• Title/Summary/Keyword: New Medical Technology

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A study on the Applicability of Software International Standards for SaMD's Cybersecurity Regulation (SaMD의 사이버보안 규제에 대한 소프트웨어 국제표준의 적용 가능성에 대한 연구)

  • Lee Young Kim;Youngjoo Chung;Gyu Ha Ryu;Baek Hwan Cho
    • Journal of Information Technology Services
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    • v.22 no.4
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    • pp.21-35
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    • 2023
  • Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.

Flagellin-Stimulated Production of Interferon-β Promotes Anti-Flagellin IgG2c and IgA Responses

  • Kang, Wondae;Park, Areum;Huh, Ji-Won;You, Gihoon;Jung, Da-Jung;Song, Manki;Lee, Heung Kyu;Kim, You-Me
    • Molecules and Cells
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    • v.43 no.3
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    • pp.251-263
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    • 2020
  • Flagellin, a major structural protein of the flagellum found in all motile bacteria, activates the TLR5- or NLRC4 inflammasome-dependent signaling pathway to induce innate immune responses. Flagellin can also serve as a specific antigen for the adaptive immune system and stimulate anti-flagellin antibody responses. Failure to recognize commensal-derived flagellin in TLR5-deficient mice leads to the reduction in anti-flagellin IgA antibodies at steady state and causes microbial dysbiosis and mucosal barrier breach by flagellated bacteria to promote chronic intestinal inflammation. Despite the important role of anti-flagellin antibodies in maintaining the intestinal homeostasis, regulatory mechanisms underlying the flagellin-specific antibody responses are not well understood. In this study, we show that flagellin induces interferon-β (IFN-β) production and subsequently activates type I IFN receptor signaling in a TLR5- and MyD88-dependent manner in vitro and in vivo. Internalization of TLR5 from the plasma membrane to the acidic environment of endolysosomes was required for the production of IFN-β, but not for other pro-inflammatory cytokines. In addition, we found that anti-flagellin IgG2c and IgA responses were severely impaired in interferon-alpha receptor 1 (IFNAR1)-deficient mice, suggesting that IFN-β produced by the flagellin stimulation regulates anti-flagellin antibody class switching. Our findings shed a new light on the regulation of flagellin-mediated immune activation and may help find new strategies to promote the intestinal health and develop mucosal vaccines.

Professional Certification of Medical Technologists in Korea, Japan, and United States of America (한국, 일본, 미국 임상병리사 전문자격)

  • Koo, Bon-Kyeong
    • Korean Journal of Clinical Laboratory Science
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    • v.51 no.1
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    • pp.1-14
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    • 2019
  • The names of medical technologist in Korea, Japan, and the United State of America vary depending on the medical system, educational system, and work areas. Conventionally, jobs equal or similar to medical technologist (commonly known as clinical laboratory technologist, medical laboratory technologist, clinical laboratory scientist, and medical laboratory scientist), histotechnologist, cytotechnologist, and genetic technologist. Jobs, such as extracorporeal technologist, medical electrophysiology technologist, and medical sonographer, allow other allied health professionals including medical technologists, to obtain their qualification. The work areas of medical technologists are classified into clinical pathologic technology, pathologic technology, clinical genetics technology, nuclear medicine in vitro technology, and clinical physiologic technology. New titles of Korean specialized medical technologists refer to certification systems, such as CLMJ, CMAJ, ASCP, IAC, ABRET, and ARMDS. Currently, there are eight types of specialized medical technologists under the cooperation of specialized academic societies. They are hematology, transfusionology, chemistry, immunology, microbiology, histology, cytology, nuclear medicine. It can be further divided into 20 categories according to the work areas such as mass spectrometry, infection control, Pathologists' Assistant, flow cytometry, HLA, cytogenetics, molecular genetics, cardiopulmonary physiology, neurophysiology (EEG/EMG/PSG/etc.), cardiac sonography, neurosonography (TCD/carotid), and medical device quality manager.

