Korea Testing and Research Institute for Mechanical, Electrical and Electronic Testing Enters Phase Two of Research on Safety of AI-based Digital Medical Devices

Development of Integrated Risk Management, SBOM, and Generative AI Red-Team Technologies
10.6 Billion Won Investment to Strengthen Response to Global Cybersecurity Regulations

On the 10th, at the President Hotel in Jung-gu, Seoul, members of Hanguk Gigye Jeongi Jeonja Siheom Yeonguwon are taking a commemorative photo at the second-year kickoff meeting of the "Research on Technology Development to Ensure Safety and Reliability of AI-based Digital Medical Products." Hanguk Gigye Jeongi Jeonja Siheom Yeonguwon.

The Korea Testing and Research Institute for Mechanical, Electrical and Electronic Testing (KTC) has launched the second year of a research and development project aimed at ensuring the safety and reliability of artificial intelligence (AI)-based digital medical devices.

KTC announced on the 12th that on the 10th it held the second-year kickoff meeting of the "Research on Technology Development to Ensure Safety and Reliability of AI-based Digital Medical Devices" at the President Hotel in Jung-gu, Seoul.

This study is a research and development project funded by the Ministry of Food and Drug Safety, with KTC serving as the lead institution. A total budget of 10.6 billion won will be invested over 33 months until December 2027. In the first year, which was last year, the focus was on establishing a safety evaluation framework, centering on security risk analysis for digital medical devices and research on cybersecurity support.

In the second year, based on the guidelines and analysis results established in the first year, the project will focus on deriving technological outcomes that can be practically applied in industrial settings. The main tasks include developing an integrated risk management system for digital medical devices, developing a software bill of materials (SBOM) authoring tool, and developing red-team testing and evaluation technology for AI-generated digital medical devices.

The research is being conducted in the form of a consortium of nine organizations, with KTC at the center, including the Electronics and Telecommunications Research Institute (ETRI), STA Consulting (STA), Seoul National University Bundang Hospital, Dongguk University Industry-Academic Cooperation Foundation, Korea Testing Laboratory (KTL), Korea Testing & Research Institute (KTR), Sparrow, and the Digital Health Security Association. The participating organizations plan to enhance collaboration to improve the completeness of the technologies.

Through this project, KTC expects to build an environment in which digital medical device manufacturers can systematically manage security vulnerabilities from the development stage, and to help strengthen capabilities to respond to medical device cybersecurity regulations in overseas markets such as North America and Europe.

Ahn Seongil, President of KTC, said, "If the first year was a period of laying the foundation for technology development, the second year is an advancement phase to enhance technological completeness based on the outcomes," adding, "We will do our best to ensure that the research is successfully completed so that it can provide practical help in securing the safety of domestic digital medical devices and enhancing corporate competitiveness."

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