scholarly journals Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and European law perspective

2020 ◽  
Author(s):  
Kaspar Rosager Ludvigsen ◽  
Shishir Nagaraja

Being connected to a network exposes surgical robots to cyberattacks, which can damage the patient or the operator. These injuries are normally caused by safety failures, such as accidents with industrial robots, but cyberattacks are caused by security failures instead. Surgical robots are increasingly sold and used in the European Union, so we decide to uncover whether this change has been considered by EU law, and which legal remedies and actions a patient or manufacturer would have in a single national legal system in the union. We first conduct a case study, where we analyse which legal remedies a patient can make use of, if they are injured by a surgical robot caused by a cyberattack in the national legal system. We also explore whether cybersecurity and cyberattacks are considered by the upcoming Medical Device Regulation of the EU. We show that the selected national legal system is adequate. This is because of its flexibility and in a certain approach even to ignore the distinction between safety and security to the benefit of the patient, and in one situation to remove liability from the manufacturer by erasing its status as party. Otherwise, unless the operator or other parties have made the cyberattack more likely to occur, the manufacturer is liable. We find that the regulation does not directly consider security defects, requiring interpretation and use of guidance to show it. Due to the risk cyberattacks pose on medical equipment, we find this to not be adequate. We further find that the regulators of medical devices, including surgical robots, will not necessarily have adequate staff or rules of enforcement, as this has been left to the member states to solve. But, we also find, due to the comprehensive number of rules that can be applied cumulatively, together with the possibility for further rules and compliance later on, that these issues could be solved in the future.

2017 ◽  
Vol 71 (0) ◽  
pp. 61-71
Author(s):  
Robert Grzeszczak

The article concerns primarily the effects of the membership of the European Union on national (Polish) law and, to a limited extent, on the political system of a state. The conclusions presented in the article are of universal value. Although the article deals with Polish affairs, the principles, tendencies and consequences identified are typical of the relationship state – the EU, both before and after accession, regardless of the state concerned. It should be, however, noted that the path to membership and the membership itself are different in each case. The practice of the Polish membership of the European Union, its systemic dimension and the changes in the national legal system (Europeanisation) do not differ significantly than in the case of other Member States. Europeanisation of Polish law, politics, economy, culture and society has been in progress since the 1990s. One can differentiate between two stages of Europeanisation: before and after Poland’s EU accession, each characterised by different conditions. Over time, this process, on the whole, has been undergoing numerous changes but it has never weakened in importance. Poland faces issues such as poor legitimation of integration processes, supremacy of the government over the parliament, passivity of parliamentary committees in controlling the government and EU institutions in the decision making process, as well as dilution of responsibility for decisions taken within the EU. The process of Europeanisation relies mostly on direct application of the standards of EU law in the national legal system, implementation of directives into national law and harmonisation or standardisation of national legal solutions so that they comply with the EU framework. It is also reception of a common, European (Union) axiology.


2020 ◽  
pp. 183-190
Author(s):  
Marios Costa ◽  
Steve Peers

This chapter outlines the framework for enforcement of European Union (EU) law, and describes the various actions that may be brought before the Court of Justice (CJ). In interpreting the relevant provisions of the Treaty on the Functioning of the European Union (TFEU), the CJ has played a key role in the enforcement of EU law especially with its insistence on the effective protection of individuals’ Union rights. The chapter also explains the significance of judicial review in the EU legal order by focusing on the jurisdiction of the CJ in the appeal cases originating from the General Court (GC). Finally, the chapter outlines how questions of infringement of EU law can also be raised in the national legal system.


