Legal Requirements Research Articles

Systematic analysis of approaches used in cardiac arrest trials to inform relatives about trial enrolment of non-surviving patients

BackgroundThe recruitment of patients to emergency research studies without the requirement for prior informed consent has furthered the conduct of randomised studies in cardiac arrest. Frameworks enabling this vary around...

The Legal Landscape for Opioid Treatment Agreements.

Opioid treatment agreements (OTAs) are documents that clinicians present to patients when prescribing opioids that describe the risks of opioids and specify requirements that patients must meet to receive their medication. Notwithstanding a lack of evidence that OTAs effectively mitigate opioids' risks, professional organizations recommend that they be implemented, and jurisdictions increasingly require them. We sought to identify the jurisdictions that require OTAs, how OTAs might affect the outcomes of lawsuits that arise when things go wrong, and instances in which the law permits flexibility for clinicians and health care institutions to adopt best practices. We surveyed the laws and regulations of all 50 states and the District of Columbia to identify which jurisdictions require the use of OTAs, the circumstances in which OTA use is mandatory, and the terms OTAs must include (if any). We also surveyed criminal and civil judicial decisions in which OTAs were discussed as evidence on which a court relied to make its decision to determine how OTA use influences litigation outcomes. Results show that a slight majority (27) of jurisdictions now require OTAs. With one exception, the jurisdictions' requirements for OTA use are triggered at least in part by long-term prescribing. There is otherwise substantial variation and flexibility within OTA requirements. Results also show that even in jurisdictions where OTA use is not required by statute or regulation, OTA use can inform courts' reasoning in lawsuits involving patients or clinicians. Sometimes, but not always, OTA use legally protects clinicians from liability. Our results show that OTA use is entwined with legal obligations in various ways. Clinicians and health care institutions should identify ways for OTAs to enhance clinician-patient relationships and patient care within the bounds of relevant legal requirements and risks.

When EU Agencies Set Up Advisory Committees: All About Autonomy?

AbstractEuropean Union (EU) agencies' relations with interest groups have received scarce research attention despite their relevance to bureaucratic autonomy and functioning. Such relations may be organised via advisory committees, which are durable organisational structures for regularised contact between an agency and those societal actors given membership by the agency. Advisory committees may be imposed by the legislator to control an agency or harnessed by the latter to build autonomy. The EU legislator leaves significant discretion to EU agencies regarding advisory committees. However, EU agencies' late emergence in already densely populated regulatory fields begs the question of whether the use of agency discretion is fully autonomous. A case in point is the Agency for the Cooperation of Energy Regulators (ACER), whose establishment and design of three European Stakeholder Committees are examined here. Advisory committees were needed by, but also imposed on, ACER, reflecting agency preferences to improve task performance as much as prior institutionalisation within the organisational field. Hence, factors beyond legal requirements can constrain agency discretion on how to organise the organisation of agency–interest group relations.

Exploring explainable AI in the tax domain

AbstractThis paper analyses whether current explainable AI (XAI) techniques can help to address taxpayer concerns about the use of AI in taxation. As tax authorities around the world increase their use of AI-based techniques, taxpayers are increasingly at a loss about whether and how the ensuing decisions follow the procedures required by law and respect their substantive rights. The use of XAI has been proposed as a response to this issue, but it is still an open question whether current XAI techniques are enough to meet existing legal requirements. The paper approaches this question in the context of a case study: a prototype tax fraud detector trained on an anonymized dataset of real-world cases handled by the Buenos Aires (Argentina) tax authority. The decisions produced by this detector are explained through the use of various classification methods, and the outputs of these explanation models are evaluated on their explanatory power and on their compliance with the legal obligation that tax authorities provide the rationale behind their decision-making. We conclude the paper by suggesting technical and legal approaches for designing explanation mechanisms that meet the needs of legal explanation in the tax domain.

