Notification Obligations Research Articles

Alzheimer’s Disease Prediction and Implications for Insurance

AbstractBackgroundThe possibilities to determine the individual risk of persons to develop future Alzheimer’s Disease and dementia have greatly increased in recent years. Promising and little invasive methods, e.g. blood or urine tests, may soon be available as predictive or early‐detection measures even for the general population. However, the knowledge incurred may be of interest not only for the affected persons themselves, but also for third parties. Particularly, the results of predictive tests may prompt disclosure or notification obligations to insurers, in turn affecting availability or affordable premiums for life or health insurance plans. This can be a substantial obstacle and burden for individuals considering to undergo predictive diagnosis. As predictive methods become more readily available, the problem gains pressing practical importance.MethodWe analyze existing legislation and jurisprudence in a variety of jurisdictions to investigate what regulations are in place for dealing with individual risk probabilities, and to what extent these are applicable or transferable to the particular problematic aspects regarding the prediction of Alzheimer’s Disease and/or dementia.ResultExisting insurance law, where in place, strikes only a rudimentary balance, and for a limited scope, mostly genetic diagnostics only. At the same time, access to disease prediction by non‐genetic means is quickly growing, and legal protections, rights and duties are largely unregulated in spite of a similar conflict of interests. The associated uncertainties for the involved parties keep increasing, and there is a pressing need for rules bringing the conflicting interests into a fair balance.ConclusionWe present efforts and their shortcomings to reduce the tension between the interest of insurers in offering affordable and calculable premiums on the basis of individual risk factors, and the particular need of affected persons to protect the results of predictive examinations due to their high sensitivity. We show how this tension could be sensibly resolved by taking into account ethical and societal values, considering the complex interests at stake.

Malicious Insiders’ Threats to the Personal Data Security. The Hard to Comply Rules of the GDPR

According to the last reports covering cybersecurity issues, the attacks initiated by malicious insiders were the costliest and the longest to resolve, even though they constitute a clear minority of all data breaches. They pose significant problems in complying with the rules on personal data protection, too. The General Data Protection Regulation (GDPR) does not differentiate the personal data breaches by the source, be it internal or external. Thus, in theory, the obligations of data controllers in the aftermath of personal data breaches caused by malicious insiders and outsiders are the same. However, the breaches caused by malicious insiders are much harder to identify, causing severe problems under the GDPR regarding the distinction between breaches of security and personal data breaches, affecting the notification obligations to data protection authorities and data subjects. This article shows that malicious insider threats are hard to appropriately address under the GDPR, which may expose, on the one hand, controllers and processors to the risk of non-compliance, potentially triggering civil liability and administrative fines, and on the other hand, the data subjects to a high risk to their rights and freedoms they will never be aware of unless such risk materializes and affects them directly. Thus, the author supports the notions for legislation changes that may help to fill the existing gap, provided that they are to be followed by comprehensive amendments regarding the content of notifications of the data subjects and investigation obligations following the information about a possible breach.

Research on the Scope of Obligations of China's Short Video Platforms in the Era of Digital Copyright

In order to balance the interests of right holders, network service providers and users, China first stipulated the "notice-takedown" rule in the Regulations on the Protection of the Right of Information Network Dissemination in 2006. Since the Internet industry is in the early stage of development, the copyright environment is relatively clear, and network service providers do not have to bear high obligations, so the allocation of copyright protection obligations in the rules is reasonable at that time. However, with the iterative development of digital technology and the Internet, various short video platforms have also risen rapidly in domestic and foreign markets. Therefore, it is necessary to re-determine the scope of obligations of short video platforms, summarize the key points of controversy between the theoretical and practical circles on the scope of obligations of short video platforms, point out the problems existing in the scope of obligations of short video platforms, and discuss the role of short video platforms in the obligation of active review, notification and review, and post-event protection obligations. Conduct an in-depth analysis of the extent of the obligations to be undertaken, and redefine the scope of obligations of the short video platform on this basis, with a view to balancing the interests of all parties and promoting the sustainable and healthy development of the short video industry.

