• Title/Summary/Keyword: Regulatory Policy

Search Result 487, Processing Time 0.023 seconds

A Study on the Establishment and Operation of a Regulatory Response Framework in connection with the Regulatory Strength of the Licensing Policy for New Medical Devices -Focusing on the Application of FMEA- (의료기기 신제품의 인허가정책 규제강도에 연계한 규제대응 프레임워크 수립 및 운영에 관한 연구 - FMEA 적용을 중심으로 -)

  • Kim, Gyosu;Ru, Gyuha;Kim, Yeonhee
    • Journal of Technology Innovation
    • /
    • v.28 no.4
    • /
    • pp.1-26
    • /
    • 2020
  • Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

Psychosocial Risks: Is Risk Management Strategic Enough in Business and Policy Making?

  • Langenhan, Melissa K.;Leka, Stavroula;Jain, Aditya
    • Safety and Health at Work
    • /
    • v.4 no.2
    • /
    • pp.87-94
    • /
    • 2013
  • Background: In times of continuous change and volatile markets, organizations are increasingly characterized by downsizing, work intensification, and resource rationalization. This has resulted in diversification, and the emergence of newrisks within the field of occupational health and safety, with an important impact. This paper focuses on one such type of risk in the modern workplace-psychosocial risks. The current study aimed to explore stakeholder perspectives, regarding the extent to which psychosocial risks are incorporated into strategic risk management practices, at both the business and policy level. Methods: Semi-structured interviews were conducted with 14 professionals, representing employer, expert, policy maker, and trade union stakeholder perspectives. Results: It was found that the majority of organizations do not sufficiently, if at all, understand and incorporate psychosocial risks into strategic decision making, whereby the key barrier related to practical difficulties of not knowing how to manage psychosocial risks adequately. Conclusion: The study found that there is a need to close the gap between policy and practice on a number of levels. Future recommendations comprise a policy framework and infrastructure underpinned by educational initiatives, partnerships, and networks to drive a shift in attitudes toward recognizing the duality of the concept of risk (including both potential negative and positive outcomes) and moving beyond simple regulatory compliance.

A Study on the Process of Policy Change of Hyper-scale Artificial Intelligence: Focusing on the ACF (초거대 인공지능 정책 변동과정에 관한 연구 : 옹호연합모형을 중심으로)

  • Seok Won, Choi;Joo Yeoun, Lee
    • Journal of the Korean Society of Systems Engineering
    • /
    • v.18 no.2
    • /
    • pp.11-23
    • /
    • 2022
  • Although artificial intelligence(AI) is a key technology in the digital transformation among the emerging technologies, there are concerns about the use of AI, so many countries have been trying to set up a proper regulation system. This study analyzes the cases of the regulation policies on AI in USA, EU and Korea with the aim to set up and improve proper AI policies and strategies in Korea. In USA, the establishment of the code of ethics for the use of AI is led by private sector. On the other side, Europe is strengthening competitiveness in the AI industry by consolidating regulations that are dispersed by EU members. Korea has also prepared and promoted policies for AI ethics, copyright and privacy protection at the national level and trying to change to a negative regulation system and improve regulations to close the gap between the leading countries and Korea in AI. Moreover, this study analyzed the course of policy changes of AI regulation policy centered on ACF(Advocacy Coalition Framework) model of Sabatier. Through this study, it proposes hyper-scale AI regulation policy recommendations for improving competitiveness and commercialization in Korea. This study is significant in that it can contribute to increasing the predictability of policy makers who have difficulties due to uncertainty and ambiguity in establishing regulatory policies caused by the emergence of hyper-scale artificial intelligence.