Implications of Price Setting Strategies for New Health Technologies from Five Countries (신의료기술에 대한 진료비 지불: 외국사례와 시사점)

  • Chung, Seol-hee;Kwon, Ohtak;Choi, Yeonmi;Moon, Kyeongjun;Chae, Jungmi;Lee, Ruri
    • Health Policy and Management
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    • v.30 no.2
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    • pp.164-177
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    • 2020
  • This study aims to compare the experience of selected countries in operating separate payment system for new healthcare technology and to find implications for price setting in Korea. We analyzed the related reports, papers, laws, regulations, and related agencies' online materials from five selected countries including the United States, Japan, Taiwan, Germany, and France. Each country has its own additional payment system for new technologies: transitional pass-through payment and new technology ambulatory payment classification for outpatient care and new technology add-on payment for inpatient care (USA), an extra payment for materials with new functions or new treatment (C1, C2; Japan), an additional payment system for new special treatment materials (Taiwan), a short-term extra funding for new diagnosis and treatment (NUB; Germany), and list of additional payments for new medical devices (France). The technology should be proven safe and effective in order to get approval for an additional payment. The price is determined by considering the actual cost of providing the technology and the cost of existing similar technologies listed in the benefits package. The revision cycle of the additional payment is 1 to 4 years. The cost or usage is monitored during that period and then integrated into the existing fee schedule or removed from the list. We conclude that it is important to set the explicit criteria to select services eligible for additional payment, to collect and analyze data to assess eligibility and to set the payment, to monitor the usage or cost, and to make follow-up measures in price setting for new health technologies in Korea.

A study on the usefulness of standard evaluation tools for ambulance ride practices of paramedic students (응급구조(학)과 학생들의 구급현장실습 표준 평가도구의 유용성에 관한 연구)

  • Hong, Sung-Gi
    • The Korean Journal of Emergency Medical Services
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    • v.24 no.3
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    • pp.41-53
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    • 2020
  • Purpose: This study tests the validity of a standard evaluation tool of ambulance ride practices with new evaluation items and supports its application by 119 preceptors. Methods: We tested the validity of standard evaluation items collected from 19 on-site professionals assessing ambulance ride practices. New evaluation items, 'understanding of emergency rescue equipment' and 'ability to communicate', were added as additional criteria. The modified Delphi technique was used to test the three evaluation areas and ten evaluation items. We used the analytic hierarchy process to analyze the weighting value of the reconstructed evaluation tool model. Results: All three evaluation areas and 10 evaluation items within the standard evaluation tools used for ambulance ride practices corresponded with the consistency index, degree of convergence, and agreement in the modified Delphi panel. Conclusion: These results provide evidence of the consistency and usefulness behind preceptors' use of this standard evaluation tool in ambulance ride practice.

Roles of Health Technology Assessment for Better Health and Universal Health Coverage in Korea (우리나라 보건의료 발전을 위한 의료기술평가의 역할)

  • Lee, Young Sung
    • Health Policy and Management
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    • v.28 no.3
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    • pp.263-271
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    • 2018
  • Health technology assessment (HTA) is defined as multidisciplinary policy analysis to look into the medical, economic, social, and ethical implications of the development, distribution, and use of health technology. Following the recent changes in the social environment, there are increasing needs to improve Korea's healthcare environment by, inter alia, assessing health technologies in an organized, timely manner in accordance with the government's strategies to ensure that citizens' medical expenses are kept at a stable level. Dedicated to HTA and research, the National Evidence-based Healthcare Collaborating Agency (NECA) analyzes and provides grounds on the clinical safety, efficacy, and economic feasibility of health technologies. HTA offers the most suitable grounds for decision making not only by healthcare professionals but also by policy makers and citizens as seen in a case in 2009 where research revealed that glucosamine lacked preventive and treatment effects for osteoarthritis and glucosamine was subsequently excluded from the National Health Insurance's benefit list to stop the insurance scheme from suffering financial losses and citizens from paying unnecessary medical expenses. For the development of HTA in Korea, the NECA will continue exerting itself to accomplish its mission of providing policy support by health technology reassessment, promoting the establishment and use of big data and HTA platforms for public interest, and developing a new value-based HTA system.