A Model of an Extending Front Loader

A Model of an Extending Front Loader

[Advance directives and mental disorders: apractice recommendation of the Commission for Ethics and Law of the German Association for Psychiatry, Psychotherapy and Psychosomatics].

Since the creation of legal requirements for advance directives by the legislator in 2009, special aspects of their application in the treatment of people with mental illnesses have been discussed. Important questions on dealing with advance directives in everyday life will be answered in apractice-oriented manner. Among other things, this document answers the question of the conditions under which apatient can refuse or consent to hospitalization and treatment in advance, and in particular how to deal with advance directives whose implementation would also affect the rights of third parties. The German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) has addressed these and other questions in the present document and added practical advice on how to formulate advance directives for people with mental illnesses and how to deal with psychiatric advance directives. The DGPPN has developed an advance directive for the area of mental health and published it on its website together with detailed explanations. With the help of this advance directive, people can decide on their treatment in phases of incapacity to consent in the context of amental crisis or illness.

Squandering Marital Movables: On Family and Criminal Law in Egypt

Abstract This essay focuses on the trousseau inventory (ayma) created by Egyptian Muslims at the time of marriage. Though not a legal requirement, creating the ayma is widespread as it proves the husband’s receipt of the wife’s property. After divorce, he must return the items listed in the inventory to her, and if he fails to do so, she may sue him for “squandering marital movables” (tabdīd manqūlāt zawjiyya), as stipulated in the Penal Code. In July 2022, when an Egyptian man posted a message suggesting that the ayma had been abolished, his post caused a huge outcry. In this essay, I address the social debate triggered by the post, introduce the case of an Egyptian woman who filed a tabdīd lawsuit to secure a divorce, and discuss judgments issued by the Court of Cassation on tabdīd cases. I argue that Egyptians use criminal law and courts to solve family disputes.

Long chain unsaturated fatty acids alter growth and reduce biofilm formation of Cronobacter sakazakii

AbstractCronobacter sakazakii is a foodborne pathogen predominately transmitted through contaminated dried foods and affects populations including neonates, infants, and the elderly. Following several recent outbreaks, it is now a notifiable infection in those under 12 months of age. Current control methods include strict manufacturing guidelines, with monitoring of this genus a legal requirement in powdered infant formula production. Fatty acids have long been known as antimicrobials, with long‐chain fatty acids increasingly identified as agents that target virulence factors. This study gives insight into the changes promoted by three long‐chain unsaturated fatty acids (oleic, linoleic, and α‐linolenic) on C. sakazakii growth, morphology, and biofilm formation. Each fatty acid was individually introduced to C. sakazakii 29544 both as a sole carbon source and as an addition to complex media. Following comparison to the untreated control, bacterial cells treated with these fatty acids showed a significant and media‐dependent impact on growth and biofilm inhibition. With further characterization, long‐chain fatty acids, including α‐linolenic acid, could be utilized as a control method with minimal safety constraints regarding their use in the food production environment.

Identifying and Dealing with Interdependencies and Conflicts between Goals in Manufacturing Companies’ Sustainability Measures

Companies are increasingly focusing on sustainable business practices. Internal and external stakeholders’ expectations manifest in legal requirements, national and international standards, and market and customer expectations, among other things, must be considered. In addition to profit maximization, which is the usual target for corporate management, management must consider environmental sustainability aspects such as resource efficiency, greenhouse gas intensity, and a company’s emissions behavior. In addition, social aspects related to the company’s employees, the immediate urban environment, the situation in the supply chain, and effects on the market environment must increasingly be considered. Specifically, companies are faced with the challenge of dealing with conflicting objectives regarding the various aspects of sustainability and, if necessary, weighing them up against each other. These trade-offs must be made against the company’s socio-economic and ecological environment, corporate strategy, and sustainability goals. This paper provides an overview of current approaches and research gaps on this topic through a literature review. It highlights the lack of methods and frameworks to specifically deal with trade-offs and conflicts between goals.

