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유럽연합과 미국의 개인정보 이전 협약 (프라이버시 쉴드)과 국내 정책 방향
윤재석(Jaesuk YUN) 한국정보보호학회 2016 정보보호학회논문지 Vol.26 No.5
유럽연합은 미국과 개인정보 이전을 위해 맺은 세이프 하버를 유럽사법재판소의 결정에 따라 새로운 협약인 프라이버시 쉴드로 최근 대체하였다. 同 협약은 보다 강화된 개인정보보호 준수 의무, 강력한 법집행, 명확한 보호 요건 및 투명성의 의무, 유럽연합 시민의 권리보호를 위한 효과적인 구제 수단 강구 등을 제시함으로써 이전보다 개선된 것으로 평가받고 있다. 본 논문에서는 유럽연합과 미국의 개인정보 이전을 위한 논의 경과와 현황을 살펴보고 국외이전 관련 제도 정비, 개인정보 국제 협력 활동과 관련한 국내 정책방향을 제시하였다. European Union and United States have introduced new Privacy Shield agreement after decision of Court of Justice of the European Union which invalidated Safe Harbor agreement. Privacy Shield agreement contains several clauses to raise the level of personal data protection such as enhanced commitments, stronger enforcement, clear safeguards and transparency obligations, and effective protection of EU citizens’ rights with several redress possibilities. This agreement has received positive response as an enhanced measure for personal data protection. This paper examines EU and US discussion history and current situation regarding Privacy Shield and suggests national policy direction such as measures for personal data transborder flow systemimprovement and international cooperation.
윤재석(Jaesuk Yun),윤경식(Kyung Sik Yoon),이용섭(Yong-seop Lee),한경문(Kyoung moon Han),차혜진(Hye Jin Cha),신지순(Jisoon Shin),김영훈(Young-Hoon Kim),박혜경(Hye-Kyung Park),김형수(Hyung Soo Kim) 대한약학회 2017 약학회지 Vol.61 No.2
Narcotics, psychotropic substances, and marihuana are controlled by ‘Act on the control of narcotics, ETC’, ‘the 1961 Single Convention on Narcotic Drugs’, or ‘the 1971 Convention on Psychotropic Substances’. However, the abuse of new psychoactive substances (NPS) is an emerging problem in Korea. According to the United Nations Office on Drugs and Crime (UNODC), about 600 NPS are defined and rapid identification methods for NPS need to be developed. Nevertheless, several counter measures have been enforced in Korea. In the present study, 33 NPS including synthetic cannabinoids, phenethylamines, tryptamines, and aminoindanes were tested using Marquis, Duquenois-Levine, Zwikker, Madelin, and Liebermann reagents. Furthermore, we suggested a coloring test sequence for the preliminary identification of unknown substances.
정태인(Jung Taein),정수연(Choung Sooyoun),윤재석(Yun Jaesuk) 한국정보보호학회 2021 情報保護學會誌 Vol.31 No.1
중국은 단일화된 개인정보보호법이 존재하지 않고, 네트워크 안전법, 형법 등에 포함된 개인정보보호 관련 조항에 근거하여 개인정보보호 정책을 수립·집행하여 왔다. 2020년 10월 중국은 개인정보보호법 초안을 공개하고 의견을 수렴하며, 입법 절차를 진행 중이다. 본고에서는 중국 개인정보보호법의 입법 취지, 주요 내용, 한국 기업에 미칠 영향 등을 살펴보고자 한다.
인체세포ㆍ조직이용 의료제품 등의 규제에 관한 국내외 규정 비교 및 안전관리 개선방안 연구
이지훈(Jihoon Lee),최수경(Soo Kyung Choi),김주희(Juhui Gim),박미영(Miyoung Park),박수현(Soo Hyun Park),최진희(Jinhee Choi),임화경(Hwakyung Lim),노혜민(Hyemin Noh),이윤희(Yun hee Lee),윤재석(Jaesuk Yun) 대한약학회 2018 약학회지 Vol.62 No.3
Over the past several decades, human-derived cells, tissues, and cell- and tissue-based therapies have contributed to essential body function regeneration in the absence of effective alternative medicine substitute. This study reviewed strength and weakness of the regulation related to human-derived cells, tissues based pharmaceutical products compared to the US regulation, and suggested points for improvement classified into three categories. First, it is necessary to supplement regulations and guidelines on donor eligibility for pharmaceutical products. Second, there is a need to integrate regulations related to classify pharmaceutical product into biologics, device, and combination products. Finally, there is a need to develop and supplement the traceability of biological traces and the regulations for biological monitoring systems of pharmaceutical products. Collectively, it would be necessary to revise the regulations and the guidelines for the approval, manufacture, management and tracking of human cell/tissue derived pharmaceutical products by collecting opinions from researchers, industry, and clinical health care workers with a systematic long-term goal.
인공지능 기반 신생혈관성 나이관련황반변성 진단보조소프트웨어 사용자 인터페이스 개선 연구
구원미(Wonmi Gu),김소영(Soyoung Kim),김영은(Young Eun Kim),박성희(Sunghee Park),김문수(Moonsu Kim),임화경(Hwakyung Lim),허태영(Tae-Young Heo),김도윤(Doyun Kim),민정기(Jung Kee Min),홍석수(Seoksu Hong),윤재석(Jaesuk Yun) 대한약학회 2024 약학회지 Vol.68 No.2
With the recent development of Software as a Medical Device (SaMD), the significance of reducing use errors in medical devices is increasing. In this study, we conducted a formative evaluation of Artificial Intelligence (AI)-based software for ophthalmic image detection and diagnosis. The software automatically displays the presence or absence of neovascular age-related macular degeneration using fundus images to assist medical personnel in making diagnostic decisions. We aimed to find ways to reduce the number of use errors in formative evaluations. For this purpose, we conducted usability testing by performing tasks based on use scenarios for usability formative evaluations with intended users in their intended use environments, and then modified the user interface to reduce use errors. The initial formative evaluation revealed errors in utilizing the capture and dragand- drop functions for uploading fundus images, checking analysis results, and perform logout procedures. To reduce use errors, we improved the function by relocating the capture icon, displaying a hand-shaped cursor during dragging, inserting a fundus position guide, and eliminating the drag-and-drop function. We have also enhanced the design to present analytics results in a more intuitive manner and added a separate logout button to reduce the risk of use error. As a result, the number of use errors in the formative evaluation decreased from six to one in the summative evaluation. The development of ophthalmic image detection and diagnosis assistant software that reflects these improvements is expected to enhance user safety, usability, and reduce use errors.