The Ministry of SMEs and Startups (MSS, Minister OH Youngju) announced on September 4 (Wednesday) that it held a forum titled “Policy Discussion for Supporting AI Healthcare SMEs and Startups” at the Melon Hall, L Tower in Yangjae, Seoul.
AI healthcare is one of the fastest growing* fields among industries utilizing AI. Previously, it was limited to analyzing images from X-rays, CT scans, and MRIs for disease screening; however, in the future, it is expected to expand into real-time diagnostics, surgical assistance, digital therapeutics, genomic analysis, and new drug development. Given that Korea has a large pool of outstanding talent in the ICT and bio sectors, AI healthcare is anticipated to become a new growth engine. Therefore, more active, and effective support is deemed necessary.
* The global market size of AI healthcare is expected to expand by more than 10 times from USD 15.8 billion in 2023 to USD 181.7 billion in 2030 (Markets and Markets).
In this regard, the MSS designated Gangwon Province as an “AI Healthcare Global Innovation Special Zone” last May to support AI healthcare companies in developing competitive products free from regulatory constraints and to facilitate rapid overseas expansion in collaboration with global certification bodies.
Furthermore, in July, the MSS announced its “Super Gap AI Startup Level-Up Strategy,” designating AI healthcare as one of the top five high-growth areas for AI startups and enhancing support in this field.
In particular, based on the business agreement signed on July 18 between LIM Jeong-wook, Deputy Minister of the Office of Startup and Venture Innovation, and Simo Dkhissi, Vice President of TUV Rheinland*, the Gangwon AI Healthcare Global Innovation Special Zone will provide technical consulting, prior review, and expedited certification covering the entire process from the development stage of AI medical devices to performance validation and testing. It also plans to promote exchanges and cooperation between experts from both countries to ensure the reliability of AI medical devices and respond to EU regulations.
* TUV Rheinland, established in 1872, is a global CE certification body operating more than 500 offices in 50 countries, focusing on the certification of medical devices, energy, and information and communication technology.
During the forum, Ferenc Kazincz, Global Medical Device Software Executive, delivered a presentation on “EU AI Regulatory Trends and Cooperation Strategies Linked to Gangwon Global Innovation Special Zone,” stating, “The EU AI Act was passed in August of this year, and its application to medical devices will begin in 2027. TUV Rheinland is responding quickly by forming a dedicated organization.” He further added, “We will actively support companies in the Gangwon AI Healthcare Global Innovation Special Zone to successfully enter the global market, especially the EU market.”
Following the keynote presentation, a panel discussion was held involving experts from industry, academia, research, and hospitals to design tailored support policies for AI healthcare companies. The discussion included assessing the capabilities of AI healthcare companies in Korea and proposing directions for domestic regulations while sharing technological and regulatory trends from the United States and Europe.
Notably, KIM Han-su, Director of Mokdong Hospital at Ewha Medical Center, who participated as a discussant, introduced the need for the introduction of AI healthcare technology in hospitals from the perspective of demand, as well as the role of hospitals as clinical providers and the medical center’s achievements and plans made in collaboration with companies. He also suggested that enhancing the autonomy of hospitals is essential to facilitate such cooperation.
LIM Jeong-wook, Deputy Minister of the Office of Startup and Venture Innovation, stated, “To foster AI healthcare companies, various support including financial assistance, validation of technological effectiveness and safety through demonstration and certification support, and prompt improvements in relevant laws and regulations are needed.” He also added, “We will gather and actively reflect the opinions of companies and experts from various fields in designing policies.”