The article defines the main aspects of mutual influence of the legal system of Ukraine reforming processes and the extension of the legal space of the European Union (EU) from the general theoretical viewpoint. The article defines the category «legal space» as an acknowledged and regulated by law life sphere of people, organizations, states and international institutions in order to achieve the agreed and common goals. The main features of the legal space as a phenomenon of legal reality are outlined: multilevel legal regulation with the application of national and international legal acts, unification of law enforcement rules, mandatory agreement on a consensual basis of actors operating within the legal space. The factors of the EU legal space extension are emphasized. It is noted that the reforming of the legal system of Ukraine and the EU legal space extension are interconnected and complementary processes. At the core of such a relationship lies the political will of Ukraine to recognize and legitimize the norms and principles of EU law on the one hand and the desire of the EU to expand the geographical and spatial boundaries of political, legal and economic influence on the other. Based on the analysis of provisions of the bilateral cooperation acts of Ukraine and the EU, as well as using the achievements of national scientists who studied the impact of EU law on the national legal system, four main aspects of the mutual influence of transformation processes of the national legal system and the scope of the extension of the regulatory capacity of the European Union law are highlighted. In particular, it is the creation of a legal basis for the development integrated ties between Ukraine and the EU, recognition of the universal values ​​of the EU in Ukraine, and the involvement of Ukraine in European politics. It is pointed to the issue of Ukraine's full participation in the realization of common policies with the EU. It is emphasized, that the main result of active interaction between the national legal system and the EU legal space is the change of methodological approaches to the analysis of the correlation of political borders of the European Union and factual territorial scope of the European legal space, especially legal borders. That is why the modern scientific community faces a new perspective task - to ground the patterns of formation of the optimal model of Ukraine's borrowing of positive legal practices from the EU legal space, provided that the national identity is preserved in the conditions of the national legal system reforming.


Author(s):  
Elena Sorokina

The preliminary ruling procedure is an essential feature of the EU legal system, which is a unique cooperation tool as part of the dialogue between the Court of Justice of the EU and national courts of the Member States. Its main purpose is to ensure uniform interpretation and application of the provisions of EU law with all Member States and to preserve the uniformity of the European legal system. The continuous use by national courts of the Member States of the mechanism of preliminary ruling and constructive inter-judicial cooperation, the Court of Justice has developed an extremely extensive case law on the prohibition of discrimination and with the result to introduce substantial changes in European anti-discrimination law.The preliminary rulings of the Court of Justice have shown its inclination to expand notions of what constitutes discrimination and in most cases the Court prompt by the desire to interpret the provisions of European law so as to ensure the full effectiveness of the law, as well as a willingness to promote and strengthen protection against discrimination in Europe. While the protection against discrimination on some grounds is stronger than others, however, the preliminary rulings of the Court of Justice are important contribution to the transformation of anti-discrimination law, promote change in the national legislation of the Member States and provide the more effective protection of human rights in general.


2018 ◽  
Vol 20 (2) ◽  
pp. 173-187
Author(s):  
Pauline Melin

In a 2012 Communication, the European Commission described the current approach to social security coordination with third countries as ‘patchy’. The European Commission proposed to address that patchiness by developing a common EU approach to social security coordination with third countries whereby the Member States would cooperate more with each other when concluding bilateral agreements with third countries. This article aims to explore the policy agenda of the European Commission in that field by conducting a comparative legal analysis of the Member States’ bilateral agreements with India. The idea behind the comparative legal analysis is to determine whether (1) there are common grounds between the Member States’ approaches, and (2) based on these common grounds, it is possible to suggest a common EU approach. India is taken as a third-country case study due to its labour migration and investment potential for the European Union. In addition, there are currently 12 Member State bilateral agreements with India and no instrument at the EU level on social security coordination with India. Therefore, there is a potential need for a common EU approach to social security coordination with India. Based on the comparative legal analysis of the Member States’ bilateral agreements with India, this article ends by outlining the content of a potential future common EU approach.