Meta-Regulation: An ideal alternative to the primary responsibility as the regulatory model of generative AI in China

Generative AI with stronger responsiveness and emergent abilities has triggered a global boom and is facing challenges such as data compliance risks during the pretraining process and risks of generating fake information, which has raised concerns among global regulatory authorities. The European Union, United States, United Kingdom, and other countries and regions are gradually establishing risk-based, scenario-based, and outcome-based governance models for generative AI. China recently introduced new regulations for the management of generative AI, which adopt a governance model focusing on generative AI service providers. It suggests that China is continuing the principle of primary responsibility in Internet governance, which encompasses legal responsibility, contractual obligations, and ethical responsibility. However, the governance model based on primary responsibility emphasizes the accountability of generative AI model service providers, with relatively limited regulation on other important entities such as users and large-scale dissemination platforms, which may not be conducive to achieving China's regulatory goals for the AI industry. In comparison, the Meta-Regulation model could be an ideal alternative for China. As a classic theory explaining the public-private relationship, the ‘Meta-Regulation’ aligns with the generative AI governance requirements. Based on the Meta-Regulation theory, the governance of generative AI in China should move towards a direction of emphasizing safety, transparency, collaborative governance, and accountability. In line with this, it is necessary to include users and large-scale dissemination platforms within the regulatory scope and establish overarching governance objectives that ensure the responsible distribution of duties among stakeholders, with regulatory authorities assuming ultimate oversight responsibility and technical coordination. At the level of specific improvement measures, it is possible to integrate the three stages of model development, usage, and content dissemination of generative AI. During the model development stage, generative AI providers have specific transparency obligations. In the usage stage, a self-regulatory system centered around platform autonomy should be constructed. In the content dissemination stage, the proactive notification obligations of the dissemination platforms should be clearly defined. Additionally, the enforcement of technical interoperability requirements is necessary, thereby promoting the orderly development of generative AI applications.

The Second Wave of the Fisheries Subsidies Negotiations: Overcapacity, Overfishing, and Other Disciplines

The Agreement on Fisheries Subsidies (AFS) was concluded by the Ministerial Conference of the World Trade Organization (WTO) in June 2022. It was negotiated following the mandate contained in the Sustainable Development Goal (SDG) 14.6 adopted by the United Nations General Assembly in 2015. In the AFS, WTO Members were able to agree on subsidy prohibitions relating to illegal, unreported, and unregulated fishing, overfished stocks and unregulated waters. However, the AFS fails to address part of the SDG 14.6 mandate concerning subsidies contributing to overcapacity and overfishing. For this reason, WTO Members have, shortly after the conclusion of the AFS, engaged in a second wave of negotiations to address the missing elements in SDG 14.6, as well as other provisions left out of the AFS. At the time of writing, the WTO Negotiating Group on Rules has produced a draft text containing the proposals of Members on overcapacity and overfishing, including a sustainability carve-out and special and differential treatment for developing countries. In addition, this text includes a subsidy prohibition with respect to subsidies contingent upon or tied to fishing and fishing related activities in waters outside the subsidizing Member’s jurisdiction and a notification obligation concerning the use of forced labour. The challenge is, therefore, to produce a text that is agreeable to both the representatives of Members sitting at the WTO Ministerial Conference and the stakeholders of each WTO Member who will decide, domestically, whether to ratify the agreement. fisheries subsidies, IUU fishing, overfished stocks, overcapacity, overfishing, forced labour, waters outside the jurisdiction

Analysis and Feasible Solution for Legislative Gaps in Notification Procedures in External Equity Transfer

In 2005, the Company Law stipulated the transfer of equity for the first time. However, in the subsequent amendments, the notification procedure for external transfer has always been unclear. As a result, there have been disputes about the time and method of the shareholder notification of the transferor in practice. This paper analyzes the disputes in case judgments before and after the entry into force of 2017 judicial interpretation, as well as the characteristics of asset and person compatibility of Limited Liability Company, and tries to find a feasible solution to alleviate the impact of legislative gaps and strengthen notification obligations. Lastly, the paper gives suggestions for improvement in the companys articles of association and for legislation, which is possible to strike a balance between the trust relationships within companies and the efficiency of business transactions.

