scholarly journals OpenEHR and General Data Protection Regulation: Evaluation of Principles and Requirements (Preprint)

2018 ◽  
Author(s):  
Duarte Gonçalves-Ferreira ◽  
Mariana Sousa ◽  
Gustavo M Bacelar-Silva ◽  
Samuel Frade ◽  
Luís Filipe Antunes ◽  
...  

BACKGROUND Concerns about privacy and personal data protection resulted in reforms of the existing legislation in the European Union (EU). The General Data Protection Regulation (GDPR) aims to reform the existing directive on the topic of personal data protection of EU citizens with a strong emphasis on more control of the citizens over their data and in the establishment of rules for the processing of personal data. OpenEHR is a standard that embodies many principles of interoperable and secure software for electronic health records (EHRs) and has been advocated as the best approach for the development of hospital information systems. OBJECTIVE This study aimed to understand to what extent the openEHR standard can help in the compliance of EHR systems to the GDPR requirements. METHODS A list of requirements for an EHR to support GDPR compliance and also a list of the openEHR design principles were made. The requirements were categorized and compared with the principles by experts on openEHR and GDPR. RESULTS A total of 50 GDPR requirements and 8 openEHR design principles were identified. The openEHR principles conformed to 30% (15/50) of GDPR requirements. All the openEHR principles were aligned with GDPR requirements. CONCLUSIONS This study showed that the openEHR principles conform well to GDPR, underlining the common wisdom that truly realizing security and privacy requires it to be built in from the start. By using an openEHR-based EHR, the institutions are closer to becoming compliant with GDPR while safeguarding the medical data.

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 ◽  
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 ◽  
pp. 155-186
Author(s):  
María Dolores Mas Badia

Despite the differences between credit risk and insurance risk, in many countries large insurance companies include credit history amongst the information to be taken into account when assigning consumers to risk pools and deciding whether or not to offer them an auto or homeowner insurance policy, or to determine the premium that they should pay. In this study, I will try to establish some conclusions concerning the requirements and limits that the use of credit history data by insurers in the European Union should be subject to. In order to do this, I shall focus my attention primarily on Regulation (EU) 2016/679. This regulation, that came into force on 24 May 2018, not only forms the backbone of personal data protection in the EU, but is also set to become a model for regulation beyond the borders of the Union. This article will concentrate on two main aspects: the lawful basis for the processing of credit history data by insurers, and the rules that should apply to decisions based solely on automated processing, including profiling.Received: 30 December 2019Accepted: 07 February 2020Published online: 02 April 2020


2021 ◽  
Vol 12 (1) ◽  
pp. 261-268
Author(s):  
Angel Manchev ◽  

The protection of personal data is one of the core values of modern European societies. This protection is provided by the law of the European Union and by the national legislations of the Member States, to which the Republic of Bulgaria also belongs. As of May 25, 2018, the protection of personal data is being expanded and updated in response to technological progress and the increasingly accelerated data exchange. The reason for this is the entry into force of Regulation (EU ) 2016/679 (General Data Protection Regulation, GDPR) and the changes in our national law that it imposes. In the sense of what has been said so far, the issues of personal data protection in children’s institutions are especially relevant, because these organizations actively handle personal data at any level of children, parents, teachers and staff. In this article, we will try to give short answers to some of the most important questions regarding personal data and the rules for their protection, according to European and Bulgarian legislation.


Author(s):  
I.A. Aleshkova

The review summarizes scientific publications that reveal current problems in the field of legal regulation of confidentiality and data protection. It is noted that the General Data Protection Regulation (GDPR) is essential for the work of international organizations. At the same time, its action gives rise to questions about the relationship between EU law and public international law. Attention is focused on those legal values that are decisive in the formation of national and international approaches. The proposed in the scientific literature models of legal regulation of confidentiality and data protection, aimed at achieving international convergence.


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.


Author(s):  
Olexander Zadereyko ◽  
Olena Trofymenko ◽  
Nataliia Loginova

In the European Union, in the first half of 2018, the General Data Protection Regulation came into force, which established the new rules for processing users’ personal data for IT companies. The operating systems (OS) are the dominant software that is responsible for collecting and processing data in computer systems. The most common OS is the Windows OS family. The authors identified Windows 10 operating systems, that collect and accumulate user's personal data; developed and tested practically an algorithm, the application of which localizes and blocks the transfer of user's personal data to official servers of the Microsoft company.


2020 ◽  
Vol 28 (1) ◽  
pp. 1-19
Author(s):  
Deva Prasad M ◽  
Suchithra Menon C

Abstract This article analyses the relevance of Personal Data Protection Bill, 2018 for developing a data protection legal framework in India. In this regard, the article attempts to analyse the evolution process of comprehensive personal data protection law in the Indian context. The manner in which the Personal Data Protection Bill, 2018 will revamp and strengthen the existing data protection regulatory framework forms the major edifice of this article. The article also dwells on the significant role played by the fundamental right to privacy judgment (Justice K.S. Puttaswamy v Union of India) of Supreme Court of India, thus preparing the regulatory ground for the evolution of the Personal Data Protection Bill, 2018. The influence of the European Union General Data Protection Regulation in shaping the Indian legal framework is highlighted. The article also discusses pertinent legal concerns that could question the effectiveness of the proposed data protection legal framework in the Indian context.


2021 ◽  
Vol 13 (3) ◽  
pp. 66
Author(s):  
Dimitra Georgiou ◽  
Costas Lambrinoudakis

The General Data Protection Regulation (GDPR) harmonizes personal data protection laws across the European Union, affecting all sectors including the healthcare industry. For processing operations that pose a high risk for data subjects, a Data Protection Impact Assessment (DPIA) is mandatory from May 2018. Taking into account the criticality of the process and the importance of its results, for the protection of the patients’ health data, as well as the complexity involved and the lack of past experience in applying such methodologies in healthcare environments, this paper presents the main steps of a DPIA study and provides guidelines on how to carry them out effectively. To this respect, the Privacy Impact Assessment, Commission Nationale de l’Informatique et des Libertés (PIA-CNIL) methodology has been employed, which is also compliant with the privacy impact assessment tasks described in ISO/IEC 29134:2017. The work presented in this paper focuses on the first two steps of the DPIA methodology and more specifically on the identification of the Purposes of Processing and of the data categories involved in each of them, as well as on the evaluation of the organization’s GDPR compliance level and of the gaps (Gap Analysis) that must be filled-in. The main contribution of this work is the identification of the main organizational and legal requirements that must be fulfilled by the health care organization. This research sets the legal grounds for data processing, according to the GDPR and is highly relevant to any processing of personal data, as it helps to structure the process, as well as be aware of data protection issues and the relevant legislation.


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