From Privacy to Data Protection in the : Implications for Big Data Health Research (Advance Article)
In conclusion, we argue that a comprehensive system of data protection, including research-specific safeguards, is essential to compensate for the loss of individual control in data-intensive health research. (Source: European Journal of Health Law)
Source: European Journal of Health Law - June 16, 2017 Category: Medical Law Authors: Menno Mostert, Annelien L. Bredenoord, Bart van der Sloot and Johannes J.M. van Delden Source Type: research
Sofia Moratti and Dennis Patterson (Advance Article)
Source:Page Count 7 (Source: European Journal of Health Law)
Source: European Journal of Health Law - June 7, 2017 Category: Medical Law Authors: Chlo é Deambrogio Source Type: research
Voluntary Additional Health Insurance in the European Union: Free Market or Regulation?
The objective of this article is to feed the discussion on the question whether and under what conditions free-market-driven additional health insurance in the European Union might be acceptable. We conclude that, provided that basic health insurance effectively covers all essential healthcare (essential healthcare services being broadly defined), additional health insurance could be regulated in the same way as all other non-life insurance. (Source: European Journal of Health Law)
Source: European Journal of Health Law - June 5, 2017 Category: Medical Law Authors: Piet Calcoen and Wynand P.M.M. van de Ven Source Type: research
Marcus D üwell, Jens Braarvig, Roger Brownsword and Dietmar MiethChristopher McCrudden
Source:Page Count 18 (Source: European Journal of Health Law)
Source: European Journal of Health Law - March 27, 2017 Category: Medical Law Authors: A.E. Harrison Source Type: research
Importing Notions in Health Law: Science and Proven Experience
In Swedish law, the notion of ‘science and proven experience’ (in Swedish,vetenskap och bepr övad erfarenhet) defines the gold standard for public decision-making and practice, especially in medicine. The notion is notoriously vague but nevertheless plays an important role in the distribution of rights and duties of patients and healthcare workers. For example, failure to provide care in accordance with this standard can lead to penal responsibility. The notion also helps to define Swedish patients ’ right to reimbursement for cross-border healthcare. From a legal point of view, the notion is especially intriguing b...
Source: European Journal of Health Law - February 8, 2017 Category: Medical Law Authors: Lena Wahlberg and Johannes Persson Source Type: research
Marketing Authorisation of Orphan Medicinal Products and Its Impact on Related Research
This article establishes that the key orphan incentive, namely the 10-year market exclusivity provision laid down in Article 8 of theEU Regulation onOMPs (Regulation 141/2000), has a huge potential impact on related research. It is argued that this provision can make it too difficult for researchers/sponsors to attain marketing approval for closely related products. This article advances two proposals to address this problem. First, it argues for new principles for assessing similarity, so as to clarify and narrow the ambit of market exclusivity. Secondly, it argues for improved conditions for a demonstration of ‘clinica...
Source: European Journal of Health Law - February 8, 2017 Category: Medical Law Authors: Sara Gerke and Shaun D. Pattinson Source Type: research
Importing Notions in Health Law:
Source:Page Count 26In Swedish law, the notion of ‘science and proven experience’ (in Swedish,vetenskap och bepr övad erfarenhet) defines the gold standard for public decision-making and practice, especially in medicine. The notion is notoriously vague but nevertheless plays an important role in the distribution of rights and duties of patients and healthcare workers. For example, failure to provide care in accordance with this standard can lead to penal responsibility. The notion also helps to define Swedish patients ’ right to reimbursement for cross-border healthcare. From a legal point of view, the notion is esp...
Source: European Journal of Health Law - February 1, 2017 Category: Medical Law Authors: Lena Wahlberg and Johannes Persson Source Type: research
Patients ’ Rights in Cross-border Healthcare (Directive 2011/24/) and How It Applies to Turkey as a Negotiating Candidate Country
Source:Page Count 13Cross-border healthcare and patient mobility across European Union Member States has been on the agenda ofEU Commission for the last decade. Directive 2011/24/EU on the application of patients ’ rights in cross-border healthcare went into force in 2013. The Directive mainly addresses the responsibilities of Member States in cross-border healthcare, regulates reimbursement procedure, and coordinates European reference networks and health technology assessment in theEU. The Directive has direct and indirect implications on Turkish health system. In this article, first an overview of Directive 2011/24/EU...
Source: European Journal of Health Law - January 26, 2017 Category: Medical Law Authors: Perihan Elif Ekmekci Source Type: research
European Court of Human Rights
Source:Page Count 22 (Source: European Journal of Health Law)
Source: European Journal of Health Law - January 22, 2017 Category: Medical Law Authors: Joseph Dute Source Type: research
Colin Francome
Source:Volume 24, Issue 1, pp 113 - 117 (Source: European Journal of Health Law)
Source: European Journal of Health Law - December 24, 2016 Category: Medical Law Authors: Natasha Hammond-Browning Source Type: research
European Court of Human Rights
Source:Volume 24, Issue 1, pp 105 - 112 (Source: European Journal of Health Law)
Source: European Journal of Health Law - December 24, 2016 Category: Medical Law Authors: Joseph Dute Source Type: research
The Legalisation of Gamete Donation in Italy
Source:Volume 24, Issue 1, pp 85 - 104Since 2004, the regulation of assisted reproduction in Italy has undergone substantial reform as an effect of key judicial intervention. Limitations on embryo production, screening and transfer, the prohibition against engaging in preimplantation genetic diagnosis (PGD) and embryo selection, and the ban on gamete donation have all been removed by courts. In this article, I discuss how judicial intervention has improved the ability of Italian couples to access assisted reproduction technologies (ARTs), and how the expansion of reproductive rights is, however, still incomplete. In partic...
Source: European Journal of Health Law - December 24, 2016 Category: Medical Law Authors: Andrea Boggio Source Type: research
Is the Equity of Access to Healthcare a European Constitutional Standard? A Comparative Review (Advance Article)
In conclusion, a hypothesis is proposed on the potential role of constitutional guarantees in preventing the deterioration of accessibility of health services. (Source: European Journal of Health Law)
Source: European Journal of Health Law - December 20, 2016 Category: Medical Law Authors: Dawid Sze ściło Source Type: research
“Why Should I Question a Patient’s Wish?”A Comparative Study on Physicians’ Perspectives on Their Duties to Respect Advance Directives (Advance Article)
This article explores factors that impede the implementation of advance directives to refuse treatment (ADs) in three European countries: England, Germany and France. Taking into account socio-cultural and legal aspects, the article shows the extent, to which the law can, and does, influence physicians ’ decisions to implementADs. The findings presented are based on qualitative interviews exploring physicians ’ sense of duty to respectADs and the reasons given for failing to implement the law. It will be argued that this depends on: 1) how strictly the legal status ofADs is defined, and 2) whether the law actually addr...
Source: European Journal of Health Law - December 18, 2016 Category: Medical Law Authors: Ruth Horn Source Type: research
eHealth Spare Parts as a Service: Modular eHealth Solutions and Medical Device Reform
Source:Page Count 24eHealth Platform as a Service ( ‘PaaS’) is an innovative way to build mHealth apps out of cloud-based generic components. Having examined the current and future regimes of safety and performance, this article concludes that the ‘selling features’ of the PaaS (outsourced creation and maintenance of cloud-based parts for eas y mHealth-building) undermine legal compliance, and the reform will not change this significantly. Although no safety and performance requirements apply yet to consumer eHealth, the medical apps are regulated. Their manufacturers must ensure the final apps are safe, while not ...
Source: European Journal of Health Law - December 11, 2016 Category: Medical Law Authors: Nadezhda Purtova Source Type: research
