Publications by authors named "Mette Hartlev"

Management of datasets that include health information and other sensitive personal information of European study participants has to be compliant with the General Data Protection Regulation (GDPR, Regulation (EU) 2016/679). Within scientific research, the widely subscribed'FAIR' data principles should apply, meaning that research data should be findable, accessible, interoperable and re-usable. Balancing the aim of open science driven FAIR data management with GDPR compliant personal data protection safeguards is now a common challenge for many research projects dealing with (sensitive) personal data.

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Health data can contain sensitive information. People who consult a doctor seek help on issues that matter to them: they typically expect some form of confidentiality. However, the notion and practices of confidentiality have changed dramatically over time.

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The human right to health requires that everyone should have equal opportunities to enjoy the highest attainable standard of health. In practice, this is hard to achieve, as health is shaped by social determinants. This article explores the impact personalized medicine and use of big data may have on health disparities.

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Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information.

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Background: In assigning responsibility for obesity prevention a distinction may be drawn between who is responsible for the rise in obesity prevalence ('backward-looking responsibility'), and who is responsible for reducing it ('forward-looking responsibility').

Methods: We study how the two aspects of responsibility figure in the obesity policies of WHO (European Region), the EU and the Department of Health (England).

Results: Responsibility for the emergence and reduction of obesity is assigned to both individuals and other actors to different degrees in the policies, combining an individual and a systemic view.

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The right to health is recognised in human rights law and is also part of the catalogue of patients' rights. It imposes a duty on governments to put in place a system of health protection making it possible for individuals to enjoy the highest attainable standard of health. However, disease patterns are constantly changing, and more and more attention is being paid to so-called lifestyle diseases.

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The demographic development is a challenge for the European healthcare systems, and to meet these challenges it is crucial to develop efficient health preventive strategies to ensure that the population is, and stays fit as long as possible. However, along with demographic development, Europe is also facing a boom in lifestyle diseases which constitute an impediment for healthy ageing. Smoking and obesity are considered to be the major causes in this regard.

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The Danish Patients' Rights Act from 1998 was the first comprehensive piece of legislation addressing the basic legal values and principles governing the relation between patient and the health care services. Since the adoption of the Act there has been continuous legislative activity in the field, and the objective of the article is to discuss how recent developments in Danish patients' rights legislation shall be interpreted in terms of balancing interests of patients towards interests of society and the health care professions.

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The five Nordic countries--Denmark, Finland, Iceland, Norway and Sweden--share a considerable part of their cultural and historical heritage. They have collaborated closely in their development of legislation during most of the 20th century and are also all traditional welfare states, but nevertheless demonstrate a surprising degree of variety in the area of health law. The Nordic Network for Research in Biomedical Law was founded in 2006, with the aim to promote intra-disciplinary collaboration and stimulate comparative Nordic research in this field of law.

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European countries share a number of fundamental values and ideas, but when it comes to the organisation of health care sectors and attitudes to basic patients' rights, there are also vast differences. Consequently, at the European level health law has to balance between the aspiration for uniformity and universal respect for fundamental rights on the one hand, and acceptance of national diversity on the other. The aim of the article is to characterise European health law in terms of both divergence and harmonisation, and to explore the tension between these two features in light of current trends and challenges.

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Danish health law does not explicitly consider the participation of patients in clinical training of medical students. This causes uncertainty with regards to patients' rights and to the obligations of the hospital and the medical student. In this paper, we evaluate the legal aspects as regards information, consent and privacy in situations where patients are involved in the training of medical students.

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