State of the European Union’s early notification obligation for drug shortages: enforcement and compliance in eight European countries (2020–2022)

BackgroundEarly notification of impending drug shortages is essential for mitigating or preventing shortages. Since 2019 pharmaceutical companies in the European Union (EU) and European Economic Area (EEA) must notify authorities of drug shortages at least two months in advance. This study’s aim was to investigate how advance notification of pharmaceutical shortages is functioning in EU/EEA countries and factors possibly associated with differences in notification times.MethodsThis was a retrospective register study using data from publicly available drug shortage registers of all national authorities in the EU/EEA area having such a register. Actual notification times for all drug shortages during January 2020–November 2022 were calculated and included in the descriptive quantitative analysis.ResultsData from eight countries (Belgium, Croatia, Finland, Germany, Norway, Slovakia, Slovenia, and Sweden) were available (18,987 notifications in total). Only 5.2% of all shortage notifications were made at least 60 days in advance and 56.2% of all notifications were made on the shortage’s starting day or even later. Data on production-related shortages were available in Belgium, Croatia, Germany, and Norway (n = 2097 showing that 3.9% of those shortages were notified at least 60 days in advance, but 74.3% were made on the starting day or even later. The longest advance notification times for drug shortages were found in Finland during a 12-month period in June 2021–May 2022 when progressive notification fees were in effect. During this national policy experiment, 20.0% of the shortages (n = 1754) were notified at least 60 days in advance, while 24.9% of the notifications occurred on the starting day or even later. Data on notification times for permanent market withdrawals of drugs were available in three countries (Belgium, Slovenia, and Slovakia, n = 1737): 21.2% of these notifications were made at least 60 days in advance, while 45.5% of the notifications occurred on the starting day or even later.ConclusionsThe EU regulatory requirement adopted in 2019 for early notification of drug shortages was unsuccessful in the eight countries having openly available statistics for follow-up. The national policy experiment in Finland with a progressive notification fee seemed to increase compliance with early notification.

THE IMPLICATIONS OF THE NEW EU FOREIGN SUBSIDIES REGULATION AND ITS DRAFT IMPLEMENTING REGULATION FOR INVESTORS AND BENEFICIARIES

This article examines the notification obligations according to the draft implementing regulation of the Foreign Subsidies Regulation (“FSR”), which was implemented by the European Parliament and the Council on January 12, 2023. The draft implementing regulation establishes an extensive notification system for mergers and acquisitions (M&A) cases and public procurement, including tenders. The article outlines the main notification obligations and the required data that must be submitted to the Commission under the FSR and its draft implementing regulation.The FSR came into effect on January 12, 2023, and will be applicable starting from July 12, 2023. As of October 12, 2023, companies are required to notify the Commission of mergers and participation in public procurement procedures when the relevant thresholds are met.The purpose of this article is to examine the FSR and its Draft Implementing Regulation, which aim to address potential distortions in the EU internal market caused by subsidies from third countries to companies operating within the EU.The analysis in this article is based on a review of the FSR and its Draft Implementing Regulation, and relevant legal sources. The article also considers the consultation period of the European Commission and feedback received from companies and stakeholders during the development of the draft implementing regulation. The methodology involves a detailed examination of the provisions, definitions, and notification requirements outlined in the FSR and its draft implementing regulation. The draft implementing regulation of the Foreign Subsidies Regulation presents new compliance and reporting requirements for companies operating within the EU, aiming to address potential distortions in the EU market caused by foreign subsidies. While the specific legal challenges can vary, companies and beneficiaries should be prepared for the new obligations and requirements. These include ensuring compliance, understanding the subsidy assessment criteria, cooperating with authorities during investigations, balancing transparency with the protection of confidential information, and potentially addressing legal challenges or disputes.The implementation of the Foreign Subsidies Regulation represents a significant step in regulating third country subsidies and promoting fair competition in the EU internal market.

