Search results for: legal and regulatory framework

Authors: Mahdieh Dehghan Nayeri, Hani Arbabi, Seid Pooyan Ghafoori

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Civic crowdfunding- crowdfunding public projects- which goes beyond people management- as a significant part of public projects stakeholders- and requires the active engagement of the public in both the financing and decision-making processes of public projects, is expanding. However, in most countries of the world, no specific legal framework has been approved for governing and managing the implementation of projects through this method. Through a systematic literature review, following the Preferred Reporting Items for Systematic Reviews (PRISMA), this article has studied and discussed the legal issues of civic crowdfunded projects in the countries leading the use of this method, in four themes; one related to the legal environment and three related to three leading players in civic crowdfunded projects include the investor, the platform, and the investee. The review showed that despite the increasing attention to people's engagement in public projects -financial and non-financial- not much scientific research has been done to formulate fully structured legal structures. Finally, neglected areas in research have been discussed as a guide for future research.

Keywords: civic crowdfunding, equity crowdfunding, public projects, legal issues, crowdsourcing

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Authors: Waheed Oseni

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This article reviews emergent global trends in intellectual property protection and identifies patenting as a strategic initiative. Recent developments in software and method of doing business patenting are fast transforming the e‐business landscape. The article discusses the emergent global regulatory framework concerning intellectual property rights and the strategic value of patenting. Important features of a corporate patenting portfolio are described. Superficially, the e‐commerce landscape appears to be dominated by dotcom start-ups or the “dotcomization” of existing brick and mortar companies. But, in reality, at its very bedrock is intellectual property (IP). In this connection, the recent avalanche of patenting of software and method‐of‐doing‐business (MDB) in the USA is a very significant development with regard to rules governing IP rights and, therefore, e‐commerce. Together with the World Trade Organization’s (WTO) IP rules, there is an emerging global regulatory framework for IP rights, an understanding of which is necessary for designing effective e‐commerce strategies.

Keywords: intellectual property, patents, methods, computer software

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Authors: Linda Ana-Maria Ungureanu

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As space exploration opens to new actors, we are faced with the interesting question of regulating more complex structures that enable private experiments. From intellectual property implications to private and public law, there is a multitude of factors and legal structures that need to be taken into consideration when opening space, and these structures need to be harmonized with the International Space Treaties governing space exploration. In this sense, this article presents an overview of the legal and contractual framework applicable to private experiments conducted in space and/or in relation to off-world environments. Additionally, the article analyses the manner in which national space agencies regulate agreements concluded with private actors and research institutions. Finally, the article sets a series of de lege ferenda proposals for the regulation of general research and development rules and intellectual property matters that are connected to experiments and research conducted in space and/or concerning off-world environments.

Keywords: private space, intellectual property, contracts, ESA guidelines, EU legislation, Intellectual property law, international IP treaties

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Authors: Tikumporn Rodkhunmuang

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The importance of ‘international law of governance’ is the means and end to deal with international affairs. This research paper seeks to first study the historical development of international law of governance from the classical period of the international legal framework of global governance until the contemporary period of its framework. Second, the international law of governance is extremely turning into the crucial point in its long history because of the changing of China's foreign policies towards ‘One Belt One Road Initiative’. Third, the proposing model of the existing international law of governance within Chinese characteristics will be the new rules and modalities of modern diplomacy and governed international affairs. Methodologically speaking, this research paper is conducting under mixed methods research, which are also included numerical analysis and theoretical considerations. As a result, this research paper is the critical point of the international legal framework of global governance that changing the diplomatic paradigm as well as turning China into a great-power in international politics. So, this research paper is useful for international legal scholars and diplomats for slightly changing their understanding of the rapidly changing their norms from western norms to the eastern norms of international law. Therefore, the outcome of the research is the modern model of China to make a diplomatic relationship with other countries in the global society.

