South Korea Health Policy Updates – August 2022

Published Aug 16, 2022

Sang-Soo Lee, PhD, MBA, Chair, ISPOR Asia Consortium Industry Committee, Sr. Director, Health Care Economics and Government Affairs (HCE&GA), Medtronic North Asia (Korea and Japan), and Head of Center of Expertise (COE), HCE&GA, Medtronic Asia Pacific, Seoul, South Korea

1. President Yoon’s administrative policy tasks were announced

On May 3, 2022, the Presidential Transition Committee announced the Korean president-elect Yoon’s administration’s policy task that is consisted of 6 directions and 110 specific policy tasks [1]. This summarizes medtech industry - related news only:


Task #25) Taking a leap as a global hub of bio digital health

  • Task Goal

    -    Perform intensive investment in health and security strategies and strengthen global cooperation to become a powerhouse for vaccines and treatments

    -    Promote the bio-health industry as a major industry for export and improve national health by spreading high-tech and precise medical care based on digital healthcare and big data

  • Details

    -    (Post COVID-19) Establishment of an innovative R&D system for health security related tasks such as infectious diseases and national tasks to be solved such as rare and incurable diseases (i.e. Korean version of ARPA-H)

    -    (Global Hub) With the World Health Organization’s bio hub training center, establish global bio-campus, host a global bio summit, and become a global center in the bio-sector

    -    (Pharma bio) Create an innovative ecosystem through creating mega funds for the development of innovative new drugs, fostering convergent talents such as doctors and scientists

    -    (Digital Health) Establish ‘health information highway’ system that allows individuals to easily utilize their medical and health information and provide customized support

    -    Laying the legal and institutional foundation for medical MyData and digital healthcare services

    -    (Big data) Expand data-based research and development, such as establishing and opening big data for healthcare and developing bio-digital and promote precise medical care

    -    (Productization Regulatory Science Innovation) Simultaneously review technology-regulatory consistence from the research stage to increase regulatory predictability and establish a full cycle support system to raise the success rate of commercialization (Comprehensive support such as pre-consultation, clinical trial design, and rapid review, and redesign of bio and digital health customized regulation)

    -    (Continued innovation in quality and production) Establish product safety and performance feedback system through collection and evaluation of use information post approval and expand national supply base such as products for rare and incurable diseases with greater public value than marketability

  • Expected results

    -    Rapid response in the crisis by preemptively developing vaccine treatments in preparation for the next pandemic

    -    Bio-health exports expanded ($25.7 billion in 2021 → $60 billion in 2030) and job creation expanded (980,000 in 2021 → 1.5 million in 2030) to create next growth engine


    Task #67) Strengthen preventive health services

    • Task Goal

      -    Expand health and medical services based on ICT innovation technology to make people healthier

      -    Strengthen support for mentally ill patients and suicide high-risk groups by expanding investment in mental health and physical health and establishing a system for responding to mental health problems

      -    Prepare for infectious diseases that can be prevented by expanding national vaccination and targets

    • Details

      -    (Smart Healthcare) Based on ICT, strengthen prevention and management of chronic diseases by local hospitals’/clinics’ providing care plans, health care services and customized education to people with chronic diseases

      -    Expand visiting medical care centered on areas such as rural areas with low medical access and promote national health coverage for continuous glucose management test

      -    (Childcare system) Introduce a pilot program for children’s health guidance (child doctor) and reinforce services for children's public specialized medical centers, etc., such as customized education and counseling

      -    (National mental health investment) Gradually introduce a separate mental health examination system from general health examination for early detection and intervention of mental health problems

      -    Reinforce full-cycle support from hospitalization to independence for severely mentally ill patients and expand R&D to overcome mental health problems

      -    (Systematization of non-face-to-face treatment) Promote institutionalization of non-face-to-face treatment centered on primary care for patients who need constant care and elimination of medical blind spots and medically vulnerable areas