An Updated Ecotoxicological Evaluation and Health Risk Assessment of Metal Contaminants in Perna viridis Mussel Harvested on March to August 2018 from Pasir Gudang Coastal Area, Malaysia

Perna viridis (P. viridis) is a significant protein source globally but is often contaminated by metals due to its filter-feeding behavior. Given that Kampung Pasir Puteh, Pasir Gudang (Johor) is Malaysia's primary P. viridis harvesting site and the last health risk assessment (2015) was incomplete, the metal contamination status remains uncertain. Graphite furnace-atomic absorption spectroscopy was employed to analyze metal contaminant concentrations in P. viridis samples collected from March to August 2018, as per Malaysian legal requirements. The R2 values varied between 0.9976 and 0.9980 for P. viridis mussels and between 0.9976 and 0.9999 for seawater. The recovery for P. viridis mussels and seawater ranged from 93.95% to 106.80% and 92.73% to 108.84%, respectively. Precision and accuracy for both intra and inter-day measurements ranged from 0.15% to 5.49% for P. viridis and 0.05% to 5.58% for seawater. The concentrations of metal contaminants in P. viridis varied significantly among the different months of sampling (p < 0.05). All P. viridis samples had higher concentration of arsenic (3.16 -75.80μgg-1) than that prescribed by the Malaysian law. Higher cadmium concentration was observed during July (2.12μgg-1) and August (2.05μgg-1) alone. With target hazard quotients and hazard indices > 1.0, the likelihood of negative health impacts from consuming these mussels cannot be ignored. TCR values for As and Cd exceeded USEPA standards, indicating a potential lifetime carcinogenic risk from continuous P. viridis consumption. Pb (21.20 to 49.28µgL-1) in all surface seawater samples was invariably higher than the allowable limit for Class 2 water areas. Metal contaminant concentrations varied significantly between P. viridis and surface seawater (p < 0.05), implying inconsistent bioaccumulation due to pollution differences. Given the significance of P. viridis mussels, concerted scientific efforts are essential to devise effective metal contaminant removal methods.

Selection of membrane for production of drinking water from surface and groundwater by nanofiltration

The aim of the work was to select a nanofiltration membrane that would ensure effective simultaneous co-removal of pollutants present in surface and groundwater, including contaminants such as bisphenol A and PFAS compunds. Series of membrane filtrations was carried out using 12 commercial nanofiltration membranes (NFX, NFG, NF270, NF90, DK, DL, TS80, SB90, TS40, XN45, NPO30, NPO10) under various operating parameters. The conducted tests showed that among tested membranes the membrane most suitable for the production of drinking water from model waters is the NF90 membrane by Dow Filmtec. Regardless of the composition of the water, its pH and transmembrane pressure, the water produced using NF90 membrane each time met the legal requirements in terms of heavy metals (chromium total, silver, nickel, lead, arsenic), iron, manganese, sulphates, chlorides, fluorides, nitrates, sodium, PFAS, tetrachlorethylene, bisphenol A and KMnO4 index. In addition, tests carried out to verify the susceptibility of the produced water to the formation of disinfection by-products (DBP - ∑THM and halogenoacetic acids) showed that DBP concentrations in produced water did not exceed the values permitted by law.

