scholarly journals Analysis of Legal and Regulatory Frameworks in Digital Health: A Comparison of Guidelines and Approaches in the European Union and United States

2020 ◽  
Vol 8 ◽  
Author(s):  
Fara Aninha Fernandes ◽  
Georgi V Chaltikyan
Keyword(s):  
United States ◽  
European Union ◽  
Digital Health ◽  
Clinical Decision Support Systems ◽  
Clinical Decision ◽  
The European Union ◽  
Regulatory Pathways ◽  
Regulatory Frameworks ◽  
The Impact ◽  
Regulatory Landscape

The advent of digital technology in healthcare presents opportunities for the improvement of healthcare systems around the world and the move towards value-based treatment. However, this move must be accompanied by strong legal and regulatory frameworks that will not only facilitate but encourage the good use of technology. The goal of the study was to assess the amenability and furtherance of regulatory frameworks in digital health by evaluating and comparing the processes, effectiveness and outcomes of these frameworks in the European Union and United States. Methods: This study incorporated two research methodologies. The first was a research of current legal and regulatory frameworks in digital health in the European Union and United States. A comprehensive online search for publications was carried out which included laws, regulations, policies, green papers, guidelines and recommendations. This research was complemented with interviews of five purposively sampled key informants in the legal and regulatory landscape. Results: Mind-maps revealed key features and challenges of the digital health field in the topics of the current state of regulation of digital health in the EU, Germany and US, regulatory pathways for digital health devices, protection and privacy of health data, mobile health validation, risk-based classification of medical devices, regulation of clinical decision support systems, telemedicine, artificial intelligence and emerging technologies, reimbursement for digital health services and liability for digital health products. The experts expressed and explained key points where current regulation is deficient. The review of the legal frameworks revealed deficiencies which provide opportunities and recommendations to further develop and strengthen the regulatory landscape. Conclusions: A key element to a robust regulatory framework is the ability to ensure trust and confidence in using digital health technology. Technology must measure the impact on quality of life and burden of disease and not merely involve the collection of data.

Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States

Cytotherapy ◽  
2021 ◽  
Vol 23 (3) ◽  
pp. 261-274
Author(s):  
Carolina Iglesias-Lopez ◽  
Mercè Obach ◽  
Antonio Vallano ◽  
Antonia Agustí
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
The European Union ◽  
Regulatory Pathways ◽  
Advanced Therapies

scholarly journals Matrix Hard - The Impact of Technological, Economic and Social Indicators on Productivity and Competitiveness

2020 ◽  
Vol 3 (4) ◽  
pp. 37-44
Author(s):  
Marina Popa ◽  
Maia Pisaniuc
Keyword(s):  
United States ◽  
European Union ◽  
World Economy ◽  
Social Indicators ◽  
The United States ◽  
The European Union ◽  
The World ◽  
The Impact ◽  
Productivity And Competitiveness ◽  
Economic And Social Indicators

The objective of this research is to demonstrate the impact of technological, economic and social indicators on productivity and competitiveness through the HARD Matrix method, proposed by the European Commission. The level of economic development of different countries, as well as the degree of diversification and specialization of their world production, determines the degree of integration of national economies in the world economy that differs considerably by country and group of countries. The expansion and amplification of the internationalization process have substantially changed the place and role of each state in the world economy. Due to this process, today's world economy is no longer a simple sum of economies put in contact, but a global-universal system, unitary through the interrelationships between the component subsystems and its extremely heterogeneous structure. In the twenty first-century, the process of amplifying innovation, the net economy, and the Covid 19 pandemic have shaped new trends in the world countries and determined the balance of power between the three great empires of the world – the United States, the European Union, and China. At the same time, there are no similar links between the United States, the European Union and China, they do not share the same culture, do not share the same geographic space, and do not use the same models of economic development, but all of them consider innovation, sophisticated business, technology, safe tools in promoting economic growth and competitiveness.

scholarly journals The Design and Impacts of Individual Sanctions: Evidence From Elites in Côte d’Ivoire and Zimbabwe

2022 ◽  
Vol 10 (1) ◽  
Author(s):  
Clara Portela ◽  
Thijs Van Laer
Keyword(s):  
United States ◽  
European Union ◽  
United Nations ◽  
Cote D'ivoire ◽  
Côte D’Ivoire ◽  
The United States ◽  
The European Union ◽  
Cote D’Ivoire ◽  
Côte D'ivoire ◽  
The Impact

Since the 1990s, sanctions senders like the European Union, the United States, and the United Nations have been imposing visa bans and asset freezes on individuals as a key element of their sanctions packages. Notwithstanding the growing centrality that individual sanctions have acquired in international sanctions practice, little is known about the impact of sanctions listings on designees. Some researchers have scrutinised targeting choices, while others have explored the effects of sanctions on designees. However, no study has yet examined the fit between targeting choices and impacts on designees. First, we interrogate the theory of targeted sanctions to identify the expectations that it generates. Second, we examine the effects on designees and contrast them with the targeting logic of the sender, in a bid to ascertain their fit. Our analysis of the cases of Côte d’Ivoire (2010–2011) and Zimbabwe (2002–2017) benefits from original interview material.