Keywords: global governance, international law, landscape, one belt one road

Procedia PDF Downloads 168

Authors: Umamaheswari Shanmugam, Silvia Ronchi

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

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Authors: Odoh Ben Uruchi

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Information Technology is an outcome of the nexus between the computer technology and the communication technology which has grown as silver fiber in Nigeria. Information Technology represents the fourth generation of human communication after sight, oral and written communications. The internet, as with all path-breaking technological developments gives us all the ample privileges to act as a global community; advertise and operate across all frontiers; over boarders and beyond the control of any government. The security concerns, computer abuse and the side effects of this technology have moved to the forefront of the consciousness of law enforcement agencies. Unfortunately, Nigeria is one of the very few countries in the world to have not legislated Cyber Laws, although several unsuccessful attempts have been made in recent times at providing the legal framework for regulating the activities in Nigerian cyberspace. Traditional legal systems have led to great difficulty in keeping pace with the rapid growth of the internet and its impact throughout Nigeria. The only existing legal frameworks are constantly being challenged by technological advancement. This has created a need to constantly update and adapt the way in which we organize ourselves as Legal Practitioners in order to maintain overall control of its domestic and national interests. This paper seeks to appraise the challenges facing the legal profession in Nigeria because of want of Cyber Laws. In doing this, the paper shall highlight the loopholes in the existing laws and recommends the way forward.

Keywords: information technology, challenges, legal profession, Nigeria

Procedia PDF Downloads 496

Authors: Effort M. Magoso

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This study analyses urban institutional arrangements and their implications on allocation of wetlands for development purposes in Zimbabwe using a case study of Harare. It was driven by the need to get to the root of the current urban assault on wetlands. The study sought to analyse institutions that influence wetlands governance in Harare, to ascertain level of wetlands loss and to determine the adequacy of the legal and regulatory framework for governing wetlands. Theories of common property resources and of institutions are the paradigms that undergird this study. A qualitative research methodology was employed, while in-depth interviews, observations and document review were used to gather data. The study found out that unchecked infrastructure developments are taking place in the city’s wetlands. Urban institutional arrangements in Harare were exposed as having negative implications on the protection of wetlands. It is the key argument of this study that good institutional arrangements are priceless in the protection of commons such as wetlands. This study also recommends a new framework that has environmentalists and technocrats as the final decision maker in land allocation as the solution to protect wetlands from undue anthropogenic activities.

Keywords: institutional arrangements, common property resources, wetlands, institutions

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Authors: Nebiat Lemenih Lenger

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Today, the digital economy is evolving faster than ever in Ethiopia. Platforms that provide a ride-hailing service are growing fast in the country. The market welcomed them as they disrupt it with quality services and lower prices. This revolution is, however, not without challenges. These include cybersecurity breaches, facilitating illegal economic activities, and challenging concepts of privacy. To mitigate the risks and utilize the benefits, appropriate regulation should be introduced in the economy. By identifying legal and institutional gaps in Ethiopia`s digital economy, this research work assists the government`s effort to create a better digital economy. Moreover, this study, being a pioneer study in the area, will be an input for further studies in academia. The research employs a qualitative legal research method and analyzes various legal and policy instruments in Ethiopia in comparison with best international experiences. As this research applies a qualitative research method, a grounded theory method of data analysis is used. The research concluded that Ethiopia is far from designing appropriate legal and regulatory infrastructures. Due to the government monopoly of the sector, there is poor digital infrastructure in the country. The existing labor laws have no specific provisions on the rights and obligations of gig workers.

