• Journal of the Korean Society of Systems Engineering
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• v.19 no.2
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• pp.92-116
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• 2023

Emerging Industries often do not match the structures and contents of existing regulations, and regulations that impose excessive burdens compared to the regulatory purpose are continuously created. These results, the emerging industries struggle to growth. In order to respond to these regulatory problems, the regulatory management policies are establishing in each country, and research on the reasonable regulatory methods and its effects on industry has continued. But companies still complain of difficulties in business due to regulations. In the background, it is analyzed that there are limitations in response to regulatory issues of the emerging industry, such as the lack of standards and expertise that can be judged as 'problems', and delay in recognizing and improving the problems of the competent ministries, over-interpretation of the risks of new technologies, and vague concerns about accidents etc., the regulation corresponding limitations is existed. In this regard, this study seeks to lay the groundwork for analysis of the major regulatory conflict issues and the reasonable countermeasures by identifying the regulatory conflict issues arising from the emergence of the innovative technologies and services, and analyzing studies to resolve them.

• Journal of Intelligence and Information Systems
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• v.27 no.3
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• pp.199-230
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• 2021

Innovative new products and services are being launched through the convergence between heterogeneous industries, and social interest and investment in convergence industries such as AI, big data-based future cars, and robots are continuously increasing. However, in the process of commercialization of convergence new products and services, there are many cases where they do not conform to the existing regulatory and legal system, which causes many difficulties in companies launching their products and services into the market. In response to these industrial changes, the current government is promoting the improvement of existing regulatory mechanisms applied to the relevant industry along with the expansion of investment in new industries. This study, in these convergence industry trends, aimed to analysis the existing regulatory system that is an obstacle to market entry of innovative new products and services in order to preemptively predict regulatory issues that will arise in emerging industries. In addition, it was intended to establish a regulatory impact analysis system to evaluate adequacy and prepare improvement measures. The flow of this study is divided into three parts. In the first part, previous studies on regulatory impact analysis and evaluation systems are investigated. This was used as basic data for the development direction of the regulatory impact framework, indicators and items. In the second regulatory impact analysis framework development part, indicators and items are developed based on the previously investigated data, and these are applied to each stage of the framework. In the last part, a case study was presented to solve the regulatory issues faced by actual companies by applying the developed regulatory impact analysis framework. The case study included the autonomous/electric vehicle industry and the Internet of Things (IoT) industry, because it is one of the emerging industries that the Korean government is most interested in recently, and is judged to be most relevant to the realization of an intelligent information society. Specifically, the regulatory impact analysis framework proposed in this study consists of a total of five steps. The first step is to identify the industrial size of the target products and services, related policies, and regulatory issues. In the second stage, regulatory issues are discovered through review of regulatory improvement items for each stage of commercialization (planning, production, commercialization). In the next step, factors related to regulatory compliance costs are derived and costs incurred for existing regulatory compliance are calculated. In the fourth stage, an alternative is prepared by gathering opinions of the relevant industry and experts in the field, and the necessity, validity, and adequacy of the alternative are reviewed. Finally, in the final stage, the adopted alternatives are formulated so that they can be applied to the legislation, and the alternatives are reviewed by legal experts. The implications of this study are summarized as follows. From a theoretical point of view, it is meaningful in that it clearly presents a series of procedures for regulatory impact analysis as a framework. Although previous studies mainly discussed the importance and necessity of regulatory impact analysis, this study presented a systematic framework in consideration of the various factors required for regulatory impact analysis suggested by prior studies. From a practical point of view, this study has significance in that it was applied to actual regulatory issues based on the regulatory impact analysis framework proposed above. The results of this study show that proposals related to regulatory issues were submitted to government departments and finally the current law was revised, suggesting that the framework proposed in this study can be an effective way to resolve regulatory issues. It is expected that the regulatory impact analysis framework proposed in this study will be a meaningful guideline for technology policy researchers and policy makers in the future.

• Journal of the Korean Society of Systems Engineering
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• v.20 no.1
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• pp.1-15
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• 2024

This study attempted to analyze whether the government's regulatory innovation efforts affect the continued operation of new products and new service-based businesses, such as regulatory compliance and response efforts, despite the perception of regulatory difficulties as business barriers for firms in new industries. Previous studies on the impact of regulations on companies in new industries were a limit to obtaining implications for regulatory issues and characteristics of each field due to the simplification of regulatory indicators and the establishment of field integration. To compensate for this, this study focused on the field of AI and DATA services, and subdivided regulatory issues to indicate practical inconvenience as variables, and model fit and hypothesis verification were performed by applying Structural Equation Model analysis based on the survey results of related companies. As a result, in the field of AI and DATA services, "Perceived regulatory irrationality" and "Perceived government regulatory innovation efforts" significantly affect the "Regulatory environment satisfaction" of the regulated, and "Perceived regulatory irrationality" and "Regulatory environment satisfaction" affect "Regulatory response efforts for companies in new industries to continue their businesses." The significance of this study is that it conducted research on the factors affecting the continuity of business of companies in the AI and DATA service sector by linking the analysis of the impact relationship between satisfaction and continuous use intention, which have been mainly used in the "Policy Acceptance Model" and "IT service sector," to "efforts for companies to continue their business in a new industrial regulatory environment." In addition, by presenting a new empirical model for new industry regulations, it is expected to be meaningful as it can provide a research foundation that can obtain practical implications in related fields.

