scholarly journals Data protection issues in cross-border interoperability of Electronic Health Record systems within the European Union

Data & Policy ◽  
2020 ◽  
Vol 2 ◽  
Author(s):  
Giorgia Bincoletto

Abstract This study investigates the data protection concerns arising in the context of the cross-border interoperability of Electronic Health Record (EHR) systems in the European Union. The article first introduces the policies on digital health and examines the related interoperability issues. Second, the work analyses the latest Recommendation of the European Commission on this topic. Then, the study discusses the rules and the obligations settled by the General Data Protection Regulation to be taken into account when developing interoperable EHRs. According to the data protection by design and by default provision, EHR systems should be designed ex ante to guarantee data protection rules.

Author(s):  
Bocong Yuan ◽  
Jiannan Li

The rapid development of digital health poses a critical challenge to the personal health data protection of patients. The European Union General Data Protection Regulation (EU GDPR) works in this context; it was passed in April 2016 and came into force in May 2018 across the European Union. This study is the first attempt to test the effectiveness of this legal reform for personal health data protection. Using the difference-in-difference (DID) approach, this study empirically examines the policy influence of the GDPR on the financial performance of hospitals across the European Union. Results show that hospitals with the digital health service suffered from financial distress after the GDPR was published in 2016. This reveals that during the transition period (2016–2018), hospitals across the European Union indeed made costly adjustments to meet the requirements of personal health data protection introduced by this new regulation, and thus inevitably suffered a policy shock to their financial performance in the short term. The implementation of GDPR may have achieved preliminary success.


Hypertension ◽  
2021 ◽  
Vol 77 (4) ◽  
pp. 1029-1035
Author(s):  
Antonia Vlahou ◽  
Dara Hallinan ◽  
Rolf Apweiler ◽  
Angel Argiles ◽  
Joachim Beige ◽  
...  

The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.


2021 ◽  
pp. 77-91
Author(s):  
Kieron O’Hara

This chapter describes the Brussels Bourgeois Internet. The ideal consists of positive, managed liberty where rights of others are respected, as in the bourgeois public space, where liberty follows only when rights are secured. The exemplar of this approach is the European Union, which uses administrative means, soft law, and regulation to project its vision across the Internet. Privacy and data protection have become the most emblematic struggles. Under the Data Protection Directive of 1995, the European Union developed data-protection law and numerous privacy rights, including a right to be forgotten, won in a case against Google Spain in 2014, the arguments about which are dissected. The General Data Protection Regulation (GDPR) followed in 2018, amplifying this approach. GDPR is having the effect of enforcing European data-protection law on international players (the ‘Brussels effect’), while the European Union over the years has developed unmatched expertise in data-protection law.


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.


2021 ◽  
Author(s):  
Jian Jia ◽  
Ginger Zhe Jin ◽  
Liad Wagman

Jia et al. study the effects of the General Data Protection Regulation on technology venture investment in the European Union.


2018 ◽  
Vol 25 (2) ◽  
pp. 36-41
Author(s):  
Cassandra Yuill

AbstractIn May 2018, the European Union (EU) introduced the General Data Protection Regulation (GDPR) with the aim of increasing transparency in data processing and enhancing the rights of data subjects. Within anthropology, concerns have been raised about how the new legislation will affect ethnographic fieldwork and whether the laws contradict the discipline’s core tenets. To address these questions, the School of Oriental and African Studies (SOAS) at the University of London hosted an event on 25 May 2018 entitled ‘Is Anthropology Legal?’, bringing together researchers and data managers to begin a dialogue about the future of anthropological work in the context of the GDPR. In this article, I report and reflect on the event and on the possible implications for anthropological research within this climate of increasing governance.


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.


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