• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Land and Housing Review
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• v.5 no.1
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• pp.25-34
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• 2014

This study starts from the fact that we need residential complex for the purpose of public interests, rather than for profits, and find a new perspective on the concept of public-oriented residential complex in the cities that had slow growth. In this study, we 1) propose a new concept of the residential complex that can vitalize regional communities and maintain the interest of the public : 'functional-mix', 'social-mix', 'spatial-mix', 2) produce a model simulation based on the development principles including development direction, types of development, and design guidelines, ; six development principles(goal, concept, development type, spatial structure, space element, spatial hierarchy), diversity of housing types, facilities that can vitalize and contribute the regional communities 3) propose practical methods that can realize and promote the proposed concept and model simulation. ; need to amend the housing construction Law.

• Journal of dental hygiene science
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• v.11 no.6
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• pp.573-581
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• 2011

The purpose of this study was to examine the professionalism of dental hygienists in dental institutions and the influential factors for their professionalism in an attempt to seek ways of enhancing the professionalism of dental hygienists. The subjects in this study were 172 dental hygienists who worked in dental institutions in Busan and Gimhae. A self-administered survey was conducted to gather data, and an experimental analysis was carried out to analyze the collected data. The major findings of the study were as follows: First, concerning professionalism, self-regulation belief(3.70) ranked highest(3.42), followed by service belief(3.65), autonomy belief(3.31), a sense of vocational calling(3.30) and utilization of the professional organization as a standard(3.12). Second, the professionalism of the dental hygienists was significantly better when their title was higher, when they were older, when they got a larger monthly pay and when they intended to work for a longer time. Third, as for the influential factors for their professionalism, age, marital status, the estimated term of working at the workplace and opinion on reemployment were also identified as the significant variables that were up to the standard level of significance(p=0.05). The findings of the study suggest that in order to boost the professionalism of dental hygienists, it's required to take institutional measures to give them more responsibility, autonomy and authority, and how to improve personnel administration by providing strong motivation for them to look at their workplaces more favorably and keep on working for a long time should discreetly be considered.

• The Journal of Society for e-Business Studies
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• v.26 no.3
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• pp.1-20
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• 2021

As the Great Reset is discussed at the World Economic Forum due to the COVID-19 pandemic, artificial intelligence, the driving force of the 4th industrial revolution, is also in the spotlight. However, corporate research in the field of artificial intelligence is still scarce. Since 2000, related research has focused on how to create value by applying artificial intelligence to existing companies, and research on how startups seize opportunities and enter among existing businesses to create new value can hardly be found. Therefore, this study analyzed the cases of startups using the comprehensive framework of the multi-level perspective with the research question of how artificial intelligence based startups, a sub-industry of software, have different innovation patterns from the existing software industry. The target firms are gazelle firms that have been certified as venture firms in South Korea, as start-ups within 7 years of age, specializing in machine learning modeling purposively sampled in the medical, finance, marketing/advertising, e-commerce, and manufacturing fields. As a result of the analysis, existing software companies have achieved process innovation from an enterprise-wide integration perspective, in contrast machine learning technology based startups identified unit processes that were difficult to automate or create value by dismantling existing processes, and automate and optimize those processes based on data. The contribution of this study is to analyse the birth of artificial intelligence-based startups and their innovation patterns while validating the framework of an integrated multi-level perspective. In addition, since innovation is driven based on data, the ability to respond to data-related regulations is emphasized even for start-ups, and the government needs to eliminate the uncertainty in related systems to create a predictable and flexible business environment.

