scholarly journals International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection

Author(s):  
Laura Bradford ◽  
Mateo Aboy ◽  
Kathleen Liddell

Abstract International health research increasingly depends on collaboration and combination using medical data to advance treatment and drug discovery. The European Union (EU), through its General Data Protection Regulation, has tightened the rules for sharing data across borders to protect individual privacy. These new rules threaten cooperation between the EU and the USA, the two largest public funders of biomedical research. This article analyzes the primary pathway for sharing research data with the USA, the US–EU Privacy Shield††, and argues that the Shield is ill-suited to support complex health studies. Its legitimacy is in question under both EU and US law, and its terms are too restrictive for the variety of exchanges underlying research, treatment, and care. As an alternative, we propose that the USA seek an additional sector-based adequacy determination based on the existing US health privacy law, the Health Insurance Portability and Accountability Act. A sector-specific approach to adequacy for health would avoid many of the most contentious issues that divide the USA and EU on data protection. It could also serve as a model for other third-party jurisdictions and facilitate international harmonization of health research practices.

Author(s):  
Szilvia Varadi

Cloud Computing is a diverse research area that encompasses many aspects of sharing software and hardware solutions, including computing and storage resources, application runtimes or complex application functionalities. In the supply of any goods and services, the law gives certain rights that protect the consumer and provider, which also applies for Cloud Computing. This new technology also moves functions and responsibilities away from local ownership and management to a third-party provided service, and raises several legal issues, such as data protection, which require this service to comply with necessary regulation. In this chapter the author investigates the revised legislation of the European Union resulting in the General Data Protection Regulation, which will be used to set up the new European Data Protection Framework. The author gathers and summarizes the most relevant changes this regulation brings to the field of Clouds, and draws relations to the previous legislation called the Data Protection Directive currently in force.


2020 ◽  
Vol 48 (S1) ◽  
pp. 187-195
Author(s):  
Edward S. Dove ◽  
Jiahong Chen

In this article, we consider the possible application of the European General Data Protection Regulation (GDPR) to “citizen scientist”-led health research with mobile devices. We argue that the GDPR likely does cover this activity, depending on the specific context and the territorial scope. Remaining open questions that result from our analysis lead us to call for lex specialis that would provide greater clarity and certainty regarding the processing of health data by for research purposes, including these non-traditional researchers.


2021 ◽  
Vol 273 ◽  
pp. 08099
Author(s):  
Mikhail Smolenskiy ◽  
Nikolay Levshin

The EU’s General Data Protection Regulation (GDPR) applies not only to the territory of the European Union, but also to all information systems containing data of EU’s citizens around the world. Misusing or carelessly handling personal data bring fines of up to 20 million euros or 4% of the annual turnover of the offending company. This article analyzes the main trends in the global implementation of the GDPR. Authors considered and analyzed results of personal data protection measures in nineteen regions: The USA, Canada, China, France, Germany, India, Kazakhstan, Nigeria, Russia, South Korea and Thailand, as well as the European Union and a handful of other. This allowed identifying a direct pattern between the global tightening of EU’s citizens personal data protection and the fragmentation of the global mediasphere into separate national segments. As a result of the study, the authors conclude that GDPR has finally slowed down the globalization of the online mediasphere, playing a main role in its regional fragmentation.


2020 ◽  
Vol 4 (2) ◽  
pp. 81-94
Author(s):  
Matúš Mesarčík

A new era of data protection laws arises after the adoption of the General Data Protection Regulation (GDPR) in the European Union. One of the newly adopted regulations of processing of personal data is Californian Consumer Privacy Act commonly referred to as CCPA. The article aims to fill the gap considering a deep analysis of the territorial scope of both acts and practical consequences of the application. The article starts with a brief overview of privacy regulation in the EU and USA. Introduction to GDPR and CCPA follows focusing on the territorial scope of respective legislation. Three scenarios of applicability are derived in the following part including practical examples.