ДИСТАНЦИОННОЕ ФАРМАЦЕВТИЧЕСКОЕ КОНСУЛЬТИРОВАНИЕ С ИСПОЛЬЗОВАНИЕМ ЧАТ-БОТА

The article discusses the use of chatbots for a variety of tasks in the medical field – such as scheduling doctor’s appointments, monitoring patients with chronic conditions, and providing healthy lifestyle recommendations – and in pharmacy operations, including verifying pharmacy addresses and hours, searching for and ordering products, and accessing information about delivery and payment, as well as operator consultations. It identifies several challenges faced in pharmaceutical counseling: time constraints, lack of motivation, absence of a dedicated counseling space, and low demand for the service. Chatbots are proposed as a solution to these issues, offering the benefit of pre-determined specific questions to address the time shortage, while the virtual nature of counseling negates the need for a physical space. Pursuant to recommended standards and legal requirements, we have developed a seven-stage model for remote pharmaceutical counseling, tailored for digital implementation. When integrated into a website, mobile app, messenger, or other online pharmacy services as a chatbot, this model enables pharmacists to consider individual client needs and provide comprehensive pharmaceutical care remotely without significantly extending consultation times. Integration with online pharmacy services is suggested to be facilitated through an API (Application Programming Interface). Furthermore, the article describes a mechanism to safeguard user personal data in the application of this algorithm.

Cloud Storage Cost Optimization: Advanced Techniques and Case Studies

The growing usage of cloud storage has revolutionized data management by offering unparalleled scalability and accessibility. However, optimizing cloud storage prices remains challenging, sometimes leading to significant unforeseen costs. This article explores a wide range of advanced techniques and practical case studies that enable enterprises to effectively navigate the intricacies of cost optimization across top cloud providers, including Google Cloud Platform (GCP), Microsoft Azure, and Amazon Web Services (AWS). Beyond selecting the most appropriate storage type for individual workloads (block, blob, or file storage), we explore advanced strategies that unlock substantial cost savings. From leveraging contractual negotiations for high-volume storage users to utilizing dedicated data transfer devices for streamlined on-premises migration, this paper equips readers with a diverse arsenal of optimization tools. We explore best practices for data lifecycle management, such as tiered backups and granular retention policies, to optimize beyond merely technical solutions. This way, we ensure that data is held at the most affordable tier depending on its frequency of access and compliance with legal requirements. By consistently analyzing cloud storage consumption and adapting responsive strategies to changing requirements, enterprises may retain optimal performance while ensuring long-term financial sustainability. This paper serves as a valuable resource for organizations seeking to master the intricacies of cloud storage cost optimization. By implementing the advanced techniques and best practices outlined herein, cloud users can confidently unlock significant cost savings and maximize the return on their cloud storage investments.

Developing a conceptual technical framework for ethical AI in procurement with emphasis on legal oversight

This study presents a conceptual technical framework aimed at promoting ethical AI deployment within the procurement domain, with a particular focus on legal oversight. As the integration of artificial intelligence (AI) technologies in procurement processes becomes increasingly prevalent, concerns surrounding ethical considerations and legal compliance have come to the forefront. The framework outlined in this study offers a structured approach to addressing these challenges, emphasizing the importance of legal oversight in ensuring ethical AI practices. Drawing on existing literature and best practices, the framework outlines key components and principles for guiding the development, implementation, and monitoring of AI systems in procurement contexts. Central to the framework is the recognition of legal requirements and regulatory frameworks governing AI deployment, including data protection laws, liability provisions, and procurement regulations. By incorporating these legal considerations into the design and operation of AI systems, organizations can mitigate risks and ensure compliance with applicable laws. Additionally, the framework emphasizes the need for transparency and accountability in AI procurement processes, advocating for clear documentation, audit trails, and stakeholder engagement mechanisms. Furthermore, the framework outlines strategies for ethical AI design, including the identification and mitigation of algorithmic bias, the promotion of fairness and equity, and the protection of privacy rights. By embedding ethical principles into the development lifecycle of AI systems, organizations can foster trust and confidence among stakeholders while minimizing the potential for harm or discrimination. Overall, the conceptual technical framework presented in this study provides a comprehensive approach to promoting ethical AI in procurement, with a specific emphasis on legal oversight. By integrating legal requirements, ethical principles, and technical considerations, organizations can ensure that AI deployment in procurement processes is conducted responsibly, transparently, and in accordance with legal and ethical standards.