• Journal of Internet Computing and Services
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• v.25 no.2
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• pp.79-92
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• 2024

ChatGPT, as a representative chatbot leveraging generative artificial intelligence technology, is used valuable not only in scientific and technological domains but also across diverse sectors such as society, economy, industry, and culture. This study conducts an explorative analysis of user sentiments and needs for ChatGPT by examining global social media discourse on Reddit. We collected 10,796 comments on Reddit from December 2022 to August 2023 and then employed keyword analysis, sentiment analysis, and need-mining-based topic modeling to derive insights. The analysis reveals several key findings. The most frequently mentioned term in ChatGPT-related comments is "time," indicative of users' emphasis on prompt responses, time efficiency, and enhanced productivity. Users express sentiments of trust and anticipation in ChatGPT, yet simultaneously articulate concerns and frustrations regarding its societal impact, including fears and anger. In addition, the topic modeling analysis identifies 14 topics, shedding light on potential user needs. Notably, users exhibit a keen interest in the educational applications of ChatGPT and its societal implications. Moreover, our investigation uncovers various user-driven topics related to ChatGPT, encompassing language models, jobs, information retrieval, healthcare applications, services, gaming, regulations, energy, and ethical concerns. In conclusion, this analysis provides insights into user perspectives, emphasizing the significance of understanding and addressing user needs. The identified application directions offer valuable guidance for enhancing existing products and services or planning the development of new service platforms.

• Information Systems Review
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• v.25 no.1
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• pp.165-187
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• 2023

The continuous increase in life expectancy and high interest in health has brought about significant changes in the use of health information by the public according to the development of information technology represented by the Internet and smartphones. As the medical market expands to the mobile health environment, many health-related apps have been created and distributed, but the acceptance rate is slow as it has become challenging to provide services due to various regulations. In this study, perceived value, perceived risk factors (psychological risk, risk of time-loss, legal risk), and perceived benefits (usefulness, interaction, autonomy) were derived and verified as factors that affect the acceptance resistance of personal health record apps based on the privacy calculation model. In addition, by analyzing the moderating effect of trust in the manufacturer, how the perceived risk and perceived benefit affect the perceived value was verified. A survey was conducted on Korean college students who recognized the personal health record apps but did not use them, and 127 samples were analyzed using structural equations. As a result of hypothesis verification, perceived value has a negative effect on acceptance resistance, perceived risk (risk of time-loss) has a negative effect on perceived value, and perceived benefits (usefulness, interaction, autonomy) were found to have a positive effect on perceived value. Trust in manufacturers has weakened the impact of perceived risks (legal risk) on perceived values. This study is expected to play an important role in maintaining a competitive advantage in the personal health record app market environment by identifying and proposing detailed criteria for reducing the acceptance resistance of personal health record apps.

• Journal of the Korean Society of Radiology
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• v.7 no.2
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• pp.113-120
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• 2013

Nowadays, the medical system towards patients changes into the medical services. As the human rights are improved and the capitalism is enlarged, the rights and needs of patients are gradually increasing. Also, based on this change, several systems in hospitals are revised according to the convenience and needs of patients. Thus, the cases of mobile portable among examinations are getting augmented. Because the number of mobile portable examinations in patient's room, intensive care unit, operating room and recovery room increases, neighboring patients are unnecessarily exposed to radiation so that the examination is legally regulated. Hospitals have to specify that "In case that the examination is taken out of the operating room, emergency room or intensive care units, the portable medical X-ray protective blocks should be set" in accordance with the standards of radiation protective facility in diagnostic radiological system. Some keep this regulation well, but mostly they do not keep. In this study, we shielded around the Collimator where the radiation is detected and then checked the change of dose regarding that of angles in portable tube and collimator before and after shielding. Moreover, we tried to figure out the effects of shielding on dose according to the distance change between patients' beds. As a result, the neighboring areas around the collimator are affected by the shielding. After shielding, the radiation is blocked 20% more than doing nothing. When doing the portable examination, the exposure doses are increased $0^{\circ}C$, $90^{\circ}C$ and $45^{\circ}C$ in order. At the time when the angle is set, the change of doses around the collimator decline after shielding. In addition, the exposure doses related to the distance of beds are less at 1m than 0.5m. In consideration of the shielding effects, putting the beds as far as possible is the best way to block the radiation, which is close to 100%. Next thing is shielding the collimator and its effect is about 20%, and it is more or less 10% by controlling the angles. When taking the portable examination, it is better to keep the patients and guardians far enough away to reduce the exposure doses. However, in case that the bed is fixed and the patient cannot move, it is suggested to shield around the collimator. Furthermore, $90^{\circ}C$ of collimator and tube is recommended. If it is not possible, the examination should be taken at $0^{\circ}C$ and $45^{\circ}C$ is better to be disallowed. The radiation-related workers should be aware of above results, and apply them to themselves in practice. Also, it is recommended to carry out researches and try hard to figure out the ways of reducing the exposure doses and shielding the radiation effectively.