The Foreign Subsidies Regulation: the challenge of notifying non-selective tax expenditure

The European Union’s new Foreign Subsidies Regulation will lead to particular challenges in the tax domain. While the final version of the FSR now contains clear links to State aid, the differences are all the more noticeable. Third country tax measures that benefit group financing or equity financing warrant special attention. Repayment of foreign tax incentives to the European Commission, as a last resort measure, might come at odds with taxing prerogatives as divided under existing bilateral tax treaties. Compliance with notification obligations when engaging in public procurement or planning a merger with or acquisition of an entity active in the EU will be hardly doable. Unlike EU State aid rules (and WTO subsidy rules), notification may also involve non-selective and non-beneficial tax measures received within a group. If these have come into the FSR’s scope by intent and not by omission, then this is to be strongly reconsidered. Sustainability tax incentives aimed at greening investment have not been exempt from scrutiny. Thus, EU subsidiaries of third country parent companies and EU parents of third country subsidiaries should gather more information for the purpose of this regulation than one might expect at first sight.

The GDPR’s Rules on Data Breaches: Analysing Their Rationales and Effects

The General Data Protection Regulation (GDPR) requires an organisation that suffers a data breach to notify the competent Data Protection Authority. The organisation must also inform the relevant individuals, when a data breach threatens their rights and freedoms. This paper focuses on the following question: given the goals of the GDPR’s data breach notification obligation, what are its strengths and weaknesses? We identify six goals of, or rationales for, the GDPR`s data breach notification obligation, and we assess the obligation in the light of those goals. We refer to insights from information security and economics, and present them in a reader-friendly way for lawyers. Our main conclusion is that the GDPR’s data breach rules are likely to contribute to the goals. For instance, the data breach notification obligation can nudge organisations towards better security; such an obligation enables regulators to perform their duties; and such an obligation improves transparency and accountability. However, the paper also warns that we should not have unrealistic expectations of the possibilities for people to protect their interests after a data breach notice. Likewise, we should not have high expectations of people switching to other service providers after receiving a data breach notification. Lastly, the paper calls for Data Protection Authorities to publish more information about reported data breaches. Such information can help to analyse security threats.

계약전 발병 부담보 조항에 관한 연구

In the past disease insurance terms and conditions, the definition of disease was expressed as “occurring during the insurance period,” and there was a problem in that the onset time depended on the patient's statement, or the insurance company claimed the onset time before the commencement of liability to avoid payment of insurance money. In addition, the Financial Supervisory Service revised the terms and conditions to protect consumer rights and interests and incorporated the pre-contract insurance policy into the standard terms and conditions. However, in June 2017, the Financial Dispute Mediation Committee of the Financial Supervisory Service determined that The pre-existing conditions exclusion clause was invalid, and in July 2018, the corresponding clause was deleted from the standard terms and conditions, so that all insurance companies stopped including the clause. When the terms and conditions were revised to protect the rights and interests of insurance consumers, the incorporated The pre-existing conditions exclusion clause refused to pay insurance money to insurance consumers who faithfully fulfilled the notification obligation. This is contrary to the insurance protection expectations of policyholders, so the Financial Supervisory Service's action to return it to its original state is acceptable. The pre-existing conditions exclusion clause itself may conflict with other terms and conditions, and it is unfair to protect the insurance company, such as restricting the payment of insurance money even when the insurance company signs an insurance contract intentionally or grossly. The problem of reverse selection, which some are concerned about, can be partially solved by the interpretation theory or law of the current insurance terms and conditions, so it is reasonable for the Financial Supervisory Service to delete the burden guarantee clause to protect insurance consumer rights.

Effectiveness of Mandatory Share Repurchase Provisions Research

The compulsory share repurchase provision of the Company Law only provides for the share repurchase of dissenting shareholders, but does not make systematic arrangements for other share repurchase situations, which has led to frequent contradictions in the application of the law in judicial practice. The existing Company Law does not make specific provisions for the repurchase of the company's statutory initiative, nor does it make legal regulations for the repurchase of the shares agreed in the articles of association and agreement. The legislation should not prohibit the repurchase of equity in the limited liability company, and only set the conditions for not allowing the repurchase of equity can be. Through the institutionalized and systematic arrangement of the resolution authority, notification obligation and disposal of repurchased equity, a systematic and complete repurchase system is constructed. For the determination of the validity of the equity repurchase agreement, the three aspects of contractual rules, shareholders' meeting voting and operating conditions should be grasped comprehensively.

