• Title/Summary/Keyword: medical law

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Guideline for Bioequivalence Studies of Generic Products for Topical Use (국소용 후발의약품의 생물학적동등성시험을 위한 가이드라인)

  • Choi, Sun-Ok;Jung, Sung-Hee;Um, So-Young;Jung, Seo-Jeong;Kim, Joo-Il;Chung, Soo-Youn
    • Journal of Pharmaceutical Investigation
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    • v.34 no.4
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    • pp.333-340
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    • 2004
  • A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

Legal Consideration of Transfer Refusal by 119 Rescuers (119구급대의 이송거절 및 거부에 대한 법적 고찰)

  • Bae Hyun-A;Lee Sang-Jin;Kim Chan-Woong;Lee Kyung-Hwan
    • Fire Science and Engineering
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    • v.19 no.4 s.60
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    • pp.47-56
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    • 2005
  • The regulation on organization and operation of rescue and aid party was amended. This Regulation is designed to provide legal formality in order to protect not only the patients' right but also 119 rescuers from liability, which is due to treatment refusal by patient and the discretionary refusal of transfer by 119 rescuers on the non-emergency situation. This study looked over the constitute of violation of emergency medical service act related to the discretionary refusal of 119 rescuers, the criminal liability owing to omission and the possibility of national indemnities on the damage of patients. This study also analyzed the courts' decision and attitude by exploring overseas judicial precedents and examined what should be considered on the execution of the newly enacted law. Finally, this study put emphasis on the importance of medical director's control, documentation of every procedure, 119 rescuer's authorization on the refusal of transfer by securing patient's informed consent.

Study on the families' participation need for labour women (산부가족의 분만참여 요구)

  • Chang, Soon-Book;Choi, Yun-Soon;Kim, Hae-Sook;Cho, Young-Sook;Lee, Hae-Woo
    • The Korean Nurse
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    • v.31 no.3
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    • pp.62-75
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    • 1992
  • This study was done to suggest basic modifications in the present situation for the family of women in labour which is a separation management method. The study design was a descriptive study. The number of the subjects were 80. they were husbands, mothers in law, and mothers of women in labour who were full term and for whom there were no complications, either for the mother or the fetus. Data collection was done with a structured questionnaire which was analyzed using frequencies. The results were as follows, 1. Most of the subjects(95.0%) wanted to participate in the labour process. 2. The subjects wanted to support the women in labour by way of encouraging(95.0%), consoling (95.0%), listening to(75.0%), praying with(68.8%), hand holding(97.5%), stroking(63.8%), helping with respiration control(50.0%), maintaining relaxation(46.3%), changing position(58.8%), and illustration (58.8 %). 3. The subjects answered that they expected their participation to have the effect of an easier labour course(52.5%), security for the women in labour(95.0%), and providing a better relationship between the women in labour(66.3%) and the new baby(55.0%). 4. The priority of the response as to who is the best supporter was husband, and mother of the women in labour in that order. It can be concluded that nurses maintained a management method which ignored the needs of the families of women in labour. If given consideration is to be given to these subjects, future programs should initiate ways to let the families participate in the labour process.

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PWM-based Integral Sliding-mode Controller for Unity Input Power Factor Operation of Indirect Matrix Converter

  • Rmili, Lazhar;Hamouda, Mahmoud;Rahmani, Salem;Blanchette, Handy Fortin;Al-Haddad, Kamal
    • Journal of Power Electronics
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    • v.17 no.4
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    • pp.1048-1057
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    • 2017
  • An indirect matrix converter (IMC) is a modern power generation system that enables a direct ac/ac conversion without the need for any bulky and limited lifetime electrolytic capacitor. This system also allows four-quadrant operation, generation of sinusoidal output voltage waveforms with variable frequency and amplitude, and control of input power factor. This study proposes a pulse-width modulation-based sliding-mode controller to achieve unity input-power factor operation of the IMC independently of the active power exchanged with the grid, as well as a fast dynamic response. The designed equivalent control law determines, at each sampling period, the appropriate q-axis component of the modulated input current to be injected into the grid through the LC input filter. An integral term of the error is included in the expression of the sliding surface to increase the accuracy of the control method. A double space vector modulation method is used to synthesize the direction of the space vector of the input currents as required by the sliding-mode controller and the space vectors of the target output voltages. Simulation and experimental results are provided to show the effectiveness and evaluate the performance of the proposed control method.

