• Korean Journal of Artificial Intelligence
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• v.11 no.2
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• pp.39-44
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• 2023

The creativity of thesis is that the significance of cyber security challenges in blockchain. The variety of enterprises, including those in the medical market, are the targets of cyberattacks. Hospitals and clinics are only two examples of medical facilities that are easy targets for cybercriminals, along with IoT-based medical devices like pacemakers. Cyberattacks in the medical field not only put patients' lives in danger but also have the potential to expose private and sensitive information. Reviewing and looking at the present and historical flaws and vulnerabilities in the blockchain-based IoT and medical institutions' equipment is crucial as they are sensitive, relevant, and of a medical character. This study aims to investigate recent and current weaknesses in medical equipment, of blockchain-based IoT, and institutions. Medical security systems are becoming increasingly crucial in blockchain-based IoT medical devices and digital adoption more broadly. It is gaining importance as a standalone medical device. Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control. The achievements of the thesis are medical equipment of blockchain-based IoT no longer exist in a vacuum, thanks to technical improvements and the emergence of electronic health records (EHRs). Increased EHR use among providers, as well as the demand for integration and connection technologies to improve clinical workflow, patient care solutions, and overall hospital operations, will fuel significant growth in the blockchain-based IoT market for linked medical devices. The need for blockchain technology and IoT-based medical device to enhance their health IT infrastructure and design and development techniques will only get louder in the future. Blockchain technology will be essential in the future of cybersecurity, because blockchain technology can be significantly improved with the cybersecurity adoption of IoT devices, i.e., via remote monitoring, reducing waiting time for emergency rooms, track assets, etc. This paper sheds the light on the benefits of the blockchain-based IoT market.

• Management & Information Systems Review
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• v.35 no.2
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• pp.221-254
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• 2016

With increasing interest of health due to population aging, medical device industry is highlighted as a promising industry. However, Korea medical device industry is not enough market competitiveness compared to global company due to a narrow domestic market and a small company structure. In order to retain the national competitiveness, it is necessary that we have to derive a central technology and its trend. This study has predicted a central technology for medical device industrial using patent network analysis. The central technology is defined as a key technology that is connected to most other technologies and that significantly affects them. For the empirical study, we conducted social network analysis using covariance and correlation coefficient between IPC codes extracted from medical device patents, introduced by Jun(2012). A social network is a social structure of diverse items as well as of human beings. In this study, we set each medical device as a node in an SNA and analyze the Degree values between them. Also, Korea health industrial statistics system are utilized for verification of selected central technology. As a result, we found that the central technology is located on the medical device items, which are listed higher the amount of production. The central technology selected through the proposed methodology will provide a inspiration for establishment of R&D policy.

• Korea Journal of Hospital Management
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• v.23 no.4
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• pp.15-25
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• 2018

Purposes: The objectives of this study present the direction of the criteria for the separately reimbursement of therapeutic medical device. Methodology: We summarized experts' opinion using Delphi survey and Analytic Hierarchy Process(AHP). 48 experts were gathered from Medical Insurance Review Nurses Association, medical device industry, academy and association, Medical Device Expert Evaluation Committee. Descriptive statistics, consistency index, content validity ratio were analyzed. Findings: Clinical utility, patient safety, infection control, cost-homogeneity, cost-effectiveness showed high feasibility and importance, but market contribution and functional utility showed low feasibility and importance in a relative sense. The results of functional utility differed between clinical and non-clinical experts. Measurability was low across the whole area. Among the criteria for the separately reimbursement of therapeutic medical device. Patient safety/infection control and clinical utility showed the highest relative importance values, analyzed using AHP. Practical Implications: Patient safety and infection control are needed to be considered as one of Value Assessment Criteria. It is important to find out how to improve the measurability of therapeutic medical device.

