Search results for: legal and regulatory.
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 2219

Search results for: legal and regulatory.

2129 Marketing and Pharmaceutical Analysis of Medical Cosmetics in Bulgaria and Japan

Authors: V. Petkova, V. Valchanova, D. Grekova, K. Andreevska, S. T. Geurguiev, V. Madgarov, D. Grekov

Abstract:

Introduction: Production, distribution and sale of cosmetics is a global industry, which played a key role in the European Union (EU), the US and Japan. A major participant EU whose market cosmetics is greater than in the US and 2 times greater than that in Japan. The output value of the cosmetics industry in the EU is estimated at about € 35 billion in 2001. Nearly 5 billion cosmetic products (number of packages) are sold annually in the EU, and the main markets are France, Germany, Italy, Spain and the UK. The aim of the study is legal and marketing analysis of cosmetic products dispensed in a pharmacy. Materials and methodology: Historical legislative analysis - the method is applied in the analysis of changes in the legislative regulation of the activities of cosmetic products in Japan and Bulgaria Comparative legislative analysis - the method is applied when comparing the legislative requirements for cosmetic products in the already mentioned countries. Both methods are applied to the following regulations: 1) Japanese Pharmaceuticals Affairs Law, Tokyo, Japan, Ministry of Health, Labour and Welfare; 2) Law on Medicinal Products for Human Use; effective from 3.01.2014. Results: The legislative framework for cosmetic products in Bulgaria and Japan is close and generally includes general guidelines: Definition of a medicinal product; Categorization of drugs (with differences in sub-categories); Pre-registration and marketing approval of the competent authorities; Compulsory compliance with gmp (unlike cosmetics); Regulatory focus on product quality, efficacy and safety; Obligations for labeling of such products; Created systems Pharmacovigilance and commitment of all parties - industry and health professionals; The main similarities in the regulation of products classified as cosmetics are in the following segments: Full producer responsibility for product safety; Surveillance of market regulatory authorities; No need for pre-registration or pre-marketing approval (a basic requirement for notification); Without restrictions on sales channels; GMP manuals for cosmetics; Regulatory focus on product safety (than over efficiency); General requirements in labeling: The main differences in the regulation of products classified as cosmetics are in the following segments: Details in the regulation of cosmetic products; Future convergence of regulatory frameworks can contribute to the removal of barriers to trade, to encourage innovation, while simultaneously ensuring a high level of protection of consumer safety.

Keywords: cosmetics, legislation, comparative analysis, Bulgaria, Japan

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2128 A Corpus-Based Contrastive Analysis of Directive Speech Act Verbs in English and Chinese Legal Texts

Authors: Wujian Han

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In the process of human interaction and communication, speech act verbs are considered to be the most active component and the main means for information transmission, and are also taken as an indication of the structure of linguistic behavior. The theoretical value and practical significance of such everyday built-in metalanguage have long been recognized. This paper, which is part of a bigger study, is aimed to provide useful insights for a more precise and systematic application to speech act verbs translation between English and Chinese, especially with regard to the degree to which generic integrity is maintained in the practice of translation of legal documents. In this study, the corpus, i.e. Chinese legal texts and their English translations, English legal texts, ordinary Chinese texts, and ordinary English texts, serve as a testing ground for examining contrastively the usage of English and Chinese directive speech act verbs in legal genre. The scope of this paper is relatively wide and essentially covers all directive speech act verbs which are used in ordinary English and Chinese, such as order, command, request, prohibit, threat, advice, warn and permit. The researcher, by combining the corpus methodology with a contrastive perspective, explored a range of characteristics of English and Chinese directive speech act verbs including their semantic, syntactic and pragmatic features, and then contrasted them in a structured way. It has been found that there are similarities between English and Chinese directive speech act verbs in legal genre, such as similar semantic components between English speech act verbs and their translation equivalents in Chinese, formal and accurate usage of English and Chinese directive speech act verbs in legal contexts. But notable differences have been identified in areas of difference between their usage in the original Chinese and English legal texts such as valency patterns and frequency of occurrences. For example, the subjects of some directive speech act verbs are very frequently omitted in Chinese legal texts, but this is not the case in English legal texts. One of the practicable methods to achieve adequacy and conciseness in speech act verb translation from Chinese into English in legal genre is to repeat the subjects or the message with discrepancy, and vice versa. In addition, translation effects such as overuse and underuse of certain directive speech act verbs are also found in the translated English texts compared to the original English texts. Legal texts constitute a particularly valuable material for speech act verb study. Building up such a contrastive picture of the Chinese and English speech act verbs in legal language would yield results of value and interest to legal translators and students of language for legal purposes and have practical application to legal translation between English and Chinese.

Keywords: contrastive analysis, corpus-based, directive speech act verbs, legal texts, translation between English and Chinese

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2127 ISMARA: Completely Automated Inference of Gene Regulatory Networks from High-Throughput Data

Authors: Piotr J. Balwierz, Mikhail Pachkov, Phil Arnold, Andreas J. Gruber, Mihaela Zavolan, Erik van Nimwegen

Abstract:

Understanding the key players and interactions in the regulatory networks that control gene expression and chromatin state across different cell types and tissues in metazoans remains one of the central challenges in systems biology. Our laboratory has pioneered a number of methods for automatically inferring core gene regulatory networks directly from high-throughput data by modeling gene expression (RNA-seq) and chromatin state (ChIP-seq) measurements in terms of genome-wide computational predictions of regulatory sites for hundreds of transcription factors and micro-RNAs. These methods have now been completely automated in an integrated webserver called ISMARA that allows researchers to analyze their own data by simply uploading RNA-seq or ChIP-seq data sets and provides results in an integrated web interface as well as in downloadable flat form. For any data set, ISMARA infers the key regulators in the system, their activities across the input samples, the genes and pathways they target, and the core interactions between the regulators. We believe that by empowering experimental researchers to apply cutting-edge computational systems biology tools to their data in a completely automated manner, ISMARA can play an important role in developing our understanding of regulatory networks across metazoans.

