scholarly journals General data protection regulations (2018) and clinical research: perspectives of patients and doctors in an Irish university teaching hospital

2021 ◽  
Author(s):  
Matthew G. Davey ◽  
John P.M. O’Donnell ◽  
Elizabeth Maher ◽  
Cliona McMenamin ◽  
Peter F. McAnena ◽  
...  
Keyword(s):  
Clinical Research ◽  
Teaching Hospital ◽  
Data Protection ◽  
Personal Data ◽  
University Teaching ◽  
European Economic Area ◽  
Level Of Education ◽  
Research Perspectives ◽  
Explicit Consent ◽  
General Data

Abstract Background Europe’s General Data Protection Regulation, or GDPR, is a set of data protection rules on the acquisition, storage, use, and access of personal data. GDPR came into effect in May 2018 when it was introduced across all 27 European Union (EU) member states and the European Economic Area (EEA). Maintaining compliance with this legislation has presented significant new challenges for ongoing clinical research. Aims To evaluate the knowledge and expectations of patients and doctors regarding GDPR and implications for future clinical research. Methods An anonymous 12-item questionnaire was circulated to patients and doctors at a University Teaching Hospital. Data analysis included descriptive statistics. Results Five hundred nine participants were included: 261 females (51.3%) and 248 males (48.7%). Three hundred fifty were patients (68.8%) and 159 were doctors (31.2%). Three hundred thirty-four participants were aware of GDPR (65.7%): 116 doctors (73.0%) and 218 patients (62.3%, P = 0.018). 71.1% of doctors were willing to allow their personal data to be processed anonymously as part of a clinical research project compared to 43.4% of patients (P < 0.001). 80.2% of patients believed explicit consent is needed before using personal data in clinical research in comparison to 60.4% of doctors (P < 0.001). Level of education impacted awareness of GDPR (P < 0.001); a higher level of education among patients increased GDPR familiarity (P < 0.001), however failed to impact doctor familiarity (P = 0.117). Conclusion GDPR has introduced complexity to the processing and sharing of personal data among researchers. This study has identified differences in the perception of GDPR and willingness to consent to data being used in clinical research between doctors and patients. Measures to adequately inform prospective research participants on data processing and the evolving landscape of data protection regulation should be prioritised.

scholarly journals AB189. SOH21AS236. General Data Protection Regulations [2018] and clinical research: perspectives of patients and doctors in a model four teaching hospital

2021 ◽  
Vol 5 ◽  
pp. AB189-AB189
Author(s):  
Elizabeth Maher ◽  
Matthew Gerard Davey ◽  
Peter Francis McAnena ◽  
Cliona McMenamin ◽  
John Phineas O’Donnell ◽  
...  
Keyword(s):  
Clinical Research ◽  
Teaching Hospital ◽  
Data Protection ◽  
Research Perspectives ◽  
General Data

Introduction

2019 ◽  
pp. 3-18
Author(s):  
David Erdos
Keyword(s):  
Data Protection ◽  
Public Discourse ◽  
Freedom Of Expression ◽  
Methodological Approach ◽  
Personal Data ◽  
European Economic Area ◽  
Normative Study ◽  
General Data Protection Regulation ◽  
General Data ◽  
Professional Artists

This chapter introduces the tension between European data protection regulation and freedom of expression, including the heightened form this tension assumes as regards the activity of professional journalists and other traditional publishers. These actors not only play a central role in public discourse but also often possess a disproportionate ability to gather, process, and disseminate personal data. It is therefore important both to examine how these interactions have played out at different times, in different places and contexts, and to consider how they might best evolve across the European Economic Area (EEA) under the new European Union (EU) General Data Protection Regulation (GDPR). The concept of traditional publishers is often equated to professional journalists and the institutional media but should also encompass professional artists and writers including academics. The chapter delineates the scope of this empirical and normative study, explores the key concepts deployed, and elucidates the methodological approach adopted.

The Risk-Based Approach to Data Protection

2020 ◽  
Author(s):  
Raphaël Gellert
Keyword(s):  
Risk Management ◽  
Data Protection ◽  
Personal Data ◽  
Management Tools ◽  
General Data Protection Regulation ◽  
Regulation Theory ◽  
Régulation Theory ◽  
General Data ◽  
Data Protection Law ◽  
The Way

The main goal of this book is to provide an understanding of what is commonly referred to as “the risk-based approach to data protection”. An expression that came to the fore during the overhaul process of the EU’s General Data Protection Regulation (GDPR)—even though it can also be found in other statutes under different acceptations. At its core it consists in endowing the regulated organisation that process personal data with increased responsibility for complying with data protection mandates. Such increased compliance duties are performed through risk management tools. It addresses this topic from various perspectives. In framing the risk-based approach as the latest model of a series of regulation models, the book provides an analysis of data protection law from the perspective of regulation theory as well as risk and risk management literatures, and their mutual interlinkages. Further, it provides an overview of the policy developments that led to the adoption of such an approach, which it discusses in the light of regulation theory. It also includes various discussions pertaining to the risk-based approach’s scope and meaning, to the way it has been uptaken in statutes including key provisions such as accountability and data protection impact assessments, or to its potential and limitations. Finally, it analyses how the risk-based approach can be implemented in practice by providing technical analyses of various data protection risk management methodologies.