Comparative Analysis on Three-Year Period Curriculum of Emergency Medical Technology of College (3년제 대학 응급구조과의 교육과정 비교 분석 - 2006학년도 시행 교육과정을 중심으로 -)

  • Kim, Hyo-Sik;Lee, Young-A
    • The Korean Journal of Emergency Medical Services
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    • v.11 no.2
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    • pp.29-50
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    • 2007
  • Purpose: This study was carried out in order to provide the basic data for the curriculum standardization of emergency medical technology by analyzing the three-year period curriculum of 9 colleges. Method: This is the descriptive analysis of the curricular of 9 colleges. The analyzed variables were the distribution, credit, mean, frequency of the liberal arts, majors, clinical and on-the-job(OJT) training courses, and teaching profession subject. Results: 1. The number of whole subjects was 61.0, the number of liberal arts was 10.3, and the number of majors was 50.7. The completion credit was 128.3, credits of liberal arts were 15.5(12.2%), and credits of majors were 112.8(87.8%). 2. The range of credits of liberal arts was 8 to 21, and most of the liberal arts were done in the first year of college. 3. The distribution of the credits of the national examination for the license was as follows; the itemized emergency care subjects were 27.9 credits, the general emergency care was 18.5 credits, basic sciences were 17.7 credits, emergency patient care was 9.5 credits, and emergency medicine law was 3.2 credits. 4. The number of other major subjects were 10.0 and showed even distribution in each semester. 5. The clinical and on-the-job(OJT) training were 4.5 subjects, the credits of completion were 14.9 and these subjects were not in the first year of college. Conclusion: This results will be helpful data for the advanced development and standardization of the new curriculum by keeping pace with the environmental change, competency improvement and the need of the learners of emergency medical technology.

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A Review on the Practical Feasibility of Phrases 'Under the Instruction of Physicians or Dentists' Specified in the Definition on the Medical Service Technologist Etc Act: Focused on Radiological Technologist (의료기사 등에 관한 법률 중 '의사 또는 치과의사의 지도 아래' 문구의 타당성에 대한 고찰: 방사선사를 중심으로)

  • Joo, Young-Cheol;Lim, Cheong-Hwan;Lim, Woo-Taek;Hong, Dong-Hee;Jung, Hong-Ryang;Kim, Eun-Hye;Yoon, Yong-Su;Jung, Young-Jin;Choi, Ji-Won;Yoo, Se-Jong
    • Journal of radiological science and technology
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    • v.44 no.5
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    • pp.535-543
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    • 2021
  • The purpose of this study is to investigate various opinions on changes and revisions in the Medical Technician Act, to compare the curriculum of radiological technologist and physicians or dentists, and to compare the definitions and scope of work of radiological technologist in Korea and abroad. From the information, The goal is to review whether the phrase 'guidance of a doctor or dentist' specified in the definition of the 'Act on Medical Technicians, etc.' is realistically appropriate. radiological technologist receive specialized college education on radioligical science & medical imaging. The training hours for radiolgical science student are greater than medical students. In addition, radiological technologists are continuously developing their competencies for new knowledge and skills through continuing education in clinical fields. In particular, radiological technologist are making steady research efforts to reduce patient exposure and improve medical image quality. As a result of this investigation, it is considered that the term "guided by a doctor or dentist" as currently defined in the 'Act on Medical Technicians, etc.' may need to be revised in consideration of the professionalism of the radiological technologist.

CardioSentinal: A 24-hour Heart Care and Monitoring System

  • Gao, Min;Zhang, Qian;Ni, Lionel;Liu, Yunhuai;Tang, Xiaoxi
    • Journal of Computing Science and Engineering
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    • v.6 no.1
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    • pp.67-78
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    • 2012
  • People are willing to spend more for their health. Traditional medical services are hospital-centric and patients obtain their treatments mainly at the clinics or hospitals. As people age, more medical services are needed to exceed the potentials of this hospital-centric service model. In this paper, we present the design and implementation of CardioSentinal, a 24-hour heart care and monitoring system. CardioSentinal is designed for in-home and daily medical services. It mainly focuses on the outpatients and elderly. CardioSentinal is an interdisciplinary system that integrates recent advances in many fields such as bio-sensors, small-range wireless communications, pervasive computing, cellular networks and modern data centers. We conducted numerous clinic trials for CardioSentinal. Experimental results show that the sensitivity and accuracy are quite high. It is not as good as the professional measurements in hospital due to harsh environments but the system provides valuable information for heart diseases with low-cost and extreme convenience. Some early experiences and lessons in the work will also be reported.