Data Protection Compliance in the Age of Digital Health

2016 ◽  
Vol 23 (3) ◽  
pp. 248-264 ◽  
Author(s):  
Victoria Hordern
Keyword(s):  
Mobile Technology ◽  
Data Protection ◽  
Digital Health ◽  
Health Data ◽  
Current Data ◽  
Smartphone Apps ◽  
Data Protection Directive ◽  
Explicit Consent ◽  
The Way

Advances in technology are transforming the way that health data is collected and used. This includes improvements in existing technology as well as innovations in mobile technology such as smartphone apps and wearables. Health data is strictly regulated under the eu Data Protection Directive 95/46/ec. Under current data protection rules, health data is broadly interpreted and will, in most circumstances not connected to the provision of healthcare, require organisations to obtain explicit consent from individuals for its collection and use. Further data protection compliance issues arise such as identifying who is a controller, ensuring transparency, using health data for research purposes and keeping health data secure. As the eu data protection landscape is due to change in the next few years and will affect the collection and use of health data, the forthcoming Data Protection Regulation also deserves attention.

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 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.

The Proposed Data Protection Regulation: The Illusion of Harmonisation, the Private/Public Sector Divide and the Bureaucratic Apparatus

2013 ◽  
Vol 15 ◽  
pp. 27-46 ◽  
Author(s):  
Peter Blume ◽  
Christian Wiese Svanberg
Keyword(s):  
Data Protection ◽  
Current Data ◽  
General Data Protection Regulation ◽  
Data Protection Directive ◽  
Central Elements ◽  
Scope Of Application ◽  
General Data ◽  
Data Protection Law ◽  
Draft Regulation ◽  
Practical Implications

AbstractThe proposal for a new General Data Protection Regulation has been billed as a harbinger of increased harmonisation, better enforcement and modernised rules within the area of data protection law. Through an analysis of several central elements in the draft Regulation—and European data protection law in general—as well as an assessment of the practical implications the proposal is likely to have if adopted, this chapter challenges whether the proposal will be able to deliver the harmonised rules that have been promised. It focuses particularly on the proposed regulations scope of application, its legal architecture, the use of discretionary provisions and related issues.It is argued that the proposal not only fails to address the root causes of why the current data protection directive (Directive 95/46) failed to bring about harmonisation and effective rules, but also looks set to transplant them into the new regulation.

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.

8. Confidentiality

Medical Law ◽  
2019 ◽  
pp. 420-469
Author(s):  
Emily Jackson
Keyword(s):  
Machine Learning ◽  
Big Data ◽  
Mobile Technology ◽  
Data Protection ◽  
Health Data ◽  
Patient Confidentiality ◽  
General Data Protection Regulation ◽  
Patients Rights ◽  
General Data ◽  
Gain Access

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate, providing students with a stand-alone resource. This chapter first examines the ethical justifications for protecting patient confidentiality and then discusses: the different legal sources of the duty of confidence, including the new General Data Protection Regulation; exceptions to the duty of confidence; and the remedies available for its breach. It briefly considers patients’ rights to gain access to their medical records. Finally, the chapter covers the implications of ‘big data’ and machine learning for healthcare, and the increasing use of mobile technology in order to generate, store and transmit health data, known as mHealth.

Protecting Personal Health Data through Privacy Awareness

2022 ◽  
Vol 6 (GROUP) ◽  
pp. 1-22
Author(s):  
Melanie Duckert ◽  
Louise Barkhuus
Keyword(s):  
Conceptual Framework ◽  
Data Protection ◽  
Data Privacy ◽  
Digital Health ◽  
Health Data ◽  
Design Guidelines ◽  
Personal Health ◽  
Health Records ◽  
Perception Of Security ◽  
Health Care Records

Digital health data is important to keep secure, and patients' perception around the privacy of it is essential to the development of digital health records. In this paper we present people's perceptions of the communication of data protection, in relation to their personal health data and the access to it; we focused particularly on people with chronic or long-term illness. Based on their use of personally accessible health records, we inquired into their explicit perception of security and sense of data privacy in relation to their health data. Our goal was to provide insights and guidelines to designers and developers on the communication of data protection in health records in an accessible way for the users. We analyzed their approach to and experience with their own health care records and describe the details of their challenges. A conceptual framework called "Privacy Awareness' was developed from the findings and reflects the perspectives of the users. The conceptual framework forms the basis of a proposal for design guidelines for Digital Health Record systems, which aim to address, facilitate and improve the users' awareness of the protection of their online health data.

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