Health research and systems’ governance are at risk: should the right to data protection override health?

Iorio, Concetta Tania Di; Carinci, Fabrizio; Oderkirk, Jillian

doi:10.1136/medethics-2013-101603

Cited by 21 publications

(15 citation statements)

References 7 publications

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“…To this end, IMIA has started initiatives with all stakeholders to support trustworthy data use [50]. Such initiatives target the level of regulation, and amendment to laws, such as the EU's General Data Protection Regulation that will substitute the current EU Data Protection Directive 95/46/EC [51,52]. Finally, data protection regulations would require that available big data-enabled health information systems allow building and maintaining a personal health record that contains all personal data, i.e.…”

Section: Big Data Side Effectsmentioning

confidence: 99%

Big Data and Biomedical Informatics: A Challenging Opportunity

Bellazzi¹

2014

Yearb Med Inform

136

101

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Big data are receiving an increasing attention in biomedicine and healthcare. It is therefore important to understand the reason why big data are assuming a crucial role for the biomedical informatics community. The capability of handling big data is becoming an enabler to carry out unprecedented research studies and to implement new models of healthcare delivery. Therefore, it is first necessary to deeply understand the four elements that constitute big data, namely Volume, Variety, Velocity, and Veracity, and their meaning in practice. Then, it is mandatory to understand where big data are present, and where they can be beneficially collected. There are research fields, such as translational bioinformatics, which need to rely on big data technologies to withstand the shock wave of data that is generated every day. Other areas, ranging from epidemiology to clinical care, can benefit from the exploitation of the large amounts of data that are nowadays available, from personal monitoring to primary care. However, building big data-enabled systems carries on relevant implications in terms of reproducibility of research studies and management of privacy and data access; proper actions should be taken to deal with these issues. An interesting consequence of the big data scenario is the availability of new software, methods, and tools, such as map-reduce, cloud computing, and concept drift machine learning algorithms, which will not only contribute to big data research, but may be beneficial in many biomedical informatics applications. The way forward with the big data opportunity will require properly applied engineering principles to design studies and applications, to avoid preconceptions or over-enthusiasms, to fully exploit the available technologies, and to improve data processing and data management regulations.

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Section: Big Data Side Effectsmentioning

confidence: 99%

Big Data and Biomedical Informatics: A Challenging Opportunity

Bellazzi¹

2014

Yearb Med Inform

136

101

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“…This may be a difficult balance to achieve and there are concerns that if regulations are too stringent they will hinder, or make impossible, research that contributes to improving health outcomes and health systems performance [27]. The Department of Health in the United Kingdom (UK) has suggested that ‘the duty to share information can be as important as the duty to protect patient confidentiality’ (p.21) [28].…”

Section: Discussionmentioning

confidence: 99%

Young people’s views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study

et al. 2016

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Background: Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees.Methods: Digitally recorded interviews were conducted with 48 participants aged 17-19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management.Results: The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to 'jury duty'. Conclusions: There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance the rights of individuals with the wider benefits from research. The suggestion that public opinion should be represented through random selection similar to jury duty may be worth pursuing in the light of the need to ensure diversity of opinion and establish trust amongst the general public about the use of 'big data' for the wider public good.

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“…According to the amended version of the Parliament, in the absence of consent from data subjects, processing of data concerning health for research purposes should only be allowed if it serves a "high public interest" and if "that research cannot possibly be carried out otherwise" (Article 81(2a)). The proposed amendments on the Commission's draft by the Parliament fueled massive concerns among the biomedical and health research community, who saw the proposed requirements as a barrier to research [19][20][21]. The pertinent provisions, and especially Articles 81 and 83 concerning the use of health data including genetic data for research purposes, were extensively discussed by the European Council afterwards.…”

Section: Processing Personal Data and Special Categories Of Data Undementioning

confidence: 99%

Rules for processing genetic data for research purposes in view of the new EU General Data Protection Regulation

2017

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Genetic data contain sensitive health and non-health-related information about the individuals and their family members. Therefore, adopting adequate privacy safeguards is paramount when processing genetic data for research or clinical purposes. One of the major legal instruments for personal data protection in the EU is the new General Data Protection Regulation (GDPR), which has entered into force in May 2016 and repealed the Directive 95/46/EC, with an ultimate goal of enhancing effectiveness and harmonization of personal data protection in the EU. This paper explores the major provisions of the new Regulation with regard to processing genetic data, and assesses the influence of such provisions on reinforcing the legal safeguards when sharing genetic data for research purposes. The new Regulation attempts to elucidate the scope of personal data, by recognizing pseudonymized data as personal (identifiable) data, and including genetic data in the catalog of special categories of data (sensitive data). Moreover, a set of new rules is laid out in the Regulation for processing personal data under the scientific research exemption. For instance, further use of genetic data for scientific research purposes, without obtaining additional consent will be allowed, if the specific conditions is met. The new Regulation has already fueled concerns among various stakeholders, owing to the challenges that may emerge when implementing the Regulation across the countries. Notably, the provided definition for pseudonymized data has been criticized because it leaves too much room for interpretations, and it might undermine the harmonization of the data protection across the countries.

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Health research and systems’ governance are at risk: should the right to data protection override health?

Cited by 21 publications

References 7 publications

Big Data and Biomedical Informatics: A Challenging Opportunity

Big Data and Biomedical Informatics: A Challenging Opportunity

Young people’s views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study

Rules for processing genetic data for research purposes in view of the new EU General Data Protection Regulation

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