Domestic Lawfare in South America

Domestic lawfare, using legal measures or their potential utilisation as strategic tools in political or ideological disputes within a nation, is a prevalent phenomenon in South America. Such measures may include lawsuits, investigations, and other legal mechanisms aimed at eradicating, intimidating, penalising, or undermining rivals to achieve specific political or policy objectives. This practice can be identified as domestic lawfare by prioritising legal technicalities over substantive matters. Its impact is of particular concern, as it is employed to suppress dissenting voices and curtail essential liberties, such as freedom of speech. This article sheds light on the significant challenge that constitutional democracies in South America currently face due to the rise of lawfare. This does not mean that it is an exclusively South American phenomenon. Influential individuals or entities around the world equipped with ample resources, financial means, influence, or political clout could deploy these assets to target individuals or organisations they perceive as threats to their interests. By examining the potential legal ramifications that may arise from rigid adherence to legal requirements, this study aims to underscore the crucial importance of legal protection as a topic requiring meticulous deliberation. Lawfare presents formidable challenges in theory and practice, making it essential to comprehend its implications fully. Understanding and addressing this issue can safeguard democratic values and protect fundamental rights.

The Expressive Dimension of Free Exercise

Abstract Expressivist theories of law focus not only on what legal arrangements do but also what they communicate. The expressivist view has gained special currency in the context of religious establishment. Even when governmental involvement with religion is not coercive or does not materially violate anyone’s rights, it may nevertheless be undesirable by virtue of expressing a preference for a certain religion or a privileged status for certain religious groups over others. The existing literature, however, lacks an equivalent expressivist analysis of the related but distinct domain of free exercise of religion. What is expressed when a religious individual or group is granted special relief from the legal requirements that would otherwise apply to them? I argue that just like religious establishments, religious exemptions not only implicate rights and material interests but also have important expressive dimensions that both help account for their value and impose limits on their desirability.

Integrating management systems in the energy sector: the case of the electricity industry in New Zealand

The New Zealand Electricity Engineers Association (EEA) asked for advice about development of a guide for a public safety management system (PSMS) for electricity distribution networks based on ISO45001 Occupational health and safety management systems. This would help eliminate overlap between legislation and standards while maintaining compliance with legal requirements. At Victoria University of Wellington we have been working on such an integrated approach and this article reports on the project and suggests how the results can be extended to include other areas of management while retaining the ability for appropriate elements to be audited and certified in accordance with systems required by legislation. The project reviewed an earlier report and literature review on PSMS for the Electricity Networks Association. Development of the legal requirements for a PSMS were reviewed and use of the International Standards Organization (ISO) framework for all management system standards proposed to encompass ISO45001 and similar standards. Relevant management content was incorporated in the high-level structure and key stakeholders contributed technical content. Use of the ISO Annex SL as a template enabled development of an integrated management system incorporating other management system standards, that would still support legal compliance while enabling elimination of duplication and clutter, and waste of resources at a time of technology change. The work was carried out in New Zealand (NZ) and may not apply in other countries with different legal requirements. Auditors may resist integrated management systems although this may not be a limitation if documentation is appropriately written. The electricity networks businesses in NZ may move to implementation of the PSMS guide but this will be an internal decision and results may take some years to declutter documentation and reduce overlapping audits under management system standards. Over the next decade the context of the New Zealand electricity industry will undergo major shifts with the need to adapt to increasing expectations for occupational health and safety and public safety, adaptation to climate change and accelerated implementation of new technologies. The electricity industry will need to apply its resources to those changes while avoiding duplicated efforts to implement multiple management systems. Developing an integrated management system that incorporates several management systems and public safety may aid protection of non-workers who cannot otherwise be “controlled” by a business.