scholarly journals Record linkage of routine data with cohorts’ data of infants under European and Portuguese law

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
J Doetsch ◽  
I Lopes ◽  
R Redinha ◽  
H Barros
Keyword(s):  
Big Data ◽  
Data Processing ◽  
Data Protection ◽  
Record Linkage ◽  
Data Science ◽  
Personal Data ◽  
Routine Data ◽  
Cohort Data ◽  
Education Data ◽  
Explicit Consent

Abstract The usage and exchange of “big data” is at the forefront of the data science agenda where Record Linkage plays a prominent role in biomedical research. In an era of ubiquitous data exchange and big data, Record Linkage is almost inevitable, but raises ethical and legal problems, namely personal data and privacy protection. Record Linkage refers to the general merging of data information to consolidate facts about an individual or an event that are not available in a separate record. This article provides an overview of ethical challenges and research opportunities in linking routine data on health and education with cohort data from very preterm (VPT) infants in Portugal. Portuguese, European and International law has been reviewed on data processing, protection and privacy. A three-stage analysis was carried out: i) interplay of threefold law-levelling for Record Linkage at different levels; ii) impact of data protection and privacy rights for data processing, iii) data linkage process' challenges and opportunities for research. A framework to discuss the process and its implications for data protection and privacy was created. The GDPR functions as utmost substantial legal basis for the protection of personal data in Record Linkage, and explicit written consent is considered the appropriate basis for the processing sensitive data. In Portugal, retrospective access to routine data is permitted if anonymised; for health data if it meets data processing requirements declared with an explicit consent; for education data if the data processing rules are complied. Routine health and education data can be linked to cohort data if rights of the data subject and requirements and duties of processors and controllers are respected. A strong ethical context through the application of the GDPR in all phases of research need to be established to achieve Record Linkage between cohort and routine collected records for health and education data of VPT infants in Portugal. Key messages GDPR is the most important legal framework for the protection of personal data, however, its uniform approach granting freedom to its Member states hampers Record Linkage processes among EU countries. The question remains whether the gap between data protection and privacy is adequately balanced at three legal levels to guarantee freedom for research and the improvement of health of data subjects.

scholarly journals Application of Blockchain in Education: GDPR-Compliant and Scalable Certification and Verification of Academic Information

2021 ◽  
Vol 11 (10) ◽  
pp. 4537
Author(s):  
Christian Delgado-von-Eitzen ◽  
Luis Anido-Rifón ◽  
Manuel J. Fernández-Iglesias
Keyword(s):  
Data Protection ◽  
Personal Data ◽  
General Data Protection Regulation ◽  
Certification System ◽  
Proposed Model ◽  
Different Types ◽  
International Regulations ◽  
Innovative Solution ◽  
General Data ◽  
Academic Information

Blockchain technologies are awakening in recent years the interest of different actors in various sectors and, among them, the education field, which is studying the application of these technologies to improve information traceability, accountability, and integrity, while guaranteeing its privacy, transparency, robustness, trustworthiness, and authenticity. Different interesting proposals and projects were launched and are currently being developed. Nevertheless, there are still issues not adequately addressed, such as scalability, privacy, and compliance with international regulations such as the General Data Protection Regulation in Europe. This paper analyzes the application of blockchain technologies and related challenges to issue and verify educational data and proposes an innovative solution to tackle them. The proposed model supports the issuance, storage, and verification of different types of academic information, both formal and informal, and complies with applicable regulations, protecting the privacy of users’ personal data. This proposal also addresses the scalability challenges and paves the way for a global academic certification system.

scholarly journals Algorithms that remember: model inversion attacks and data protection law

2018 ◽  
Vol 376 (2133) ◽  
pp. 20180083 ◽  
Author(s):  
Michael Veale ◽  
Reuben Binns ◽  
Lilian Edwards
Keyword(s):  
Data Protection ◽  
Personal Data ◽  
Training Data ◽  
Theme Issue ◽  
Future Directions ◽  
Model Inversion ◽  
General Data Protection Regulation ◽  
General Data ◽  
Inference Attacks ◽  
Use Of Models

Many individuals are concerned about the governance of machine learning systems and the prevention of algorithmic harms. The EU's recent General Data Protection Regulation (GDPR) has been seen as a core tool for achieving better governance of this area. While the GDPR does apply to the use of models in some limited situations, most of its provisions relate to the governance of personal data, while models have traditionally been seen as intellectual property. We present recent work from the information security literature around ‘model inversion’ and ‘membership inference’ attacks, which indicates that the process of turning training data into machine-learned systems is not one way, and demonstrate how this could lead some models to be legally classified as personal data. Taking this as a probing experiment, we explore the different rights and obligations this would trigger and their utility, and posit future directions for algorithmic governance and regulation. This article is part of the theme issue ‘Governing artificial intelligence: ethical, legal, and technical opportunities and challenges’.

