Developed countries such as the United States, Europe, and Japan are spurring the creation of a so called `digital healthcare` system that combines medical and information technology (ICT). Korea, on the other hand, has advanced technology and infrastructure, but digital healthcare system is in the process.

US Food and Drug Administration recently announced the "Digital Healthcare Innovation Plan," which focuses on improving the digital healthcare system and nurturing experts, according to the medical and digital healthcare industries on Tuesday. The FDA`s plan is very innovative. What is noteworthy is a new approach to regulating digital healthcare products, focusing on `developers` rather than `products`. FDA plans to grant "pre-approval" to companies with appropriate qualifications and to apply a simplified licensing process for the products they produce. Pre-approved companies can collect actual practice data after product launch and utilize it for formal licensing. The FDA plans to select nine companies to carry out pilot projects and then expand the scope of application.

Digital healthcare is a technology which combines ICT with medical care to prevent diseases and help patients to treat and manage them. It has been pointed out that regulations in the field of digital healthcare do not follow the rate of technological innovation. New innovations that are beyond the scope of existing medical products, from smartphone applications (apps) to AI (artificial intelligence), are emerging. However, existing institutional frameworks have difficulties in evaluating the safety and effectiveness of these products, It has been.

Meanwhile, in the US and Europe, the foundation for digital health care industry is being developed. Germany adopted the E-Health Act last year to support the innovation of the medical industry in relation to the "Industry 4.0" strategy being pursued by the government. In accordance with this law, which provides an institutional basis for the construction of future medical systems, Germany plans to introduce new regulations for the use of electronic health insurance cards and personal data security by the end of next year for building telemedicine infrastructure. The UK is promoting tax benefits and corporate incentive policies to promote telemedicine and promote the commercialization of research results in the digital healthcare field. Japan has designated the digital health care industry as a national strategic industry, .

Choi Yoon-seop, director of the Digital Healthcare Research Center, pointed out, "The flow of advanced countries like these is a commitment by regulators to change the way they regulate technology, ultimately to help patients in the digital healthcare industry."

Korea is in a position to establish a digital health care system in contrast to this global trend, and the benefits to return to patients and the growth of related industries are at the root. The doctor-patient-to-patient telemedicine that has been repeatedly piloted for more than 10 years has been stigmatized by the ‘medical commercialization’ policy as the regime has changed, and the improvement of the personal information protection law, which prevents the use of patient data, has been discussed at the theoretical level for several years. It is stopping.

There is also concern that the government has recently strengthened its health insurance coverage, and that the introduction of new medical technologies such as digital health care is further shrinking. A representative from a healthcare company said, "The government is growing uncertainties as it does not offer comprehensive measures for digital healthcare." Some companies are turning their eyes to overseas. However, it is difficult to raise profits yet."

By Nam Do Yeong namdo0@


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