Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.
The recent medical treatment guidelines and the development of information technology make hospitals reduce the expense in surrounding environment and it requires improving the quality of medical treatment of the hospital. That is, with the new guidelines and technology, hospital business escapes simple fee calculation and insurance claim center. Moreover, MIS(Medical Information System), PACS(Picture Archiving and Communications System), OCS(Order Communicating System), EMR(Electronic Medical Record), DSS(Decision Support System) are also developing. Medical Information System is evolved toward integration of medical IT and situation si changing with increasing high speed in the ICT convergence. These changes and development of ubiquitous environment require fundamental change of medical information system. Mobile medical information system refers to construct wireless system of hospital which has constructed in existing environment. Through RFID development in existing system, anyone can log on easily to Internet whenever and wherever. RFID is one of the technologies for Automatic Identification and Data Capture(AIDC). It is the core technology to implement Automatic processing system. This paper provides a comprehensive basic review of RFID model in Korea and suggests the evolution direction for further advanced RFID application services. In addition, designed and implemented DB server's agent program and Client program of Mobile application that recognized RFID tag and patient data in the ubiquitous environments. This system implemented medical information system that performed patient data based EMR, HIS, PACS DB environments, and so reduced delay time of requisition, medical treatment, lab.
Medical practice is characterized by various physiological response and uncapacity of prediction, therefore when medical accident occur it's hard to prove medical professionals' mistake. Though medical accident by medical professionals' mistake will be compensated anyhow, about irresistible medical accidents, no one should be not bound to compensate, victims get into very difficult situation. So, the nation don't negligent irresistible medical accidents but compensate anyway. As in the past, to the legal principle's constitution of irresistible medical accidents, theory of liability without fault was adapted, and it was said this theory was illogical in theory of liability with fault. But the subject of compensation to irresistible medical accidents is nation, nation don't participate in medical treatment therefore there is no room to occur mistake. And it is not reasonable to regard medical agency as a truster of public service, to cast to it responsibility of medical accidents. The problem of compensation to irresistible medical accidents is understood under the theory of social compensation. Social compensation is consisted of compensation to sacrifice and contribution to nation and society and compensation to sacrifice revealed under danger, the compensation to irresistible medical accidents belongs to the latter. This is near to concept of relief, is applied to national compensation system supplementarily, and compensation have no option but to compensate minimum. And there are not relation between national compensation system of irresistible medical accidents and proof liability transposition and theory of liability with out fault, merely in side of sharing responsibility burden between medical treater and victim, it is reasonable to discuss transportation of proof liability and compulsive liability insurance together.
Journal of The Korea Institute of Healthcare Architecture
/
v.23
no.1
/
pp.37-46
/
2017
Purpose: There is little information about China's medical service system and health care facilities in Korean medical architecture papers, which is inconvenient for scholars engaged in medical building research and comparison. Futhermore, the transformation of the notion of health and the ascension of the service needs show the lack of medical function, and then make functions of hospital construction are always in the state of dynamic renewal. Therefore, the purpose of this study is to analyze the Chinese medical service system and general hospital related laws and regulations for future research to provide effective analysis of data, and find shortcomings. Methods: This study was conducted by a research on law and regulation of China's medical service system and general Hospital. Results: At present hospital construction in China is in the period of rapid development and it exposes the layout of medical health facilities is not reasonable and the service does not reach the designated position and so on. Overall, it requires more detailed guidelines to enhance the quality of medical health services. Implications: It is expected that the research of this paper will provide effective reference for future research on Chinese medical architecture system and medical facilities, and can promote and perfect the construction of Chinese medical architecture theory system.
Journal of Information Technology Applications and Management
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v.12
no.2
/
pp.129-143
/
2005
In recent years, two major streams in medical information systems are:1) system integration among OCS(Order Communication System), EMR(Electronic Medical Record), PACS(Picture Archiving and Communication System), and ERP(Enterprise Resource Planning) and 2) system integration through medical collaboration between East and West medical service providers. One of the characteristics which differentiate the Korean medical industry from the western medical industry is the East-West medical collaboration. In many respects there are many differences between East and West medical treatment. Although East and West medical treatment have developed from different medical philosophies and standards, we assume that the better medical care can be provided by integrating their medical procedures effectively. The two possible approaches to the integration of East and West medical information systems are suggested in this paper:One is loosely coupled model and the other is tightly coupled model. EMR improves the quality of medical record which reflects the quality of clinical practice. It provides more efficient and convenient way of input, retrieval, storage, communication and management of medical data. We abstracted the standard medical procedures from the two medical procedures performed in Daejeon Oriental Hospital and Hehwa Clinic at Daejeon University and also abstracted database schema by analyzing the characteristics of information needed in East-West medical collaboration. Our EMR is composed of two types of data:one is structured data and the other is unstructured data, which are formalized by SOAP(Subjective, Objective, Assessment, Plan) format. Currently the integrated system is implemented and operated successfully for six months.
