“Korea introduces world’s first ‘digital 메이저사이트 products law,’ opening doors for corporate opportunities by easing ‘메이저사이트 AI’ regulations”

[by Yu, Suin] “The United States represents the largest market, however, Korea is leading in terms of regulatory relaxation,” stated Park Hye-yi, Director of Regulatory Aff메이저사이트rs (RA) at Coreline Soft, in a recent interview with <THE BIO.

Park has been at the forefront of navigating regulatory changes concerning AI-based 메이저사이트 devices. As a pioneer in Korea’s 메이저사이트 AI industry, she rapidly expanded her global regulatory portfolio, ultimately earning the title of “securing the highest number of U.S. Food and Drug Administration (FDA) approvals among Korean companies.” Drawing on this experience, she now serves as the Director of the Digital Health Regulatory Support Division at the Korea 메이저사이트 Devices Industry Association (KMDIA), where she monitors regulatory developments and communicates industry challenges to the relevant authorities, effectively serving as a bridge between the private sector and the government.

Notably, with the implementation of the “Digital 메이저사이트 Products Act” in Korea this January, Park’s role has taken on even greater importance. On April 10, THE BIO visited Coreline Soft’s headquarters in Mapo District, Seoul, to speak with Par about the company’s accomplishments and to gain insights into the future trajectory of the Korean 메이저사이트 AI industry.

◇"11 FDA-approved 메이저사이트 boost global market status as approval strategy proves effective"

“Prior to my joining the company, regulatory frameworks for 메이저사이트 devices were predominantly centered on ‘hardware.’ Traditional 메이저사이트 devices involved tangible manufacturing processes, whereas software, often simply written onto CDs, did not fit neatly into existing regulatory categories, making the approval process particularly challenging.”

Director Park Hye-yi joined Coreline Soft in 2016, at a time when the concept of ‘software as a 메이저사이트 device (SaMD)’ was still relatively unfamiliar. SaMD refers to 메이저사이트 products developed in software form, utilizing digital technologies such as artificial intelligence (AI) or virtual and augmented reality (VR/AR) to serve 메이저사이트 purposes.

Park firmly believed that Coreline Soft’s innovative 메이저사이트 AI solutions could only be applied to real-world clinical settings if they successfully navigated the critical gateway of regulatory approval. With this in mind, she undertook a comprehensive analysis of regulatory guidelines from dozens of countries to facilitate global market entry. This strategic approach culminated in 2018 with the first U.S. Food and Drug Administration (FDA) approval of ‘AVIEW,’ an AI-based integrated product line. Since then, Coreline Soft has secured FDA approval for a total of 11 products, marking the highest number of FDA approvals among Korean companies specializing in AI-driven 메이저사이트 diagnostics.

“This achievement represents more than just a number, it signifies international recognition of our technological consistency, clinical efficacy, and overall quality system,” Park expressed. “The United States, being the largest 메이저사이트 market, imposes stringent regulatory requirements. The guidelines are often non-specific, requiring tailored strategies for each case. As Coreline Soft’s regulatory approval strategy continues to prove effective, the company’s standing in the global market is also steadily advancing.”

◇'Chest-based integrated screening'as key strategy, with lung cancer screening solution ‘AVIEW LCS Plus’ g메이저사이트ning attention

메이저사이트 Soft has positioned ‘chest-based integrated screening’ as its core strategic focus. The chest houses several vital organs, making it a critical area for identifying life-threatening conditions. Given that early detection significantly improves treatment outcomes, the company emphasizes the importance of rapid and accurate diagnostic capabilities.

Coreline Soft primarily targets the so-called ‘BIG 3’ diseases; lung cancer, cardiovascular disease, and chronic obstructive pulmonary disease (COPD), which together account for approximately 50% of premature death in the world. Among its FDA-approved products are ‘CAD,’ an 메이저사이트-based pulmonary nodule detection support software, ‘CAC,’ an automated solution for coronary artery calcification analysis, and ‘RT ACS,’ a chronic obstructive pulmonary disease analysis solution.

Among the company’s offerings, the lung cancer screening solution ‘AVIEW LCS Plus’ has recently garnered significant attention in the global market. According to Park, the solution’s key competitive advantage lies in its ability to simultaneously analyze three major diseases using a single ‘chest CT scan.’ Because it minimizes radiation exposure while detecting major diseases, AVIEW LCS Plus is being integrated into national lung cancer screening pilot programs in major European countries, including Germany, France, and Italy, as well as in Korea.

Coreline Soft is also working to expand its portfolio by developing diagnostic solutions for critical conditions such as cerebral hemorrhage, pulmonary embolism, and aortic dissection. In emergency wards, where it is challenging for radiologists to constantly review CT images, there is a risk of missing the ‘golden hour.’ To address this, Park highlighted the company’s efforts to create AI technology tailored for emergency 메이저사이트 environments, driven by close collaboration with healthcare professionals. In addition, ‘NeuroCAD,’ a brain hemorrhage diagnosis assistance solution, was recognized as an ‘innovative 메이저사이트 technology’ and entered the Korean non-covered and selectively covered market in January 2024.

◇Radical shift in the Korean 메이저사이트 AI market: emphasizing deregulation and fee support

As Coreline Soft expanded its product portfolio and overcame international regulatory barriers, radical changes also occurred in the Korean 메이저사이트 AI market. AI-driven 메이저사이트 data analysis began to see practical application in clinical settings, while telemedicine, digital therapeutics (DTx), and personalized precision medicine gained widespread adoption. These advancements contributed to a paradigm shift in 메이저사이트 services, moving from a ‘treatment’-centered approach to one that emphasizes ‘prevention.’

Regulatory authorities have developed distinct management systems, such as licensing guidelines for software 메이저사이트 devices, to foster industry growth. “Our country is more proactive than any other in establishing guidelines and supporting regulatory relaxation,” Park remarked. “The Ministry of Food and Drug Safety stands out as nearly the only authority to have created product-specific approval review guidelines.”

Recently, the world’s first ‘Digital 메이저사이트 Products Act’ was enacted to offer tailored support for innovative 메이저사이트 devices, such as 메이저사이트 AI and digital therapeutics. This move came in response to industry concerns that the existing 메이저사이트 device regulations did not adequately reflect the rapid development of digital 메이저사이트 technologies nor the unique characteristics of AI-based products. The bill went into effect on January 24.

“The Digital 메이저사이트 Products Act is designed to support faster approvals by aligning with the unique characteristics of standalone software 메이저사이트 devices. As a regulation specifically tailored to 메이저사이트 AI, it offers significant potential benefits for the industry if properly implemented,” Park explained. “Since this is the initial introduction of the bill, there may be challenges, such as increased cost burdens and higher initial regulatory entry barriers. Close collaboration between companies and regulatory authorities will be crucial for the smooth establishment of the law.”

“To secure competitiveness for global expansion, it is essential to establish a public-private collaborative infrastructure that enables the safe use of 메이저사이트 data. Additionally, it is important to seek public procurement measures that can provide opportunities for the early introduction and validation of 메이저사이트 AI products,” she further commented.

Park pointed out that, in addition to regulatory relaxation, financial support is crucial to ensure that products can be effectively used in actual clinical settings. She explained that in the United States, regulatory bodies and insurance organizations (CMS, private insurance companies) are institutionally connected, which enables companies to generate revenue by receiving ‘메이저사이트 codes (CPT)’ and ‘CMS fees’ following FDA approval. However, Korea’s insurance reimbursement system has not yet evolved to keep pace with the rapid change occurring in clinical settings.