976 resultados para Regulatory Administrative Law
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Dissertação (mestrado)—Universidade de Brasília, Faculdade de Direito, Programa de Pós-Graduação em Direito, 2016.
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Abstract: The implementation of Fundamental Constitutional Health and Social Rights is necessary, appropriate and proportionate, following the demands of the population. Accountability and self-responsibility play a very important role. This requires the development of constitutional principles that protect public funds against corruption and offer a constitutional right to health protection. Financial and criminal liability might provide an incentive to improve the management of public funds and reinforce fundamental constitutional principles, particularly regarding the right to health. Constitutional, administrative and criminal issues, as well as public management and administration and the science of good governance, should be articulated in a single strategy also in the health sector. In Portugal and Brazil, as examples, the Federal Court / Constitutional Court, the Supreme Court / High Court of Justice or the Court of Auditors should be considered together.
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This thesis studies how commercial practice is developing with artificial intelligence (AI) technologies and discusses some normative concepts in EU consumer law. The author analyses the phenomenon of 'algorithmic business', which defines the increasing use of data-driven AI in marketing organisations for the optimisation of a range of consumer-related tasks. The phenomenon is orienting business-consumer relations towards some general trends that influence power and behaviors of consumers. These developments are not taking place in a legal vacuum, but against the background of a normative system aimed at maintaining fairness and balance in market transactions. The author assesses current developments in commercial practices in the context of EU consumer law, which is specifically aimed at regulating commercial practices. The analysis is critical by design and without neglecting concrete practices tries to look at the big picture. The thesis consists of nine chapters divided in three thematic parts. The first part discusses the deployment of AI in marketing organisations, a brief history, the technical foundations, and their modes of integration in business organisations. In the second part, a selected number of socio-technical developments in commercial practice are analysed. The following are addressed: the monitoring and analysis of consumers’ behaviour based on data; the personalisation of commercial offers and customer experience; the use of information on consumers’ psychology and emotions, the mediation through marketing conversational applications. The third part assesses these developments in the context of EU consumer law and of the broader policy debate concerning consumer protection in the algorithmic society. In particular, two normative concepts underlying the EU fairness standard are analysed: manipulation, as a substantive regulatory standard that limits commercial behaviours in order to protect consumers’ informed and free choices and vulnerability, as a concept of social policy that portrays people who are more exposed to marketing practices.
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Aunque ni la Directiva 85/374/CEE relativa a la aproximación de las disposiciones legales, reglamentarias y administrativas de los Estados Miembros en materia de responsabilidad por los daños causados por productos defectuosos, ni el Real Decreto Legislativo 1/2007, de 16 de noviembre, por el que se aprueba el texto refundido de la Ley General para la Defensa de los Consumidores y Usuarios y otras leyes complementarias, que recoge dicha directiva en la actualidad en el sistema español, ni el d.p.r. 24 maggio 1988, nº 224, posteriormente introducido en el d. lgs 6 settembre 2005, nº 206, que hace lo mismo en el sistema italiano, establecen diferencias entre los distintos tipos de defectos que convierten a un producto en «defectuoso», la doctrina ha seguido diferenciando entre defectos de fabricación, defectos de información y defectos de diseño. La presente tesis intenta comprobar si tal clasificación es meramente académica, o si por el contrario, el que el defecto sea de un tipo o sea de otro implicará alguna especialidad en su tratamiento jurídico, y ello lo hace centrándose en los defectos de diseño, que han dado lugar a unos importantes desarrollos en la jurisprudencia norteamericana, y que. parecen estar asociados a los llamados «riesgos de desarrollo». Para ello se analiza la más reciente jurisprudencia norteamericana, italiana y española.