17. The European Union and the USA

2017 ◽  
Author(s):  
Michael Smith ◽  
Rebecca Steffenson
Keyword(s):  
United States ◽  
European Union ◽  
International Relations ◽  
The United States ◽  
The European Union ◽  
The Usa ◽  
Security Questions ◽  
The Impact ◽  
Policy Mechanisms ◽  
The Eu

This chapter examines the evolution of the European Union's relations with the United States. More specifically, it looks at the ways in which EU–US relations enter into the international relations of the EU as well as the implications for key areas of the EU's growing international activity. The chapter begins with an overview of the changing shape and focus of the EU–US relationship as it enters into economic, political, and security questions. It then considers the impact of EU–US relations on the EU's system of international relations, on the EU's role in the processes of international relations, and on the EU's position as a ‘power’ in international relations. It shows that the EU–US relationship has played a key (and contradictory) role in development of the EU's foreign policy mechanisms.

The Impact of Contingency Fees on Collective Antitrust Actions: Experiments from Lithuania and Poland

2016 ◽  
Vol 41 (3-4) ◽  
pp. 368-395 ◽  
Author(s):  
Žygimantas Juška
Keyword(s):  
United States ◽  
European Union ◽  
Conflicts Of Interest ◽  
Group Actions ◽  
The United States ◽  
Individual Behavior ◽  
The European Union ◽  
Contingency Fees ◽  
The Individual ◽  
The Impact

Contingency-fee agreements are one—if not the only—tool that can be used to ensure that small-stakes collective antitrust actions are heard, yet they are subject to strong resistance from the European Union. There is a concern that contingency fees could lead to abuses of the system or conflicts of interest, as has been seen in the United States. Contrary to eu policy, two proactive member states—Lithuania and Poland—have introduced the possibility of using contingency fees in group litigation in order to facilitate group actions. Despite having a lot of potential, this paper will demonstrate that the introduction alone of contingency fees will not facilitate the compensation objective that is embedded in the Directive on damages actions. In addition, it will show that the safeguard policy against frivolous litigation is sufficient to limit the possibilities for litigation abuses, but it is ineffective for monitoring the individual behavior of group representatives.

scholarly journals A Critical Evaluation of the Estonian Cyber Incident

2020 ◽  
Vol 1 (2) ◽  
pp. 7-14
Author(s):  
Donald L. Buresh
Keyword(s):  
United States ◽  
European Union ◽  
North Atlantic ◽  
Critical Evaluation ◽  
The United States ◽  
Cyber Attacks ◽  
The European Union ◽  
The North ◽  
The North Atlantic ◽  
The Impact

This paper evaluates the effect of the Estonian cyber incident on Estonia, Russia, the United States, the European Union, and the North Atlantic Treaty Organization, also known as NATO. The paper employs the Valeriano and Maness criteria for evaluating a cyber incident critically. The article asks how did the Estonian cyber incident come to pass, what were the foreign policy and international relationship effects, what was the impact on Estonia, and how did Estonia react to the attack. The essay concludes that the Estonian cyber incident was a catalyst, prompting the nations listed herein to address the effects of cyber-attacks, and then search for acceptable solutions.

scholarly journals Economic and financial results of the USA and the European Union sanctions war against Russia: first results

2021 ◽  
Vol 39 (68) ◽  
pp. 251-272
Author(s):  
Ilmir Nusratullin ◽  
Raul Yarullin ◽  
Tagira Ismagilova ◽  
Olga Eremeeva ◽  
Tatiana Ermoshina
Keyword(s):  
United States ◽  
European Union ◽  
Financial Sector ◽  
The United States ◽  
Federal State ◽  
The European Union ◽  
Russian Economy ◽  
First Results ◽  
The Usa ◽  
The Impact

As part of this study, the goal is set to assess the impact of sanctions imposed by the United States and the European Union on the economy and financial sector of Russia, to identify the effectiveness of the initial goals of these countries. To achieve the goal, the legal acts concerning the imposed sanctions of the USA and the European Union against Russia were first analyzed, a chronology of events was described, and sanctions were classified. Further, based on the data of the World Bank and the Federal State Statistics Service of the Russian Federation, the results of the sanction pressure on the Russian economy and financial sector were estimated. Then the results of this study were compared with the results obtained by other scholars. The paper concluded that the sanctions of the United States and the European Union did have an impact on the economy and financial sector of Russia, but this influence was not as significant as the leaders of these countries expected. In addition, the impact of the sanctions is gradually decreasing despite the introduction of new sanctions on various pretexts.

scholarly journals The Impact of Externalization of Migration Controls on the Rights of Asylum Seekers and Other Migrants

2016 ◽  
Vol 4 (4) ◽  
pp. 190-220 ◽  
Author(s):  
Bill Frelick ◽  
Ian M. Kysel ◽  
Jennifer Podkul
Keyword(s):  
United States ◽  
European Union ◽  
Human Rights ◽  
Asylum Seekers ◽  
The United States ◽  
Legal Responsibility ◽  
The European Union ◽  
Migration Flow ◽  
Protection Of Human Rights ◽  
The Impact