Recently the development of medical modality like as MRI, 3D US, DR etc is very active. Therefore it is more required not only the enhancement of quality in medical service but the improvement of medical system based on quantization, minimization, and optimization of high speed. Especially, as the changing into the digital modality system, it gets to start using ASIC(Application Specific Integrated Circuit) to realize one board system. It requires the implementation of hardware debugging and effective speedy algorithm with more speed and accuracy in order to support and replace existing device. If objected image could be linked to high speed process board with special interface and pre-processed using FPGA, it can be used in real time image processing and protocol of HIS(Hospital Information System). This study can support the basic circuit design of medical image board which is able to realize image processing basically using digitalized medical image, and to interface between existing device and image board containing image processing algorithm.
Recently the structure of disease is changing its form into chronic disease. Taking into consideration this, the health care system doesn't cope with this tendency. With the health care system for acute disease, it is difficult to decrease medical care cost. At this point, Health education like primary health care can reduce risk factors and possibilities of occurrence of disease. This can cut off the medical insurance finance further more cuts off the rates of insurance cost. This is why health education is the principle part of medical insurance service. Though the law shows health education must be executed in the field of Medical insurance, still it is not enough. In order to carry out health education in the medical insurance organization, the efforts we should make are as follows: 1. Recognize the importance of health education. 2. Set the clear goals in health education. 3. Organize health education system. 4. Train health workers. 5. Systematize health education service. 6. Reform the medical insurance system. 7. Evaluate the effect of health education and practice the model.
Purpose: The purpose is to understand the perception of medical providers at tertiary hospitals in Seoul on the importance-performance of the reform on a doctor-designation system, and to provide the policy suggestion of the perception on such a system. Methodology: To achieve the purpose, this study utilized structured survey tools to conduct a questionnaire survey of nursing, administrative and medical technology professionals at six tertiary hospitals in Seoul. An importance-performance analysis was utilized for an analysis that showed the perception of the reform on a doctor-designation system. Findings: First, it was identified that those medical providers had the highest perception of the importance about the performance of the reform on a doctor-designation system. Second, according to the result of action grid of an importance-performance analysis (IPA), it can be identified that in the 2nd stage of 'Concentrate here' included are the items as to design and effect of medical care quality and subsidies & patient infection and safety and control fees, effect of income security of the method for compensating for loss established by the government and offering sufficient information on general medical services and doctor-designation medical services. In the 1st stage of 'Keep up the Good Work', and the 2nd stage of 'Concentrate here' included is the item as to the performance of patients of the reform on a doctor designation system. Practical Implications: There could be identified the effect of the reform bill on the perception of medical providers. It is expected that a better environment would be provided for patients to use a hospital and for medical providers to offer medical services, if the goverment makes efforts to improve methods for compensating for loss and continuous monitoring of the performance of patients.
The teaching and learning environment in medical schools is significantly different from that of other academic fields. An educational information system specifically designed for medical education could be an important solution for the unique context of medical education. In this study, the concept of the educational information system has been reviewed, and how such a system can be utilized effectively for medical education has also been explored. This paper also addresses how learning management systems for online learning could be made more effective through educational information systems. The application of flipped learning, which has been developing rapidly to improve teaching and learning, for medical education was also investigated. In conclusion, it was found that educational information systems could be a solution to various teaching and learning issues in medical schools. In particular, given that high performing students tend to enter medical schools, using educational information systems to improve the teaching and learning environment in medical school should be investigated further.
The purposes of this study which was conducted by inquiring into some curricula for Emergency Medical Dispatchers(EMDs) are to introduce a curriculum into Korea and develop a textbook for training of the EMDs in Korea. The conclusions from this study were summarized as follows; (1) There are some professional demands in our Emergency Medical Dispatch field therefore, now it is necessary to set up an education system for the EMDs in Korea and give them a suitable name to this change. (2) Some historical turning points which are condensed from the developmental process in the USA. including "Medical Self Help" with no formal dispatch protocols, Medical Priority Dispatch System, Practice Standard, Dispatch Protocols will serve as a good reference for establishing and education system for the EMDs. (3) To effectively train the EMDs in Korea, we needed to be introduced to Emergency Medical Dispatch : National Standard of Curriculum from the U.S. Department of Transportation & the National Highway Traffic Safety Administration which is made up Basic Emergency Medical Concepts, Information Gatherin & Dispatch, Introduction to the Emergency Medical Dispatch Protocol Reference System(EMDPRS) & 32 Chief Complaint Types. (4) The introduced curriculum closely related to the medical director, the direct indirect medical control, the scope of practice in the USA, should be revised for the Emergency Medical Service System of Korea. But to reduce the developmental process & time, it is necessary to postpone the consideration on these factors until publishing a new textbook. (5) This study which gives the cornerstone about some developmental methods on textbook for EMDs will be helpful to build up an education system for EMDs such as Curriculum, EMD Certification, National Academy of Emergency Medical Dispatch to fit the Emergency Medical Service System of Korea in the future.
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