Keywords: gene expression analysis, high-throughput sequencing analysis, transcription factor activity, transcription regulation

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2126 Stuck Down in the Mess of Aisles: Need of a Practical Consumer Welfare Policy Framework in Sri Lanka with Special Reference to Japan

Authors: E. N. R. de Silva

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The main purpose of this research is to set a policy framework for establishing a legal, institutional and social infrastructure that enhances the welfare, health, safety and economic interest of the consumers in Sri Lanka. It will help to develop an approach to continuously and successfully advocate for a consumer protection legal reform agenda and also it is significant as it gives directions to create national consumer protection associations in Sri Lanka. The methodology adopted for this research is purely a qualitative approach and it is generally and specifically categorized. Generally, part of this research looked at the existing laws, regulations and how effective they are in order to protect consumers. It will analyze the consumer protection framework and specially, consumer protection enhanced by the public organizations in Japan. This research offers a model with methods and legal instruments to enforce advocacy group to enhance consumer welfare, also brings out reforms to be made in the national legal framework on consumer welfare.

Keywords: consumer protection association, consumer protection law, consumer welfare, legal framework

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2125 Technical and Legal Definitions in Cyber Terrorism

Authors: Pardis Moslemzadeh Tehrani, Nazura Abdul Manap, Hamed Ladoni Damghani, Rohimi Bin Shapiee

Abstract:

In recent years the speed of new technology has brought forth so many new issues. Cyberspace is among the new technologies that need novel ways to address the various issues that have arisen. While cyberspace is a technical notion that defies a single definition, this new technology requires the adoption and application of new laws. In order to manage issues arising from the existence of cyberspace, proper policies and definitions must be formulated which satisfy both technical and legal aspects. One difficulty in this regard is due to the unique features of cyberspace architecture. This article proposes to define cyberspace and cyber terrorism. This will allow for a more effective and comprehensive addressing of legal issues as they can then be handled better by introducing a new factor to the otherwise ordinary analysis in whichever field is implicated such as the nature and place of use.

Keywords: cyberspace, cyber terrorism, technical definition, legal definition

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2124 Law and its Implementation and Consequences in Pakistan

Authors: Amir Shafiq, Asif Shahzad, Shabbar Mehmood, Muhammad Saeed, Hamid Mustafa

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Legislation includes the law or the statutes which is being reputable by a sovereign authority and generally can be implemented by the courts of law time to time to accomplish the objectives. Historically speaking upon the emergence of Pakistan in 1947, the intact laws of the British Raj remained effective after ablution by Islamic Ideology. Thus, there was an intention to begin the statutes book afresh for Pakistan's legal history. In consequence thereof, the process of developing detailed plans, procedures and mechanisms to ensure legislative and regulatory requirements are achieved began keeping in view the cultural values and the local customs. This article is an input to the enduring discussion about implementing rule of law in Pakistan whereas; the rule of law requires the harmony of laws which is mostly in the arrangement of codified state laws. Pakistan has legal plural civilizations where completely different and independent systems of law like the Mohammadan law, the state law and the traditional law exist. The prevailing practiced law in Pakistan is actually the traditional law though the said law is not acknowledged by the State. This caused the main problem of the rule of law in the difference between the state laws and the cultural values. These values, customs and so-called traditional laws are the main obstacle to enforce the State law in true letter and spirit which has caused dissatisfaction of the masses and distrust upon the judicial system of the country.

Keywords: consequences, implement, law, Pakistan

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2123 Competition in Kenya: The Legal and Institutional Framework and an Appraisal of Key Market Players

Authors: Edwin Njoroge Kimani, Alan M. Munyao

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Despite Kenya’s status as a regional economic powerhouse, it struggles with economic shocks that expose the consumers. This, however, seems not to affect major cooperates such as those in the telecommunication and energy sectors. Through their operations, they have not only been able to fluctuate prices at will but also they have been accused of curtailing their rivals from penetrating the market. This study, through literature review of the legal and institutional framework, reports and publications interrogates the law and uncovers the following; i) failings of the legal framework to define market dominance and abuse of such positions, ii) the participation of the state, iii) the inertia of the government to prosecute corporations that abuse their market dominance, iv) the role of the state as a market player and as a regulator through the Competition Authority of Kenya. This study concludes that the market distortion is as a result of weak legal and institutional framework as well as conflict of interest by the government. Not much has been researched in the field of competition law the greater East Africa. This research is intended to form part of the growing research in the field and inform legal reform.

Keywords: competition law, economic power, dominance, Kenya

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2122 Governance of the Waters in the Upper Iguazu Watershed: Case Study in Passaúna and Miringuava Watersheds

Authors: Matheus Fonseca Durães, Bruno da Silva Pereira, Bruna Stewart

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The concept of Brazil’s water governance has been the topic of discussion and has undergone legal and organizational improvements due to the need to promote a more effective and sustainable relationship with natural resources and stemming from conflicts related to shortcomings in decision-making. The Waters Act has enabled Brazil to create interesting mechanisms for integrated management, but, on the other hand, it has created a challenge that involves the implementation of the principles established in this legal framework. This study aims to evaluate some challenges and opportunities for water governance in two watersheds based on data collection and analysis of concessions, the water use register, and flow data. The elements presented demonstrated, via an analysis of legally instituted criteria, that the level of commitment of water resources is high, especially to public supply, and the adoption of the reference flow constituted one of the main barriers to implementing an efficient system, demonstrating the need for a regulatory policy that considers the hydrological behavior of the watersheds. Finally, the current water management model presents challenges to be addressed to achieve the objectives proposed by the water policy, such as ensuring sustainable, rational, and integrated use of water resources.

