European Journal of Risk Regulation最新文献_第3页

De Facto Rule-Making Below the Level of Implementing Acts: Double-Delegated Rule-Making in European Union Electricity Market Regulation 实施法案层面以下的事实规则制定：欧盟电力市场监管中的双重授权规则制定

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-04-19 DOI: 10.1017/err.2024.15

Torbjørg Jevnaker, Karianne Krohn Taranger, Per Ove Eikeland, Marie Byskov Lindberg

{"title":"De Facto Rule-Making Below the Level of Implementing Acts: Double-Delegated Rule-Making in European Union Electricity Market Regulation","authors":"Torbjørg Jevnaker, Karianne Krohn Taranger, Per Ove Eikeland, Marie Byskov Lindberg","doi":"10.1017/err.2024.15","DOIUrl":"https://doi.org/10.1017/err.2024.15","url":null,"abstract":"Within the area of electricity market regulation, a practice has emerged in which the chain of delegation has gone beyond the European Commission, resulting in double delegation. During 2015–2017, the European Commission adopted implementing regulations requiring detailed European terms, conditions and methodologies (TCMs) for electricity markets and system operation to be jointly adopted by national energy regulators. Should the latter fail to agree within a predefined time limit, rule-making would move to the Agency for the Cooperation of Energy Regulators. This rule-making procedure entails that, depending on the dynamic within the procedure, different actors would adopt the TCMs. This article examines how double-delegated rule-making unfolds in a novel and emerging practice, evolving beneath implementing acts. By analysing the factors behind whether TCMs are adopted jointly by national agencies or not, the study investigates whether this form of delegated rule-making in a network setting delivers decisions or whether rule-making by a European Union agency is needed.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140629938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

European Health Data Space – Is the Proposed Certification System Effective against Cyber Threats? 欧洲健康数据空间--拟议的认证系统能否有效防范网络威胁？

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-04-18 DOI: 10.1017/err.2024.25

Federica Casarosa

{"title":"European Health Data Space – Is the Proposed Certification System Effective against Cyber Threats?","authors":"Federica Casarosa","doi":"10.1017/err.2024.25","DOIUrl":"https://doi.org/10.1017/err.2024.25","url":null,"abstract":"<p>The proposal for a European Health Data Space aims at creating a common space where individuals may control their health data in a trusted and secure way. The objective is not only improving healthcare delivery, but also enhancing the opportunities to use health data for research and innovation. To achieve these results, the proposal implements a mandatory self-certification scheme for European health records systems as well as for wellness devices and applications, setting up essential requirements related to interoperability and security. Although this is the first intervention that sets a horizontal framework that is mandatory for all Member States, the security requirements that are included in the legislative proposal are not sufficiently detailed and comprehensive. Given that cyberthreats are increasing and security incidents affecting health data may potentially have an impact on the lives of patients, it is important that cybersecurity measures are adopted and implemented in the most effective way. The paper will analyse the European Health Data Space proposal pointing to the open issues and doubts that may be emerging and it will compare them with the proposed Cyber Resilience Act, identifying the issues that may be solved thanks to this horizontal regulation and the ones that instead remain open.</p>","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140613297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Precautionary Principle and Impact Assessment: The Case of School Closures during the Pandemic in Ireland 预防原则和影响评估：爱尔兰大流行病期间学校关闭的案例

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-04-18 DOI: 10.1017/err.2024.26

Sarah Arduin

引用次数: 0

Regulatory Approaches Towards AI-Based Medical Device Cybersecurity: A Transatlantic Perspective 实现基于人工智能的医疗设备网络安全的监管方法：跨大西洋视角

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-04-15 DOI: 10.1017/err.2024.23

Elisabetta Biasin, Erik Kamenjašević

{"title":"Regulatory Approaches Towards AI-Based Medical Device Cybersecurity: A Transatlantic Perspective","authors":"Elisabetta Biasin, Erik Kamenjašević","doi":"10.1017/err.2024.23","DOIUrl":"https://doi.org/10.1017/err.2024.23","url":null,"abstract":"Cybersecurity of medical devices has become a concrete concern for regulators and policymakers in the European Union and United States. Following the COVID-19 pandemic, there has been an increase in cyber-attacks on critical healthcare infrastructures and their IT systems, which have suffered service disruptions and put patients’ health and safety at risk. The increase in cyberattacks on healthcare infrastructure, including medical devices, exacerbated by the growing digitalisation of healthcare services in the EU and the US, has led legislators and regulatory bodies to pay more attention to cybersecurity. Cybersecurity of AI-based medical devices requires the assessment of three areas subject to evolving regulatory approaches: medical devices, Artificial Intelligence (AI), and cybersecurity. Although they may appear distinguished in regulatory matters, the existence of AI-based medical devices and their possible cyber vulnerabilities makes clear that the three are intertwined and deserve closer attention from a regulatory point of view. Few scholars have devoted attention to AI and cybersecurity together. Even less, in our understanding, few comprehensive and EU/US comparative pieces of literature reflect on this specific issue. This paper aims to fill this gap and address the main implications of different regulatory approaches toward AI medical device cybersecurity in the EU and the US. The research stems from the assumption that regulation of medical devices in the EU has been historically inspired by regulatory trends in the US, although with the different cultural, societal, and legal traditions that made them adapt to the specificities of the territory. The paper observes that the US is a rule-based system reflecting a “command-and-control” approach, while the EU system is a principle-based one. While they share the main characteristic of being risk-regulation-based systems, their differences impact how AI-enhanced cybersecurity is regulated.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140593582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Delegated Rule-making in Times of Crisis: New Challenges for Democratic Scrutiny? 危机时期的授权规则制定：民主监督的新挑战？

