OP279 Data Protection In The European Union Post-General Data Protection Regulation (GDPR): A Barrier Or An Enabler Of Pharmaceutical Innovation?

2021 ◽  
Vol 37 (S1) ◽  
pp. 10-11
Author(s):  
Amanda Cole ◽  
Adrian Towse
Keyword(s):  
Data Protection ◽  
Cyber Security ◽  
Digital Health ◽  
Good Practice ◽  
Unmet Need ◽  
Scientific Research ◽  
Health Data ◽  
The European Union ◽  
General Data Protection Regulation ◽  
General Data

IntroductionThe expansion of health data offers exciting opportunities to support better and more efficient drug discovery, development and implementation. Data protection and governance provide the legal framework to balance safeguarding patients’ privacy with the benefits to society of medical research. Our aim is to highlight current legal barriers to the better use of health data and propose ways to address them.MethodsAnalysis of the relevant legislative texts was supplemented by interviews with external experts in data protection, health research, informatics and cyber security and a workshop with pharmaceutical industry members. We investigated the legal issues arising for six key activities along the pharmaceutical lifecycle, from identifying unmet need through to health technology assessment and pharmacovigilance.ResultsThe General Data Protection Regulation (GDPR) was introduced in May 2018 to Harmonise data protection across Europe. However, considerable ambiguity remains, particularly around the appropriate legal bases for data processing in the absence of consent: scientific research, public interest, or provision of health or social care. Other key themes included data subject rights, anonymization, compatibility of primary and secondary (re-)use of data, heterogeneity arising from divergent interpretation, the need for guidance on digital health, and the importance of trust.ConclusionsWe speculate which legal bases are most appropriate for the six pharmaceutical activities studied, but clear guidance and consensus is required. The GDPR was not designed to hamper scientific research, and the issues identified arose from uncertainties rather than barriers per se. Industry and academic researchers should therefore deal proactively with the prevailing uncertainties, share good practice, and engender trust by co-creating a code of conduct and outlining principles of responsible use. Engagement with patients will be critical in encouraging a shared understanding of the value to society of health data for research.

scholarly journals The Policy Effect of the General Data Protection Regulation (GDPR) on the Digital Public Health Sector in the European Union: An Empirical Investigation

2019 ◽  
Vol 16 (6) ◽  
pp. 1070 ◽  
Author(s):  
Bocong Yuan ◽  
Jiannan Li
Keyword(s):  
European Union ◽  
Financial Performance ◽  
Data Protection ◽  
Digital Health ◽  
Rapid Development ◽  
Health Data ◽  
Personal Health ◽  
The European Union ◽  
General Data Protection Regulation ◽  
General Data

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.

scholarly journals COVID-19: Putting the General Data Protection Regulation to the Test (Preprint)

2020 ◽  
Author(s):  
Stuart McLennan ◽  
Leo Anthony Celi ◽  
Alena Buyx
Keyword(s):  
Health Care ◽  
Data Protection ◽  
Health Research ◽  
Health Care Organizations ◽  
Digital Health ◽  
Health Data ◽  
Individual Risk ◽  
Risk Minimization ◽  
General Data Protection Regulation ◽  
General Data

UNSTRUCTURED The coronavirus disease (COVID-19) pandemic is very much a global health issue and requires collaborative, international health research efforts to address it. A valuable source of information for researchers is the large amount of digital health data that are continuously collected by electronic health record systems at health care organizations. The European Union’s General Data Protection Regulation (GDPR) will be the key legal framework with regard to using and sharing European digital health data for research purposes. However, concerns persist that the GDPR has made many organizations very risk-averse in terms of data sharing, even if the regulation permits such sharing. Health care organizations focusing on individual risk minimization threaten to undermine COVID-19 research efforts. In our opinion, there is an ethical obligation to use the research exemption clause of the GDPR during the COVID-19 pandemic to support global collaborative health research efforts. Solidarity is a European value, and here is a chance to exemplify it by using the GDPR regulatory framework in a way that does not hinder but actually fosters solidarity during the COVID-19 pandemic.

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
Keyword(s):  
European Union ◽  
Electronic Health Record ◽  
Data Protection ◽  
Digital Health ◽  
Health Record ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Cross Border ◽  
General Data ◽  
Electronic Health

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.

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.

scholarly journals COVID-19: Putting the General Data Protection Regulation to the Test

10.2196/19279 ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e19279 ◽  
Author(s):  
Stuart McLennan ◽  
Leo Anthony Celi ◽  
Alena Buyx
Keyword(s):  
Health Care ◽  
Data Protection ◽  
Health Research ◽  
Health Care Organizations ◽  
Digital Health ◽  
Health Data ◽  
Individual Risk ◽  
Risk Minimization ◽  
General Data Protection Regulation ◽  
General Data

The coronavirus disease (COVID-19) pandemic is very much a global health issue and requires collaborative, international health research efforts to address it. A valuable source of information for researchers is the large amount of digital health data that are continuously collected by electronic health record systems at health care organizations. The European Union’s General Data Protection Regulation (GDPR) will be the key legal framework with regard to using and sharing European digital health data for research purposes. However, concerns persist that the GDPR has made many organizations very risk-averse in terms of data sharing, even if the regulation permits such sharing. Health care organizations focusing on individual risk minimization threaten to undermine COVID-19 research efforts. In our opinion, there is an ethical obligation to use the research exemption clause of the GDPR during the COVID-19 pandemic to support global collaborative health research efforts. Solidarity is a European value, and here is a chance to exemplify it by using the GDPR regulatory framework in a way that does not hinder but actually fosters solidarity during the COVID-19 pandemic.

Building trust and transparency? Challenges of the opt-out system and the secondary use of health data in England

2019 ◽  
Vol 19 (2-3) ◽  
pp. 159-181 ◽  
Author(s):  
Janos Meszaros ◽  
Chih-hsing Ho
Keyword(s):  
United Kingdom ◽  
Data Protection ◽  
Health Data ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Secondary Use ◽  
Building Trust ◽  
The United Kingdom ◽  
Opt Out ◽  
General Data

After the failure of the care.data programme, a revised opt-out system has been introduced for British citizens to protect their health data from 2018. However, there are several exemptions from the previous and the revised opt-out systems, some of which are overly broad. For instance, the opt-outs may be completely ignored in the case of ‘anonymised’ data. The data protection terminology in the United Kingdom is slightly different from that in the European Union, and the key issue is that the terms are not used consistently, even in the most important documents and guidelines. This situation may lead to a weak opt-out system with transparency issues, which might erode public trust and lead to a repeat of the care.data failure. Furthermore, the United Kingdom intends to comply with the General Data Protection Regulation after Brexit, thus these differences may cause compatibility issues in the future.

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 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. 

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