      -    (Expanding vaccination) Expand mandatory vaccinations and manage vaccine safety such providing free rotavirus vaccination for infants and toddlers

    • Expected results

      -    Prepare for an increase in future medical expenses by strengthening the chronic disease management such as hypertension and diabetes, providing support for proactive and regular health care services in daily lives, and expanding vaccination support

      -    Solve mental health problem such as depression caused by the prolonged COVID-19

      2. HIRA opens common data model (CDM) for comparative research

      On May 25, 2022, Health Insurance and Review Assessment Service (HIRA) announced that it will open the international standard common data model (CDM) for comparative research among countries where mid- to long-term research is possible, and among countries and specific institutions [2]. It said that researchers can gain insight into the essence of data by comparing the national medical information from HIRA and data from medical institutions. In this model, there is no risk of leakage of sensitive personal information in that the analysis result value is shared rather than the data itself. HIRA preferentially opens ‘COVID-19 patient data’, which is in high demand for research and is consisted of 5 years of national medical care information (2018-2022), representing about 20% of the total population. The opening up of CDM data will take place in three phases:

    • Step 1: Confirmed COVID-19 patient data. Medical care use information such as underlying diseases of the cumulative confirmed COVID-19 patients will be opened in a common data method
    • Stage 2: Vaccinated population data. If it is possible to link the data from the first stage to the latest 'Korea Disease Control and Prevention Agency (KDCA) vaccination information' in 2022, it will be available as cohort (population group) data
    • Stage 3: Total disease data. Open data for all diseases by continuously transforming HIRA’s medical care claims data into a common data model


      HIRA plans to receive applications for using the common data model from July. Researchers can apply for research and analysis tasks such as COVID-19-related sequelae, adverse reactions, and changes in medical care use patterns of COVID-19 confirmed patients with the common data model.

      3. AI-empowered digital health technology is determined to be applied to the ‘temporary deferment of new Health Technology Assessment (nHTA)’ program

      On June 8, 2022, the Ministry of Health and Welfare (MoHW) announced the draft amendments to ‘temporary deferment of new Health Technology Assessment (nHTA)’ program for 3 newly selected products: 1) Assistance Screening Test of Amnestic Mild Cognitive Impairment(aMCI) using Machine Learning(ML)-based EEG Analyzing Algorithm Software, 2) Plasma Protein(APOC1, NCHL1, CAH1) Test to Assist Screening for Breast Cancer [Liquid Chromatography- Tandem Mass Spectrometry] and 3) Monitoring the Risk of Pre-Cardiac Arrest within 24 hours [3]. Among these three technologies applied to the ‘temporary deferment of new Health Technology Assessment (nHTA)’ program, the “Monitoring the Risk of Pre-Cardiac Arrest within 24 hours” is a technology used to monitor the risk of cardiac arrest within 24 hours. It is used for adult patients over the age of 19 who have been hospitalized for 24 hours or more in general wards, excluding intensive care units and emergency rooms. The patient's age, vital signs (systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and body temperature) and time of measurement collected from electronic medical records are analyzed, and the risk of cardiac arrest within 24 hours is provided with scaled scores between 0 and 100. The technology involved is VUNO Med–DeepCARS (MFDS regulatory approval number: 21-709, August 23, 2021), and nHTA is deferred from August 1, 2022 to July 31, 2024.

      Note) ‘temporary deferment of new Health Technology Assessment (nHTA)’ program: in the special case of a new medical technology which received regulatory approval based on review of the clinical research literature, MOHW allowed the nHTA review to be deferred for certain periods and provided temporary permission to market access on conditions that 1) comparative clinical research evidence against existing technologies is collected and submitted for regulatory approval (however, if the indication is for rare disease, or there are no alternative technologies available, this requirement is waived), and 2) the technology is used only for the indications licensed by Ministry of Food and Drug Safety (MFDS). During the deferment period, the costs of both medical procedure and technology usage are borne by the patient.


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on Update my browser now