Regulatory Safeguards Research Articles

What Gastroenterologists Should Know About COVID-19 Vaccines

What Gastroenterologists Should Know About COVID-19 Vaccines

Digitalne valute centralnih banaka

Central Bank digital currencies are a digital challenge to the international monetary and financial system. Since the development of cryptocurrency, such as bitcoin, the modern world has faced the possibility of digital technological transformation and providing a digital form of payment for the economy and the household. In addition, the announcement of a digital currency that would have a global reach, such as the Libre issued by the social network Facebook, raised questions about legal and regulatory safeguards, financial stability, and the role of the digital currency in society. All this influenced the leading central banks to recognize the need to conduct a detailed analysis of the possibilities of issuing digital currency of the central bank, which would be a supplement to the cash and non-cash form of payment. These analyzes include considering the advantages and disadvantages of that currency, determining its design and technological solution, as well as the necessary regulatory adjustments. In the coming period, we will witness a technological transformation in the operations of central banks, which, as before, should take care of preserving price and financial stability as its main goals, but also respond to new challenges of digital business.

The USMCA and Mexico’s Prospects under the New North American Trade Regime

After 26 years of trading under the North American Free Trade agreement (NAFTA), Mexico and its North American partners enter a new phase with the entry into force of United States-Mexico-Canada Agreement (USMCA) on 1 July 2020. This note quantifies the potential impact of the agreement on Mexico and assesses its implications for Mexico’s economic development in the context of the evolving knowledge-based and data-driven economy, the restructuring of global supply chains in response to the risks that were highlighted by the pandemic-driven economic crisis, and the changes to global trade and investment patterns driven by the trade and technology friction between the United States and China. The USMCA provides a major overhaul of the NAFTA based largely on the text of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). It introduces some minor improvements to market access but its main effect for the industrial sectors of the economy is to intensify trade and investment diversion through more restrictive rules of origin, including onerous new requirements for labour value content in the automotive sector that impose significant adjustments on Mexico’s auto sector producers. The agreement builds on the institutional framework of the NAFTA, retaining the binational panel review mechanism for trade remedies – now Chapter 30 – intact, preserving the investor-state-dispute-settlement (ISDS) mechanism for Mexico-US investments only, improving state-to-state dispute settlement mechanism by addressing procedural weaknesses in the NAFTA version that had undermined its use, and introducing a new rapid-response mechanism for challenges to Mexico’s compliance with the labour market measures newly incorporated in the USMCA. The agreement, however, leaves open the use of US Section 232 “national security” tariffs and thus does not address the main new source of uncertainty concerning assured access to the US market for its North American partners. The analysis concludes that the net impact on Mexico is to reduce real gross domestic product (GDP) by about -0.8% compared to the NAFTA, once the economic adjustments are fully in place. Since Mexico had already signed onto disciplines on data localization and cross-border data flows under the CPTPP, the digital economy measures have little direct impact; however, how Mexico engages in the digital economy, both to tap the economic potential and to develop regulatory safeguards will be an important determinant of how well it fares under the new USMCA trade regime.

Lessons Relearned? H1N1, COVID-19, and Vaccination Planning.

Lessons Relearned? H1N1, COVID-19, and Vaccination Planning.

Irrigation of wheat with select hydraulic fracturing chemicals: Evaluating plant uptake and growth impacts.

Oilfield flowback and produced water (FPW) is a waste stream that may offer an alternative source of water for multiple beneficial uses. One practice gaining interest in several semi-arid states is the reuse of FPW for agricultural irrigation. However, it is unknown if the reuse of FPW on edible crops could increase health risks from ingestion of exposed food, or impact crop growth. A greenhouse experiment was conducted using wheat (Triticum aestivum) to investigate the uptake potential of select hydraulic fracturing additives known to be associated with health risks. The selected chemicals included acrylamide, didecyldimethylammonium chloride (DDAC), diethanolamine, and tetramethylammonium chloride (TMAC). Mature wheat grain was extracted and analyzed by liquid chromatography-triple quadrupole mass spectrometry (LC-QQQ) to quantify chemical uptake. Plant development observations were also documented to evaluate impacts of the chemicals on crop yield. Analytical results indicated that TMAC and diethanolamine had significantly higher uptake into both wheat grain and stems than control plants which were not exposed to the four chemicals under investigation. Acrylamide was measured in statistically higher concentrations in the stems only, while DDAC was not detected in grain or stems. Growth impacts included lodging in treated wheat plants due to increased stem height and grain weight, potentially resulting from increased nitrogen application. While analytical results show that uptake of select hydraulic fracturing chemicals in wheat grain and stems is measurable, reuse of FPW for irrigation in real world scenarios would likely result in less uptake because water would be subject to natural degradation, and often treatment and dilution practices. Nonetheless, based on the outstanding data gaps associated with this research topic, chemical specific treatment and regulatory safeguards are still recommended.