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-04-12 DOI: 10.1017/err.2024.24

Giulia Gallinella, Thomas Christiansen

{"title":"Delegated Rule-making in Times of Crisis: New Challenges for Democratic Scrutiny?","authors":"Giulia Gallinella, Thomas Christiansen","doi":"10.1017/err.2024.24","DOIUrl":"https://doi.org/10.1017/err.2024.24","url":null,"abstract":"The delegation of powers to the European Commission, facilitating the adoption of non-legislative acts to implement centrally provisions of European legislation, has long been an essential part of administrative governance in the European Union. However, the established practice of delegating legslative and implementing powers to the European Commission has increased over the last decade, at the same time in the context of the various crises that the EU has had to confront during this period. The crisis context has generally demonstrated that executive institutions often emergency politics, and the amplified use of delegated powers in such circumstances raises questions about the capacity of legislative institutions to carry out their usual control and scrutiny functions. The concern here is whether – at times when the established mechanisms of control need to be carried out in times of crisis, under greater time pressure – there is the risk of legislative institutions (that had originally delegated powers to the Commission) are being sidelined, with the detrimental effects that this may have on the democratic accountability of the whole process. Against this background of normative question-marks, this article examines empirically to what extent the scrutiny of the Commission’s adoption of delegated powers has fundamentally changed during times of emergency. In particular, it provides an analysis of the use of delegated powers by the European Commission in the context of the EU’s response to the Covid-19 pandemic in order to establish whether the Council and the European Parliament managed to enable the usual control mechanisms effectively. By way of conclusion, the article discusses the implications of the findings for the wider discussion and the future use of emergency governance in the European Union.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140593736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Addictive Design as an Unfair Commercial Practice: The Case of Hyper-Engaging Dark Patterns 上瘾设计是一种不公平的商业行为：超吸引人的暗色图案案例

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-03-25 DOI: 10.1017/err.2024.8

Fabrizio Esposito, Thaís Maciel Cathoud Ferreira

引用次数: 0

Behavioural Analysis and Regulatory Impact Assessment 行为分析和监管影响评估

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-03-22 DOI: 10.1017/err.2024.1

James R. Drummond, Claudio M. Radaelli

引用次数: 0

Prioritisation under Value Chain Due Diligence 价值链尽职调查下的优先排序

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-03-19 DOI: 10.1017/err.2024.19

João Teixeira de Freitas

{"title":"Prioritisation under Value Chain Due Diligence","authors":"João Teixeira de Freitas","doi":"10.1017/err.2024.19","DOIUrl":"https://doi.org/10.1017/err.2024.19","url":null,"abstract":"This article analyses the mechanisms of prioritisation and hierarchisation of risk contained under influential soft law frameworks on value chain due diligence. It identifies the main stages of the due diligence process where prioritisation may be required and clarifies the criteria that may be used by corporations for prioritisation decisions. The article contributes to the development of the literature concerning prioritisation mechanisms under value chain due diligence norms, highlighting, from a compliance perspective, how corporations are expected to prioritise both their evaluations to identify and assess adverse impacts as well as their actions to address specific impacts identified and assessed. In doing so, it showcases the challenges present when comparing the significance of adverse impacts pertaining to different policy fields and their implications in a prioritisation context. It then compares the solutions found in these soft law frameworks concerning prioritisation to the ones contained in European laws and legislative proposals on the subject. The analysis reveals the different approaches used by legislators and reflects on their repercussions for prioritisation mechanisms, suggesting the reinforcement and clarification of prioritisation requirements in accordance with international frameworks of reference.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140171671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Right to Refuse Equivalence of Sanitary and Phytosanitary Measures: Trading on Regulatory Trust? 拒绝动植物卫生检疫措施等效性的权利：监管信任交易？

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-03-14 DOI: 10.1017/err.2024.7

Christian Delev, Jochelle Greaves Siew

{"title":"The Right to Refuse Equivalence of Sanitary and Phytosanitary Measures: Trading on Regulatory Trust?","authors":"Christian Delev, Jochelle Greaves Siew","doi":"10.1017/err.2024.7","DOIUrl":"https://doi.org/10.1017/err.2024.7","url":null,"abstract":"Equivalence is an essential discipline for liberalising trade between States whose sanitary and phytosanitary (SPS) measures are based on divergent regulatory approaches. During the Uruguay Round negotiations, “equivalence” under the SPS Agreement was regarded by negotiators as being “of great importance”, and it was even considered to establish a right for exporting States. In practice, the discipline has remained ineffective, with only thirty-six equivalence recognition decisions made since 1995. This article argues that the underperformance of equivalence as an obligation is structural in nature: in effect, the SPS Agreement establishes a conditional right of importing Members to refuse equivalence requests. As such, exporting Members only gain equivalence protection where they either demonstrate that their measures (1) meet the importing Member’s appropriate level of protection or (2) achieve the same level of protection as parties to recognition agreements. Finally, the need for fostering regulatory trust between domestic SPS regulatory agencies is underscored as a prerequisite for achieving broader equivalence recognition.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140152333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Groups of Persons in the Proposed AI Act Amendments 拟议的《人工智能法》修正案中的人群

IF 2.9

European Journal of Risk Regulation Pub Date : 2024-03-11 DOI: 10.1017/err.2024.13

Liubomir Nikiforov

引用次数: 0