Wars, conflict, and persecution have forced more people to flee their homes and seek refuge and safety elsewhere than at any time since the end of World War II. As displaced people and other migrants increasingly move out of the conflict-ridden and less developed regions of their displacement and into relatively rich and stable regions of the world, the countries of destination are increasingly working to contain and even stem the migration flow before it reaches their shores. Perversely, countries that have developed generally rights-sensitive standards and procedures for assessing protection claims of asylum seekers within their jurisdictions have simultaneously established barriers that prevent migrants, including asylum seekers, from setting foot on their territories or otherwise triggering protection obligations. Consequently, those who would otherwise have been able to avail themselves of asylum procedures, social support, and decent reception conditions are often relegated to countries of first arrival or transit that have comparatively less capacity to ensure protection of human rights in accordance with international standards. This paper seeks to develop a working definition of the externalization of migration controls and how such externalization of the border implicates the human rights of migrants, and asylum seekers in particular. Although the majority of those migrants seeking legal protections stay in countries neighboring their own, hundreds of thousands continue their journeys in search of protection and stability in more distant states, including in the European Union, the United States, and Australia. In response to the significant increase in asylum seekers arriving at their borders, all three entities have significantly increased deterrence measures with the hopes of keeping new arrivals from entering. This paper will thus highlight a number of the most troubling externalization strategies used by the European Union, the United States, and Australia. Finally, because rights-threatening externalization law, policies, and practices implicate the international legal responsibility of the destination states pursuing them, the paper will conclude by presenting recommendations that could strengthen protection of human rights in the context of state actions seeking to manage migration.

The Impact of International Sanctions on Russia’s Media Economy

2017 ◽  
Vol 2 (1) ◽  
pp. 80-97 ◽  
Author(s):  
Ilya Kiriya
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
The European Union ◽  
Economic Stability ◽  
Russian State ◽  
International Sanctions ◽  
The Impact ◽  
Media Corporations ◽  
Aligned Media

To punish Russia for the annexation of Crimea from Ukraine, the United States and the European Union introduced a set of economic sanctions against Russian state companies and individuals closely affiliated with the Kremlin. The goal of this article is to look at the sanctions in relation to the process of the current consolidation of media assets and revenues in the hands of Russia’s biggest media empires, most of whom are close to the Kremlin. It questions whether the sanctions achieved the intended goal of undermining economic stability inside Russia or if, rather, they benefitted major state-aligned media corporations. The main conclusion drawn from the study is that the international sanctions have radically changed the structure of Russia’s media in a manner contrary to their intention. The sanctions unwittingly favored the biggest players to the detriment of the smaller, protecting state-aligned media and their financial incomes. In the climate of sanctions, media tycoons close to the Kremlin used their lobbying capacity in parliament to acquire advantages, primarily in terms of advertisement. Thus, smaller competitors were pushed out of the market and their shares were redistributed among a few major stakeholders.

scholarly journals ENERGY SECURITY OF THE REPUBLIC OF CRIMEA UNDER THE INTERNATIONAL SANCTIONS

2018 ◽  
pp. 119-130
Author(s):  
Матвей Оборин ◽  
Matvey Oborin ◽  
Ирина РОДЕНКО ◽  
Irina RODENKO
Keyword(s):  
United States ◽  
European Union ◽  
United States Of America ◽  
Energy Security ◽  
The United States ◽  
Point Of View ◽  
The European Union ◽  
Energy Complex ◽  
The Republic ◽  
The Impact

The article defines the essence of the sanctions of the European Union, the United States of America and Ukraine that have been applied to Russia, compiles the list of sanctions against the Republic of Crimea, and determines their impact on energy security of the Republic of Crimea. The authors discuss the features of sanctions as economic constraints: their goals, objectives, and ef- fects, which allows talking about efficiency; the relationship with the political course. The article characterizes the fuel and energy complex as an important sphere of economic activity of the country from the point of view of influencing the national economy development, social sphere, quality of public services. The authors justify the energy sector development with the economic and financial point of view, priority investments for the Republic of Crimea. The article presents and summarizes the main types of sanctions against the Republic of Crimea, the impact of sanctions on Ukraine in fuel and energy complex. The article is aimed at determining the nature and effects of the applied sanc- tions of the European Union countries, the United States of America and Ukraine on fuel and energy security of the Republic of Crimea. The system approach, analysis, synthesis, expert evaluation, comparison, ob- servation, generalization are the main methods of the article. The main results are based on the analysis of the fuel and energy complex of the Republic of Crimea: the potential, power, types of energy, the main company. The article analyzes the development of the state unitary enterprise "Chernomorneftegaz", representing the oil and gas industry of the Republic of Crimea, at which sanctions of the European Union and the United States of America direct the sanctions. Scientific novelty consists in structuring the essence of the sanctions against the Republic of Crimea and the definition of activities aimed at minimizing their impact on fuel and energy complex of the Republic of Crimea.

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