European Journal of Risk Regulation最新文献

英文中文

The “Safe and Sustainable by Design” Concept – A Regulatory Approach for a More Sustainable Circular Economy in the European Union? 安全和可持续的设计 "概念--在欧盟实现更可持续的循环经济的监管方法？

IF 2.9 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-05-08 DOI: 10.1017/err.2024.29

Leonie Reins, Julia Wijns

The creation of a more sustainable economy is one of the main targets of the European Green Deal and the new Circular Economy Action Plan. Technological innovation is needed, among other things, to render materials, products, and production processes more sustainable. Given the goals of the European Green Deal, the regulatory concept of “Safe and Sustainable by Design” is increasingly receiving attention. The concept is (arguably) a precautionary and preventative measure that is implemented at the early stages of the design of a technology. Therefore, it is often described as a tool for lowering the risks that follow from efforts to create a more circular economy. The concept was included in the European Chemicals Strategy of the European Commission. The aim of the strategy is to accelerate progress towards the discovery of more sustainable chemicals and towards a toxicity-free environment. In this paper, we will explore the benefits and disadvantages of integrating the “Safe and Sustainable by Design” concept into the regulation of technology. As a form of regulation by technology, this concept can enhance sustainability. We will first describe the origins of the concept and its current use. Then, we will analyse its implications for the circular economy.

创建更具可持续性的经济是欧洲绿色协议和新的循环经济行动计划的主要目标之一。要使材料、产品和生产流程更具可持续性，就必须进行技术创新。鉴于欧洲绿色交易的目标，"设计安全与可持续 "的监管概念正日益受到关注。可以说，这一概念是在技术设计的早期阶段实施的预防性措施。因此，它经常被描述为降低风险的一种工具，而这些风险来自于创造更多循环经济的努力。这一概念已被纳入欧盟委员会的欧洲化学品战略。该战略的目标是加快发现更多可持续化学品和实现无毒环境的进程。在本文中，我们将探讨将 "安全和可持续设计 "概念纳入技术监管的利弊。作为技术监管的一种形式，这一概念可以增强可持续性。我们将首先介绍这一概念的起源及其目前的使用情况。然后，我们将分析其对循环经济的影响。

{"title":"The “Safe and Sustainable by Design” Concept – A Regulatory Approach for a More Sustainable Circular Economy in the European Union?","authors":"Leonie Reins, Julia Wijns","doi":"10.1017/err.2024.29","DOIUrl":"https://doi.org/10.1017/err.2024.29","url":null,"abstract":"The creation of a more sustainable economy is one of the main targets of the European Green Deal and the new Circular Economy Action Plan. Technological innovation is needed, among other things, to render materials, products, and production processes more sustainable. Given the goals of the European Green Deal, the regulatory concept of “Safe and Sustainable by Design” is increasingly receiving attention. The concept is (arguably) a precautionary and preventative measure that is implemented at the early stages of the design of a technology. Therefore, it is often described as a tool for lowering the risks that follow from efforts to create a more circular economy. The concept was included in the European Chemicals Strategy of the European Commission. The aim of the strategy is to accelerate progress towards the discovery of more sustainable chemicals and towards a toxicity-free environment. In this paper, we will explore the benefits and disadvantages of integrating the “Safe and Sustainable by Design” concept into the regulation of technology. As a form of regulation by technology, this concept can enhance sustainability. We will first describe the origins of the concept and its current use. Then, we will analyse its implications for the circular economy.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140933999","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 Reform of International Investment Law: Whose Rule of Law? 国际投资法改革：谁的法治？

IF 2.9 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-04-29 DOI: 10.1017/err.2024.28

Ivana Damjanovic

Public and political controversies over Investor–State Dispute Settlement (ISDS) have prompted reform processes in international investment law, at bilateral, regional and multilateral levels, with different actors shaping the future of international investment governance. In its essence, the options for the ISDS reform reflect the diverging perspectives on the rule of law in international law. Ultimately, they present a choice about who should control power over States’ action in issues of public importance – the States who have created the system, or international investment tribunals who have shaped the legal development of the system. This paper considers the application of the rule of law as a normative meta-principle to international investment law and its dispute settlement, and it sheds light on different perspectives of this concept, as they shape the ongoing ISDS reform(s).

