scholarly journals Research Biobanks and Health Databases: The WMA Declaration of Taipei, Added Value to European Legislation (Soft and Hard Law)

2018 ◽  
Vol 25 (5) ◽  
pp. 501-516
Author(s):  
Gauthier Chassang ◽  
Emmanuelle Rial-Sebbag
Keyword(s):  
Scientific Research ◽  
Added Value ◽  
General Assembly ◽  
General Data Protection Regulation ◽  
European Guidelines ◽  
Health Related Research ◽  
Health Related ◽  
General Data ◽  
Research Biobanks ◽  
Essential Contribution

AbstractBiobanks and health databases make an essential contribution to health-related research (‘5P medicine’: predictive/preventive/personalised/participatory/provable). Since 1947, the World Medical Association (WMA) has addressed important issues in medical practice and scientific research, adopting guidelines that are recognised as global ethical standards. In October 2016, the WMA’s 67th General Assembly, held in Taipei, Taiwan, adopted a new Declaration on the Ethical Considerations regarding Health Databases and Biobanks, revising the Declaration adopted by the 53rd WMA General Assembly in 2002. Considering the way health databases and biobanks are currently used in research, the new recommendations are designed to facilitate the responsible collection and storage of human samples and/or associated data, and the provision of these bioresources for scientific research aimed at benefitting patients and populations. We analyse the Declaration of Taipei’s scope and content, highlighting its innovative features compared with other recent European guidelines and the General Data Protection Regulation (GDPR).

scholarly journals Datos relativos a la salud y datos genéticos: consecuencias jurídicas de su conceptualización / Health data and Genetic data: the legal consequences of their conceptualization

2018 ◽  
pp. 55-66
Author(s):  
Daniel Jove Villares
Keyword(s):  
Data Protection ◽  
Genetic Data ◽  
Health Data ◽  
General Data Protection Regulation ◽  
Related Information ◽  
Health Related ◽  
General Data ◽  
New Criteria ◽  
Legal Consequences ◽  
Scope Of Protection

Existen determinadas categorías de datos que, por sus características, requieren de un régimen más estricto, regulación que, en ocasiones está necesitada de concreción. El presente trabajo incide en la necesidad de repensar qué datos genéticos y qué informaciones relacionadas con la salud deben considerarse como sensibles, amén de proponer nuevos criterios para su delimitación. La clarificación de la esfera de protección de estas tipologías de datos se hace perentoria en aquellos ordenamientos en que se establezcan limitaciones adicionales para las categorías de datos que protagonizan este artículo. Situación que el Reglamento General de Protección de Datos de la Unión Europea habilita.   There are certain categories of data which, due to their characteristics, require a stricter regime, regulation which, at times, needs to be specified. This paper focuses on the need to rethink which genetic data and health-related information should be considered as sensitive and to propose new criteria for their delimitation. The clarification of the scope of protection of these types of data is urgently needed in those legal systems in which additional limitations are established for the categories of data covered by this article. Situation that the European Union's General Data Protection Regulation enables. 

Protecting Genetic Privacy in Biobanking through Data Protection Law

2021 ◽  
Author(s):  
Dara Hallinan
Keyword(s):  
Data Protection ◽  
Critical Infrastructure ◽  
Legal Framework ◽  
Privacy Rights ◽  
Genetic Privacy ◽  
General Data Protection Regulation ◽  
General Data ◽  
Research Biobanks ◽  
The Subject ◽  
Data Protection Law

Biobanks are critical infrastructure for medical research. Biobanks, however, are also the subject of considerable ethical and legal uncertainty. Given that biobanks process large quantities of genomic data, questions have emerged as to how genetic privacy should be protected. What types of genetic privacy rights and rights holders should be protected and to what extent? Since 25 May 2018, the General Data Protection Regulation (GDPR) has applied and now occupies a key position in the European legal framework for the regulation of biobanking. This book takes an in-depth look at the function, problems, and opportunities presented by European data protection law under the GDPR as a framework for the protection of genetic privacy in biobanking. It argues that the substantive framework presented by the GDPR already offers an admirable baseline level of protection for the range of genetic privacy rights engaged by biobanking. The book further contends that while numerous problems with this standard of protection are indeed identifiable, the GDPR offers the flexibility to accommodate solutions to these problems, as well as the procedural mechanisms to realise these solutions.

Introducing Key Elements Regarding Access to Personal Data for Scientific Research in the Perspective of Developing Innovative Medicines

2020 ◽  
Vol 27 (3) ◽  
pp. 195-212
Author(s):  
Jean Herveg ◽  
Annagrazia Altavilla
Keyword(s):  
Data Protection ◽  
Open Data ◽  
Scientific Research ◽  
Personal Data ◽  
Private Life ◽  
Fundamental Rights ◽  
Future Research ◽  
General Data Protection Regulation ◽  
Public Sector Information ◽  
General Data

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.