Comic Strips on Health Drawn by a Medical Doctor (의사가 그리는 건강 상식 만화)

  • Kim, Seul Ki;Lee, Jin Han;Chung, Min Suk
    • The Journal of the Korea Contents Association
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    • v.18 no.12
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    • pp.102-107
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    • 2018
  • Through the humorous comic strips which contain beneficial health information, people are able to accept the information willingly. The corresponding author as a medical doctor has elaborated four-frame comic strips including the health information and published 27 episodes in the major domestic newspaper. The aim of this research informing the author's experiences was to help other experts distribute their knowledge through the comics. For the comic strips, writing was succeeded by drawing. Writing was done as follows: First, the useful and followable health information was introduced to make the comic strips beneficial. Second, the information was logically explained to make the comic strips easy. Third, the information was mixed with joke to make the comic strips funny. As far as the author experienced, it was advantageous for the experts to draw comics by themselves. If ones have expertise in their fields such as law, architecture, they can be confident of drawing good comics.

Verification of Extended Source-To-Imager Distance (SID) Correction for Portal Dosimetry

  • Son, Jaeman;Kim, Jung-in;Park, Jong Min;Choi, Chang Heon
    • Progress in Medical Physics
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    • v.29 no.4
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    • pp.137-142
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    • 2018
  • This study aimed to evaluate and verify a process for correcting the extended source-to-imager distance (SID) in portal dosimetry (PD). In this study, eight treatment plans (four volumetric modulated arc therapy and four intensity-modulated radiation therapy plans) at different treatment sites and beam energies were selected for measurement. A Varian PD system with portal dose image prediction (PDIP) was used for the measurement and verification. To verify the integrity of the plan, independent measurements were performed with the MapCHECK device. The predicted and measured fluence were evaluated using the gamma passing rate. The output ratio was defined as the ratio of the absolute dose of the reference SID (100 cm) to that of each SID (120 cm or 140 cm). The measured fluence for each SID was absolutely and relatively compared. The average SID output ratios were 0.687 and 0.518 for 120 SID and 140 SID, respectively; the ratio showed less than 1% agreement with the calculation obtained by using the inverse square law. The resolution of the acquired EPIDs were 0.336, 0.280, and 0.240 for 100, 120, and 140 SID, respectively. The gamma passing rates with PD and MapCHECK exceeded 98% for all treatment plans and SIDs. When autoalignment was performed in PD, the X-offset showed no change, and the Y-offset decreased with increasing SID. The PD-generated PDIP can be used for extended SID without additional correction.

Korean Dental Hygienists' Job Description Based on Systematic Review

  • Kim, Sun-Mi;Ahn, Eunsuk;Hwang, Soo-Jeong;Jeong, Soon-Jeong;Kim, Bo-Ra;Han, Ji-Hyoung
    • Journal of dental hygiene science
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    • v.20 no.4
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    • pp.187-199
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    • 2020
  • Background: Korean dental hygienists perform various tasks under the supervision of dentists in addition to the tasks listed in the law. Many meaningful studies have been conducted to determine the actual tasks of dental hygienists, but these studies did not show common results due to the differences in research methods or designs. Hence, this study aimed to review the reported data on the tasks of dental hygienists in Korea and to clarify them based on a systematic literature review. Methods: For the literature search, the COre, Standard, and Ideal model presented by the National Library of Medicine was referenced. Seven databases were searched for literatures published in Korea, including PubMed, and Google Scholar. Of the 352 studies found using key words, titles, and abstracts, 46 were finally extracted based on the first and second exclusion criteria. After confirming the tasks of Korean dental hygienists in 46 literatures, 136 tasks were listed and calculated as appearance rate in the literature. Results: The most common tasks in 46 studies were fluoride application (67.2%), radiography (65.4%), scaling (65.4%), sealant (60.7%), patient management and counseling (56.7%), tooth-brushing education (52.2%), impression taking with alginate (50.1%), and making temporary crowns (47.9%). The most mentioned tasks of dental hygienists in public health centers were fluoride application (100%), sealant (100%), oral health education (71.4%), public oral health program evaluation (71.4%), school fluoride mouth-rinsing program (71.4%), water fluoridation (57.1%), tooth-brushing education (57.1%), school oral health programs (57.1%), and public elderly oral health programs (57.1%). Conclusion: This study showed that Korean dental hygienists had 136 tasks by reviewing 46 related studies and that the main job of Korean dental hygienists was oral disease prevention including scaling, sealant, and fluoride application.