Keywords: Ethiopia, gig economy, digital, ride-hailing, regulation

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Authors: Sricheta Chowdhury

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To require a woman to choose between her work and her personal life is the most acute form of discrimination that can be meted out against her. No woman should be given a choice to choose between her motherhood and her career at Bar, yet that is the most detrimental discrimination that has been happening in Indian Bar, which no one has questioned so far. The falling number of women in practice is a reality that isn’t garnering much attention given the sharp rise in women studying law but is not being able to continue in the profession. Moving from a colonial misogynist whim to a post-colonial “new-age construct of Indian woman” façade, the policymakers of the Indian Judiciary have done nothing so far to decolonize itself from its rudimentary understanding of ‘equality of gender’ when it comes to the legal profession. Therefore, when Indian jurisprudence was (and is) swooning to the sweeping effect of transformative constitutionalism in the understanding of equality as enshrined under the Indian Constitution, one cannot help but question why the legal profession remained out of brushing effect of achieving substantive equality. The Airline industry’s discriminatory policies were not spared from criticism, nor were the policies where women’s involvement in any establishment serving liquor (Anuj Garg case), but the judicial practice did not question the stereotypical bias of gender and unequal structural practices until recently. That necessitates the need to examine the existing Bar policies and the steps taken by the regulatory bodies in assessing the situations that are in favor or against the purpose of furthering women’s issues in present-day India. From a comparative feminist point of concern, South Africa’s pro-women Bar policies are attractive to assess their applicability and extent in terms of promoting inclusivity at the Bar. This article intends to tap on these two countries’ potential in carving a niche in giving women an equal platform to play a substantive role in designing governance policies through the Judiciary. The article analyses the current gender composition of the legal profession while endorsing the concept of substantive equality as a requisite in designing an appropriate appointment process of the judges. It studies the theoretical framework on gender equality, examines the international and regional instruments and analyses the scope of welfare policies that Indian legal and regulatory bodies can undertake towards a transformative initiative in re-modeling the Judiciary to a more diverse and inclusive institution. The methodology employs a comparative and analytical understanding of doctrinal resources. It makes quantitative use of secondary data and qualitative use of primary data collected for determining the present status of Indian women legal practitioners and judges. With respect to quantitative data, statistics on the representation of women as judges and chief justices and senior advocates from their official websites from 2018 till present have been utilized. In respect of qualitative data, results of the structured interviews conducted through open and close-ended questions with retired lady judges of the higher judiciary and senior advocates of the Supreme Court of India, contacted through snowball sampling, are utilized.

Keywords: gender, higher judiciary, legal profession, representation, substantive equality

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Authors: Sophie Lemoussu, Jean-Charles Chaudemar, Robertus A. Vingerhoeds

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Many innovative projects exist in the field of aeronautics, each addressing specific areas so to reduce weight, increase autonomy, reduction of CO2, etc. In many cases, such innovative developments are being carried out by very small enterprises (VSE’s) or small and medium sized-enterprises (SME’s). A good example concerns airships that are being studied as a real alternative to passenger and cargo transportation. Today, no international regulations propose a precise and sufficiently detailed framework for the development and certification of airships. The absence of such a regulatory framework requires a very close contact with regulatory instances. However, VSE’s/SME’s do not always have sufficient resources and internal knowledge to handle this complexity and to discuss these issues. This poses an additional challenge for those VSE’s/SME’s, in particular those that have system integration responsibilities and that must provide all the necessary evidence to demonstrate their ability to design, produce, and operate airships with the expected level of safety and reliability. The main objective of this research is to provide a methodological framework enabling VSE’s/SME’s with limited resources to organize the development of airships while taking into account the constraints of safety, cost, time and performance. This paper proposes to provide a contribution to this problematic by proposing a Model-Based Systems Engineering approach. Through a comprehensive process modeling approach applied to the development processes, the regulatory constraints, existing best practices, etc., a good image can be obtained as to the process landscape that may influence the development of airships. To this effect, not only the necessary regulatory information is taken on board, also other international standards and norms on systems engineering and project management are being modeled and taken into account. In a next step, the model can be used for analysis of the specific situation for given developments, derive critical paths for the development, identify eventual conflicting aspects between the norms, standards, and regulatory expectations, or also identify those areas where not enough information is available. Once critical paths are known, optimization approaches can be used and decision support techniques can be applied so to better support VSE’s/SME’s in their innovative developments. This paper reports on the adopted modeling approach, the retained modeling languages, and how they all fit together.

Keywords: aeronautics, certification, process modeling, project management, regulation, SME, systems engineering, VSE

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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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Authors: Daud Abdia, Aqsa Shamim, Farhan Tabassum

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In order to achieve specific goals, basketball players have to use different skills to enhance their motivation, one such skill is deliberate practice. The aim of this study was to explore the relationship between deliberate practice of dribbling and self-regulatory behavior of male basketball players. For this purpose, a sample of 108 basketball players using stratified sampling was taken from public and private sector universities. Sample was divided into two groups that are experimental (n=54) and control group (n=54) using comparative experimental design. Experimental group was involved in the training of deliberate practice of dribbling for 5 weeks. Amounts of weekly practice activity and Self-Regulation of Learning Self-Report Scale (SRL-SRS) were used for self-regulatory behavior to collect data after the deliberate practice. The reliability of amounts of weekly practice activity was found to be 0.852, whereas SRL-SRS was found to be 0.890. The results of the study indicated a strong positive correlation between deliberate practice of dribbling and self-regulatory behavior (r=0.755, n=54, p=.000). Whereas, paired sample t-test; t(53)=1.37, p < 0.005 shows statistically significant improvement in the self-regulatory behavior after the training program of deliberate practice from 3.02 ± 0.64m to 3.21 ± 0.75m (p < 0.005). It was concluded that in order to enhance the self-regulatory behavior of basketball players we should work on the deliberate practice of the players.