Keywords: management, hydrology, public policies, Brazil

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2121 Judicial Control in a Context of the Concept of Legal Policy of the Republic of Kazakhstan

Authors: G. A. Kuanaliyeva, G. T. Aigarinova, G. K. Shulanbekova

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This article is devoted to judicial control in criminal legal proceedings of the Republic of Kazakhstan in the light of the new Concept of legal policy till 2020. In article the general characteristic and concept of judicial control, and also its signs and types are considered. Different views of scientists are analyzed. Foreign experiment on application of judicial control is given. The author states also the point sight on this problem and gives the definition to concept of judicial control. The code of criminal procedure of the Republic of Kazakhstan (RK Criminal Procedure Code) doesn't consolidate concept of judicial control. The author in article suggests making change and addition to the existing Code of criminal procedure of the Republic of Kazakhstan by definition of judicial control. The decree of the President of the Republic of Kazakhstan of August 24, 2009 No. 858 approved the Concept of legal policy of the Republic for the period from 2010 to 2020. The new Concept of legal policy of the Republic of Kazakhstan, defines prospects of development of national legal system of the country on the following decade. The concept of legal policy completely mentions also institute of judicial control. Since finding of the independence by Kazakhstan the set of laws, including the rights directed on providing, freedoms and a legitimate interest of citizens was accepted. Certainly, in any country, whatever democratic it was, there are problems to human rights. However, it is obvious that Kazakhstan strongly intends to guarantee all Republic of Kazakhstan proclaimed in the Constitution the rights and freedoms of the citizens. Our country seeks for creation of the constitutional state, tries to provide a guarantee from various arbitrariness in activity of competent government bodies, officials. In the concept of legal policy of the Republic of Kazakhstan it is specified: "...priority of development of the criminal procedure right there is a further consecutive realization of the fundamental principles of the criminal legal proceedings directed on protection of the rights and freedoms of the person". Judicial control just also is such guarantee.

Keywords: rights and freedoms of the person, concept, legal policy, court, judicial control

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2120 Corporate Law and Its View Point of Locking in Capital

Authors: Saad Saeed Althiabi

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This paper discusses the corporate positioning and how it became popular as a way to systematize production because of the unique manner in which incorporation legalized organizers to secure financial capital through locking it in. The power to lock in capital comes from the fact that a corporate exists as a separate legal entity, whose survival and governance are separated from any of its participants. The law essentially creates a different legal person when a corporation is created. Although this idea has been played down in the legal learning of the last decades in favor of the view that a corporation is purely something through which natural persons interrelate, recent legal research has begun to reassess the importance of entity status. Entity status, under the law and the related separation of governance from input of financial capital through the configuration of a corporation, sanctioned corporate participants to do somewhat more than connect in a series of business transactions.

Keywords: corporate law, entity status, locking in capital, financial capital

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2119 State’s Responsibility of Space Debris

Authors: Athari Farhani

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Abstract The existence of space debris is a direct implication of human activities in outer space. The amount of orbital debris resulting from human exploration and use of outer space has been steadily increasing in the history of human exploration and use of outer space, so that space debris in the responsibility of the launching state. Space debris not only hs a direct impact on environmentalpollution but can also harm and endanger the safety of human life. Despite the legal provisions governing the exploration and use of outer space, both international space law and liability convention, however, these legal provisions are only basic prinsiples, so that further thought or effort are needed, such as new international legal instruments to regulate the existence of space debris. The method used in this research is normative juridical with an approach to written legal regulation, especially international agreements related to space law.

Keywords: state’s responsibility, space debris, outerspace, international law

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2118 The Targeted Killing of Soleimani between International Law and US Domestic Law

Authors: Mohammad Yousef

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The issue of targeted killing has become a part of modern international law topics, as its spread has been accompanied by the technological development of weapons and military equipment, especially armed drones. Until now, there is no specific definition or legal framework for targeted killing in international law, and the issue of its compatibility with international law is still subject to debate and controversy. The case of the targeted killing of General Qassem Soleimani sparked waves of reactions and discussions between legal scholars and US officials in an argument about the legality of killing him in the light of international law rules and US domestic law. This paper firstly discusses the legality of targeted killing in international law and US domestic law; after that, it studies the legal bases and the legal system that governs these operations, while in the second section, it sheds light on the case of Soleimani’s targeted killing in light of international law and US domestic law, by examining the different views of jurists in this regard.

Keywords: targeted killing, international law, US domestic law, Qassem Soleimani

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2117 Regulatory Frameworks and Bank Failure Prevention in South Africa: Assessing Effectiveness and Enhancing Resilience

Authors: Princess Ncube

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In the context of South Africa's banking sector, the prevention of bank failures is of paramount importance to ensure financial stability and economic growth. This paper focuses on the role of regulatory frameworks in safeguarding the resilience of South African banks and mitigating the risks of failures. It aims to assess the effectiveness of existing regulatory measures and proposes strategies to enhance the resilience of financial institutions in the country. The paper begins by examining the specific regulatory frameworks in place in South Africa, including capital adequacy requirements, stress testing methodologies, risk management guidelines, and supervisory practices. It delves into the evolution of these measures in response to lessons learned from past financial crises and their relevance in the unique South African banking landscape. Drawing on empirical evidence and case studies specific to South Africa, this paper evaluates the effectiveness of regulatory frameworks in preventing bank failures within the country. It analyses the impact of these frameworks on crucial aspects such as early detection of distress signals, improvements in risk management practices, and advancements in corporate governance within South African financial institutions. Additionally, it explores the interplay between regulatory frameworks and the specific economic environment of South Africa, including the role of macroprudential policies in preventing systemic risks. Based on the assessment, this paper proposes recommendations to strengthen regulatory frameworks and enhance their effectiveness in bank failure prevention in South Africa. It explores avenues for refining existing regulations to align capital requirements with the risk profiles of South African banks, enhancing stress testing methodologies to capture specific vulnerabilities, and fostering better coordination among regulatory authorities within the country. Furthermore, it examines the potential benefits of adopting innovative approaches, such as leveraging technology and data analytics, to improve risk assessment and supervision in the South African banking sector.

