▲ Gangwon Special Self-Governing Province and Gangwon Technopark are conducting various demonstrations after holding a declaration ceremony marking the start of demonstrations for the Gangwon Precision Medicine Industry Regulatory Sandbox Special Zone project.

Province and GangwonTP Verify Safe Use of Medical Information
3 companies and 13 hospitals collaborate to advance the industry
Creation of a “Data Safe Zone” to provide customized services
AI solutions to diagnose and predict four diseases, including chronic liver disease, prostate cancer, and brain injury

100 new hires and KRW 2 billion in investment attracted

Gangwon Special Self-Governing Province has been carrying out demonstration projects to verify a system for using personal medical information after being designated by the Ministry of SMEs and Startups as a Precision Medicine Industry Regulatory Sandbox Special Zone, with the goal of resolving inconveniences in the medical field and developing the precision medicine industry. Gangwon Technopark (GangwonTP), together with three hospitals including Kangwon National University Hospital, and 13 companies including AIDOT, is advancing Gangwon’s precision medicine industry based on the regulatory sandbox special zone. This article looks back on achievements to date and future directions since the designation in August 2021.

▲ Gangwon Special Self-Governing Province and Gangwon Technopark are conducting various demonstrations after holding a declaration ceremony marking the start of demonstrations for the Gangwon Precision Medicine Industry Regulatory Sandbox Special Zone project.

What is the Gangwon Precision Medicine Industry Regulatory Sandbox Special Zone?

The Gangwon Precision Medicine Industry Regulatory Sandbox Special Zone was pursued to conduct various demonstrations for the safe and trustworthy use of health and medical data—with personal information protection as the top priority—in order to activate precision medicine for improving public health. In the past, the legal basis for activating the use of personal medical information was unclear, creating many difficulties for industrial development using such information. Under the Personal Information Protection Act, data can be used if it is pseudonymized; however, due to the principle that special laws take precedence, the Bioethics Act and the Medical Service Act take precedence over the Personal Information Protection Act, which has imposed restrictions on the use of health and medical information.

In addition, there was no clearly specified legal basis for secondary use—such as the secondary use of genomes analyzed from human-derived materials—and for secondary use of personal information when collecting human-derived materials. Based on the “Three Data Laws”, guidelines for using health and medical data for the use of pseudonymized information have been established and operated, but there have been difficulties in reflecting the special characteristics of health and medical data.

In this situation, because the deferral of pseudonymization and standards for using genomes collected for medical treatment purposes in hospitals are unclear, if imaging data (MRI, CT) are pseudonymized in accordance with the health and medical data utilization guidelines, the loss of data is large, which has limited industrialization.

In this context, Gangwon Special Self-Governing Province and GangwonTP are verifying the process and system under which, through the regulatory sandbox special zone, personal medical information held by medical institutions can be used without re-consent, while minimizing the risk of personal identification, and can be safely used in a space (Data Safe Zone) equipped with physical, logical, and administrative supplementary systems. Through the precision medicine industry regulatory sandbox special zone, the province is promoting a project to develop AI solutions that diagnose and predict four diseases—chronic (alcoholic) liver disease, prostate cancer, brain injury, and facial bone fractures—and plans to invest approximately KRW 13 billion in national and local funds, with the project scheduled to run until November 2023.

▲ The Data Safe Zone established by Gangwon Special Self-Governing Province and Gangwon Technopark.

Establishing the Data Safe Zone: outcomes of about 100 new hires and KRW 2 billion in investment attraction

The demonstration process for the Gangwon Precision Medicine Industry Regulatory Sandbox Special Zone proceeds through: △ data collection and pseudonymization, △ Safe Zone construction and data loading, and △ data access and analysis. Data collection and pseudonymization are being carried out by Hallym University Chuncheon Sacred Heart Hospital, Kangwon National University Hospital, and Wonju Yonsei Medical Center. Construction of the Safe Zone and data loading are led by GangwonTP and Douzone Bizon.