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Changing or creating an organisation means creating a new process. Each process involves many risks that need to be identified and managed. The main risks considered here are procedural and legal risks. The former are related to the risks of errors that may occur during processes, while the latter are related to the compliance of processes with regulations. Managing the risks implies proposing changes to the processes that allow the desired result: an optimised process. In order to manage a company and optimise it in the best possible way, not only should the organisational aspect, risk management and legal compliance be taken into account, but it is important that they are all analysed simultaneously with the aim of finding the right balance that satisfies them all. This is the aim of this thesis, to provide methods and tools to balance these three characteristics, and to enable this type of optimisation, ICT support is used. This work isn’t a thesis in computer science or law, but rather an interdisciplinary thesis. Most of the work done so far is vertical and in a specific domain. The particularity and aim of this thesis is not to carry out an in-depth analysis of a particular aspect, but rather to combine several important aspects, normally analysed separately, which however have an impact and influence each other. In order to carry out this kind of interdisciplinary analysis, the knowledge base of both areas was involved and the combination and collaboration of different experts in the various fields was necessary. Although the methodology described is generic and can be applied to all sectors, the case study considered is a new type of healthcare service that allows patients in acute disease to be hospitalised to their home. This provide the possibility to perform experiments using real hospital database.
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Amid the trend of rising health expenditure in developed economies, changing the healthcare delivery models is an important point of action for service regulators to contain this trend. Such a change is mostly induced by either financial incentives or regulatory tools issued by the regulators and targeting service providers and patients. This creates a tripartite interaction between service regulators, professionals, and patients that manifests a multi-principal agent relationship, in which professionals are agents to two principals: regulators and patients. This thesis is concerned with such a multi-principal agent relationship in healthcare and attempts to investigate the determinants of the (non-)compliance to regulatory tools in light of this tripartite relationship. In addition, the thesis provides insights into the different institutional, economic, and regulatory settings, which govern the multi-principal agent relationship in healthcare in different countries. Furthermore, the thesis provides and empirically tests a conceptual framework of the possible determinants of (non-)compliance by physicians to regulatory tools issued by the regulator. The main findings of the thesis are first, in a multi-principal agent setting, the utilization of financial incentives to align the objectives of professionals and the regulator is important but not the only solution. This finding is based on the heterogeneity in the financial incentives provided to professionals in different health markets, which does not provide a one-size-fits-all model of financial incentives to influence clinical decisions. Second, soft law tools as clinical practice guidelines (CPGs) are important tools to mitigate the problems of the multi-principal agent setting in health markets as they reduce information asymmetries while preserving the autonomy of professionals. Third, CPGs are complex and heterogeneous and so are the determinants of (non-)compliance to them. Fourth, CPGs work but under conditions. Factors such as intra-professional competition between service providers or practitioners might lead to non-compliance to CPGs – if CPGs are likely to reduce the professional’s utility. Finally, different degrees of soft law mandate have different effects on providers’ compliance. Generally, the stronger the mandate, the stronger the compliance, however, even with a strong mandate, drivers such as intra-professional competition and co-management of patients by different professionals affected the (non-)compliance.
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FinTech (financial technology, ‘‘FinTech’’) is a double-edged sword as it brings both benefits and risks. This study appraised FinTech’s technological nature that brings changes in complexity in modern financial markets to identify the information deficits and its undesirable outcomes. Besides, as FinTech is still developing, the information regarding, for instance, whether and how to apply regulation may be insufficient for both regulators and those regulated. More one-size-fits-all regulation might accordingly be adopted, thereby resulting in the adverse selection. Through the lens of both law and economics and law and technology, this study suggested AFR (adaptive financial regulation, ‘‘AFR’’) of FinTech to solve the underlying pacing issue. AFR is dynamic, enabling regulatory adjustments and learning. Exploring and collecting information through experiments and learning from experiments are the core of AFR. FinTech regulatory sandboxes epitomize AFR. This study chose Taiwan as a case study. This study found several barriers to adaptive and effective FinTech regulation. Unduly emphasizing consumer protection and the innovation entry criterion by improperly imposing limits on the entry into sandboxes, ignoring post-sandbox mechanisms, and relying on detailed, specific and prescriptive rules to formulate sandboxes are examples. To solve these barriers, this study proposed several solutions by looking into the experiences in other jurisdictions and analyzing. First, striking a balance between encouraging innovation and ensuring financial stability and consumer protection is indispensable. Second, entry to sandboxes should be facilitated by improving the selection criteria. Third, adhering to realizing regulatory adjustment and learning to adapt regulation to technology, this study argued that systematic post-sandbox mechanisms should be established. Fourth, this study recommended “more principles-based sandboxes”. Principles rather than rules should be the base on which sandboxes or FinTech regulation are established. Having principles could provide more flexibility, being easier to adjust and adapt, and better at avoiding.