Telecommunication Regulatory Policy and the Implementation of the Telecommunications Regulatory in Europe (유럽의 통신 규제제도와 이행현황 분석)

  • 민대홍;강선아
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
    • /
    • 2002.11a
    • /
    • pp.706-709
    • /
    • 2002
  • 1999년에 있었던 리스본에서의 유럽정상회담을 통하여 EU의 각 국가는 디지털화-지식기반의 경제체제로의 전환을 모색하게 되었다. 이러한 신경제체제로의 전환을 위한 대표적인 육성산업으로서 통신산업에 주목하게 되었다. 이러한 통신산업의 육성과 서비스 보급에 따른 이용자의 권익보호를 위하여 유럽연합은 통신규제정책에 대한 framework을 규정하게 되었다. 규제틀의 주요 원칙은 비차별성으로서, 기존의 사업자는 새로 시장에 진입한 신규사업자에 대해서 상호접속이나 설비병설(collocation)과 같은 서비스 제공시에 자사의 부서나 계열회사에게 제공하는 것과 비교하여 차별적으로 처리하지 말도록 하고 있다. 이러한 비차별성을 원칙으로 벤치마킹모형과 최적관행(best practice) 요금을 권장하고 있는데, 벤치마킹모형은 Bottom-Up형태의 통신망 재설계를 실시할 것을 권고하고 있다.

  • PDF

A Study on the Protection Methods for Students from Inappropriate Internet Sites (불건전(不健全)한 인터넷 자원(資源)으로부터의 청소년(靑少年) 보호방안(保護方案)에 관한 연구(硏究))

  • Joo, Young-Ju;Kwak, Eun-Soon
    • Journal of the Korean Institute of Educational Facilities
    • /
    • v.6 no.1
    • /
    • pp.5-20
    • /
    • 1999
  • With the advent of internet, the modern society is enjoying the benefits of the information age. As one of undesirable side effects of utilization of internet, however, it is often mentioned that young students are helplessly exposed to inappropriate and unqualified information. Therefore, in this paper, we will clarify the nature of inappropriate information to the younger generation and will argue for the needs of protecting the youth from inappropriate information. Especially the merits and limits of often motioned five different protective and regulatory measures are presented and analyzed, those are, establishment of acceptable use policy, active utilization of supervisory organization, promotion of Internet rating system, installation of filtering software, and legal and regulatory protection. As a fundamental means of resolving the problems, however, enforcement of systematic information literacy education, promotion of active utilization of sound information, development of search engines for the youth, design of diverse filtering softwares which can be selected by users, and increased attention by parents and teachers are suggested.

  • PDF

Examining China's Internet Policies through a Bibliometric Approach

  • Li, Jiang;Xu, Weiai Wayne;Wang, Fang;Chen, Si;Sun, Jianjun
    • Journal of Contemporary Eastern Asia
    • /
    • v.17 no.2
    • /
    • pp.237-253
    • /
    • 2018
  • In order to understand China's internet governance, this paper examined 1,931 Internet policies of China by bibliometric techniques. Specifically, the bibliometric techniques include simple document counting, co-word analysis, collaboration network analysis and citation analysis. The findings include: (1) China's Internet legislations mainly emphasized e-commerce and Internet governance, and, to some extent, neglected personal data protection; (2) China's Internet is under intensive multiple regulatory controls by central government. A large number of government agencies are involved in Internet policy-making. The Propaganda Department of the Central Committee of the Communist Party of China and the State Information Leading Group of the State Council, enforced fewer policy documents, but occupy higher positions in the Internet governance hierarchy; (3) China's Internet legislation system is primarily composed of industry-specific administrative rules, rather than laws or administrative regulations. Nevertheless, laws and administrative regulations received significantly more citations owing to their superior force. This paper also discussed current gaps in China's internet governance and how the country's internet policies are situated in the broader global context.