2021 ◽  
Vol 28 (2) ◽  
pp. 531-565
Author(s):  
Md. Toriqul Islam ◽  
Mohammad Ershadul Karim

The General Data Protection Regulation (the GDPR) of the European Union (EU) emerges as a hot-button issue in contemporary global politics, policies, and business. Based on an omnibus legal substance, extensive extraterritorial scope and influential market powers, it appears as a standard for global data protection regulations as can be witnessed by the growing tendency of adopting, or adjusting relevant national laws following the instrument across the globe. Under Article 3, of the GDPR applies against any data controller or processor within and outside the EU, who process the personal data of EU residents. Therefore, the long arm of the GDPR is extended to cover the whole world, including Malaysia. This gives rise to tension worldwide, as non-compliance thereof leads to severe fines of up to €20 million or 4% of annual turnover. This is not a hypothetical possibility, rather a reality, as a huge amount of fines are already imposed on many foreign companies, such as Google, Facebook, Uber, and Equifax to name a few. Such a scenario, due to the existence of state sovereignty principles under international law, has made the researchers around the world curious about some questions, why does the EU adopt an instrument having the extraterritorial application; whether the extraterritorial scope is legitimate under normative international law; how the provisions of this instrument can be enforced, and how these are justified. This article attempts to search for answers to those questions by analyzing the relevant rules and norms of international law and the techniques of the EU employed. The article concludes with the findings that the extraterritorial scope of the GDPR is justified under international law in a changed global context. The findings of this article will enlighten the relevant stakeholders, including Malaysian policymakers and business entities, to realise the theoretical aspects of inclusion of the extraterritorial feature of the GDPR, and this understanding may facilitate them to map their future strategies.


2021 ◽  
Vol 30 ◽  
pp. 99-110
Author(s):  
Paloma Krõõt Tupay ◽  
Martin Ebers ◽  
Jakob Juksaar ◽  
Kea Kohv

The General Data Protection Regulation (GDPR) is, together with its seven principles, designed to function as the cornerstone of data protection in the European Union. Although the GDPR was meant to keep up with technological and socioeconomic changes while guaranteeing fundamental rights, its unclear wording with regard to the use of artificial intelligence (AI) systems has led to uncertainty. Therefore, the development and application of ever new AI systems raises various, as yet unresolved questions. Moreover, the complexity of legal requirements poses the risk of inhibiting AI innovation in the European Union. On the other hand, the GDPR gives Member States certain leeway to regulate data processing by public authorities. Therefore, data protection requirements for AI systems in public administration must be assessed under both the GDPR and national law. Against this backdrop, the article aims to guide the reader through the relevant data-protection rules applicable to AI systems in both the EU and in Estonia.


2021 ◽  
Vol 60 (1) ◽  
pp. 53-98
Author(s):  
Michael S. Aktipis ◽  
Ron B. Katwan

On July 16, 2020, the Court of Justice of the European Union (CJEU) issued its ruling in Data Protection Commissioner v. Facebook Ireland Limited and Maximillian Schrems, commonly known as Schrems II, invalidating the EU–U.S. Privacy Shield as a valid transfer mechanism under the EU's General Data Protection Regulation (GDPR) and creating significant legal uncertainty for the continued availability of another widely used transfer mechanism, Standard Contractual Clauses (SCCs), for transfers of EU personal data from commercial entities in the EU to the United States. The widely anticipated ruling marked the second time in five years that the CJEU had invalidated the legal foundation for such data transfers, which in both cases had been the result of a carefully negotiated compromise balancing European data privacy concerns with statutory and constitutional limitations of the U.S. system (see Schrems I).


2019 ◽  
Vol 24 (1) ◽  
pp. 1-5
Author(s):  
Ralf Kneuper

In May 2018, the General Data Protection Regulation (GDPR 2016) came into effect in the European Union (EU), defining requirements on how to handle personal data of EU citizens. This report discusses the effects of this regulation on software development organisations outside the EU, and summaries the software requirements that result from GDPR and therefore apply to most information technology (IT) systems that will handle data of individuals based in the EU.


2020 ◽  
Vol 3 (1) ◽  
Author(s):  
George Suciu ◽  
Cristiana Istrate ◽  
Mari-Anais Sachian ◽  
Oana Chenaru ◽  
Gheorghe Florea

Since the establishment of IoT (Internet of Things), a variety of end devices become interconnected with one another, and thus, new types of security challenges appeared which have to be taken care of. Personal data, at the moment, have a higher risk of being hacked by various types of cyberattacks, as a result of the abundance of connectivity in the cloud realm. To face this type of challenges, the European Union decided to implement in 2018 the GDPR (General Data Protection Regulation) that implies that personal data of any kind can be shared with a third party only with their accord and can be, as well, deleted by them, whenever they desire. Henceforth, this paper introduces the PARFAIT project that will take into account this regulation and will integrate a platform with the purpose of protecting the personal data in IoT based applications, especially for smart home, smart office and smart hotel use cases.


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