Keywords: self-regulatory behavior, deliberate practice, dribbling, basketball

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Authors: Sonia Anand Knowlton

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As the use of Artificial Intelligence is becoming increasingly integrated in virtually every area of life, the need and interest to logically formalize the law and judicial reasoning is growing tremendously. The study of argumentation frameworks (AFs) provides promise in this respect. AF’s provide a way of structuring human reasoning using a formal system of non-monotonic logic. P.M. Dung first introduced this framework and demonstrated that certain arguments must prevail and certain arguments must perish based on whether they are logically “attacked” by other arguments. Dung labelled the set of prevailing arguments as the “preferred extension” of the given argumentation framework. Trevor Bench-Capon’s Value-based Argumentation Frameworks extended Dung’s AF system by allowing arguments to derive their force from the promotion of “preferred” values. In VAF systems, the success of an attack from argument A to argument B (i.e., the triumph of argument A) requires that argument B does not promote a value that is preferred to argument A. There has been thorough discussion of the application of VAFs to the law within the computer science literature, mainly demonstrating that legal cases can be effectively mapped out using VAFs. This article analyses VAFs from a jurisprudential standpoint to provide a philosophical and theoretical analysis of what VAFs tell the legal community about the judicial reasoning, specifically distinguishing between legal and moral reasoning. It highlights the limitations of using VAFs to account for judicial moral reasoning in theory and in practice.

Keywords: nonmonotonic logic, legal formalization, computer science, artificial intelligence, morality

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Authors: Violeta Kapageorgiadou

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Over the past decade, millions of individuals from middle-eastern and African countries have migrated to Europe to seek refuge. The majority of these refugees emigrate from Muslim majority countries and seek to integrate into European societies. Notably, Greece has hosted thousands of individuals seeking asylum since 2015. Many of these individuals have applied for asylum. They have sought to integrate into the Greek society and to navigate their way through the national and European legal systems with regard to their status. This paper, drawn from a PhD thesis project, focuses on the legal consciousness of migrants and the processes open to asylum seekers to assert their rights, notably with regard to incidents of hate crime and including their interactions with the legal authorities in Greece. The research seeks to capture the factors that influence the views and behaviors of migrants towards the law and their legal rights, using legal consciousness as a theoretical framework. The research findings indicate that asylum seekers have developed a multidimensional legal consciousness influenced by their religious and political background, legal knowledge, previous (negative) experiences with the legal system and their socio-economic status in Greece. Asylum seekers, while aware of the rights essential for their survival in the host country (such as applying for asylum to obtain a secure status, claiming for benefits and housing), were unaware of, and less willing to engage with, legal authorities and rights which they did not find essential for their survival. They viewed hate incidents against them as less important, not worth reporting and sometimes did not even consider these incidents as crimes. The research suggests that asylum seekers in Greece are a vulnerable population who need mechanisms to support them and raise their legal consciousness around their rights in order to better integrate, develop and thrive in the host society. Moving forwards, a better understanding of refugees' and asylum seekers’ reactions towards hate crime will help to create future policies and support mechanisms that could improve the lives of these individuals.

Keywords: hate crime, legal consciousness, legal rights, migrations

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Authors: Inigo de Miguel Beriain

