE(Intergration the Healthcare Enterprise) Connectathon. The device also has been presented and test-run at the HIMSS (Healthcare Information and Management Systems Society) convention in October 2010.
HiCare HX-461 features a 10.2-inch touchscreen and easy interface for users of all ages. The device can be shared by multiple users, and supports communications with other external devices through various interfaces (wired/wireless, blue tooth, USB2.0). The system also supports a wide range of tests, including ECG, oxygen saturation, and body temperature.
Using HiCare, patients can monitor various biometrics including blood pressure, blood sugar level, body fat, etc. at the comfort of their home. The data is then transmitted in real-time to HiCare service server for analysis, which sends the result and feedback of the analysis back to the home device. The server maintains a database for each patient, and the physicians can access this data to provide real-time consultations for patients at home.
The patients can directly access the patient support center for help through the VoIP and video phone function, which enables an immediate response to possible emergencies.
Equipped with various functions including, camera, multimedia services, and health information, HiCare is truly a home health gateway device for a multimedia generations.
HiCare is the first home healthcare device approved by KFDA. Since the new law regarding remote and ubiquitous healthcare enforces use of KFDA-approved devices, HiCare is expected to be the frontrunner in the home healthcare devices market when the law becomes effective.
MKE (Korea Ministry of Knowledge Economy) has selected HiCare for “Smart Care 2010,” its showcase project based on the new u-healthcare model. The device will be distributed to 4,000 homes participating in the project.
Mr. Jong-Yoon Won, Insung’s CEO, states that “KFDA approval on HiCare HX-461 marks an important milestone for Insung and u-healthcare industry. We are also soon to get FDA approval and CE marking, and then proactively promote the device in the global market.”
The prospective target market for Insung’s HiCare HX-461 includes Northern Europe, China, and Vietnam. The company is expecting the KFDA approval on the device will provide leverage for its business in the global market, as well as in Korea.
* KFDA (Korea Food and Drug Administration): enforces legislations, regulations, and standards regarding food and drug products traded in Korea
* CE (Conformité Européene) marking: is given to products that satisfy conditions specified by the EU Directives in terms of safety, health, environment, and customer protection. A CE marking is required for all products presenting customer safety issues before being traded in an EU country. The marking is necessary for a product in order to be exported to Europe.
* FDA (Food and drug Administration): enforces laws regarding all food and drug products manufactured, distributed, or sold in the U.S.A.
* ISO (International Organization for Standardization): is an international organization established in 1946 to promote cooperation between countries in intellectual activities in the areas of science, technology, and economy.
* IEEE (Institute of Electrical and Electronics Engineers): is an expert organization of scholars and practitioners of electrical engineering, electronics, communications, and computer sciences from all over the world. Major activities include conferencing, publication, standardization, and provision of information.
* HL7 (Health Level 7): specifies standards regarding communications of medical information between multiple devices and systems
* CHA (Continua Health Alliance): is an international alliance of u-health devices industry
* Plug fest: is an event hosted by CHA for tests of device compatibility
* IHE (Integrating the Healthcare Enterprise): is an international organization of healthcare enterprises
* HIMSS (Healthcare Information and Management Systems Society): is a non-profit organization established to promote the development of healthcare information and management systems. HIMSS conference is one of the largest-scale events in the industry, where industry experts, government leaders, and scholars gather for knowledge exchange and networking.