• Journal of Preventive Medicine and Public Health
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• v.49 no.1
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• pp.23-34
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• 2016

South Korea's state health insurer, the National Health Insurance Service (NHIS), is in the process of a compensation suit against tobacco industry. The tobacco companies have habitually endeavored to ensure favorable outcomes in litigation by misusing scientific evidence or recruiting scientists to support its interests. This study analyzed strategies that tobacco companies have used during the NHIS litigation, which has been receiving world-wide attention. To understand the litigation strategies of tobacco companies, the present study reviewed the existing literature and carried out content analysis of petitions, preparatory documents, and supporting evidence submitted to the court by the NHIS and the tobacco companies during the suit. Tobacco companies misrepresented the World Health Organization (WHO) report's argument and misused scientific evidence, and removed the word "deadly" from the title of the citation. Tobacco companies submitted the research results of scientists who had worked as a consultant for the tobacco industry as evidence. Such litigation strategies employed by the tobacco companies internationally were applied similarly in Korean lawsuits. Results of tobacco litigation have a huge influence on tobacco control policies. For desirable outcomes of the suits, healthcare professionals need to pay a great deal of attention to the enormous volume of written opinions and supporting evidence that tobacco companies submit. They also need to face the fact that the companies engage in recruitment of scientists. Healthcare professionals should refuse to partner with tobacco industry, as recommended by Article 5.3 of the WHO Framework Convention on Tobacco Control.

• The Korean Journal of Air & Space Law and Policy
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• v.28 no.2
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• pp.63-96
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• 2013

Recently, U.S. Department of Transportation (DOT) expanded the "Enhancing Airline Passenger Protections" on August 23, 2011 and October 24, 2011. The Rule regulates tarmac delays, denied boarding compensation, customer service plans, and fare advertising. The adopted rule is to protect passengers by improving passenger service requirements on U.S. national or domestic carriers and foreign air carriers as well. The major issues are as follows: First, regarding to so called Tarmac Delay, carriers must establish a Tarmac Delay Contingency Plan setting forth the number of hours the carrier will permit an aircraft to remain on the tarmac at U.S. airports before allowing passengers to deplane. Carriers also must provide passengers with food and water in the event the aircraft remains on the tarmac for two or more hours and must provide operable lavatories and medical attention while the aircraft remains on the tarmac, irrespective of the length of the delay. Carriers also must create and retain records regarding tarmac delays lasting more than three hours. Also they need to update passengers every 30 minutes during a tarmac delay of the status of the flight and the reason for the delay, allow passengers to deplane if the aircraft is at the gate or another disembarkation area with the door open. Second, carriers now must adopt a "Customer Service Plan" that addresses offering customers the lowest fares available, notifying customers about delays, cancellations, and diversions; timely delivery of baggage; accommodating passengers' needs during tarmac delays and in "bumping cases"; and ensuring quality customer service. Third, the new regulations also increase minimum denied boarding compensation limits to $650 / $1,300 or 200% / 400% of the fare, whichever is less. Last, the DOT also has modified its policies related to enforcement of Rules pertaining to full fare advertising. The Rule states that the advertised price for air transportation must be the entire price to be paid by the customer. Similarly, Korea revised the passenger protection clauses within Aviation Act. However, it seems to be required to include various more issues such as Tarmac Delay, oversales of air tickets, involuntary denied boarding passengers, advertisements, etc.