Regulatory Challenges of Data Mining Practices: The Case of the Never-ending Lifecycles of ‘Health Data’

2018 ◽  
Vol 25 (3) ◽  
pp. 284-307
Author(s):  
Giovanni Comandè ◽  
Giulia Schneider
Keyword(s):  
Data Mining ◽  
Data Protection ◽  
Personal Data ◽  
Health Data ◽  
General Level ◽  
General Data Protection Regulation ◽  
The Face ◽  
General Data ◽  
Level Of Analysis

Abstract Health data are the most special of the ‘special categories’ of data under Art. 9 of the General Data Protection Regulation (GDPR). The same Art. 9 GDPR prohibits, with broad exceptions, the processing of ‘data concerning health’. Our thesis is that, through data mining technologies, health data have progressively undergone a process of distancing from the healthcare sphere as far as the generation, the processing and the uses are concerned. The case study aims thus to test the endurance of the ‘special category’ of health data in the face of data mining technologies and the never-ending lifecycles of health data they feed. At a more general level of analysis, the case of health data shows that data mining techniques challenge core data protection notions, such as the distinction between sensitive and non-sensitive personal data, requiring a shift in terms of systemic perspectives that the GDPR only partly addresses.

scholarly journals Data Sharing Under the General Data Protection Regulation

Hypertension ◽  
2021 ◽  
Vol 77 (4) ◽  
pp. 1029-1035
Author(s):  
Antonia Vlahou ◽  
Dara Hallinan ◽  
Rolf Apweiler ◽  
Angel Argiles ◽  
Joachim Beige ◽  
...  
Keyword(s):  
European Union ◽  
Data Protection ◽  
Personal Data ◽  
Research Approach ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Personal Data Protection ◽  
Protection Legislation ◽  
General Data ◽  
Almost All

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.

scholarly journals The EU General Data Protection Regulation (GDPR)

2020 ◽  
Keyword(s):  
Data Protection ◽  
Personal Data ◽  
Privacy Regulation ◽  
General Data Protection Regulation ◽  
Data Protection Directive ◽  
Ongoing Work ◽  
Protection Legislation ◽  
Recent Reform ◽  
General Data ◽  
The Eu

This new book provides an article-by-article commentary on the new EU General Data Protection Regulation. Adopted in April 2016 and applicable from May 2018, the GDPR is the centrepiece of the recent reform of the EU regulatory framework for protection of personal data. It replaces the 1995 EU Data Protection Directive and has become the most significant piece of data protection legislation anywhere in the world. This book is edited by three leading authorities and written by a team of expert specialists in the field from around the EU and representing different sectors (including academia, the EU institutions, data protection authorities, and the private sector), thus providing a pan-European analysis of the GDPR. It examines each article of the GDPR in sequential order and explains how its provisions work, thus allowing the reader to easily and quickly elucidate the meaning of individual articles. An introductory chapter provides an overview of the background to the GDPR and its place in the greater structure of EU law and human rights law. Account is also taken of closely linked legal instruments, such as the Directive on Data Protection and Law Enforcement that was adopted concurrently with the GDPR, and of the ongoing work on the proposed new E-Privacy Regulation.

scholarly journals Location Privacy in the Wake of the GDPR

2019 ◽  
Author(s):  
Yola Georgiadou ◽  
Rolf de By ◽  
Ourania Kounadi
Keyword(s):  
Data Protection ◽  
Location Privacy ◽  
Cultural Theory ◽  
Personal Data ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Digital Ecosystem ◽  
Protection Legislation ◽  
General Data ◽  
Conducting Research

The General Data Protection Regulation (GDPR) protects the personal data of natural persons and at the same time allows the free movement of such data within the European Union (EU). Hailed as majestic by admirers and dismissed as protectionist by critics, the Regulation is expected to have a profound impact around the world, including in the African Union (AU). For European&ndash;African consortia conducting research that may affect the privacy of African citizens, the question is &lsquo;how to protect personal data of data subjects while at the same time ensuring a just distribution of the benefits of a global digital ecosystem?&rsquo; We use location privacy as a point of departure, because information about an individual&rsquo;s location is different from other kinds of personally identifiable information. We analyse privacy at two levels, individual and cultural. Our perspective is interdisciplinary: we draw from computer science to describe three scenarios of transformation of volunteered/observed information to inferred information about a natural person and from cultural theory to distinguish four privacy cultures emerging within the EU in the wake of GDPR. We highlight recent data protection legislation in the AU and discuss factors that may accelerate or inhibit the alignment of data protection legislation in the AU with the GDPR.

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