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Genetic data of deceased persons are of great interest for both biomedical research and clinical use. This is due to several reasons. On the one hand, many of our diseases have a genetic component; on the other hand, we share genes with a good part of our biological family. Therefore, it would be possible to improve our response considerably to these pathologies if we could use these data. Unfortunately, at the present moment, the status of data on the deceased is far from being satisfactorily resolved by the EU data protection regulation. Indeed, the General Data Protection Regulation has explicitly excluded these data from the category of personal data. This decision has given rise to a fragmented legal framework on this issue. Consequently, each EU member state offers very different solutions. For instance, Denmark considers the data as personal data of the deceased person for a set period of time while some others, such as Spain, do not consider this data as such, but have introduced some specifically focused regulations on this type of data and their access by relatives. This is an extremely dysfunctional scenario from multiple angles, not least of which is scientific cooperation at the EU level. This contribution attempts to outline a solution to this dilemma through an alternative proposal. Its main hypothesis is that, in reality, health data are, in a sense, a rara avis within data in general because they do not refer to one person but to several. Hence, it is possible to think that all of them can be considered data subjects (although not all of them can exercise the corresponding rights in the same way). When the person from whom the data were obtained dies, the data remain as personal data of his or her biological relatives. Hence, the general regime provided for in the GDPR may apply to them. As these are personal data, we could go back to thinking in terms of a general prohibition of data processing, with the exceptions provided for in Article 9.2 and on the legal bases included in Article 6. This may be complicated in practice, given that, since we are dealing with data that refer to several data subjects, it may be complex to refer to some of these bases, such as consent. Furthermore, there are theoretical arguments that may oppose this hypothesis. In this contribution, it is shown, however, that none of these objections is of sufficient substance to delegitimize the argument exposed. Therefore, the conclusion of this contribution is that we can indeed build a general framework on the processing of personal data of deceased persons in the context of the GDPR. This would constitute a considerable improvement over the current regulatory framework, although it is true that some clarifications will be necessary for its practical application.

Keywords: collective data conceptual issues, data from deceased people, genetic data protection issues, GDPR and deceased people

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Authors: Sonia Mannan, M. Jobair Alam

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The concept of palliative care in Bangladesh largely remained limited to the sympathetic caring of patients with a life-limiting illness. Quality of Life (QoL) issues are rarely practiced in Bangladesh. Furthermore, palliative medicine, in the perspective of holistic palliative care service, does not have its proper recognition in Bangladesh. Apart from those socio-medical aspects, palliative care patients face legal issues that impact their quality of life, including access to health services and social benefits and dealing with other life-transactions of the patients and their families (such as disposing of property; planning for children). This paper is an attempt to articulate these legal dimensions of the right to palliative care in the context of Bangladesh. The major focus of this paper will be founded on the doctrinal analysis of the constitutional provisions and other relevant legislation on the right to health and their judicial interpretation, which is argued to offer a meaningful space for the right to palliative care. This paper will also investigate the gaps in the said legal framework to better secure such care. In conclusion, a few recommendations are made so that the palliative care practices in Bangladesh are better aligned with international standards, and it can respond more humanely to the patients who need palliative care.

Keywords: Bangladesh, constitution, legal regime, palliative care, quality of life

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Authors: Neslihan Cetin

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In this study, we will aim to analyze how the period of the state of emergency in Turkey lead to gaps in law and the formation of areas in which there was a complete lack of supervision. The state of emergency that was proclaimed following the coup attempt of July 15, 2016, continued until July 18, 2018, that is to say, 2 years, without taking into account whether the initial circumstances persisted. As part of this work, we claim that the state of emergency provided the executive power with important tools for governing, which it took constant use. We can highlight how the concern for security at the center of the basic considerations of the people in a city was exploited as a foundation by the military power in Turkey to interfere in the political, legal, and social spheres. The constitutions of 1924, 1961, and 1982 entrusted the army with the role of protector of the integrity of the state. This became an instrument at the hands of the military to legitimize their interventions in the name of public security. Its interventions in the political field are indeed politically motivated. The constitution, the legislative, and regulatory systems are modified and monopolized by the military power that dominates the legislative, regulatory, and judicial power, leading to a state of exception. With the political convulsions over a decade, the government was able to usurp the instrument called the state of exception. In particular, the decree-laws of the state of emergency, which the executive makes frequent and generally abusive use, became instruments in the hands of the government to take measures that it wishes to escape from the rules and the pre-established control mechanisms. Thus the struggle against the political opposition becomes more unbalanced and destructive. To this must also be added the ineffectiveness of ex-post controls and domestic remedies. This research allows us to stress how a legal concept, such as ‘the state of emergency’ can be politically exploited to make it a legal weapon that continues to produce victims.