As medical data are provided through the Data Safe Zone, related companies such as AIDOT, LifeSemantics, Neurophet, and Geovision are accessing and analyzing the medical data to develop AI solutions that can provide patient-tailored services.

In particular, beyond the budget for the precision medicine special zone project, the province additionally invested budget to build the Data Safe Zone and achieved the result of being designated and approved in February of this year by the Ministry of Science and ICT (MSIT) as a Data Safe District. With the designation of the MSIT Data Safe District as support, through the precision medicine industry regulatory sandbox special zone project the province has completed the development of medical AI solutions for the four diseases—chronic (alcoholic) liver disease, prostate cancer, brain injury, and facial bone fractures—and is in the process of obtaining approvals and licenses for commercialization, achieving economic outcomes such as about 100 new hires and KRW 2 billion in investment attraction.

In the field of development and demonstration of a precision medicine AI solution for diagnosing and predicting chronic (alcoholic) liver disease, AIDOT, Sopung & Company, and the Hallym University Industry-Academic Cooperation Foundation are participating, have obtained GMP for in vitro diagnostic medical devices, and plan to complete approvals and licensing within 2024.

In the development and demonstration of a precision medicine AI solution for predicting the occurrence of prostate cancer, LifeSemantics, Kangwon National University Hospital, and Yonsei University Wonju Severance Christian Hospital are participating, building an AI assistant for prostate cancer diagnosis through the combination of clinical data and genomic data. The software is expected to undergo testing developed by KCL (Korea Conformity Laboratories), and they plan to receive a KOLAS-accredited test report.

In the field of development and demonstration of an AI solution for treatment strategies for brain injury patients, Neurophet, Kangwon National University Hospital, and Yonsei University Wonju Severance Christian Hospital are participating, have completed the AI solution product build, and published a paper related to the AI solution’s AI algorithm in an academic journal.

In the development and demonstration of a precision medicine AI solution for diagnosing facial bone fractures, Geovision, GeomexSoft, and Kangwon National University Hospital are participating; they have completed the filing of two patent applications for facial bone fracture AI analysis and have obtained GMP certification. In addition, they plan to present a deep-learning model for facial bone fractures at the Radiological Society of North America (RSNA).

Expectations for promoting data use by activating the use of personal medical information

If the Gangwon Precision Medicine Industry Regulatory Sandbox Special Zone achieves results aligned with its goals, it is expected that, based on the outcomes of pseudonymization processing and the construction/operation of the Data Safe Zone, it will be possible to establish a system for using personal medical information without personal information leakage incidents.

Through the acquisition of approvals and licenses and entry into global markets for AI solutions developed using personal medical information, it becomes possible to establish references for industrial utilization. The province has secured special regulatory exemptions for three regulations related to the use of medical data and new medical technology assessment through the precision medicine regulatory sandbox special zone project, and is pursuing four demonstration projects.

In Geovision’s demonstration case, rapid imaging tests and readings are needed in emergency rooms to protect the golden time for emergency patients, but difficulties have arisen due to a shortage of radiology specialists. With the introduction of an AI solution, it is expected to help alleviate gaps caused by the lack of radiologists and reduce radiologists’ image-reading time.

LifeSemantics is currently in the stage of upgrading functionality and aims to commercialize the solution as an AI medical device in the second half of 2025. Prostate cancer is the fourth-ranked disease in male cancer prevalence and incidence, with an incidence of 65.6 per 100,000 people as of 2019, but because most cases have no symptoms, early detection is important. The government has established the 4th Comprehensive Cancer Control Plan, and because prostate cancer is included among the 10 cancer types covered in the strategy, it is expected that this solution will contribute to the plan to utilize advanced technologies within national screening.

Through the demonstration project, Neurophet is expected to upgrade tES LAB, an existing brain imaging treatment planning software, and verify safety and effectiveness; if it obtains approval as a Class 3 medical device, commercialization of medical devices including tDCS treatment devices is expected to become possible. Kim Ho-seok

Joint Planning: Gangwon Technopark

Gangwon Domin Ilbo / 2023.11.09 / Reporter Kim Ho-seok