Unwavering Regulatory Safeguards for COVID-19 Vaccines

Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine

Regulatory Provision of the Passenger's Rights in the System of Warranties of their Compliance and Realization

The article deals with topical issues of securing the rights of the passenger. As violations of this kind of rights are frequent and the means of protection of their rights, except for air transport, are virtually absent under the transport law of Ukraine, except for the possibility of compensation for non-pecuniary damage, the presence and amount of which is determined by court procedure, there is an urgent need to determine and regulate this civil rights, how it is under EU law on new civilizational approaches; securing regulatory safeguards to enforce and exercise their rights. The authors conclude that according to the legislation of Ukraine there are practically no guarantees for the exercise of the rights of the passenger, which is unacceptable at this stage of civilization development. As the mechanism for securing this kind of civil rights under EU law, which is based on the concept of creating a competitive environment, regulating and securing the rights of passengers, establishing negative consequences for the carrier in the event of a violation of the passenger's rights in the form of compensation amounts, despite the fact that he is debatable and imperfect, however, it can be implemented into the national legislation of Ukraine. In addition to the right to require the carrier to deliver it to its destination, the basic rights of the passenger must be legally enshrined and guaranteed: security, human rights, mobility, non-discrimination, assistance in transportation, accessibility, full and reliable information, on the use of remedies, on compensation in case of violation of rights, etc.

Pure Altruistic Gift and the Ethics of Transplant Medicine

The article argues that altruistic giving based on anonymity, which is expected to promote social solidarity and block trade in human body parts, is conceptually defective and practically unproductive. It needs to be replaced by a more adequate notion which responds to the human practices of giving and receiving. The argument starts with identification of the main characteristics of the anonymous altruistic donation: social separation of the organ donor (or donor family) from the recipient, their mutual replaceability, non-obligatoriness of donation, and non-obligatoriness of reciprocation on the recipient’s part. Since these characteristics are also central to typical market relations, anonymous altruistic donation not only cannot promote solidarity but may encourage proposals for (regulated) markets of transplantable organs. Thus, transplant ethics needs to be reframed. It needs to be rooted in, rather than promote, the practices of giving and receiving known to human societies. As the basis for such reframing, the idea of sharing in another’s misfortune is proposed. It relies on the human practices of giving and receiving and, with appropriate regulatory safeguards, can provide a better conceptual basis for blocking commercial exchanges of human body parts.

Algorithmic Analysis of Social Behavior for Profiling, Ranking, and Assessment

In this chapter we look at the global development of “people-scoring” and its implications. Unlike traditional credit scoring, which is used to evaluate individuals’ financial trustworthiness, social scoring seeks to comprehensively rank individuals based on social, reputational, and behavioral attributes. The implications of widespread social scoring are far-reaching and troubling. Bias and error, discrimination, manipulation, privacy violations, excessive market power, and social segregation are only some of the concerns we have discussed and elaborated on in previous works. In this chapter, we describe the global shift from financial scores to social credit, and show how, notwithstanding constitutional, statutory, and regulatory safeguards, the U.S. and other western democracies are not as far from social credit as we seem to believe.

Killing Wolves Legally: Exploring the Scope for Lethal Wolf Management under European Nature Conservation Law

This article seeks to identify to what extent, and under what conditions, lethal wolf management can be conducted in EU countries without violating applicable European legal frameworks, in particular the Habitats Directive. The analysis carried out to that end demonstrates that certain variables are tightly related with the options of EU member states to allow the killing of wolves under the Directive, namely (1) the conservation status of the populations in question; (2) the quality of the scientific evidence showing that the various conditions of the Directive's derogation clause are met; (3) the quality of supervision and regulatory safeguards in member states’ hunting regimes and wolf plans; and (4) the extent and quality of intergovernmental cooperation targeting transboundary wolf populations. As these variables improve, so does the scope for legally viable wolf hunting.