Experience of Healthcare Providers in the Advanced Practice Nurse System (전문간호사제도에 대한 의료인의 경험)

  • Kim, Min Young;Jeon, Mi-Kyeong;Choi, Su Jung;Kim, Jeong Hye;Kim, Heeyoung;Leem, Cho Sun
    • Journal of Korean Critical Care Nursing
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    • v.14 no.2
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    • pp.42-56
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    • 2021
  • Purpose : The purpose of this study was to understand and describe the experiences of the advanced nurse practitioner (APN) system used by healthcare providers including APNs, doctors who worked with APNs, and APN master's course professors at a graduate school. Methods : Qualitative data were collected via snowball sampling. The participants were nine APNs, six doctors, and three professors. They were divided into three focus groups, each of which consisted of all three types of healthcare providers. Data were collected via interviews with the three focus groups conducted from September to October 2019. All interviews were audiotaped and transcribed verbatim. The transcribed data then underwent qualitative content analysis. Results : Based on the data, we extracted four themes and 14 categories. The themes were "Role and system of APNs started according to healthcare environment changes", "Optimal healthcare provider to ensure quality of care", "Confused role and system of APNs due to incomplete medical law", and "Tasks for the stable operation of the APN system." Conclusion : For quality treatment and safety of patients, a legal basis must be established for the APN system. For its stable operation, social consensus regarding legislation about APNs' scope of practice is required. Finally, a discussion is necessary about the integration of APNs' 13 fields.

A Study on the Safe Use of Data in the Digital Healthcare Industry Based on the Data 3 Act (데이터 3법 기반 디지털 헬스케어 산업에서 안전한 데이터 활용에 관한 연구)

  • Choi, Sun-Mi;Kim, Kyoung-Jin
    • Journal of the Korea Convergence Society
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    • v.13 no.4
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    • pp.25-37
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    • 2022
  • The government and private companies are endeavoring to help the digital healthcare industry grow. This includes easing regulations on the big data industry such as the amendment of the Data 3 Act. Despite these efforts, however, there have been constant demands for the amendment of laws related to the medical field and for securing medical data transmissions. In this paper, the Data 3 Act of Korea and the legal system related to healthcare are examined. Then the legal, institutional, and technical aspects of the strategies are compared to understand the issues and implications. Based on this, a legal and institutional strategy suitable for the digital healthcare industry in Korea is suggested. Additionally, a direction to improve social perception along with technical measures such as safe de-identification processing and data transmission are also proposed. This study hopes to contribute to the spread of various convergent industries along with the digital healthcare industry.

Application of sigmoidal optimization to reconstruct nuclear medicine image: Comparison with filtered back projection and iterative reconstruction method

  • Shin, Han-Back;Kim, Moo-Sub;Law, Martin;Djeng, Shih-Kien;Choi, Min-Geon;Choi, Byung Wook;Kang, Sungmin;Kim, Dong-Wook;Suh, Tae Suk;Yoon, Do-Kun
    • Nuclear Engineering and Technology
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    • v.53 no.1
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    • pp.258-265
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    • 2021
  • High levels for noise and a loss of true signal make the quantitative interpretation of nuclear medicine (NM) images difficult. An application of profile optimization using a sigmoidal function in this study was used to acquire the NM images with high quality. And the images were acquired by using three kinds of reconstruction method using each same sinogram: a standard filtered back-projection (FBP), an iterative reconstruction (IR) technique, and the sigmoidal function profile optimization (SFPO). Comparison of image according to reconstruction method was performed to show a superiority of the SFPO for imaging. The images reconstructed by using the SFPO showed an average of 1.49 times and of 1.17 times better in contrast than the results obtained using the standard FBP and the IR technique, respectively. Higher signal to noise ratios were obtained as an average of 12.30 times and of 3.77 times than results obtained using the standard FBP and the IR technique, respectively. This study confirms that reconstruction with SFPO (vs FBP and vs IR) can lead to better lesion detectability and characterization with noise reduction. It can be developed for future reconstruction technique for the NM imaging.