Keywords: banks, resolution, liquidity, regulation

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2116 Challenges of Blockchain Applications in the Supply Chain Industry: A Regulatory Perspective

Authors: Pardis Moslemzadeh Tehrani

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Due to the emergence of blockchain technology and the benefits of cryptocurrencies, intelligent or smart contracts are gaining traction. Artificial intelligence (AI) is transforming our lives, and it is being embraced by a wide range of sectors. Smart contracts, which are at the heart of blockchains, incorporate AI characteristics. Such contracts are referred to as "smart" contracts because of the underlying technology that allows contracting parties to agree on terms expressed in computer code that defines machine-readable instructions for computers to follow under specific situations. The transmission happens automatically if the conditions are met. Initially utilised for financial transactions, blockchain applications have since expanded to include the financial, insurance, and medical sectors, as well as supply networks. Raw material acquisition by suppliers, design, and fabrication by manufacturers, delivery of final products to consumers, and even post-sales logistics assistance are all part of supply chains. Many issues are linked with managing supply chains from the planning and coordination stages, which can be implemented in a smart contract in a blockchain due to their complexity. Manufacturing delays and limited third-party amounts of product components have raised concerns about the integrity and accountability of supply chains for food and pharmaceutical items. Other concerns include regulatory compliance in multiple jurisdictions and transportation circumstances (for instance, many products must be kept in temperature-controlled environments to ensure their effectiveness). Products are handled by several providers before reaching customers in modern economic systems. Information is sent between suppliers, shippers, distributors, and retailers at every stage of the production and distribution process. Information travels more effectively when individuals are eliminated from the equation. The usage of blockchain technology could be a viable solution to these coordination issues. In blockchains, smart contracts allow for the rapid transmission of production data, logistical data, inventory levels, and sales data. This research investigates the legal and technical advantages and disadvantages of AI-blockchain technology in the supply chain business. It aims to uncover the applicable legal problems and barriers to the use of AI-blockchain technology to supply chains, particularly in the food industry. It also discusses the essential legal and technological issues and impediments to supply chain implementation for stakeholders, as well as methods for overcoming them before releasing the technology to clients. Because there has been little research done on this topic, it is difficult for industrial stakeholders to grasp how blockchain technology could be used in their respective operations. As a result, the focus of this research will be on building advanced and complex contractual terms in supply chain smart contracts on blockchains to cover all unforeseen supply chain challenges.

Keywords: blockchain, supply chain, IoT, smart contract

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2115 Systematic Identification of Noncoding Cancer Driver Somatic Mutations

Authors: Zohar Manber, Ran Elkon

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Accumulation of somatic mutations (SMs) in the genome is a major driving force of cancer development. Most SMs in the tumor's genome are functionally neutral; however, some cause damage to critical processes and provide the tumor with a selective growth advantage (termed cancer driver mutations). Current research on functional significance of SMs is mainly focused on finding alterations in protein coding sequences. However, the exome comprises only 3% of the human genome, and thus, SMs in the noncoding genome significantly outnumber those that map to protein-coding regions. Although our understanding of noncoding driver SMs is very rudimentary, it is likely that disruption of regulatory elements in the genome is an important, yet largely underexplored mechanism by which somatic mutations contribute to cancer development. The expression of most human genes is controlled by multiple enhancers, and therefore, it is conceivable that regulatory SMs are distributed across different enhancers of the same target gene. Yet, to date, most statistical searches for regulatory SMs have considered each regulatory element individually, which may reduce statistical power. The first challenge in considering the cumulative activity of all the enhancers of a gene as a single unit is to map enhancers to their target promoters. Such mapping defines for each gene its set of regulating enhancers (termed "set of regulatory elements" (SRE)). Considering multiple enhancers of each gene as one unit holds great promise for enhancing the identification of driver regulatory SMs. However, the success of this approach is greatly dependent on the availability of comprehensive and accurate enhancer-promoter (E-P) maps. To date, the discovery of driver regulatory SMs has been hindered by insufficient sample sizes and statistical analyses that often considered each regulatory element separately. In this study, we analyzed more than 2,500 whole-genome sequence (WGS) samples provided by The Cancer Genome Atlas (TCGA) and The International Cancer Genome Consortium (ICGC) in order to identify such driver regulatory SMs. Our analyses took into account the combinatorial aspect of gene regulation by considering all the enhancers that control the same target gene as one unit, based on E-P maps from three genomics resources. The identification of candidate driver noncoding SMs is based on their recurrence. We searched for SREs of genes that are "hotspots" for SMs (that is, they accumulate SMs at a significantly elevated rate). To test the statistical significance of recurrence of SMs within a gene's SRE, we used both global and local background mutation rates. Using this approach, we detected - in seven different cancer types - numerous "hotspots" for SMs. To support the functional significance of these recurrent noncoding SMs, we further examined their association with the expression level of their target gene (using gene expression data provided by the ICGC and TCGA for samples that were also analyzed by WGS).

