It has been found that the South Korean smart healthcare industry is mired in excessive regulations. Last year, no more than three mobile healthcare apps obtained the local medical device authorization and one out of the three was the National Health Insurance Service’s to boot. Each of the three apps provides nothing more than patient information collection and observation. On the contrary, the Food & Drug Administration of the United States allowed the sale of a total of 36 digital healthcare devices last year.
Such a stark contrast has to do with strict regulations on telemedicine in South Korea. Unlike the United States and China, South Korea has yet to deal with this type of regulations with smaller hospitals and clinics and civic organizations opposed to telemedicine, claiming that it would result in less and less patients in smaller hospitals and clinics and form the first step of for-profit medical corporations.
Regulations on cloud services are hindering the growth of the South Korean smart healthcare industry, too. At present, patient information and data cannot be sent abroad although the information and data can be kept out of medical institutions in South Korea, which means companies in the industry are compelled to use local cloud services instead of the better ones provided by Amazon, Google, etc.
Another roadblock is the South Korean government’s time-consuming approval of innovative devices. For example, smartphone apps for blood sugar management, heart rate sensing and the like could hit the South Korean market as recently as July last year, much later than in many other countries, after their classification as not medical devices but personal healthcare products.
The distinction between medical practices and healthcare services is still unclear in South Korea, too. “Most guidelines of the Ministry of Food & Drug Safety refer to foreign cases such as those of the FDA of the U.S. and thus it is very hard to obtain an approval for technology originating in South Korea,” said an industry source, adding, “One typical example of this is the ministry’s guidelines related to the IBM Watson, which were prepared very promptly unlike those associated with AI medical devices developed by South Korean venture firms.”