• Journal of Biomedical Engineering Research
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• v.39 no.6
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• pp.268-277
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• 2018

With drastic change in the market and technology of medical devices, a comparative analysis is necessary in advanced systems internationally in order to prepare domestically applicable plans for improvement in classification and differential grade management for items of medical devices. This research examines and analyzes the differences of definition and legal systems of medical devices among Korea, United States, EU, Japan and China, and investigates classification and grading system of each country to identify disadvantages of classification and grading structures for medical device in Korea. This research suggests ways to supplement the disadvantages of domestic classification and grading system of medical devices, and elicits differential management plans for medical devices.

• The Journal of Korean Medicine
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• v.32 no.2
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• pp.79-91
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• 2011

Objectives: The purpose was to study the market of traditional Korean medical devices and survey, list and number medical devices in traditional Korean medical clinics. Methods: we researched in three ways. 1. We investigated the list of devices regarded as traditional Korean medical devices in 'Report on production, export, and import of medical devices.' 2. We investigated the statistics of medical devices equipped in traditional Korean medical clinics through the website of the Health Insurance Review & Assessment Service. 3. We surveyed medical devices in traditional Korean medical clinics by mail. Results: 1. We could not directly investigate the market for traditional Korean medical devices because they were not categorized as such ('traditional Korean medical devices'). 2. The number of medical devices in traditional Korean medical clinics has increased alongside the increase of traditional Korean medical clinics. 3. Traditional Korean medical clinics hold over 64,962 medical devices and have below 50 percent of traditional Korean medical diagnosis devices. 4. Meridian function testing machines, pulse diagnosis devices, and yangdorak showed ranking of equipment-ratio equal to ranking of insurance fees. Conclusions: Traditional Korean medical device regulations should be enacted following definitive and concrete Korean traditional medical concepts by the Korean traditional medical society.

• The Korean Society of Law and Medicine
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• v.15 no.2
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.215-221
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• 2019

The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.

• Journal of Biomedical Engineering Research
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• v.29 no.6
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• pp.415-430
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• 2008

The technologies in medical electronic implant(MEI) devices are developing rapidly, and already, there are various kinds of the MEI devices in the current medical equipments market. Recently, the global market scale of MEI devices have been increased about 13% year by year, and the import amount of MEI devices in Korea is increasing rapidly. In the near future, the demands of MEI devices will be magnificently increasing by the continuous development of the biomedical electronics devices which coupled with neural, brain and other organs will bring us to tremendous effects, such as providing new therapeutic solutions to patients, extension and saving human life, and an important clue of medical development. However, the investment of the research and the activity of developments in this field are still very weak in the Korea. Consequently, this paper introduces about the research trends of MEI devices, and technological problems those must be solved, and then concludes with the suggestions in order to be the leading country in this field.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.129-133
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• 2010

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

• Journal of Biomedical Engineering Research
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• v.42 no.6
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• pp.259-267
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• 2021

Recently, the market for personal health care and medical devices based on Bluetooth Low Energy(BLE) has grown rapidly. BLE is being used in various medical data communication devices based on low power consumption and universal compatibility. However, since data errors occurring in the transmission of medical data can lead to medical accidents, it is necessary to analyze the causes of errors and study methods to reduce data error. In this paper, the minimum communication speed to be used in medical devices was set to at least 800 byte/sec based on the wireless electrocardiography regulations of the Ministry of Food and Drug Safety. And the data loss rate was tested when data was transmitted at a speed higher than 800 byte/sec. The factors that cause communication data error were classified, and the relationship between each factor and the data error rate was analyzed through experiments. When there were two or more activated peripherals connected to the central, data error occurred due to channel hopping and bottleneck, and the data error rate increased in proportion to the communication distance and the number of activated peripherals. Through this experiment, when the BLE is used in a medical device that intermittently transmits biosignal data, the risk of a medical accident is predicted to be low if the number of peripherals is 3 or less. But, it was determined that BLE would not be suitable for the development of a biosignal measuring device that must be continuously transmitted in real time, such as an electrocardiogram.