Keywords: constitutional law, state of emergency, rule of law, instrumentalization of law

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Authors: Murat Yildiz, Burcu Yildiz

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Price Cap Regulation is a form of economic regulation designed in the 1980s in the United Kingdom. Price cap regulation sets a cap on the price that the utility provider can charge. The cap is set according to several economic factors, such as the price cap index, expected efficiency savings and inflation. It has been used by several countries as a regulatory regime in several sectors. Container port privatization is still in early stages in some countries. Lack of a general framework can be an impediment to privatization. This paper aims a general framework to comprising decisions to be made for variables which are able to accommodate the variety of container terminals. Several approaches that may be needed as well as a passage between approaches.

Keywords: Price Cap Regulation, ports privatization, container terminal price regime, earning sharing

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Authors: Marisa Catarina da Conceição Dinis

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The commercial companies’ management has suffered an important material and legal transformation in the last years, mainly related to the changes in the Portuguese legal framework and because of the fact they were recently object of great expansion. In fact, next to the smaller family businesses, whose management is regularly assumed by partners, companies with social investment highly scattered, whose owners are completely out from administration, are now arising. In those particular cases, the business transactions are much more complex and require from the companies’ managers a highly technical knowledge and some specific professionals’ skills and abilities. This kind of administration carries a high-level risk that can both result in great success or in great losses. Knowing that the administration performance can result in important losses to the companies, the Portuguese legislator has created a legal structure to impute them some responsibilities and sanctions. The main goal of this study is to analyze the Portuguese law and some jurisprudence about companies’ management rules and about the conflicts between the directors and the company. In order to achieve these purposes we have to consider, on the one hand, the legal duties directly connected to the directors’ functions and on the other hand the disrespect for those same rules. The Portuguese law in this matter, influenced by the common law, determines that the directors’ attitude should be guided by loyalty and honesty. Consequently, we must reflect in which cases the administrators should respond to losses that they might cause to companies as a result of their duties’ disrespect. In this way is necessary to study the business judgment rule wich is a rule that refers to a liability exclusion rule. We intend, in the same way, to evaluate if the civil liability that results from the directors’ duties disrespect can extend itself to those who have elected them ignoring or even knowing that they don´t have the necessary skills or appropriate knowledge to the position they hold. To charge directors’, without ruining entrepreneurship, charging, in the same way, those who select them reinforces the need for more responsible and cautious attitudes which will lead consequently to more confidence in the markets.

Keywords: business judgment rule, civil liability of directors, duty of care, duty of care, Portuguese legal framework

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Authors: Umamaheswari Shanmugam, Silvia Ronchi, Radu Vornicu

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that are able to use the large amount and variety of data generated during healthcare services every day. As we read the news, over 500 machine learning or other artificial intelligence medical devices have now received FDA clearance or approval, the first ones even preceding the year 2000. One of the big advantages of these new technologies is the ability to get experience and knowledge from real-world use and to continuously improve their performance. Healthcare systems and institutions can have a great benefit because the use of advanced technologies improves the same time efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and also to protect patients’ safety. The evolution and the continuous improvement of software used in healthcare must take into consideration the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device approval, but they are necessary to ensure performance, quality, and safety, and at the same time, they can be a business opportunity if the manufacturer is able to define in advance the appropriate regulatory strategy. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems.

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Authors: M. Yasin Al-Arif, Mohammad Faisol Soleh

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The Indonesia’s Constitution in Article 18b explained that the state recognizes and respects indigenous peoples and their traditional rights that are guaranteed by the law. Despite already guaranteed its existence; in practice such indigenous law is often considered contrary to positive law by legal experts. It is because of legal positivism paradigm which requires the written law as the main reference for the settlement of legal disputes. Carok’s culture is one of the indigenous cultures of Madura to resolve legal disputes that still thrives until today. Carok’s culture is in outside the legal process, and through a fight between the disputing parties until one dies. On the other hand, the legal positivism does not give place to accommodate Carok as indigenous dispute settlement, until it must be solved through trial. This way of settlement has not been successfully satisfying the indigenous people, thus although it has been done through its verdict in the trial, but Carok still be used by them. From the explanation above, Carok’s culture must be accommodated as the main settlement process and legal process of law as the alternative to the effectiveness of dispute resolution in Madura Indonesia.