• Interdisciplinary Bio Central
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• v.1 no.2
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• pp.6.1-6.4
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• 2009

We stand at the brink of a fundamental change in how medicine will be practiced. Over the next 5-20 years medicine will move from being largely reactive to being predictive, personalized, preventive and participatory (P4). Technology and new scientific strategies have always been the drivers of revolutions and this is certainly the case for P4 medicine, where a systems approach to disease, new and emerging technologies and powerful computational tools will open new windows for the investigation of disease. Systems approaches are driving the emergence of fascinating new technologies that will permit billions of measurements on each individual patient. The challenge for health information technology will be how to reduce this enormous amount of data to simple hypotheses about health and disease. We predict that emerging technologies, together with the systems approaches to diagnosis, therapy and prevention will lead to a down turn in the escalating costs of healthcare. In time we will be able to export P4 medicine to the developing world and it will become the foundation of global medicine. The "democratization" of healthcare will come from P4 medicine. Its first real emergence will require the unprecedented integration of biology, medicine, technology and computation. as well as societal issues of major importance: ethical, regulatory, public policy, economic, and others. In order to effectively move the P4 scientific agenda forward new strategic partnerships are now being created with the large-scale integration of complementary skills, technologies, computational tools, patient records and samples and analysis of societal issues. It is evident that the business plans of every sector of the healthcare industry will need to be entirely transformed over the next 10 years.and the extent to which this will be done by existing companies as opposed to newly created companies is a fascinating question.

• Journal of Biomedical Engineering Research
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• v.43 no.3
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• pp.153-160
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• 2022

As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.

• Korean Security Journal
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• no.47
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• pp.7-36
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• 2016

The security providers industry, often referred to as an industry with unconfined growth ceiling, has entered a remarkable mass-growth phase since the 1980. In the modern era, private-sector security increasingly cover functions relating to general security awareness (including counter-terrorism) in partnership with State bodies, and the scale of operations continue to accelerate, relative to the expanding roles. In the era of pluralisation of policing, there has been widening efforts pursued to develop a range of regulatory strategies internationally in order to manage such growth and development. To date, in South Korea, a diverse set of industry review studies have been conducted. However, the analyses have been conventionally confined to North America, Britain, Germany and Japan, while developments in other world regions remain unassessed. This article is intended to inform the drivers and determinants of regulatory reforms in Australia, and examine the effectiveness of the main pillars of licensing innovations. Over the past decades, the Australian regime has undergone a wave of reforms in response to emerging issues, and in recognition of the industry as a 'public good' due to underpopulation density and the resulting security challenges. The focus of review in this study was on providing a detailed review of the regulatory approach taken by Australia that has expanded police-private security co-operation since the 1980s. The emphasis was on examining the core pillars of risk management strategies and oversight practices progressed to date and evaluating areas of possible improvement in regulation relative to South Korea. Overall, this study has identified three key features of Australian regime: (1) close checks on questionable close associates (including fingerprinting), (2) power of inspection and seizure without search warrant, (3) the 'three strikes' scheme. The rise of the private security presence in day-to-day policing operations means that industry warrant some intervening government-sponsored initiative. The overall lessons learnt from the Australian case was taken into account in determining the following checks and balances that would provide the ideal setting for the best-practice arrangement: (1) regulatory measure should be evaluated against a set of well-defined indicators, such as the merits of different enforcement tools for each given risk, (2) information about regulatory impacts should be analysed by a specialist research institute, (3) regulators should be innovative in applying a range of strategies available to them by employing a mixture of compliance promotional strategies, and adjust the mix as required.

• The Korean Journal of Air & Space Law and Policy
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• v.30 no.1
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• pp.207-244
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• 2015

Aviation safety is the stage in which the risk of harm to persons or of property damage is reduced to, and maintained at or below, an acceptable level through a continuing process of hazard identification and risk management. Many accidents and incidents have been taking place since 2014, while there had been relatively safer skies before 2014. International civil aviation community has been exerting great efforts to deal with these emerging issues, thus enhancing and ensuring safety throughout the world over the years. The Preamble of the Chicago Convention emphasizes safety and order of international air transport, and so many Articles in the Convention are related to the safety. Furthermore, most of the Annexes to the Convention are International Standards and Recommended Practices pertaining to the safety. In particular, Annex 19, which was promulgated in Nov. 2013, dealing with safety management system. ICAO, as law-making body, has Air Navigation Commission, Council, Assembly to deliberate and make decisions regarding safety issues. It is also implementing USOAP and USAP to supervise safety functions of member States. After MH 370 disappeared in 2014, ICAO is developing Global Tracking System whereby there should be no loophole in tracking the location of aircraft anywhere in world with the information provided by many stakeholders concerned. MH 17 accident drove ICAO to install web-based repository where information relating to the operation in conflict zones is provided and shared. In addition, ICAO has been initiating various solutions to emerging issues such as ebola outbreak and operation under extreme meteorological conditions. Considering the necessity of protection and sharing of safety data and information to enhance safety level, ICAO is now suggesting enhanced provisions to do so, and getting feedback from member States. It has been observed that ICAO has been approaching issues towards problem-solving from four different dimensions. First regarding time, it analyses past experiences and best practices, and make solutions in short, mid and long terms. Second, from space perspective, ICAO covers States, region and the world as a whole. Third, regarding stakeholders it consults with and hear from as many entities as it could, including airlines, airports, community, consumers, manufacturers, air traffic control centers, air navigation service providers, industry and insurers. Last not but least, in terms of regulatory changes, it identifies best practices, guidance materials and provisions which could become standards and recommended practices.