The Role of Efficient Pricing in Enabling a Low-Carbon Electricity Sector

Producers and consumers will make the investments and innovations necessary to transition to a low carbon electricity supply industry only if they are compensated for their efforts. In the absence of explicit government support for these activities, this outcome will occur only if wholesale and retail prices provide this compensation. Efficient wholesale and retail pricing provides compensation for the cost-effective deployment of these innovations. Multi-settlement locational marginal pricing markets set efficient short-term wholesale electricity prices. Marginal cost-based pricing of transmission and distribution networks is increasingly important in regions with solar resources. More efficient wholesale and retail pricing implies significantly greater price volatility, particularly as the share of intermittent renewable generation increases, which requires implementing a number of competition and regulatory safeguards to protect consumers, while still providing the price signals necessary for a least cost transition to a low-carbon electricity supply industry.

Enforcement of directors’ duties in Malaysia and Australia: the implications of context

ABSTRACTIn recent years, the misappropriation of corporate assets by 1MDB, a high-profile Malaysian company, has precipitated international investigations by regulatory authorities. Although the scandal resulted in the imprisonment of Singaporean bankers, for many years no enforcement proceedings were taken against the directors of 1MDB in Malaysia despite the existence of corporate law modelled substantially on Anglo-Australian law. The article investigates the enforcement of directors’ duties in Malaysia and seeks to explain the manner and extent to which regulatory safeguards against the expropriation of corporate property are enforced. The analysis draws from the Australian experience to illuminate the differences across jurisdictions. Features of the Malaysian context are examined to explain differences in the enforcement of directors’ duties across countries. The findings reveal the significance of the politics-business nexus, corporate ownership structures and cultural norms for the enforcement of corporate law. The implications of the Malaysian experience are considered within a broader regional context.

Visual Surveillance Within the EU General Data Protection Regulation: A Technology Perspective

From an individual's perspective, technological advancement has merits and demerits. Video captured by surveillance cameras while a person goes about their daily life may improve their personal safety but the images collected may also represent an invasion of their privacy. Because of the ease of digital information sharing, there exists a need to protect that visual information from illegal utilization by untrusted parties. The European parliament has ratified the General Data Protection Regulation (GDPR), which has been effective since May 2018 with a view to ensuring the privacy of European Union (EU) citizens' and visitors' personal data. The regulation has introduced data safeguards through Pseudonymisation, Encryption, and Data protection-by-design. However, the regulation does not assist with technical and implementation procedures, such as video redaction, to establish those safeguards. This paper refers to the GDPR term “personal data” as “visual personal data” and aims to discuss regulatory safeguards of visual privacy, such as reversible protection, from the technological point-of-view. In the context of GDPR, the roles of machine learning (i.e. within computer vision), image processing, cryptography, and blockchain are explored as a way of deploying Data Protection-by-Design solutions for visual surveillance data. The paper surveys the existing market-based data protection solutions and provides suggestions for the development of GDPR-compliant Data Protection-by-Design video surveillance systems. The paper is also relevant for those entities interacting with EU citizens from outside the EU and for those regions not currently covered by such regulation that may soon implement similar provisions.

Circumventing regulatory safeguards: Laricobius spp. and biocontrol of the hemlock woolly adelgid

Abstract Biological control entails introducing non‐native natural enemies to control weeds and pests. Instances of poorly regulated biocontrol have had harmful consequences leading to significant efforts to improve risk assessment of agents before release. Laricobius naganoensis (Coleoptera: Derodontidae) was inadvertently imported to eastern North America with Laricobius osakensis, introduced from Japan to control the hemlock woolly adelgid Adelges tsugae (Hemiptera: Adelgidae). The United States Department of Agriculture (U.S.D.A.) subsequently permitted introduction of L. naganoensis as a biocontrol agent and contaminant, requiring no study or monitoring owing to difficulty of the effort required to distinguish it from L. osakensis. The Plant Protection Act of 2000 (7 U.S.C. § § 7701–7786) assigns U.S.D.A. responsibility for vetting and reducing risk from biocontrol agents while ensuring the process is transparent, accessible, and based on scientific evidence. Typically, release of a new agent involves a 30‐day period when the public may review and comment on an assessment of risk associated with the introduction, an Environmental Assessment (EA). No public review and comment period was allowed before L. naganoensis’ introduction, and the EA was not made public. Biocontrol practitioners and stakeholders agree that critical scientific evaluation of multiple lines of evidence is necessary to evaluate risk associated with new introductions. The importance of accurate agent identification and avoidance of contamination has long been recognised, and procedures to minimise risk are well known. While such processes might be difficult to implement, those challenges should not justify a release that circumvents regulatory safeguards.