Keywords: cancer genomics, enhancers, noncoding genome, regulatory elements

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2114 The Impact of Regulatory Changes on the Development of Mobile Medical Apps

Authors: M. McHugh, D. Lillis

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Mobile applications are being used to perform a wide variety of tasks in day-to-day life, ranging from checking email to controlling your home heating. Application developers have recognized the potential to transform a smart device into a medical device, by using a mobile medical application i.e. a mobile phone or a tablet. When initially conceived these mobile medical applications performed basic functions e.g. BMI calculator, accessing reference material etc.; however, increasing complexity offers clinicians and patients a range of functionality. As this complexity and functionality increases, so too does the potential risk associated with using such an application. Examples include any applications that provide the ability to inflate and deflate blood pressure cuffs, as well as applications that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy. If an unapproved mobile medical application is marketed by a medical device organization, then they face significant penalties such as receiving an FDA warning letter to cease the prohibited activity, fines and possibility of facing a criminal conviction. Regulatory bodies have finalized guidance intended for mobile application developers to establish if their applications are subject to regulatory scrutiny. However, regulatory controls appear contradictory with the approaches taken by mobile application developers who generally work with short development cycles and very little documentation and as such, there is the potential to stifle further improvements due to these regulations. The research presented as part of this paper details how by adopting development techniques, such as agile software development, mobile medical application developers can meet regulatory requirements whilst still fostering innovation.

Keywords: agile, applications, FDA, medical, mobile, regulations, software engineering, standards

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2113 The Return of the Rejected Kings: A Comparative Study of Governance and Procedures of Standards Development Organizations under the Theory of Private Ordering

Authors: Olia Kanevskaia

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Standardization has been in the limelight of numerous academic studies. Typically described as ‘any set of technical specifications that either provides or is intended to provide a common design for a product or process’, standards do not only set quality benchmarks for products and services, but also spur competition and innovation, resulting in advantages for manufacturers and consumers. Their contribution to globalization and technology advancement is especially crucial in the Information and Communication Technology (ICT) and telecommunications sector, which is also characterized by a weaker state-regulation and expert-based rule-making. Most of the standards developed in that area are interoperability standards, which allow technological devices to establish ‘invisible communications’ and to ensure their compatibility and proper functioning. This type of standard supports a large share of our daily activities, ranging from traffic coordination by traffic lights to the connection to Wi-Fi networks, transmission of data via Bluetooth or USB and building the network architecture for the Internet of Things (IoT). A large share of ICT standards is developed in the specialized voluntary platforms, commonly referred to as Standards Development Organizations (SDOs), which gather experts from various industry sectors, private enterprises, governmental agencies and academia. The institutional architecture of these bodies can vary from semi-public bodies, such as European Telecommunications Standards Institute (ETSI), to industry-driven consortia, such as the Internet Engineering Task Force (IETF). The past decades witnessed a significant shift of standard setting to those institutions: while operating independently from the states regulation, they offer a rather informal setting, which enables fast-paced standardization and places technical supremacy and flexibility of standards above other considerations. Although technical norms and specifications developed by such nongovernmental platforms are not binding, they appear to create significant regulatory impact. In the United States (US), private voluntary standards can be used by regulators to achieve their policy objectives; in the European Union (EU), compliance with harmonized standards developed by voluntary European Standards Organizations (ESOs) can grant a product a free-movement pass. Moreover, standards can de facto manage the functioning of the market when other regulative alternatives are not available. Hence, by establishing (potentially) mandatory norms, SDOs assume regulatory functions commonly exercised by States and shape their own legal order. The purpose of this paper is threefold: First, it attempts to shed some light on SDOs’ institutional architecture, focusing on private, industry-driven platforms and comparing their regulatory frameworks with those of formal organizations. Drawing upon the relevant scholarship, the paper then discusses the extent to which the formulation of technological standards within SDOs constitutes a private legal order, operating in the shadow of governmental regulation. Ultimately, this contribution seeks to advise whether a state-intervention in industry-driven standard setting is desirable, and whether the increasing regulatory importance of SDOs should be addressed in legislation on standardization.

Keywords: private order, standardization, standard-setting organizations, transnational law

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2112 People Experiencing Economic Disadvantages and Access to Justice System: The Case of Unemployed People in Australia

Authors: M. Shahadat Hossain

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People experiencing economic disadvantages have limited access to justice system. Employment status is a key indicator of economic disadvantage. There is a link between employment status and vulnerability to legal problems. This paper addresses the obstacles unemployed people experience to secure justice in Australia. This paper further explores exiting services for economically disadvantaged people to secure justice where these unemployment people can get access. It reveals that unemployed people are vulnerable to multifaced crime and violence. Due to high cost of legal services, these unemployed people are unable to afford legal services to access justice. They are often found higher levels of nonactions in terms of access to justice also due to lack of their initiatives. This paper further reveals that legal aid commissions are state and territory statutory agencies in Australia which provide free legal information, advice, duty lawyers, and legal representation services. Community legal centres are independent, non-profit government organizations with a focus of early advice, problem solving, and working with other agencies to address connected, financial, and health problems. Moreover, the private profession helps people who cannot afford to pay for a lawyer in several ways. But there are problems of shortage of funding for these legal services and making available to economically disadvantaged people. However, this paper argues that people experiencing long-term unemployment face barriers to secure justice due to their economic disadvantages. It further argues that services available for them to access to justice is inadequate.