2019 ◽  
Vol 11 (1) ◽  
pp. 237 ◽  
Author(s):  
Radka MacGregor Pelikánová

The commitment of the European Union (EU) to Corporate Social Responsibility (CSR) is projected into EU law about annual reporting by businesses. Since EU member states further develop this framework by their own domestic laws, annual reporting with CSR information is not unified and only partially mandatory in the EU. Do all European businesses report CSR information and what public declaration to society do they provide with it? The two main purposes of this paper are to identify the parameters of this annual reporting duty and to study the CSR information provided by the 10 largest Czech companies in their annual statements for 2013–2017. Based on legislative research and a teleological interpretation, the current EU legislative framework with Czech particularities is presented and, via a case study exploring 50 annual reports, the data about the type, extent and depth of CSR is dynamically and comparatively assessed. It appears that, at the minimum, large Czech businesses satisfy their legal duty and e-report on CSR to a similar extent, but in a dramatically different quality. Employee matters and adherence to international standards are used as a public declaration to society more than the data on environmental protection, while social matters and research and development (R&D) are played down.


Public Law ◽  
2020 ◽  
pp. 355-396
Author(s):  
Mark Elliott ◽  
Robert Thomas

This chapter focuses on the constitutional implications of the UK’s membership of the European Union and the constitutional implications of its exit from the EU (or ‘Brexit’). The chapter examines how EU law was accommodated within the UK legal system during the period of the UK’s membership of the EU, and in particular considers the consequences of the primacy of EU law for the doctrine of parliamentary sovereignty. The chapter also considers the extent to which lessons learned about the UK constitution as a result of EU membership will remain relevant now that the UK has left the EU.


2021 ◽  
pp. 1-11
Author(s):  
Margot Horspool ◽  
Matthew Humphreys ◽  
Michael Wells-Greco

This introductory chapter traces the development of the European Union. Since its inception in 1952, the EU has matured and developed from a Community of like-minded states into a Union of a greater diversity of states, with a comprehensive legal system which is increasingly penetrating the national legal systems of Member States. From the six original members, the EU now counts 27 Member States. Eleven of the thirteen newer Member States are in Central and Eastern Europe, and have discarded their old Communist regimes, turning into democracies with the qualifications to join the Union. The latest developments and changes, including Brexit and the effects of Covid-19, are also discussed.


Author(s):  
Paul Craig ◽  
Gráinne de Búrca

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate, providing able students with a stand-alone resource. The EU develops policy through regulations, directives, and decisions. Any developed legal system must have a mechanism for testing the legality of such measures. This chapter focuses on access to justice and review of legality by the EU Courts. There are a number of ways in which EU norms can be challenged, but the principal Treaty provision is Article 263 of the Treaty on the Functioning of the European Union (ex Article 230 EC). Five conditions must be satisfied before an act can successfully be challenged: (i) the relevant body must be amenable to judicial review; (ii) the act has to be of a kind that is open to challenge; (iii) the institution or person making the challenge must have standing to do so; (iv) there must be illegality of a type mentioned in Article 263(2); and (v) the challenge must be brought within the time limit indicated in Article 263(6).


2019 ◽  
Vol 30 (4) ◽  
pp. 1187-1220
Author(s):  
Francisco de Abreu Duarte

Abstract This article develops the concept of the monopoly of jurisdiction of the Court of Justice of the European Union (CJEU) through the analysis of the case study of the Investment Court System (ICS). By providing a general framework over the criteria that have been developed by the Court, the work sheds light on the controversial principle of autonomy of the European Union (EU) and its implications to the EU’s external action. The work intends to be both pragmatic and analytical. On the one hand, the criteria are extracted as operative tools from the jurisprudence of the CJEU and then used in the context of the validity of the ICS. This provides the reader with some definitive standards that can then be applied to future cases whenever a question concerning autonomy arises. On the other hand, the article questions the reasons behind the idea of the monopoly of jurisdiction of the CJEU, advancing a concept of autonomy of the EU as a claim for power and critiquing the legitimacy and coherence of its foundations. Both dimensions will hopefully help to provide some clarity over the meaning of autonomy and the monopoly of jurisdiction, while, at the same time, promoting a larger discussion on its impact on the external action of the EU.


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