scholarly journals Przetwarzanie danych osobowych do celów badań naukowych. Aspekty prawne

2019 ◽  
pp. 79-101 ◽  
Author(s):  
Aleksandra Pyka

This article refers to the issue of personal data processing conducted in connection with scientific research and in accordance with the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). It is not uncommon for the purposes of scientific research to process personal data, which is connected with the obligation to respect the rights of the data of the subjects involved. Entities conducting scientific research that process personal data for this purpose are required to apply the general reg­ulation governing, among others, the obligations imposed on the controllers. The issue of personal data processing for scientific research purposes has also been regulated in national legislation in connection with the need to apply the General Data Protection Regulation. The article discusses the basics of the admissibility of data processing for the needs of scientific research; providing personal data regarding criminal convictions and offences extracted from public registers at the request of the entity conducting scientific research; exercising the rights of the data of the subjects concerned; as well as the implementation of appropriate technical and organizational measures to ensure the security of data processing. In addition, the article discusses the issue of anonymization of personal data carried out after achieving the purpose of personal data processing, as well as the processing of special categories of personal data. The topics discussed in the article were not discussed in detail, as this would require further elaboration in a publication with a much wider volume range.

2019 ◽  
pp. 248-262
Author(s):  
Lee A Bygrave

This chapter focuses on Articles 22 and 25 of the EU’s General Data Protection Regulation (Regulation 2016/679). It examines how these provisions will impact automated decisional systems. Article 22 gives a person a qualified right ‘not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her’. Article 25 imposes a duty on controllers of personal data to implement technical and organizational measures so that the processing of the data will meet the Regulation’s requirements and otherwise ensure protection of the data subject’s rights. Both sets of rules are aimed squarely at subjecting automated decisional systems to greater accountability. The chapter argues that the rules suffer from significant weaknesses that are likely to hamper their ability to meet this aim.


2020 ◽  
Vol 27 (3) ◽  
pp. 195-212
Author(s):  
Jean Herveg ◽  
Annagrazia Altavilla

Abstract This article aims at opening discussions and promoting future research about key elements that should be taken into account when considering new ways to organise access to personal data for scientific research in the perspective of developing innovative medicines. It provides an overview of these key elements: the different ways of accessing data, the theory of the essential facilities, the Regulation on the Free Flow of Non-personal Data, the Directive on Open Data and the re-use of public sector information, and the General Data Protection Regulation (GDPR) rules on accessing personal data for scientific research. In the perspective of fostering research, promoting innovative medicines, and having all the raw data centralised in big databases localised in Europe, we suggest to further investigate the possibility to find acceptable and balanced solutions with complete respect of fundamental rights, as well as for private life and data protection.


2021 ◽  
Vol 11 (22) ◽  
pp. 10574
Author(s):  
Sung-Soo Jung ◽  
Sang-Joon Lee ◽  
Ieck-Chae Euom

With the growing awareness regarding the importance of personal data protection, many countries have established laws and regulations to ensure data privacy and are supervising managements to comply with them. Although various studies have suggested compliance methods of the general data protection regulation (GDPR) for personal data, no method exists that can ensure the reliability and integrity of the personal data processing request records of a data subject to enable its utilization as a GDPR compliance audit proof for an auditor. In this paper, we propose a delegation-based personal data processing request notarization framework for GDPR using a private blockchain. The proposed notarization framework allows the data subject to delegate requests to process of personal data; the framework makes the requests to the data controller, which performs the processing. The generated data processing request and processing result data are stored in the blockchain ledger and notarized via a trusted institution of the blockchain network. The Hypderledger Fabric implementation of the framework demonstrates the fulfillment of system requirements and feasibility of implementing a GDPR compliance audit for the processing of personal data. The analysis results with comparisons among the related works indicate that the proposed framework provides better reliability and feasibility for the GDPR audit of personal data processing request than extant methods.