Keywords: economic disadvantages, unemployment, access to justice, Australia

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2111 Criminal Liability for Criminal Tax

Authors: Theresia Simatupang dan Rahmayanti

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Tax Law is a legal product and therefore should be subject to the legal norms, both about this actions, implementation, and about the material. Law has always aimed at providing justice, and besides that the law as a tool used to organize the order or rule of law. tax classification of a crime in this is very necessary, because the crime of taxation is very detrimental to the country and is still very high in society and socialization associated with punishment in sentencing that would have to provide a deterrent for the perpetrators, so refer to the this, these criminal offenses can endanger the stability of the nation's economy and the country that require special snacks. The application of legal sanctions against the perpetrators of the crime of taxation already has a strong legal basis, namely UU KUP. UU KUP have loaded threat (sanctions) severe punishment for tax payers who commit offenses and crimes in the field of taxation, which is contained in Article 38, and Article 39, Article 41, Article 41 A, and 41 B as well as Article 43 of Law and Law No. 12 KUP about 1985 Land Tax and Building. Criminal sanctions against violators of the tax provision are important because tax payers sanctions for violating tax laws.

Keywords: accountability, tax crime, criminal liability, taxation

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2110 The Novelty of Mobile Money Solution to Ghana’S Cashless Future: Opportunities, Challenges and Way Forward

Authors: Julius Y Asamoah

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Mobile money has seen faster adoption in the decade. Its emergence serves as an essential driver of financial inclusion and an innovative financial service delivery channel, especially to the unbanked population. The rising importance of mobile money services has caught policymakers and regulators' attention, seeking to understand the many issues emerging from this context. At the same time, it is unlocking the potential of knowledge of this new technology. Regulatory responses and support are essential, requiring significant changes to current regulatory practices in Ghana. The article aims to answer the following research questions: "What risk does an unregulated mobile money service pose to consumers and the financial system? "What factors stimulate and hinder the introduction of mobile payments in developing countries? The sample size used was 250 respondents selected from the study area. The study has adopted an analytical approach comprising a combination of qualitative and quantitative data collection methods. Actor-network theory (ANT) is used as an interpretive lens to analyse this process. ANT helps analyse how actors form alliances and enrol other actors, including non-human actors (i.e. technology), to secure their interests. The study revealed that government regulatory policies impact mobile money as critical to mobile money services in developing countries. Regulatory environment should balance the needs of advancing access to finance with the financial system's stability and draw extensively from Kenya's work as the best strategies for the system's players. Thus, regulators need to address issues related to the enhancement of supportive regulatory frameworks. It recommended that the government involve various stakeholders, such as mobile phone operators. Moreover, the national regulatory authority creates a regulatory environment that promotes fair practices and competition to raise revenues to support a business-enabling environment's key pillars as infrastructure.

Keywords: actor-network theory (ANT), cashless future, Developing countries, Ghana, Mobile Money

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2109 Contested Space for Regulation in Higher Education

Authors: Sulila Anar

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Institutions of any kind are regulated by laws which could be formal or informal, visible or invisible that influences the very structure of the institutions itself. Here in this paper the attempt will be to see how institutions of higher education are regulated by the regulatory institutions by taking the case of India, the third largest education system in the world. The attempt is to try to see how regulation of higher education creates a space for contestation among regulatory institutions based on secondary resources and how this affects the governance of university to achieve the goals and visions.

Keywords: higher education, regulation, autonomy, space

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2108 Semantic Textual Similarity on Contracts: Exploring Multiple Negative Ranking Losses for Sentence Transformers

Authors: Yogendra Sisodia

Abstract:

Researchers are becoming more interested in extracting useful information from legal documents thanks to the development of large-scale language models in natural language processing (NLP), and deep learning has accelerated the creation of powerful text mining models. Legal fields like contracts benefit greatly from semantic text search since it makes it quick and easy to find related clauses. After collecting sentence embeddings, it is relatively simple to locate sentences with a comparable meaning throughout the entire legal corpus. The author of this research investigated two pre-trained language models for this task: MiniLM and Roberta, and further fine-tuned them on Legal Contracts. The author used Multiple Negative Ranking Loss for the creation of sentence transformers. The fine-tuned language models and sentence transformers showed promising results.

Keywords: legal contracts, multiple negative ranking loss, natural language inference, sentence transformers, semantic textual similarity

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2107 Moderation Effects of Legal Origin on Corruption and Corporate Performance

Authors: S. Sundarasen, I. Ibrahim

Abstract:

This study examines whether the legal origin of a country alters the association between corruption and corporate performance in the East Asia and South East Asia Region. A total of 18,286 companies from 14 countries in the East Asia and South East Asia Region are tested using Generalized Least Square (GLS) panel and pool data analysis with the cross-section being the income level. The data is further analyzed in terms of high income, upper middle income and low-income countries within the East and South Asia region. The empirical results indicate that legal origin positively moderates the relationship between a country’s corruption level and firm performance. As for the sub-analysis, legal origin positively moderates only in the high and upper middle-income countries. As for the low-income countries, no significance is documented in both the common and civil law.

Keywords: corruption, performance, legal origin, East Asia and South East Asia Region

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2106 Examining Occupational Health and Safety Supervision in Turkey by Comparison to EU Countries

Authors: Nuray Gökçek Karaca

Abstract:

This study aims to examine the application of occupational health and safety supervision in Turkey and EU countries in terms of legal regulations. The results of research reveal that occupational health and safety supervision in EU countries, whatever the understanding of welfare state, is effectively carried out and almost all legal regulations on this subject are consistent with the EU directives. On the other hand, there are serious problems in applications, not legal regulations, of occupational health and safety supervision in Turkey by the side of EU countries. Indeed, Turkey has modern regulations on occupational health and safety supervision whereas there are several problems such as ignoring prevention policy on occupational health and safety supervision, understanding of monotype inspector, problems resulting from this understanding and dispersed structure of occupational health and safety organizations in workplaces. As a result, Turkey needs to carry out effective supervision mechanisms.