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The purpose of this research study is to discuss privacy and data protection-related regulatory and compliance challenges posed by digital transformation in healthcare in the wake of the COVID-19 pandemic. The public health crisis accelerated the development of patient-centred remote/hybrid healthcare delivery models that make increased use of telehealth services and related digital solutions. The large-scale uptake of IoT-enabled medical devices and wellness applications, and the offering of healthcare services via healthcare platforms (online doctor marketplaces) have catalysed these developments. However, the use of new enabling technologies (IoT, AI) and the platformisation of healthcare pose complex challenges to the protection of patient’s privacy and personal data. This happens at a time when the EU is drawing up a new regulatory landscape for the use of data and digital technologies. Against this background, the study presents an interdisciplinary (normative and technology-oriented) critical assessment on how the new regulatory framework may affect privacy and data protection requirements regarding the deployment and use of Internet of Health Things (hardware) devices and interconnected software (AI systems). The study also assesses key privacy and data protection challenges that affect healthcare platforms (online doctor marketplaces) in their offering of video API-enabled teleconsultation services and their (anticipated) integration into the European Health Data Space. The overall conclusion of the study is that regulatory deficiencies may create integrity risks for the protection of privacy and personal data in telehealth due to uncertainties about the proper interplay, legal effects and effectiveness of (existing and proposed) EU legislation. The proliferation of normative measures may increase compliance costs, hinder innovation and ultimately, deprive European patients from state-of-the-art digital health technologies, which is paradoxically, the opposite of what the EU plans to achieve.
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Big data and AI are paving the way to promising scenarios in clinical practice and research. However, the use of such technologies might clash with GDPR requirements. Today, two forces are driving the EU policies in this domain. The first is the necessity to protect individuals’ safety and fundamental rights. The second is to incentivize the deployment of innovative technologies. The first objective is pursued by legislative acts such as the GDPR or the AIA, the second is supported by the new data strategy recently launched by the European Commission. Against this background, the thesis analyses the issue of GDPR compliance when big data and AI systems are implemented in the health domain. The thesis focuses on the use of co-regulatory tools for compliance with the GDPR. This work argues that there are two level of co-regulation in the EU legal system. The first, more general, is the approach pursued by the EU legislator when shaping legislative measures that deal with fast-evolving technologies. The GDPR can be deemed a co-regulatory solution since it mainly introduces general requirements, which implementation shall then be interpretated by the addressee of the law following a risk-based approach. This approach, although useful is costly and sometimes burdensome for organisations. The second co-regulatory level is represented by specific co-regulatory tools, such as code of conduct and certification mechanisms. These tools are meant to guide and support the interpretation effort of the addressee of the law. The thesis argues that the lack of co-regulatory tools which are supposed to implement data protection law in specific situations could be an obstacle to the deployment of innovative solutions in complex scenario such as the health ecosystem. The thesis advances hypothesis on theoretical level about the reasons of such a lack of co-regulatory solutions.
