Todays’ healthcare system has recognized the advantages of using big data to improve the quality of healthcare.
From the Healthcare, Smart healthcare is a new category of Healthcare and it’s classified by the technology that leads to better diagnostic tools and better treatment for patients. But The most Korea experts have described Smart Healthcare as medical and various technology Convergence during the 2018 Smart Healthcare Conference in South Korea. For example, Information Technology, Biology Technology with Medical Technology to get a Healthcare service for anyone and everywhere. Mostly Smart healthcare included Wellness and Mobile healthcare as the smartphone, Internet of Things (IoT) and SNS.
Global Smart Healthcare product market will reach a value of US$57.85 billion and expend at a CAGR of 8.84 from 2015 to 2023. Among of Southeast Asia is looking to have a high level of mobile telemedicine adoption (62%), the second highest activity globally for mobile health surveillance initiatives (38%) (Source: Transparency Market Research and World Health Organization) However, In South Korea, such a stark contrast has to do with strict regulations on telemedicine. Unlike the United States and China.
During the 2018 Smart Healthcare Conference in South Korea. The Korea experts are negatively forecasting The Korea Smart Healthcare industry Because Korea companies in the industry are compelled to use local cloud services instead of the better one provided by Amazon, Google, etc. This regulations on cloud services are hindering the growth of South Korean smart healthcare. And also, to promote smart healthcare must be considered the registration policy by Korea government.
| United States | Europe | China | Japan | South Korea | |
| Regulatory authorities | FDA | EC/CA | CFDA | MHLW/PMDA | MFDS |
| classification | I/II/III | I/IIa/IIb/III | 1/2/3 | I/II/III/IV | 1/2/3/4 |
| laws | FD&C Act | 93/42/EEC
concerning medical devices |
Medical Device Management Division | Pharmacetical & Medical Appliances Act | Medical Appliances Act |
| Advance permission | 510(k)/PMA | CE Marking, NB,MEDDEV | Registration of Medical Applicances | manufacture and sale | GMP/Test |
| Post Management | labelling, MDR,PMS | MDVS,PMCF | Distributors management, advertisement, side effect report. | GQP, GVP, Side effect report, Re-call | Revaluation, tracking management Side effect report. |
| Quality assurance | QSR (ISO13485) | ENISO 13485:2016 | GB/T19001+YY/T0287 | QMS(ISO13485+a) | KGMP
(ISO13485:2003) |
| Communication | FCC | CE RED | SPRC | MTC | KC |
Table 1. Smart Health Care registration management.
As noted above, The registration and functional technology are important in smart healthcare.
However, The most important thing to achieve success in the smart healthcare industry in South Korea. There are need to consider a question about what we need is functional or trend that consumers need. And also, create the business models as B2B than B2C. Smart healthcare needs to change or improve patient or customers health habit.
In a sense, Our Digitalization is one of the solutions for the smart healthcare industry. If we want to improve customer health habit, must manage it. If we want to manage it. must do measurement properly. I believe that our digitalization can build a Distribution, Confidence, and Connection between the customer and our partner on smart healthcare industry through design the application to target the functional market; NutroxSun for skin protection from UV; MetabolAid for Satiety and Weight management, Metabolic syndrome. Zeropollution for skin protection from pollution. It will make an accurate direction of target market.
Jane Lee
Korea General Manager