Keywords: legal rules, occupational health and safety, inspection, supervision, legislation

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2105 Country Experience on Regulation of Traditional Medicine in Eritrea

Authors: Liya Abraham

Abstract:

Eritrea is located along the Red Sea, north of the Horn of Africa, between Djibouti and Sudan and has a population of about 3.2 million as of 2010. It has six administrative regions; Anseba, Debub, Debubawi K’eyih Bahri, Gash-Barka, Ma'akel, and Semenawi K’eyih Bahri. Eritrea has got its independence in 1991 after 30 years war of liberation. The country is blessed with various medicinal flora and fauna, and marine and terrestrial biodiversity. Traditional Medicine (TM) has been an integral part of the Eritrean culture for centuries. So far, more than 19 TM modalities have been recognized, and are broadly categorized as; herbal, procedure-based and spiritual. Despite the availability of modern medicine to the majority of the population, TM is still widely practiced. The rationale behind widespread use is accessibility, affordability and cultural acceptability. Hence, TM is of great contribution to the Eritrean health care system. As a matter of fact, harnessing the potential contribution of effective and safe TM in order to attain Universal Health Coverage (UHC) has been emphasized in the WHO TM strategy 2014-2023. The Eritrean TM, however, was operating without regulation and reliable scientific justification behind its safety and efficacy. Thus, the Ministry of Health (MoH), in recognition of the role of TM in primary healthcare and safeguard public health, established a regulatory body for TM so-called as Traditional Medicine Unit (TMU) in 2012. The mission of the unit is to ensure rational TM use through an integrated health service delivery system and contribute to the country’s economic and social development. The unit has established its national TM policy in 2017. The activities of the unit are guided by the National TM Advisory Committee (TMAC), responsible for the provision of technical assistance and advisory role. Moreover, the Legal Framework and Code of Ethics and Practice which provide a legal basis for the regulation of TM have also been drafted. In recognition of the importance of TM research and development, the unit launched a nationwide TM survey in 2017 and had surveyed two zones (Gash-Barka and Debub). The findings of the survey were subjected to a research dissemination workshop and publication in international journals. Furthermore, TM-related adverse events reporting tool (Green Form) aiming to guide regulatory interventions and researches have been established by the unit, and ever since reports are flowing. The unit has also been offering training to THPs, pharmacy students and health care professionals regarding TM and its regulatory activities. In addition, as part of the establishment of the national medicinal plants' database and herbal monograph, more than 329 and 30 medicinal plants, have been compiled respectively. In conclusion, TM is still widely accepted and practiced in Eritrea. The TMU ever since its establishment is endeavoring to ensure the safety and efficacy of the TM, and its integration in the mainstream health service delivery system.

Keywords: efficacy, regulation, safety, traditional medicine, traditional medicine unit, universal health coverage

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2104 Tracing the History of Indian Legal System Vis-A-Vis the Code of Hammurabi

Authors: Vandana Kumari

Abstract:

One of the most ancient and detailed legal codes proclaimed the Babylonian King Hammurabi during his reign in the erstwhile Mesopotamian society, provides a fascinating account of the social and justice system of Babylon. The 282 laws intricately carved on eight feet black stone stela serve as an important source of contemporary commercial, family and criminals laws. This paper attempts an inquiry into the contemporary relevance of this legal code to our current legal system. An exhaustive study of one of ancient legal system based on a series of practical experiences rather than being founded on mere theoretical ideologies can be assumed pertinent to the promulgation of practically viable laws in our country. The first chapter of the paper focuses on law seven which established the rules of commerce and the role of government in overseeing justice and honesty regarding the law of property. The second chapter deals with the laws of family, marriages, divorce and adoption prevailing in the Babylonian era. The third chapter traces the earliest known history of criminal jurisprudence which impregnated the principle of an eye for an eye. The paper is not merely a theoretical account of the Mesopotamian way of living but a novice attempt to discover the roots of Indian laws in the ruins of the courtrooms of the Hammurabi Empire.

Keywords: Babylonian legal system, Contemporary relevance, criminal jurisprudence, Hammurabi Code

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2103 Progress of Legislation in Post-Colonial, Post-Communist and Socialist Countries for the Intellectual Property Protection of the Autonomous Output of Artificial Intelligence

Authors: Ammar Younas

Abstract:

This paper is an attempt to explore the legal progression in procedural laws related to “intellectual property protection for the autonomous output of artificial intelligence” in Post-Colonial, Post-Communist and Socialist Countries. An in-depth study of legal progression in Pakistan (Common Law), Uzbekistan (Post-Soviet Civil Law) and China (Socialist Law) has been conducted. A holistic attempt has been made to explore that how the ideological context of the legal systems can impact, not only on substantive components but on the procedural components of the formal laws related to IP Protection of autonomous output of Artificial Intelligence. Moreover, we have tried to shed a light on the prospective IP laws and AI Policy in the countries, which are planning to incorporate the concept of “Digital Personality” in their legal systems. This paper will also address the question: “How far IP of autonomous output of AI can be protected with the introduction of “Non-Human Legal Personality” in legislation?” By using the examples of China, Pakistan and Uzbekistan, a case has been built to highlight the legal progression in General Provisions of Civil Law, Artificial Intelligence Policy of the country and Intellectual Property laws. We have used a range of multi-disciplinary concepts and examined them on the bases of three criteria: accuracy of legal/philosophical presumption, applying to the real time situations and testing on rational falsification tests. It has been observed that the procedural laws are designed in a way that they can be seen correlating with the ideological contexts of these countries.

