• KIM, YONG-WOO
  • Advisor
  • KIM&CHANG

Curriculum Vitae

Education

YONSEI UNIVERSITY(2001). Bachelor of Science in engineering, Electrical and Electronics Engineering
YONSEI UNIVERSITY(2005). Master of Science in engineering, Software Engineering

Professional Experience

1. KIM&CHANG Law Firm (2013~2018)
- Advisor, Medical Device (E.g., Regulation/Reimbursement) and Digital Healthcare(E.g. AI/Cloud/Big Data) Sector
2. TÜV-SÜD Korea(2011~2013)
- EN ISO 13485 Lead Auditor, MDD/CAMCAS/JGMP Auditor, IEC 60601-1 Test Engineer
3. MFDS(Ministry of Food and Drug Safety)(2006~2011)
- Government Officer, Medical Device Sector, Technical Part Reviewer
4. LG Electronics(2005~2006)
- Researcher, R&D of 3G Mobile Phone
5. Samsung Electro-Mechanics(2001~2003)
- Researcher, R&D of Windows Device Driver

Research Interests

Regulation/Reimbursement/Industrial Code of Medical Device and Digital Healthcare Sector

Honors & Awards

Publications

Abstract

Introduction of the product approval procedure related to medical device using Big Data and AI(Artificial Intelligence) Technology

The Ministry of Food and Drug Safety (the “MFDS”) has recently announced guidelines related to artificial intelligence (“AI”), the main player of the so-called 4th industrial revolution. These guidelines, known as the Approval and Examination Guidelines for Medical Devices Employing Big Data and Artificial Intelligence Technologies (the “Guidelines”) contain detailed information on how to regulate medical devices that employ AI in accordance with the Medical Device Act. The Guidelines classify certain forms of AI that act in the place of healthcare professionals (AI that analyzes the state of the patient or diagnoses and predicts the patient’s disease) as medical devices and specify the necessary procedures for approval of such devices. The Guidelines are the first of its kind that have been officially announced by a national government regarding AI, and are expected to attract attention from a wide range of entities in the related industries, including foreign government authorities. The Guidelines set forth the following with regard to products (software) that employ big data and AI technologies: (i) classification standards; (ii) clinical effectiveness verification methods, and (iii) approval standards for product changes. The detailed information of the Guidelines will be provided at the time of presentation.