The Opportunities and Challenges of WTO Transparency Mechanism During the COVID-19 Epidemic–Focusing on the Notification Obligations

The Opportunities and Challenges of WTO Transparency Mechanism During the COVID-19 Epidemic–Focusing on the Notification Obligations

Limitations of CISG and Product Liability Act on Buyer’s Notification Obligation

Purpose - From the time when the existing international trade and international transportation were not smooth enough, the global trade market has rapidly shifted from offline to online and B2C online export has recently emerged as a new trend of export. Unlike companies that import goods in large quantities to date, for individual consumers, as a buyer, it is not easy to deal with material and personal damage due to defects in the imported goods. In CISG, although it is the most important factor in practice in defining the buyer’s obligation to notify of nonconformities, many disputes arise in the ’notification within a reasonable period’. It is not easy to detect defects within two years depending on the changing trade transaction method, and the specific period of the goods may vary. Depending on the characteristics of the goods, defects in the goods may occur after two years, and the period of two years is contrary to the purpose of protecting the buyer. Therefore, the elements of the rigid CISG need to be revised.
 Design/Methodology/Approach - This paper studies the main issues of the notification obligation of CISG and the Product Liability Act based on the legal approach. Based on the notification obligations of the CISG and the Product Liability Act, the reasonable period defined by the CISG shall be appropriately determined by adapting to specific events rather than uniform. In other words, through case comparison, it was found that CISG had a reasonable period of up to 2 years, but was given a reasonable period of at least 2 years and at least 10 years under the Product Liability Act. Therefore, the amendment is proposed to meet the purpose of protecting the buyer in the CISG’s obligation to notify.
 Findings - This paper improves the CISG clause, which is rigid and contrary to its purpose, and protects buyers who have suffered losses due to defective goods.
 Research Implications - This study is meaningful to protect buyers who lose their right to claim nonconformity from defective goods due to the application of CISG provisions that are criticized for being excessively harsh in international commodity trading, which will also be a reference for subsequent studies by other scholars.

Yükseköğretim Kurumlarında Gerçekleştirilen Buluşlar

Sınai Mülkiyet Kanunu ile yükseköğretim kurumlarında mevcut buluş potansiyelinin ortaya çıkarılması ve ekonomiye kazandırılması için bilimsel araştırma ve çalışmalar sonucu ortaya çıkan buluşlar üzerinde yükseköğretim kurumuna hak sahipliği talebinde bulunma imkanı verilmiştir. Buluş potansiyeli en yüksek kurumlardan biri olan yükseköğretim kurumlarında hak sahipliği konusunun çözümü, buluş sahibi ve yükseköğretim kurumu açısından önemlidir. Mevcut buluşların patent sürecine dahil edilmesi ve ticarileştirilmesi ile ülke ekonomisi ve toplum yarar sağlar. Patent hakkının korunması, ülke içinde ekonomik büyümeyi beraberinde getirerek, teknoloji üretimi ile transferine uygun zemin hazırlar. Yükseköğretim kurumlarında gerçekleştirilen buluş üzerinde hak sahipliğinin belirlenmesi, başvuru ve bildirim yükümlülüğü, hak sahipliği kararına itiraz, hakkın devri ve buluştan elde edilecek gelirin paylaşımı Sınai Mülkiyet Kanunu ve Çalışan Buluşlarına, Yükseköğretim Kurumlarında Gerçekleştirilen Buluşlara ve Kamu Destekli Projelerde Ortaya Çıkan Buluşlara Dair Yönetmelik çerçevesinde incelenecektir.

The Conflict Problems and Solutions Between Informed Consent Right and Right to Life and Health

Before the promulgation of the Civil Code of the People’s Republic of China, there was a conflict between patients' right of informed consent and patients' right to life and health, which mainly came from three aspects: medical staff, patients and the lack of law. Compared with existing laws and regulations, the Civil Code not only further defines the scope of the right of informed consent, but also makes detailed provisions on the obligation of medical notification and the right of emergency intervention. In order to alleviate the conflict between the two, the author puts forward improvement suggestions from three aspects: improving the legal details, popularizing the legal awareness and promoting the medical insurance system. In the introduction part, this paper makes a analysis of the informed consent right prior to the promulgation of the Civil Code, and the second part lists relevant cases. This paper analyzes the reasons for the conflict of informed consent rights in Part III and explains the relevant amendments made in the Civil Code in Part IV. This paper also summarizes the solutions of alleviating the informed consent dispute and makes relevant suggestions.