Keywords: intellectual property, artificial intelligence, digital personality, legal progression

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2102 Japanese and Europe Legal Frameworks on Data Protection and Cybersecurity: Asymmetries from a Comparative Perspective

Authors: S. Fantin

Abstract:

This study is the result of the legal research on cybersecurity and data protection within the EUNITY (Cybersecurity and Privacy Dialogue between Europe and Japan) project, aimed at fostering the dialogue between the European Union and Japan. Based on the research undertaken therein, the author offers an outline of the main asymmetries in the laws governing such fields in the two regions. The research is a comparative analysis of the two legal frameworks, taking into account specific provisions, ratio legis and policy initiatives. Recent doctrine was taken into account, too, as well as empirical interviews with EU and Japanese stakeholders and project partners. With respect to the protection of personal data, the European Union has recently reformed its legal framework with a package which includes a regulation (General Data Protection Regulation), and a directive (Directive 680 on personal data processing in the law enforcement domain). In turn, the Japanese law under scrutiny for this study has been the Act on Protection of Personal Information. Based on a comparative analysis, some asymmetries arise. The main ones refer to the definition of personal information and the scope of the two frameworks. Furthermore, the rights of the data subjects are differently articulated in the two regions, while the nature of sanctions take two opposite approaches. Regarding the cybersecurity framework, the situation looks similarly misaligned. Japan’s main text of reference is the Basic Cybersecurity Act, while the European Union has a more fragmented legal structure (to name a few, Network and Information Security Directive, Critical Infrastructure Directive and Directive on the Attacks at Information Systems). On an relevant note, unlike a more industry-oriented European approach, the concept of cyber hygiene seems to be neatly embedded in the Japanese legal framework, with a number of provisions that alleviate operators’ liability by turning such a burden into a set of recommendations to be primarily observed by citizens. With respect to the reasons to fill such normative gaps, these are mostly grounded on three basis. Firstly, the cross-border nature of cybercrime brings to consider both magnitude of the issue and its regulatory stance globally. Secondly, empirical findings from the EUNITY project showed how recent data breaches and cyber-attacks had shared implications between Europe and Japan. Thirdly, the geopolitical context is currently going through the direction of bringing the two regions to significant agreements from a trade standpoint, but also from a data protection perspective (with an imminent signature by both parts of a so-called ‘Adequacy Decision’). The research conducted in this study reveals two asymmetric legal frameworks on cyber security and data protection. With a view to the future challenges presented by the strengthening of the collaboration between the two regions and the trans-national fashion of cybercrime, it is urged that solutions are found to fill in such gaps, in order to allow European Union and Japan to wisely increment their partnership.

Keywords: cybersecurity, data protection, European Union, Japan

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2101 The Role of the Indonesian Armed Forces to Combat Terrorism Acts During the COVID 19 Pandemic Era

Authors: Aulia Rosa Nasution

Abstract:

This research aims to analyze the involvement of the Indonesian Armed Forces in overcoming terrorism acts under legal perspectives based on Acts No. 34 of 2004, which regulates the role and mechanism of the Indonesian Armed Forces in combating terrorism. The main question of this research is, firstly, the military authority in combating terrorism acts, secondly, the implementation of Acts Number 34/2000, and thirdly, law enforcement to combat terrorism under national and international law. The methodology of this research is juridical normative based on the legal instruments and legal principles, and international norms. The result of this study explains the involvement of the Indonesian Army in combating terrorism as a part of the nonmilitary operation which has been implemented in Indonesia as part of national defence and security.

Keywords: acts of terrorism, Indonesian armed forces, legal protection

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2100 Role of Pro-Inflammatory and Regulatory Cytokines in Pathogenesis of Graves’ Disease in Association with Autoantibody Thyroid and Regulatory FoxP3 T-Cells

Authors: Dwitya Elvira, Eryati Darwin

Abstract:

Background: Graves’ disease (GD) is an autoimmune thyroid disease. Imbalance of Th1/Th2 cells and T-regulatory (Treg)/Th17 cells was thought to play pivotal role in the pathogenesis of GD. Treg FoxP3 produced TGF-β to maintain regulatory function, and Th17 cells produced IL-17 as cytokines that were thought in mediating several autoimmune diseases. The aim of this study is to assess the role of IL-17 and TGF-β in the pathogenesis of GD and to investigate its correlation with Thyroid Stimulating Hormone Receptor Antibody (TRAb) and Treg FoxP3 expression. Method: 30 GD patients and 27 age and sex-matched controls were enrolled in this study. Diagnosis of GD was based on clinical and biochemical of GD. Serum IL-17, TGF-β, TRAb, and FoxP3 were measured by enzyme-linked immunosorbent assay (ELISA). Data were analyzed by using SPSS 21.0 (SPSS Inc.). Spearman rank correlation test was used for assessment of correlation. The statistical significance was accepted as P<0.05. Result: There was no significant correlation between IL-17 and TGF-β serum with expression of FoxP3 level in GD, but there was significant correlation between TGF-β and TRAb serum level (P<0.05). Serum levels of IL-17 and TGF-β were found to be elevated in patient group compared to control, where mean values of IL-17 were 14.43±2.15 pg/mL and TGF-β were 10.44±3.19 pg/mL in patients group; and in control group, level of IL-17 were 7.1±1.45 pg/mL and TGF-β were 4.95±1.35 pg/mL. Conclusion: Serum Il-17 and TGF-β were elevated in GD patients that reflect the role of inflammatory and regulatory cytokines activation in pathogenesis of GD. There was significant correlation between TGF-β and TRAb, revealing that Treg cytokines may play a role in pathogenesis of GD.

Keywords: IL-17, TGF-B, FoxP3, TRAb, Graves’ disease

Procedia PDF Downloads 247