Following last year's initiation, the Ministry of Food and Drug Safety (MFDS) is set to implement the Big Tech Regulatory Innovation Program this year. This year's program will see the participation of four new companies: Samsung Electronics, Samsung Fire and Marine Insurance, Hyundai Motor, and SKT.

The MFDS has been conducting the Big Tech Regulatory Innovation Program since last year, focusing on enhancing regulations concerning artificial intelligence (AI)-based medical devices. The program involved five companies, including KT, LGU+, Naver, Kakao Brain, and Kakao Healthcare, who provided their insights and perspectives.

Through this program, MFDS and big tech companies have identified five key tasks concerning generative AI medical devices (AIMDs), including relaxing clinical standards, establishing screening standards, supporting rapid commercialization, facilitating clinical, demonstration, and approval consulting for overseas markets, and promoting the use of RWD/RWE (real-world data/real-world evidence) in domestic approvals.

The ministry plans to expand the regulatory improvement targets to digital and AI medical devices this year.

The main businesses of the newly participating companies are Samsung Electronics' wearable devices and apps for monitoring blood pressure, ECG, and others; Samsung Fire’s app (Anyfit Plus) that provides meaningful healthcare services to health insurance subscribers; Hyundai Motor's wearable rehabilitation robot; and SKT's 'pet AI healthcare service (X Caliber: X-ray-based animal imaging diagnosis aid).

The ministry will meet with each company starting this month to learn about its business progress and plans and discover additional regulatory improvement issues. It will also hold semi-annual meetings with all big tech companies participating in the regulatory innovation program.

Starting with a visit to Samsung Fire and Naver on March 12, MFDS plans to visit Kakao Healthcare, Kakao Brain, KT, LGU+, Samsung Electronics, Hyundai Motor, and SKT in April and plans to visit them at least twice a year.

"We expect the Big Tech Regulatory Innovation Program 2024 to achieve field-oriented regulatory innovation that companies can practically experience, and we plan to do our best to ensure that our regulations will soon become global regulations so that Korean companies can lead the global digital medical device market," the ministry said.