Reasons for Proposal

With the advent of the 4th Industrial Revolution, the paradigm of medical services is shifting from supplier and treatment to patient and prevention. It is expected that the vitalization of Digital Healthcare, which utilizes digital technologies such as data, network, artificial intelligence, etc. in the healthcare field, will be able to overcome the Iron Triangle for Healthcare and realize future state-of-the-art medical care. According to a survey conducted by the Korea Health Industry Development Institute in 2021, 71.8% of domestic medical personnel agree on the need for digital healthcare, and awareness of the need for digital healthcare is spreading throughout the healthcare industry.

In addition, Korea is facing a rapidly aging population, with the elderly population expected to exceed 10 million by 2025 when it becomes a super-aged society. That is why it is necessary to actively utilize digital technology in the medical field to achieve patient safety, enhance medical service quality, manage public health, etc. And it is also necessary to streamline the healthcare system and alleviate the rapid increase in medical expenditures by utilizing digital technology.

Meanwhile, Korea has a large amount of health and medical data with high potential value due to the characteristics of the national health insurance-based health and medical system with an Electronic Medical Record System coverage rate exceeding 90%. Combining this with Korea’s excellent ICT capabilities, it is expected that it will lead not only to innovation in healthcare services but also to innovation and growth in the overall digital and bio-health industries such as medical devices, medicines, etc.

Major developed countries such as the U.S., Great Britain, Japan, Germany, Finland, etc. have already preemptively established “digital health innovation strategies” at the national level. Apart from the existing healthcare-related laws, they are making efforts to promote digital healthcare and share and use healthcare data, while at the same time enacting a separate new law to revitalize precision medical care, which is a personalized medical concept.

Accordingly, Korea also intends to revitalize digital-based healthcare services and systematically foster and support the digital and bio-health industries by enacting new laws to promote digital healthcare and promote the utilization of healthcare data. In addition, by establishing a whole-cycle management system for sharing and utilizing healthcare data, the plan is to lay the foundation for utilizing it to enhance public health while safely protecting healthcare data that includes the public’s sensitive personal information.

By creating a foundation for the future state-of-the-art medical development environment and contributing to improving national health and the quality of life, it is expected to proactively respond to social problems such as COVID-19 and aging, improve the quality of medical services such as achieving patient safety and realizing personalized precision medical care, and foster the digital and bio-health industries also called the “second semiconductor industry” as a new growth engine for Korea.

Major Provisions

A. Establish the concept of digital healthcare centering on healthcare, such as defining “Digital healthcare” as a series of activities and means that contribute to the improvement of public health, such as prevention, diagnosis, treatment of disease and health management using intelligent information technology and healthcare data, and defining “Healthcare data” as healthcare information under Article 3 of the Framework Act on Healthcare and Medical Services that can be processed in an optical or electronic manner, and stipulate relationships with related laws in the healthcare field such as the Medical Service Act, the Pharmaceutical Affairs Act, the Bioethics and Safety Act, the Medical Devices Act, etc. (Article 2).

B. Stipulate that the Minister of Health and Welfare can establish the basic plan and implementation plan after consultation with the relevant central administrative agencies to promote digital healthcare and promote the utilization of healthcare data, and stipulate that the digital healthcare policy review committee can be established under the Prime Minister so that the public and private sectors can cooperate to discuss digital healthcare and healthcare data policies (Articles 6 through 8).

C. Revitalize big data research in the health and medical field and strengthen personal information protection by clearly stipulating in the law the scope, methods, and procedures related to pseudonym processing of health and medical data, that used to be stipulated at the guideline level despite the revision of the Three Data Acts to promote the use of big data for research purposes (Articles 10 and 11).

D. Introduce the right to request transmission in order to create an ecosystem where the people can share and utilize their own personal medical data of their own accord for various purposes such as care as well as medical and healthcare services, and establish the management system necessary to safely protect personal healthcare data (Articles 13 through 18).

E. Establish a system improvement process to reflect new digital healthcare products, services, and technologies in healthcare policies after social discussion, and establish a separate digital healthcare specialized regulatory sandbox system that reflects the special characteristics of digital healthcare directly related to people’s lives and health (Article 9, Articles 19 through 26).

F. Stipulate that the government can promote projects such as data standards and quality management, R&D promotion, personnel training, factual survey, international cooperation, etc. to support the promotion of digital healthcare and healthcare data utilization and provide the necessary support (Article 12, Articles 29 through 35).