Korea covers 49 of 549 approved medical AI devices

The figures come from Ministry of Food and Drug Safety data discussed at a symposium Eulji University Medical Center held in Seoul to mark its 70th anniversary, the Korea Times reported. As of the first half of this year, 549 AI medical devices had received regulatory approval in Korea. National health insurance covered 49 of them.

That is roughly one funded device in 11. The report gave no breakdown of the 49 covered devices by category and did not explain the coverage criteria behind them.

Approval is not clinical need

Seo Joon-beom, a professor at Asan Medical Center, said approval and clinical need are separate questions. "This is a global challenge. Regulatory approval does not necessarily mean a technology is needed in clinical practice," he said, according to the Korea Times.

Seo said Korea has yet to settle its longstanding reimbursement question: whether hospitals should be paid more for these technologies. That is the hinge for buyers. A cleared device that no insurer pays for is a device hospitals have less reason to buy, whatever the certificate says. For manufacturers, the reimbursement decision sets the commercial clock, not the regulator's stamp.

Regional gap

Park Jung-hwan of the health ministry's Medical AI and Data Policy Division pointed to a second gap. "Health care disparities between the Seoul metropolitan area and other regions remain significant, while underserved areas continue to struggle with essential services such as emergency, pediatric and maternity care," Park said. "New AI technologies are also concentrated in the capital region, leaving regional public hospitals behind in AI transformation."

The government aims to make Korea the first country to fully integrate AI into health care, the Korea Times reported. The Presidential Council on National Artificial Intelligence Strategy set a national AI health care strategy in August, with the goal of building a digital health care infrastructure within the current administration's term.

Park said AI-powered health care services can overcome geographical barriers and narrow regional gaps. He said AI could analyze patient transfer and emergency room data to ensure timely treatment during the critical golden hour, and analyze personal medical records to prevent the same tests when patients switch hospitals.

What would change the arithmetic

Seo called for Korea to develop its own health care foundation models rather than rely on foreign technologies. He cited Epic's database covering 100 million patients as an example and called for greater access to research data. He also said Korea should integrate public health insurance data with private medical data and establish a public AI health care platform to support clinical adoption.

Kim Hyeon-chang, director of the Yonsei Institute for Digital Health, said the goal is not simply high-performance AI but better disease prevention, treatment and health management. Korea Advanced Institute of Science and Technology professor Jung Jae-seung said AI could shift health care from treatment to prediction and prevention.

The open question is whether the government's strategy changes the payment arithmetic for any of the 549. The Korea Times report offered no timetable for expanding insurance coverage beyond the 49. Until that changes, Korea's medical AI market remains split between devices that have clearance and devices that have a payer.