Impact of the COVID-19 pandemic on compulsory notification of meningitis during the first wave of the pandemic in Brazil: an ecological study using P-score

Meningitis is listed as one of the diseases requiring compulsory notification in Brazil. It can affect all age groups and also has no seasonality. Cases can be recorded in all months of the year and in all states of Brazil. Despite its importance, the obligation of immediate notification may have been compromised by the coronavirus disease 2019 (COVID-19) pandemic. To analyze the immediate impact of the COVID-19 pandemic on compulsory notifications of meningitis in Brazil and its states during the first wave of the pandemic. This was an ecological study involving all confirmed cases of meningitis in Brazil, in its regions and in its states. Data for the months from 2015 to 2020 were obtained from the database of the Notifiable Diseases Information System (Sistema de Informação de Agravos de Notificação, SINAN), in the Department of Informatics of the National Health System (Departamento de Informática do Sistema Único de Saúde, DATASUS). The P-score was used to obtain the percentage change in the numbers of cases reported in 2020. A 45.7% reduction in notifications of meningitis in Brazil was observed. Regarding the regions and the states, with the exception of Roraima, all of them showed a negative P-score, with decreasing curves each month. The pandemic caused a negative impact on meningitis notifications in Brazil.

Regulating Composite Platform Economy Services: Examining the Applicable Legal Framework in Light of Recent Judicial Developments

Numerous platform operators provide composite services comprising electronic and non-electronic elements, whose legal classification has been highly debated. This is partly explained by the fact that theEU law regime applicable to information society services (ISS) is far more favourable to businesses than that applicable to other types of services. The most recent case-law, however, has noticeably strengthened Member State regulatory prerogatives regarding ISS by, inter alia, giving a whole new meaning to the provisions of the E-commerce Directive. This twenty-year old legal act certainly needed reshuffling, but the Court’s approach has created a high degree of uncertainty forMember States wishing to regulate ISS in compliance with their notification obligations. Further, the applicable legal framework fails to guarantee the freedom to provide composite platform economy services that classify as two independent services of offline and online nature. The present article presents the main takeaways from recent judgments and highlights the structural differences between the legal regime applicable to ISS and that applicable to other kind of services, as well as their shortcomings. Digital Single Market – Regulation of the platform economy – Composite services – notification – online platform liability – e-commerce – Digital Services Act – Directive 2000/31 – Directive 2015/1535 – Directive 2006/123

Foreign Subsidies Regulation and EU International Procurement – Necessity, Changes and Challenges

Chapter 4 of the Regulation on foreign subsidies distorting the internal market is designed to fill a regulatory gap, to ensure that foreign subsidies can be addressed in individual public procurement procedures. This article describes the international context in which this “procurement pillar” is embedded, and illustrates the main features of the ex ante notification obligation that is at the heart of Chapter 4. It also explains the specific aspects and notions of the review procedure for foreign subsidies.

EXAMINATION OF ATTITUDES OF SPECIAL EDUCATION TEACHERS TOWARDS CHILD NEGLECT AND ABUSE REPORTING IN TERMS OF DIFFERENT VARIABLES

In this study, the attitudes of special education teachers working in various schools in the Turkish Republic of Northern Cyprus towards reporting child neglect and abuse were examined according to various variables. In accordance with this purpose, 86 special education teachers participated in the study. A personal information form and a "teacher attitudes towards the reporting of child abuse and neglect" survey were applied to the participants. Four out of ten of the participating teachers indicated that they received education on child abuse, and nine out of ten stated that marrying a child younger than 18 should be considered as an abuse. On the other side, one in six teachers stated that they had been abused as children. In the matter of responding to reports of child abuse and neglect and meeting the need, teachers do not find the current system effective and adequate. When the responses of the teachers to the survey were examined, it was observed that they thought it was significant for teachers to fulfill their obligation of notification to reduce and prevent child abuse and neglect in the long run. As a result, it is important for teachers to have knowledge of the legal legislation on abuse of children, what civil and public institutions they can reach on this issue and what common activities can be carried out with them, what reactions they can give in times of crisis or critical situations, and how they can guide people. In-service training on the related issues can be shown as a requirement. 
 
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