Anonymity in EU Health Law: Not an Alternative to Information Governance

2020 ◽  
Vol 28 (3) ◽  
pp. 478-501
Author(s):  
Miranda Mourby
Keyword(s):  
Data Protection ◽  
Big Data Analytics ◽  
Cell Therapies ◽  
General Data Protection Regulation ◽  
Legal Standard ◽  
Advanced Therapies ◽  
Information Governance ◽  
Health Related ◽  
General Data ◽  
Privacy And Confidentiality

Abstract Data sharing has long been a cornerstone of healthcare and research and is only due to become more important with the rise of Big Data analytics and advanced therapies. Cell therapies, for example, rely not only on donated cells but also essentially on donated information to make them traceable. Despite the associated importance of concepts such as ‘donor anonymity’, the concept of anonymisation remains contentious. The Article 29 Working Party’s 2014 guidance on ‘Anonymisation Techniques’ has perhaps helped encourage a perception that anonymity is the result of data modification ‘techniques’, rather than a broader process involving management of information and context. In light of this enduring ambiguity, this article advocates a ‘relative’ understanding of anonymity and supports this interpretation with reference not only to the General Data Protection Regulation but also to European Union health-related legislation, which also alludes to the concept. Anonymity, I suggest, should be understood not as a ‘technique’ which removes the need for information governance but rather as a legal standard of reasonable risk-management, which can only be satisfied by effective data protection. As such, anonymity can be not so much an alternative to data protection as its mirror, requiring similar safeguards to maintain privacy and confidentiality.

Is the GDPR and Its Right to Data Portability a Major Enabler of Citizen Science?

Global Jurist ◽  
2018 ◽  
Vol 18 (2) ◽  
Author(s):  
Paul Quinn
Keyword(s):  
Citizen Science ◽  
Scientific Research ◽  
Legal Rights ◽  
The Internet ◽  
Self Monitoring ◽  
General Data Protection Regulation ◽  
Legal Context ◽  
Wide Range ◽  
General Data ◽  
Data Portability

Abstract Citizen science is an emerging trend with an ever greater number of adherents. It involves the collection and contribution of large amounts of data by private individuals for scientific research. Often such data will concern the individuals themselves and will be collected through processes of self monitoring. This phenomenon has been greatly influenced by the Internet of Things (IoT) and the connectivity of a wide range monitoring devices through the internet. In collecting such data use will often be made of the services of various commercial organisations, for example that offer cloud storage services. The possibility of data portability is extremely important in citizen science as it allows individuals (or data subjects) to be able move their data from one source to another (i. e. to new areas of scientific research). This article explores the limits and possibilities that legal rights to data portability offer, in particular the new right as outlined by the European Union’s General Data Protection Regulation. In doing so this article will look at where this right (and how it operates in the international legal context) is able to facilitate the phenomenon of citizen science.

scholarly journals Data protection, scientific research, and the role of information

2020 ◽  
Author(s):  
Rossana Ducato
Keyword(s):  
Data Protection ◽  
Critical Role ◽  
Scientific Research ◽  
Information Provision ◽  
Research Information ◽  
Legal Regime ◽  
General Data Protection Regulation ◽  
General Data ◽  
Role Of Information

This paper aims to assess the information duties set out in the General Data Protection Regulation (GDPR) and national adaptations when the purpose of processing is scientific research. Information about the processing plays a critical role for data subjects in general. However, it becomes even more central in the research context, due to the peculiarities of the legal regime applicable to it. The analysis critically points out that the GDPR’s information obligations are not entirely satisfying and present some flaws. Furthermore, the GDPR information duties risk suffering from the same shortcomings usually addressed in the literature about mandated disclosures. The paper argues that the principle of transparency, developed as a “user-centric” concept, can support the adoption of solutions that embed behavioural insights to support the rationale of the information provision better.

scholarly journals The Impact of the New European Union General Data Protection Regulation (GDPR) on Data Collection at Mass Gatherings

2019 ◽  
Vol 34 (s1) ◽  
pp. s138-s138
Author(s):  
Annelies Scholliers ◽  
Dimitri De Fré ◽  
Inge D’haese ◽  
Stefan Gogaert
Keyword(s):  
European Union ◽  
Data Collection ◽  
Data Protection ◽  
Scientific Research ◽  
Personal Data ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Mass Gatherings ◽  
General Data ◽  
The Law

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.

scholarly journals Big Tech platforms in health research: Re-purposing big data governance in light of the General Data Protection Regulation’s research exemption

2021 ◽  
Vol 8 (1) ◽  
pp. 205395172110187
Author(s):  
Luca Marelli ◽  
Giuseppe Testa ◽  
Ine van Hoyweghen
Keyword(s):  
Big Data ◽  
Data Protection ◽  
Health Research ◽  
Digital Health ◽  
Scientific Research ◽  
Current Data ◽  
Data Governance ◽  
General Data Protection Regulation ◽  
Research Activities ◽  
General Data

The emergence of a global industry of digital health platforms operated by Big Tech corporations, and its growing entanglements with academic and pharmaceutical research networks, raise pressing questions on the capacity of current data governance models, regulatory and legal frameworks to safeguard the sustainability of the health research ecosystem. In this article, we direct our attention toward the challenges faced by the European General Data Protection Regulation in regulating the potentially disruptive engagement of Big Tech platforms in health research. The General Data Protection Regulation upholds a rather flexible regime for scientific research through a number of derogations to otherwise stricter data protection requirements, while providing a very broad interpretation of the notion of “scientific research”. Precisely the breadth of these exemptions combined with the ample scope of this notion could provide unintended leeway to the health data processing activities of Big Tech platforms, which have not been immune from carrying out privacy-infringing and socially disruptive practices in the health domain. We thus discuss further finer-grained demarcations to be traced within the broadly construed notion of scientific research, geared to implementing use-based data governance frameworks that distinguish health research activities that should benefit from a facilitated data protection regime from those that should not. We conclude that a “re-purposing” of big data governance approaches in health research is needed if European nations are to promote research activities within a framework of high safeguards for both individual citizens and society.

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