Keywords: carok, dispute settlement, legal positivism, madura’s culture

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Authors: David P. Horton, Gary Lynch-Wood

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Western populations are aging, prone to various lifestyle health problems, and increasing their demand for health and social care services. This demand has created enormous fiscal and regulatory challenges. In response, government institutions have deployed strategies of behavior modification to encourage people to exercise greater personal responsibility over their health and care needs (i.e., welfare responsibilisation). Policy strategies are underpinned by the assumption that people if properly supported, will make better health and lifestyle selections. Not only does this absolve governments of the responsibility for meeting all health and care needs, but it also enables government institutions to assert fiscal control over welfare spending. Looking at the regulation of health and social care in the UK, the authors identify and outline a suite of regulatory tools that are designed to extract and manage the resources of health and social care services users and to encourage them to make (‘better’) use of these resources. This is important for our understanding of how health and social care regulation is responding to ongoing social and economic challenges. It is also important because there has been a failure to systematically examine the relevance of resources for regulation, which is surprising given that resources are crucial to how and whether regulation succeeds or fails. In particular, drawing from the regulatory welfare state concept, the authors analyse the key legal and regulatory changes and mechanisms that have been introduced since the 2008 financial crisis, focusing on critical measures such as the Health and Social Care Act and regulations introduced under the National Health Service Act. The authors show how three types of user resources (i.e., tangible, labor, and data) are being used to assert fiscal control and increase welfare responsibilisation. Amongst other things, the paper concludes that service users have become more than rule followers and targets of behavioral modification; rather, they are producers of resources that regulatory systems have come to rely on.

Keywords: health care, regulation, resources, social care

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Authors: Mark Lokanan

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The paper analyzes the processing of complaints against investment brokers and dealer members through the Investment Industry Regulatory Organization of Canada (IIROC) from 2008 to 2017. IIROC is the self-regulatory organization (SRO) that is responsible for policing investment dealers and brokerage firms that trade in Canada’s securities market. Data from the study came from IIROC's enforcement annual reports for the years examined. The case processing is evaluated base on the misconduct funnel that was originally designed for street crime and applies to the enforcement of investment fraud. The misconduct funnel is used as a framework to examine IIROC’s claim that it brought in more complaints (funnel in) than government regulators and shows how these complaints are funneled out and funneled away as they are processed through IIROC’s enforcement system. The results indicate that IIROC is ineffective in disciplining its members and is unable to handle the more serious quasi-criminal and improper sales practices offenses. It is hard not to see the results of the paper being used by the legislator in Ottawa to show the importance of a federal securities regulatory agency such as the Securities and Exchange Commission (SEC) in the United States.

Keywords: investment fraud, securities regulation, compliance, enforcement

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Authors: Mustafa Arikan, Ibrahim Ercan

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In this paper, protection of program formats was investigated in terms of program formats. Protection of program formats was studied in the French Law in the sense of competition law and CPI. Since the English Judicial system exhibits differences from the legal system of Continental Europe, its investigation bears a special significance. The subject was also handled in German Law at length. Indeed, German Law was investigated in detail within the overall framework of the study. Here, the court decisions in the German Law and the views in the doctrine were expressed in general. There are many court decisions in the American legal system concerning the subject. These decisions also present alternatives in terms of a solution to the problem.

Keywords: comparative law, protection of television programme formats, intellectual property, american legal system

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

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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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Authors: Ivan Poza Martínez

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The international energy landscape has been significantly affected by the Covid-19 pandemic and te conflict in Ukraine. The Vaca Muerta sedimentary formation in Argentina´s Neuquén province has become a crucial area for energy production, specifically in the shale gas ad shale oil sectors. The massive investment required for theexploitation of this reserve make it essential to understand te determinants of the investment in the upstream sector at both local ad international levels. The aim of this study is to identify the qualitative and quantitative determinants of investment in Vaca Muerta. The research methodolody employs both quantiative ( econometrics ) and qualitative approaches. A linear regression model is used to analyze the impact in non-conventional hydrocarbons. The study highlights that, in addition to quantitative factors, qualitative variables, particularly the design of a regulatory framework, significantly influence the level of the investment in Vaca Muerta. The analysis reveals the importance of attracting both domestic and foreign capital investment. This research contributes to understanding the factors influencing investment inthe Vaca Muerta regioncomapred to other published studies. It emphasizes to role of qualitative varibles, such as regulatory frameworks, in the development of the shale gas and oil sectors. The study uses a combination ofquantitative data , such a investment figures, and qualitative data, such a regulatory frameworks. The data is collected from various rpeorts and industry publications. The linear regression model is used to analyze the relationship between the variables and the investment in Vaca Muerta. The research addresses the question of what factors drive investment in the Vaca Muerta region, both from a quantitative and qualitative perspective. The study concludes that a combination of quantitative and qualitative factors, including the design of a regulatory framework, plays a significant role in attracting investment in Vaca Muerta. It highlights the importance of these determinants in the developmentof the local energy sector and the potential economic benefits for Argentina and the Southern Cone region.