有关 "投资者与国家争端解决"（ISDS）的公众和政治争议促使国际投资法在双边、区域和多边层面上进行改革，不同的参与者塑造了国际投资治理的未来。从本质上讲，投资者与国家争端解决机制改革方案反映了对国际法法治的不同观点。归根结底，它们提出了一种选择，即谁应该控制国家在具有公共重要性的问题上的行动权--是创建该体系的国家，还是塑造该体系法律发展的国际投资法庭。本文探讨了将法治作为规范性元原则应用于国际投资法及其争端解决的问题，并阐明了对这一概念的不同观点，因为它们影响着正在进行的国际投资争端解决机制改革。

引用次数: 0

Enforcement of Multilateral Trade Regulation by Non-State Actors – Desirable and Feasible? 非国家行为者执行多边贸易法规--可取与可行？

IF 2.9 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-04-22 DOI: 10.1017/err.2024.20

Iveta Alexovičová

Since its inception, the inter-state dispute settlement system of the World Trade Organisation has generally been praised for effectively protecting the rule of law in international trade relations. While the relatively recent dismantling of this system does not necessarily mean the end of the WTO nor of the binding nature of its rules, the current crisis may be a good opportunity to reconsider the role of the rule of law in international trade relations and the ways in which it could further be accommodated. One suggestion, occasionally raised in the past, would be strengthening the enforcement of WTO rules by opening it to private action, either before national courts or through international adjudication. After all, the latter has been widely available to foreign investors covered by thousands of international investment agreements in force for decades. This contribution recalls the reasons behind the current lack of private enforcement of WTO law and argues that developments in international trade relations and experiences with investor-state dispute settlement are likely to work against rather than in favor of its introduction in the foreseeable future. Increased transparency and institutionalisation of non-state actors’ role in trade enforcement is therefore recommended instead.

自成立以来，世界贸易组织的国家间争端解决体系因有效保护国际贸易关系中的法治而受到普遍赞誉。虽然这一体系最近被解散并不一定意味着世界贸易组织的终结，也不一定意味着其规则约束力的终结，但当前的危机可能是一个很好的机会，让我们重新考虑法治在国际贸易关系中的作用，以及如何进一步容纳法治。过去偶尔会提出的一个建议是，通过向私人诉讼开放，无论是在国家法院还是通过国际裁决，来加强世贸组织规则的执行。毕竟，数十年来，数以千计的现行国际投资协定已为外国投资者广泛提供了后者。本文回顾了目前世贸组织法律缺乏私人执行的原因，并认为国际贸易关系的发展和投资者与国家争端解决的经验很可能在可预见的将来不利于而不是支持私人执行。因此，建议提高非国家行为者在贸易执法中的作用的透明度并使之制度化。

{"title":"Enforcement of Multilateral Trade Regulation by Non-State Actors – Desirable and Feasible?","authors":"Iveta Alexovičová","doi":"10.1017/err.2024.20","DOIUrl":"https://doi.org/10.1017/err.2024.20","url":null,"abstract":"Since its inception, the inter-state dispute settlement system of the World Trade Organisation has generally been praised for effectively protecting the rule of law in international trade relations. While the relatively recent dismantling of this system does not necessarily mean the end of the WTO nor of the binding nature of its rules, the current crisis may be a good opportunity to reconsider the role of the rule of law in international trade relations and the ways in which it could further be accommodated. One suggestion, occasionally raised in the past, would be strengthening the enforcement of WTO rules by opening it to private action, either before national courts or through international adjudication. After all, the latter has been widely available to foreign investors covered by thousands of international investment agreements in force for decades. This contribution recalls the reasons behind the current lack of private enforcement of WTO law and argues that developments in international trade relations and experiences with investor-state dispute settlement are likely to work against rather than in favor of its introduction in the foreseeable future. Increased transparency and institutionalisation of non-state actors’ role in trade enforcement is therefore recommended instead.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140634921","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

Between Aims and Execution: Value Trade-Offs in the Practical Implementation of the European Arrest Warrant? – ERRATUM 目标与执行之间：欧洲逮捕令实际执行中的价值权衡？- ERRATUM

IF 2.9 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-04-19 DOI: 10.1017/err.2024.31