Is the Precautionary Principle Unscientific?: 'Rationality' of the Precautionary Principle and its Conflicts with Risk Analysis Framework (사전주의의 원칙은 비과학적인가?: 위험 분석과의 논쟁을 통해 본 사전주의 원칙의 '합리성')

  • Ha, Dae-Cheong
    • Journal of Science and Technology Studies
    • /
    • v.10 no.2
    • /
    • pp.143-174
    • /
    • 2010
  • How can a regulatory policy to address potential hazards be made legitimate in the face of scientific uncertainty? The precautionary principle has been gradually regarded as the most persuasive answer to this intricate question in Europe since the 1970s and generally recognized as a guiding principle in international environmental law. This principle, however, has often been subject to diverse concerns and criticisms due to its vague definition. This article tries to elaborate the precautionary principle while reviewing both the validity and unreasonableness of these criticisms over this principle. Then, this article explores the policy relevance of this principle by applying this elaborated definition to the concrete case of risk governance such as the risk assesment of food safety. In the end, this paper emphasizes the fact that the precautionary principle can be applied in the field of risk governance, refuting the argument that the precautionary principle is only a moral attitude or a political position.

  • PDF

Financial Regulation and R&D Investment (금융규제와 R&D 투자 - 자기자본, 금리 및 업무영역 규제를 중심으로 -)

  • Kim, Byung-Woo
    • Journal of Korea Technology Innovation Society
    • /
    • v.12 no.3
    • /
    • pp.582-613
    • /
    • 2009
  • In this study, we made a critical review on the regulatory policies in financial sector of Korea, analysed their effects on the firm's innovation, and suggested some policy implications. Many innovation researchers and policy makers expected that such a liberal system of regulation would lead Korea's national innovation system to the quantum leap. Our analyses of financial regulations show, however, that changes of regulatory systems (deregulation for interest rate) in the last decade did not always promoted the firm's innovation. The firms now encounter Basel II, and since it could cause bipolarization between R&D performing firms, it is necessary to add complementary policy such as collateralization or netting. Finally, simple empirical anlysis shows that the trend of universal banking may affect R&D investment positively.

  • PDF

Nanotechnology Risk Governance in Korea (나노기술에 대한 한국의 위험거버넌스 분석)

  • Kim, Eun-sung
    • Journal of Technology Innovation
    • /
    • v.21 no.3
    • /
    • pp.1-39
    • /
    • 2013
  • This article explores the risk governance of nanotechnology in Korea in light of a regulatory law approach, a soft law approach, and a participatory governance approach. The risk governance of nanotechnology in Korea has three characteristics. First, there are many existing regulatory laws that can be applied to the regulation of nanotechnology. However, these laws have exemptions, the extent of which are larger than that of the Europe and the United States. Second, the soft law approach is the most prevalent risk policy in Korea at present, but is limited because it is being driven by the government without active, voluntary participation of relevant companies. Third, no case of participatory governance took place when it comes to nanotechnology technology assessment. As policy recommendations to improve Korean nanotechnology risk governance, this article suggests pre-market screening, mandatory governmental registration of nanomaterials, transition management of code of conduct, and the design of interdisciplinary research and development project for real-time technology assessment.

A Regulatory Analysis on the Reverse Discrimination against Korean Domestic Businesses in relation to the Data Protection and Regulatory Improvement Orientation (개인정보 관련 국내기업의 역차별 상황에 관한 규제 분석과 개선방안에 관한 연구)

  • Lee, Inho;Kim, Seo-An
    • The Journal of Society for e-Business Studies
    • /
    • v.25 no.4
    • /
    • pp.1-14
    • /
    • 2020
  • IT businesses in Korea have relatively strong regulations. While providing the same service, domestic businesses are in a situation of 'reverse discrimination of regulations' as they are less competitive than global IT companies in accordance with the application of the personal information protection legislation in Korea. In this paper, Personal Information Protection legislation was classified and laws of major countries were analyzed in comparative ways. It also compared and analyzed the "private policy" presented by representative Internet sites (Naver, Daum, Google, Facebook) that provide services to users in Korea. We also proposed three aspects of legislation improvement to address reverse discrimination.