Keywords: vaca muerta, FDI, shale gas, shale oil, YPF

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Authors: Erinda Male

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Participation of a lawyer in any criminal proceedings on behalf of an accused person or a victim is essential to a fair trial. Legal representation is particularly crucial in proceedings before international tribunals, especially in the International Criminal Court. The paper thus focuses on the importance of the legal representation of victims and defendants before the ICC, as well as on the role of the legal representative in the proceedings before the court and the principle of freedom of choice of legal representatives. Also, the paper presents a short overview of the significance of legal representatives for victims and the necessity to protect their primary role in the ICC system, and ensure that it is coherent and respectful of victims’ rights. Victim participation is an important part of the ICC Statute and it is designed to help ensure that those most affected by the crimes are able to engage with the Court. Proper and quality legal representation ensures meaningful participation of victims at stages of the proceedings before ICC. Finally, the paper acknowledges the role of legal representatives during the pre-trial, trial and post-trial phase, the different modalities in selecting the legal representatives as well as balancing victims’ participation with the right of the accused to a fair trial.

Keywords: fair trial, freedom of choice principle, international criminal court, legal representatives, victims

Procedia PDF Downloads 366

Authors: Ananya Das, Arun Kumar, Gazala Habib, Vivekanandan Perumal

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Regulatory bodies has proposed limits on Particulate Matter (PM) concentration in air; however, it does not explicitly indicate the incorporation of effects of toxicities of constituents of PM in developing regulatory limits. This study aimed to provide a structured approach to incorporate toxic effects of components in developing regulatory limits on PM. A four-step human health risk assessment framework consists of - (1) hazard identification (parameters: PM and its constituents and their associated toxic effects on health), (2) exposure assessment (parameters: concentrations of PM and constituents, information on size and shape of PM; fate and transport of PM and constituents in respiratory system), (3) dose-response assessment (parameters: reference dose or target toxicity dose of PM and its constituents), and (4) risk estimation (metric: hazard quotient and/or lifetime incremental risk of cancer as applicable). Then parameters required at every step were obtained from literature. Using this information, an attempt has been made to determine limits on PM using component-specific information. An example calculation was conducted for exposures of PM_2.5 and its metal constituents from Indian ambient environment to determine limit on PM values. Identified data gaps were: (1) concentrations of PM and its constituents and their relationship with sampling regions, (2) relationship of toxicity of PM with its components.

Keywords: air, component-specific toxicity, human health risks, particulate matter

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Authors: Geuna Kim, Sanghyun Kim

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This study investigates various factors that may influence the ISM process, including the organization’s internal needs and external pressure, and examines the role of regulatory pressure in ISM development and performance. The 105 sets of data collected in a survey were tested against the research model using SEM. The results indicate that NP and TP had positive effects on the ISM process, except for perceived benefits. Regulatory pressure had a positive effect on the relationship between ISM awareness and ISM development and performance.

Keywords: information security management, need pull, technology push, regulatory pressure

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Authors: Amy Gooden

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When human genomic data is considered, this is often done through only one dimension of the law, or the interplay between the various dimensions is not considered, thus providing an incomplete picture of the legal framework. This research considers and analyzes the various dimensions in South African law applicable to genomic sequence data – including property rights, personality rights, and intellectual property rights. The effective use of personal genomic sequence data requires the acknowledgement and harmonization of the rights applicable to such data.

Keywords: artificial intelligence, data, law, genomics, rights

Procedia PDF Downloads 116