Strategic Indeterminacy and Online Privacy Policies: (Un)informed Consent and the General Data Protection Regulation

AbstractArticle 12 of the General Data Protection Regulation (GDPR) requires data controllers to provide data subjects with any information relating to data processing operations “in a concise, transparent, intelligible and easily accessible form, using clear and plain language.” Linguistic inclusivity of privacy policies is no longer a matter of style, but has been a binding legal requirement under the new data protection framework. Article 5 GDPR sets forth the requirements of lawfulness, fairness and transparency and prohibits any data processing operations which do not meet the standards of specification, explicitness and legitimacy of processing purposes [29]. In this study, a quantitative and qualitative analysis of linguistic indeterminacy in a corpus of 350 online privacy policies is presented and it is argued that a considerable number of data controllers continue to make use of strategic vagueness in the context of purpose limitation, therefore potentially prejudicing compliance with the GDPR. A legal-linguistic perspective on the current challenges of informed consent in European data protection law is provided. Finally, it is concluded that while the GDPR has contributed significantly to the linguistic empowerment of the data subject, the framework fails to satisfy the expectation of creating a participatory culture (see [36]) with a high degree of informational self-determination.

Nasab Anak Di Luar Perkawinan dalam Penetapan Pengadilan Agama di Indonesia

In the context of family law, the nasab of children outside of marriage has grown to be a complicated legal and social issue in many nations, including Indonesia. With a particular emphasis on the ruling of the Pengadilan Agama Talu Number 173/Pdt.P/2021/PA.Talu, this article examines the question of the nasab of children born outside of marriage within the context of a Religious Court ruling. In order to determine the nasab of children born outside of marriage, this article employs both national legal requirements and the principles of Islamic law. We also examine the Talu Religious Court's ruling, which is the major point of interest. The analysis covers the legal factors, justifications, and ratio decidendi that the Religious Court used to reach its decision. It is critical to comprehend how the Religious Court developed legal principles, interpreted legal authorities, and considered the decision's social ramifications. The piece also looks at how the Talu Religious Court's ruling may affect family courts and society at large. The paper concludes by summarizing the consequences of the Talu Religious Court's ruling regarding the determination of the nasab of unmarried children and illustrating how legal perspectives have evolved in this area. This article may offer legal professionals, academics, and the general public new perspectives on the problem of the nasab of children born outside of marriage and the function of Religious Courts in governing and adjudicating such matters. In order to safeguard children's rights and preserve a harmony between religious norms and legal requirements in the country, more research in this field is required to determine the long-term effects of such rulings.

Factors influencing marine ecological environment governance toward sustainability: a case study of Zhejiang Province

At present, the marine ecological environment is facing enormous pressure from human activities, and there is an urgent need for coordinated governance by multiple entities to ensure that the marine ecological environment can continuously meet the needs of sustainable development. Marine ecological environmental governance plays multiple roles in the sustainable development of the ocean characteristics. Most existing studies have explored this field from the perspective of the government and public, while failing to adequately account for the factors influencing enterprises’ participation in marine ecological environmental governance. This paper is an effort to provide some empirical research on the influencing factors of enterprises’ participation in marine ecological environmental governance. Based on existing literature, empirical research (213 middle managers were surveyed from 68 coastal enterprises in Zhejiang, China), this study extracts eight core factors that influence corporate participation in marine ecosystems and uses the Fuzzy Decision-making Trial and Evaluation Laboratory approach (Fuzzy DEMATEL). Furthermore, experts from Chinese backgrounds elucidated the complex interdependencies among the factors, based on which key influencing factors were identified. The empirical results indicate that government attention and support, legal and regulatory requirements, and cost-benefit accounting have a positive net effect on corporate participation in marine ecosystem management; when these factors are improved, they drive improvements in other factors(Corporate Capital Capability, Corporate Social Responsibility, Government Enforcement and Appraisal, The Attention of Corporate Leaders, Corporate Internal Management System). Additionally, interviews with Chinese business people support the robustness of the findings and suggest that policymakers cannot ignore government enforcement and assessment efforts. Overall, the study findings can help advance corporate participation in marine environmental governance.