Bjorn Kleizen, J. Wynen, Veronica Junjan

引用次数: 0

Consumer Decision-Making Autonomy in the Digital Environment: Towards a New Understanding of National Courts’ Obligation to Assess Ex Officio Violations of Fair Commercial Practices 数字环境中的消费者决策自主权：实现对国家法院评估依职权违反公平商业惯例的义务的新理解

IF 2.9 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-04-19 DOI: 10.1017/err.2024.11

Zanda Davida

Digitalisation has changed traders’ possibilities of influencing the autonomy of consumer choice in the digital environment. The digital market of the European Union involves a wide spectrum of commercial practices – such as dark and addictive patterns, target advertising and personalisation – that nudge consumers to take decisions that are not in their favour. One of the main aims of the Unfair Commercial Practices Directive 2005 is to protect the freedom of consumer decision-making. However, currently, the Directive’s capacity to safeguard consumer choice in the digital environment is not sufficiently effective. Through the lens of law prohibiting unfair commercial practices, this article analyses the means available to consumer courts to strengthen consumer decision-making autonomy in the digital environment. The article argues that regulation of prohibition of unfair commercial practices regarding the digital environment should be modernised by obliging – in certain circumstances – national courts ex officio to assess violations of fair commercial practices and by reversing the burden of argumentation and proof.

数字化改变了商家在数字环境中影响消费者自主选择的可能性。欧盟的数字市场涉及多种商业行为，如暗箱操作、上瘾模式、目标广告和个性化等，这些行为会诱导消费者做出不利于他们的决定。2005 年不公平商业行为指令》的主要目标之一就是保护消费者的决策自由。然而，目前该指令在数字环境中保障消费者选择权的能力还不够有效。本文通过禁止不公平商业行为的法律视角，分析了消费者法庭在数字环境中加强消费者决策自主权的可用手段。文章认为，禁止数字环境中不公平商业行为的法规应当现代化，在某些情况下，国家法院有义务依职权评估违反公平商业行为的行为，并颠倒论证和举证责任。

{"title":"Consumer Decision-Making Autonomy in the Digital Environment: Towards a New Understanding of National Courts’ Obligation to Assess Ex Officio Violations of Fair Commercial Practices","authors":"Zanda Davida","doi":"10.1017/err.2024.11","DOIUrl":"https://doi.org/10.1017/err.2024.11","url":null,"abstract":"Digitalisation has changed traders’ possibilities of influencing the autonomy of consumer choice in the digital environment. The digital market of the European Union involves a wide spectrum of commercial practices – such as dark and addictive patterns, target advertising and personalisation – that nudge consumers to take decisions that are not in their favour. One of the main aims of the Unfair Commercial Practices Directive 2005 is to protect the freedom of consumer decision-making. However, currently, the Directive’s capacity to safeguard consumer choice in the digital environment is not sufficiently effective. Through the lens of law prohibiting unfair commercial practices, this article analyses the means available to consumer courts to strengthen consumer decision-making autonomy in the digital environment. The article argues that regulation of prohibition of unfair commercial practices regarding the digital environment should be modernised by obliging – in certain circumstances – national courts ex officio to assess violations of fair commercial practices and by reversing the burden of argumentation and proof.","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":"140630061","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

Behavioural Economics and Regulation: The Design Process of Regulatory Nudges by Maria C de Campos, London, Routledge, 2023, 232 pp. 行为经济学与监管：玛丽亚-C-德-坎波斯（Maria C de Campos）著，伦敦，Routledge 出版社，2023 年，232 页。

IF 2.9 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-04-19 DOI: 10.1017/err.2024.18

Ollie Bartlett

引用次数: 0

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 Q1 Social Sciences

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

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.

在电力市场监管领域，出现了一种做法，即授权链已超越欧盟委员会，造成双重授权。2015-2017 年期间，欧盟委员会通过了实施条例，要求各国能源监管机构共同通过欧洲电力市场和系统运行的详细条款、条件和方法（TCM）。如果后者未能在预定时限内达成一致，则规则制定工作将移交给能源监管机构合作局。这一规则制定程序意味着，根据程序内的动态，不同的行为者将采用《国家电力条例》。本文探讨了双重授权的规则制定是如何在新出现的实践中展开的，如何在实施法案之下演变。通过分析国家机构是否联合采用《中医药法》背后的因素，本研究探讨了这种网络环境下的授权规则制定形式是否能做出决定，或者是否需要由欧盟机构制定规则。

{"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 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-04-18 DOI: 10.1017/err.2024.25

Federica Casarosa

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.

