Ministry of SMEs and Startups Explores Global Expansion Strategies for AI Healthcare Startups and Venture Companies

The Ministry of SMEs and Startups, Gangwon Province, TUV Rheinland, and experts from industry, academia, research institutes, and hospitals gathered to explore global expansion strategies for artificial intelligence (AI) healthcare startups and venture companies.

On the 4th, the Ministry of SMEs and Startups held a 'Policy Discussion Forum for Fostering AI Healthcare SMEs and Startups' at the Melon Hall in EL Tower, Yangjae, Seoul.

AI healthcare is one of the fastest-growing sectors among industries utilizing AI. While it previously focused on analyzing images such as X-rays, CT scans, and MRIs to detect diseases, its scope is expanding to include real-time diagnosis and surgical assistance, digital therapeutics, genomic analysis, and new drug development. As Korea has many talents in the ICT and bio fields and this sector is expected to become a new growth engine, more proactive and effective support is required.

Accordingly, in May, the Ministry of SMEs and Startups designated Gangwon Province as an 'AI Healthcare Global Innovation Special Zone' to support AI healthcare companies in developing competitive products free from regulatory constraints and to enable rapid overseas expansion through collaboration with global certification bodies. In July, the ministry announced the 'Super-gap AI Startup Level-up Strategy,' designating AI healthcare as one of the five high-growth sectors for AI startups and strengthening support.

In particular, within the Gangwon AI Healthcare Global Innovation Special Zone, based on a memorandum of understanding signed on July 18 between Lim Jeong-wook, Director of the Startup Venture Innovation Office at the Ministry of SMEs and Startups, and Simo Dekishi, Vice Chairman of TUV Rheinland, a global CE certification body, support will be provided from the AI medical device development stage through performance verification, technical consultation, pre-review, and rapid certification. Additionally, exchanges and cooperation between experts from both countries will be promoted to secure the reliability of AI medical devices and respond to EU regulations.

At this forum, Ferenc Kazincz, Global Head of Medical Device Software, delivered a presentation titled 'EU AI Regulatory Trends and Gangwon Global Innovation Special Zone Cooperation Strategy,' stating, “The EU AI Act was passed in August this year, and its application to medical devices will begin in 2027. TUV Rheinland is responding swiftly by establishing a dedicated organization,” and added, “We will actively support companies in the Gangwon AI Healthcare Global Innovation Special Zone aiming to enter the European market to successfully expand into the global market.”

Following the keynote presentation, a panel discussion was held with experts from industry, academia, research, and hospitals to design customized support policies for AI healthcare companies. They assessed the capabilities of Korean AI healthcare companies, suggested directions for domestic regulations, and shared technological and regulatory trends from the United States and Europe.

Participating as a panelist, Kim Han-su, Director of Mokdong Hospital at Ewha Medical Center, introduced the necessity of adopting AI healthcare technologies in hospitals from the demand side, the hospital’s role as a clinical provider, and the achievements and plans realized through cooperation with companies at Ewha Medical Center. He proposed that enhancing hospital autonomy is essential to further promote such cooperation.

Lim Jeong-wook, Director of the Startup Venture Innovation Office, stated, “To foster AI healthcare companies, multifaceted support is needed, including funding, demonstration and certification support to prove technological effectiveness and safety, and rapid improvement of related laws and systems,” and added, “We will listen to the opinions of companies and experts from various fields and actively reflect them in policy design.”

This content was produced with the assistance of AI translation services.