An Innovative Approach to Improving the Proposed CMS Star Rating "Statin Use in Persons with Diabetes".

The Statin Use in Persons with Diabetes (SUPD) measure has been adopted by the Centers for Medicare and Medicaid Services as a display measure for Medicare Part C and Part D plan sponsors and is slated for inclusion within the primary star rating measure set. As such, the measure has become a focal point for quality improvement efforts by many health plans. Current pharmacy-based interventions reported in the literature involve pharmacists recommending that a patient's provider issue a prescription for a statin; studies to date have not shown that this intervention has been effective for the majority of patients with diabetes. One innovative option is pharmacist prescriptive authority of statins for patients with diabetes. In such a model, a pharmacist identifies a patient with diabetes who is not on a statin, assesses the patient for contraindications and appropriateness of therapy, and works directly with the patient to close the gap in care. This solution could lead to earlier initiation of statin therapy and reduce the burdens associated with multiple communications with the patient's primary care provider. In 2018, Idaho became the first state to allow pharmacist prescribing to close the SUPD measure, with certain regulatory safeguards in place. DISCLOSURES: No funding supported the writing of this article. The authors have nothing to disclose.

Civil liability for misuse of online communication through websites: an analytical study of UAE law

ABSTRACTThis paper takes the UAE legal system as case in point to illustrate certain challenges posed for jurists by the spread of the Internet. Since it enables large-scale participatory multimedia content production, the Internet is surrounded by regulatory safeguards for ensuring its public accountability. In the UAE, the National Media Council holds responsibility for licensing media outlets, including online ones, and for overseeing content published therein. Together, legal disciplines on content, regulatory accountability frameworks and the collaborative nature of Internet content production form the context in which existing regimes, such as for civil liability (tort), call for interpretive adaptation. This is what this paper undertakes, with respect to civil liability claims for misuse of online communication through websites. A close analytical study of UAE law helps clarify how civil liability is established and apportioned between the National Media Council (vicarious liability), media outlets and individual users, alongside other findings.

Medicine, Body Fluid and Food: The Regulation of Human Donor Milk in Canada.

The use of peer-to-peer online networks to access both pasteurized and unpasteurized human donor milk is increasing in Canada. In the absence of a mother's own milk, donor milk is the next best nutrition available for all infants in need of supplementation. Limited supply and the cost of pasteurized milk puts it out of reach for many. Although milk banks in Canada all operate on a non-profit basis, there is a lack of regulatory safeguards regarding for-profit operations and private milk exchange. This paper describes regulation of human donor milk and identifies gaps putting families at risk.

Media diversity in Portugal: political framework and current challenges

This article addresses the current “state of the art” in Portuguese media diversity policy, focusing on the social inclusiveness domain within public service media. The indicators assess regulatory and policy safeguards for community media, access to media by minorities, local and regional communities, women and people with disabilities, as well as the country’s media literacy environment. Although the majority of these in dicators have legal safeguards or benefit from specific policies, we concluded there is still considerable work to be done, particularly in the realms of media literacy and the representation of minority groups and women in the media. This article results from an on-going research, gathering data and literature review from the following projects: Media Pluralism Monitor (MPM) project, implemented by the Centre for Media Pluralism and Media Freedom (CMPF) at the European University Institute and funded by the European Commission; and DIVinTV - Public Television and Cultural Diversity in Portugal, funded by FCT.

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety. Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices.

Regulatory Safeguards in Mega-regionals against Sovereignty Loss

Trade and investment agreements are disputed because they limit the regulatory autonomy of national legislatures of participating countries. This is particularly true of mega-regionals given their expanded scope. On that account, negotiators build safe-guards into the agreements with a view to containing the intrusion into the national legal order. The debate revolves around whether the envisaged safeguards are sufficient to achieve that goal or whether, de lege ferenda, more needs to be done to find the right power balance. The present essay, first of all, elucidates the extent of sovereignty loss as a result of mega-regionals, and secondly, explores some options to secure policy space for national lawmakers, such as the use of broader exception clauses or the setting of guidelines for the calculation of damages.