欧洲健康数据空间提案旨在创建一个共同空间，让个人可以通过可信和安全的方式控制自己的健康数据。其目的不仅在于改善医疗服务，还在于增加将健康数据用于研究和创新的机会。为了取得这些成果，该提案为欧洲健康记录系统以及健康设备和应用程序实施了一项强制性自我认证计划，设定了与互操作性和安全性相关的基本要求。虽然这是首次制定对所有成员国都具有强制性的横向框架，但立法提案中包含的安全要求还不够详细和全面。鉴于网络威胁日益增加，影响健康数据的安全事件可能会对患者的生命造成潜在影响，因此必须以最有效的方式采取和实施网络安全措施。本文将对欧洲健康数据空间提案进行分析，指出可能出现的未决问题和疑虑，并将其与拟议的《网络复原力法》进行比较，找出通过这一横向法规可能解决的问题和仍未解决的问题。

{"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 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-04-18 DOI: 10.1017/err.2024.26

Sarah Arduin

The development of the precautionary principle by the EU Courts has often been interpreted by scholars as inconsistent with another trend in EU risk regulation: one that is evidence-based and relies on impact assessment. This article argues that the two trends – precaution and regulatory impact assessment – are not mutually exclusive. Together they may, in fact, act as a procedural safeguard against discretionary decisions that have an impact on fundamental rights, especially under conditions of epistemic uncertainty. The article illustrates this claim by looking at the decisions to close schools in Ireland during the pandemic.

欧盟法院对预防原则的发展往往被学者们解释为与欧盟风险监管的另一种趋势不一致，即以证据为基础并依赖于影响评估。本文认为，这两种趋势--预防和监管影响评估--并不相互排斥。事实上，它们可以共同作为程序保障，防止影响基本权利的自由裁量决定，尤其是在认识论不确定的条件下。文章通过研究爱尔兰在大流行病期间关闭学校的决定来说明这一观点。

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 Q1 Social Sciences

European Journal of Risk Regulation

Pub Date : 2024-04-15 DOI: 10.1017/err.2024.23

Elisabetta Biasin, Erik Kamenjašević

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.

医疗设备的网络安全已成为欧盟和美国监管机构和政策制定者关注的具体问题。COVID-19 大流行之后，针对关键医疗基础设施及其 IT 系统的网络攻击不断增加，导致服务中断，危及患者的健康和安全。欧盟和美国医疗服务的数字化程度不断提高，加剧了对包括医疗设备在内的医疗基础设施的网络攻击，这促使立法者和监管机构更加关注网络安全问题。基于人工智能的医疗设备的网络安全需要对三个领域进行评估，这三个领域的监管方法也在不断变化：医疗设备、人工智能（AI）和网络安全。虽然它们在监管问题上似乎有所区别，但基于人工智能的医疗设备的存在及其可能存在的网络漏洞清楚地表明，三者是相互交织的，值得从监管角度给予更密切的关注。很少有学者将人工智能和网络安全放在一起研究。据我们了解，很少有综合性的欧盟/美国比较文献对这一具体问题进行反思。本文旨在填补这一空白，探讨欧盟和美国对人工智能医疗设备网络安全的不同监管方法的主要影响。这项研究源于这样一个假设，即欧盟的医疗设备监管历来受到美国监管趋势的启发，尽管不同的文化、社会和法律传统使其适应了当地的特殊性。本文认为，美国的制度以规则为基础，反映了一种 "命令与控制 "的方法，而欧盟的制度则以原则为基础。虽然它们的主要特点都是基于风险监管的体系，但它们之间的差异影响了如何监管人工智能增强型网络安全。

{"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

首页上一页

下一页尾页

类型

全部化学•材料生命科学医学物理工程技术环境•农林材料科学地球科学法学管理学化学环境科学与生态学计算机科学教育学经济学农林科学人文科学生物学数学物理与天体物理心理学综合性期刊其他工业工程理学历史学农学文学信息工程

数据库

全部 ACS Publications Elsevier ieeexplore Springer The Royal Society of Chemistry Wiley

期刊

European Journal of Risk Regulation

全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.

﹀