Jehovah’s Witnesses and Blood Transfusions: An Analysis of the Legal Protections Afforded to Adults and Children in European/English Human Rights Contexts (Advance Article)
This article considers the degree to which the religious beliefs of Jehovah’s Witnesses are given consideration in European and English courts. Adults’ refusal of blood transfusions is examined within the context of European human rights jurisprudence. A focus is also placed on the position of Jehovah’s Witness children who refuse blood transfusions in the specific context of English medical law due to the prevalence of related case law in this jurisdiction. It is argued that the European Court of Human Rights has given appropriate protection to the will-rights of competent adult Jehovah’s Witnesses who refuse bloo...
Source: European Journal of Health Law - July 13, 2016 Category: Medical Law Authors: Clayton Ó Néill Source Type: research
The Anonymisation of Research Data — A Pyric Victory for Privacy that Should Not Be Pushed Too Hard by the Data Protection Framework?
Source: Page Count 21Personal health data is essential to many forms of scientific research. Such data may come from a large variety of sources including electronic health records (EHRs), datasets used for previous research and from data linked to biobanks. European data protection law recognises that in addition to using consent as a legal basis for the processing of personal health data for scientific research, such data may be used without consent where it is in the ‘public interest’. Despite the existence of such a legal option, ethics bodies in a number of states have shown reticence to utilise it, often pushing r...
Source: European Journal of Health Law - July 13, 2016 Category: Medical Law Authors: Paul Quinn Source Type: research
Legal Perspectives on Post-mortem Use of Biomaterial and Data for Research: A Focus on the German Situation
Source: Page Count 17Analyses of biobank informed consent forms show that most of them do not include provisions for post-mortem use of biomaterial and data obtained from a donor who later dies. When these biobanks are confronted with issues of secondary use of these bioresources for research, especially when not completely anonymised, or when genetic research is involved which could reveal not only the identity of the donor, but also those of his biological relatives, they are often confused. Looking at the existing regulatory framework of biobanks, we conclude that no clear guidelines exist on this issue. Although the do...
Source: European Journal of Health Law - July 13, 2016 Category: Medical Law Authors: Stefanie Hänold, Nikolaus Forgó, Dania Kobeissi and Iheanyi Nwankwo Source Type: research
Defining the Threshold of Permissible Risk for Non-therapeutic Clinical Trials with Children in Europe
This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with IMPs and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the US. (Source: European Journal of Health Law)
Source: European Journal of Health Law - June 14, 2016 Category: Medical Law Authors: Katherine Wade* Source Type: research
Theodore Bennett
Source: Volume 23, Issue 3, pp 319 - 324 (Source: European Journal of Health Law)
Source: European Journal of Health Law - June 13, 2016 Category: Medical Law Authors: Samuel Walker Source Type: research
European Court of Human Rights
Source: Volume 23, Issue 3, pp 305 - 317 (Source: European Journal of Health Law)
Source: European Journal of Health Law - June 13, 2016 Category: Medical Law Authors: Joseph Dute Source Type: research
Electronic Health Record in Italy and Personal Data Protection
Source: Volume 23, Issue 3, pp 265 - 277The present article deals with the Italian Electronic Health Record (hereinafter EHR), recently introduced by Act 221/2012, with a specific focus on personal data protection. Privacy issues — e.g., informed consent, data processing, patients’ rights and minors’ will — are discussed within the framework of recent e-Health legislation, national Data Protection Code, the related Data Protection Authority pronouncements and EU law. The paper is aimed at discussing the problems arising from a complex, fragmentary and sometimes uncertain legal framework on e-Health. (Source: Europe...
Source: European Journal of Health Law - June 13, 2016 Category: Medical Law Authors: Silvio Bologna, Alessandro Bellavista, Pietro Paolo Corso and Gianluca Zangara Source Type: research
Data Protection Compliance in the Age of Digital Health
Source: Volume 23, Issue 3, pp 248 - 264Advances 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 ...
Source: European Journal of Health Law - June 13, 2016 Category: Medical Law Authors: Victoria Hordern Source Type: research
Legal Status of Telemedicine in the Internal Market
This article presents a legal framework within which it is possible to provide qualifying health services with the help of information and telecommunications technology (ICT) as ISS. Due to the ambiguity of EU regulation, the problem regarding how to determine whether a particular medical service corresponds to favourable structural ISS conditions is considered. Since telemedicine makes a wide application of electronic devices possible, a new element appears in the relationship between physicians and their patients. Therefore, using electronic devices may cause numerous doubts regarding the normative status of these device...
Source: European Journal of Health Law - June 13, 2016 Category: Medical Law Authors: Grzegorz Glanowski Source Type: research
Editorial: EHealth Law: The Final Frontier?
Source: Volume 23, Issue 3, pp 227 - 230 (Source: European Journal of Health Law)
Source: European Journal of Health Law - June 13, 2016 Category: Medical Law Authors: André den Exter Source Type: research
The Legalisation of Gamete Donation in Italy (Advance Article)
Source: Page Count 20Since 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 particular, I discuss t...
Source: European Journal of Health Law - June 7, 2016 Category: Medical Law Authors: Andrea Boggio Source Type: research
Legal Status of Telemedicine in the Internal Market (Advance Article)
This article presents a legal framework within which it is possible to provide qualifying health services with the help of information and telecommunications technology (ICT) as ISS. Due to the ambiguity of EU regulation, the problem regarding how to determine whether a particular medical service corresponds to favourable structural ISS conditions is considered. Since telemedicine makes a wide application of electronic devices possible, a new element appears in the relationship between physicians and their patients. Therefore, using electronic devices may cause numerous doubts regarding the normative status of these device...
Source: European Journal of Health Law - June 2, 2016 Category: Medical Law Authors: Grzegorz Glanowski Source Type: research
New Legal Capacity Laws and the United Nations Convention on the Rights of Persons with Disabilities: An Overview of Five Countries in Europe
Source: Page Count 26Several state parties to the United Nations Convention on the Rights of Persons with Disabilities (CRPD) undertook recent revisions of their national legal capacity laws. These revisions aim to promote the autonomy of persons with disabilities as set forward by the CRPD. At the same time, the CRPD Committee calls for the abolishment of all forms of substitute decision-making through its first General Comment on Article 12 of the Convention. We thus describe the main components of new legal capacity laws of Belgium, the Czech Republic, France, Germany, and Switzerland and assess those in light of the Ge...
Source: European Journal of Health Law - May 16, 2016 Category: Medical Law Authors: Marie Fallon-Kund and Jerome E. Bickenbach Source Type: research
Informed Consent Obtainment, Malpractice Litigation, and the Potential Role of Shared Decision-making Approaches (Advance Article)
Source: Page Count 21Malpractice lawsuits are a substantial concern in health systems with miscommunication, inadequate information, and unsuccessful patient involvement in decision-making seeming to be contributing factors. This paper draws attention to the explicit role of informed consent (IC) obtainment in actualized complaint cases and to what extent novel methods to exercise IC through means of shared decision-making (SDM) and supporting tools might be applicable. A national sample of cases from the Health Professionals Disciplinary Board in Denmark is reviewed and discussed together with international legal instrume...
Source: European Journal of Health Law - May 3, 2016 Category: Medical Law Authors: Søren Fryd Birkeland Source Type: research
Should Anthroposophic Medicinal Products Be Regulated in Europe?
Source: Page Count 21European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market....
Source: European Journal of Health Law - April 28, 2016 Category: Medical Law Authors: Geneviève Michaux Source Type: research