2019 ◽  
Vol 34 (s1) ◽  
pp. s138-s138
Author(s):  
Annelies Scholliers ◽  
Dimitri De Fré ◽  
Inge D’haese ◽  
Stefan Gogaert

Introduction:As of May 2018, a new European privacy law called the General Data Protection Regulation (GDPR) is in order. With this law, every organization operating in the European Union (EU), needs to adhere to a strict set of rules concerning collection and processing of personal data.Aim:To explore the consequences of the GDPR for data collection at mass gatherings in the European Union.Methods:Since the law was published on April 27, 2016, a thorough reading of the law was conducted by 4 persons with a background in mass gathering health. The GDPR consists of 99 articles organized into 11 chapters. There are also 173 recitals to further explain certain ambiguities. Key articles and recitals relating to healthcare and scientific research were identified. Possible pitfalls and opportunities for data collection and processing at mass gatherings were noted.Discussion:Under article 4, key definitions are noted. There is a clear definition of “data concerning health”. According to the GDPR, health data is a special category of personal data which should not be processed according to article 9(1). However, there is an exception for scientific research (article 9(2)(j)). There are a few safeguards in place, as laid out in article 89. One interesting point is that according to article 89(2), certain derogations can take place if the law interferes with scientific research. The GDPR has major consequences for data collection and processing in the EU. However, with the use of certain safeguards (e.g., pseudonymization) there are still ample opportunities for scientific research. It is important to review one’s method of data collection to make sure it complies with the GDPR.


Author(s):  
Santa Slokenberga ◽  
Olga Tzortzatou ◽  
Jane Reichel

AbstractThe General Data Protection Regulation (GDPR) is already four years old legal instrument, with over two years of practical experience, yet, several central questions on its application, its importance in scientific research, rights of the data subjects, and obligations on the controllers and processors remain uncharted. In this edited volume, questions ranging from the meaning of the GDPR provisions for a particular research project to impact of the GDPR on long term collaborations, when the UK is leaving the EU are is discussed. This chapter sets out the aim of this book and provides an overview of how various contributions interplay to shed light on how the GDPR shapes the research regimes on the use of personal data in biobanking by EU Member States.


2021 ◽  
Vol 11 (2) ◽  
pp. 3-24
Author(s):  
Jozef Andraško ◽  
Matúš Mesarčík

Abstract The article focuses on the intersections of the regulation of electronic identification as provided in the eIDAS Regulation and data protection rules in the European Union. The first part of the article is devoted to the explanation of the basic notions and framework related to the electronic identity in the European Union— the eIDAS Regulation. The second part of the article discusses specific intersections of the eIDAS Regulation with the General Data Protection Regulation (GDPR), specifically scope, the general data protection clause and mainly personal data processing in the context of mutual recognition of electronic identification means. The article aims to discuss the overlapping issues of the regulation of the GDPR and the eIDAS Regulation and provides a further guide for interpretation and implementation of the outcomes in practice.


2018 ◽  
Vol 4 (2) ◽  
pp. 99-104
Author(s):  
Pedro Miguel Freitas

The aim of this paper is to analyse the punitive regime foreseen in the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (GDPR). The administrative fines’ regime found in Article 83 of the GDPR and some of the questions it arises will be explored. We conclude that the Member States should adopt a critical stance when adapting their national legislation to the norms of the GDPR. The fundamental principles enshrined in national constitutions and supranational legal texts must be closely analysed and observed since the GDPR introduces a mandatory sanctions framework.


Bioethica ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. 6
Author(s):  
Albena Kuyumdzhieva

The present manuscript examines the new ethics data protection requirements introduced for the research projects funded by the European Programme Horizon 2020.Initially, reference is made to the basic data protection principles introduced by the General Data Protection Regulation (GDPR) and the derogations permitted in the research field in favor of the science advancement. Although these derogations are subject to a number of safeguards to protect personal data, new ethics requirements are introduced for research projects funded by the European Programme Horizon 2020. The aim of these safeguards is the increased transparency and accountability at the data processing and the consequent enhanced protection of the individuals’ rights. These requirements are geared to the main research ethics postulate, which requires free, voluntary and informed participation of the research subject.Under these new requirements, Horizon 2020 beneficiaries/applicants must comply with a set of predefined standards, reflecting their ethical and legal obligations, provide a detailed and precise description of the technical and organisational measures that will be implemented in order to safeguard the rights of the research participants and also demonstrate their observance. In addition, depending on the type of the data being processed and the data processing techniques, the H2020 applicants/beneficiaries may need to provide a number of additional documents/explanations and implement further measures.


Author(s):  
Raphaël Gellert

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.


Sign in / Sign up

Export Citation Format

Share Document