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Distributed argumentation technology is a computational approach incorporating argumentation reasoning mechanisms within multi-agent systems. For the formal foundations of distributed argumentation technology, in this thesis we conduct a principle-based analysis of structured argumentation as well as abstract multi-agent and abstract bipolar argumentation. The results of the principle-based approach of these theories provide an overview and guideline for further applications of the theories. Moreover, in this thesis we explore distributed argumentation technology using distributed ledgers. We envision an Intelligent Human-input-based Blockchain Oracle (IHiBO), an artificial intelligence tool for storing argumentation reasoning. We propose a decentralized and secure architecture for conducting decision-making, addressing key concerns of trust, transparency, and immutability. We model fund management with agent argumentation in IHiBO and analyze its compliance with European fund management legal frameworks. We illustrate how bipolar argumentation balances pros and cons in legal reasoning in a legal divorce case, and how the strength of arguments in natural language can be represented in structured arguments. Finally, we discuss how distributed argumentation technology can be used to advance risk management, regulatory compliance of distributed ledgers for financial securities, and dialogue techniques.
Transatlantic regulatory divergence in pharmaceuticals: exploring economic and cultural explanations
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The analysis delves into the regulatory divergence between the EU and the US in the pharmaceutical sector. Through law and economics, political science, and cultural theory perspectives, the study explores how collective preferences within each jurisdiction shape regulations. By identifying cultural orientations such as individualism in the US and hierarchy in the EU, the research suggests that underlying cultural factors play a significant role in regulatory decisions. Despite calls for regulatory harmonization, the recognition of legitimate differences in preferences due to cultural diversity emphasizes that uniformity may not always be the best solution, showcasing the importance of understanding cultural influences in shaping regulatory landscapes.
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The effects of ionic strength on ions in aqueous solutions are quite relevant, especially for biochemical systems, in which proteins and amino acids are involved. The teaching of this topic and more specifically, the Debye-Hückel limiting law, is central in chemistry undergraduate courses. In this work, we present a description of an experimental procedure based on the color change of aqueous solutions of bromocresol green (BCG), driven by addition of electrolyte. The contribution of charge product (z+|z-|) to the Debye-Hückel limiting law is demonstrated when the effects of NaCl and Na2SO4 on the color of BCG solutions are compared.
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Universidade Estadual de Campinas. Faculdade de Educação Física
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Universidade Estadual de Campinas . Faculdade de Educação Física
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Association studies between ADIPOR1 genetic variants and predisposition to type 2 diabetes (DM2) have provided contradictory results. We determined if two single nucleotide polymorphisms (SNP c.-8503G>A and SNP c.10225C>G) in regulatory regions of ADIPOR1 in 567 Brazilian individuals of European (EA; N = 443) or African (AfA; N = 124) ancestry from rural (quilombo remnants; N = 439) and urban (N = 567) areas. We detected a significant effect of ethnicity on the distribution of the allelic frequencies of both SNPs in these populations (EA: -8503A = 0.27; AfA: -8503A = 0.16; P = 0.001 and EA: 10225G = 0.35; AfA: 10225G = 0.51; P < 0.001). Neither of the polymorphisms were associated with DM2 in the case-control study in EA (SNP c.-8503G>A: DM2 group -8503A = 0.26; control group -8503A = 0.30; P = 0.14/SNP 10225C>G: DM2 group 10225G = 0.37; control group 10225G = 0.32; P = 0.40) and AfA populations (SNP c.-8503G>A: DM2 group -8503A = 0.16; control group -8503A = 0.15; P = 0.34/SNP 10225C>G: DM2 group 10225G = 0.51; control group 10225G = 0.52; P = 0.50). Similarly, none of the polymorphisms were associated with metabolic/anthropometric risk factors for DM2 in any of the three populations, except for HDL cholesterol, which was significantly higher in AfA heterozygotes (GC = 53.75 ± 17.26 mg/dL) than in homozygotes. We conclude that ADIPOR1 polymorphisms are unlikely to be major risk factors for DM2 or for metabolic/anthropometric measurements that represent risk factors for DM2 in populations of European and African ancestries.