EUROPEAN JOURNAL OF HEALTH LAW最新文献

{"title":"Health Care Complaints and Professional Legal Responsibility - A Cross-Country Comparative Review.","authors":"Søren Fryd Birkeland","doi":"10.1163/15718093-bja10100","DOIUrl":"https://doi.org/10.1163/15718093-bja10100","url":null,"abstract":"<p><p>One approach to stimulating patient safety and health care quality is through holding health care professionals legally responsible for their performance. Law and health care variation across countries, however, makes it difficult to get an overview and make comparisons of the personal legal responsibility of health care providers. This article describes health care professional liability and complaint measures in some European countries (UK, The Netherlands, Sweden and Denmark) and US. Countries all have established a public authority to assess complaints about health professional performance and opportunities for economic compensation. The assessment of health professional legal responsibility generally relies on comparisons to supposedly \"objective\" standards predominantly dictated by the health profession. In line with the aim of ensuring acceptable care for all, health ethics principles on justice, respect for patients' autonomy, and the duty to do good and prevent harm may provide an attractive supplement in the description of legal responsibility in the health professions.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"30 3","pages":"297-321"},"PeriodicalIF":0.8,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10022043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparing the Decriminalisation of Assisted Dying in Europe.","authors":"Jessica Maureen Krüger","doi":"10.1163/15718093-bja10101","DOIUrl":"https://doi.org/10.1163/15718093-bja10101","url":null,"abstract":"<p><p>Assisted dying is subject to markedly different laws in different European countries, and the legislation is rapidly changing in many of them. This article seeks to enhance our understanding of how public and health-care professionals' opinions shape assisted dying legislation in Europe. To that end, data on the attitudes of the general public as well as health-care professionals was systematically collected, analysed and compared to the legal situation in seven European countries, covering the period from 1990 until 2021.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"30 3","pages":"243-271"},"PeriodicalIF":0.8,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10019386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the Dutch Rules on Health Data in the Light of the GDPR.","authors":"Irith Kist","doi":"10.1163/15718093-bja10096","DOIUrl":"https://doi.org/10.1163/15718093-bja10096","url":null,"abstract":"<p><p>In 2021, the European Commission published its Assessment of the EU Member States' rules on health data in the light of General Data Protection Regulation. The Commission concluded that the GDPR has been interpreted in many ways in the EU as regards health research, and national implementation legislation has resulted in a fragmented legal landscape. Several lawful bases are used as a legitimation for the secondary use of health data. I address the Dutch legislation on the re-use, or secondary use of health data for scientific research where explicit consent is the general rule. However, both the GDPR, the Dutch GDPR Implementation Act and sectoral health legislation leave room for alternatives. I conclude that a further review of these alternatives is required to enhance scientific health research with the secondary use of health data, and I sketch a few avenues for further exploration.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"30 3","pages":"322-344"},"PeriodicalIF":0.8,"publicationDate":"2022-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10022040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Secondary Use of Personal Health Data: When Is It “Further Processing” Under the GDPR, and What Are the Implications for Data Controllers?","authors":"Regina Becker, Davit Chokoshvili, Giovanni Comandé, Edward S. Dove, Alison Hall, Colin Mitchell, Fruzsina Molnár-Gábor, Pilar Nicolàs, Sini Tervo, Adrian Thorogood","doi":"10.1163/15718093-bja10094","DOIUrl":"https://doi.org/10.1163/15718093-bja10094","url":null,"abstract":"<p>Contemporary biomedical research heavily relies on secondary use of personal health data that were obtained in a different clinical or research setting. Under the European Union’s General Data Protection Regulation (<span style=\"font-variant: small-caps;\">GDPR</span>), data controllers processing personal data must comply with the principle of purpose limitation, which restricts further processing of personal data beyond the purpose for which the data were initially collected. However, “further processing” is not explicitly defined, resulting in considerable interpretive ambiguities as to whether “secondary use” of data by researchers constitutes “further processing” under the <span style=\"font-variant: small-caps;\">GDPR</span>. This ambiguity is problematic as it exposes researchers to potential non-compliance risks. In this article, we analyse the term “further processing” within the meaning of the <span style=\"font-variant: small-caps;\">GDPR</span>, elucidate important aspects in which it differs from “secondary use”, and discuss the implications for data controllers’ <span style=\"font-variant: small-caps;\">GDPR</span> compliance obligations. Subsequently, we contextualise this analysis within a broader discussion of regulating scientific research under the <span style=\"font-variant: small-caps;\">GDPR</span>.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"373 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138542564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On the Administrative Powers of the WHO: A Lesson from the Pandemic","authors":"Donato Vese","doi":"10.1163/15718093-bja10093","DOIUrl":"https://doi.org/10.1163/15718093-bja10093","url":null,"abstract":"\u0000The WHO’s management of the pandemic has drawn sharp criticism. It has been suggested that there is an urgent need for a reform providing more intrusive administrative powers. By contrast, this paper argues that the WHO needs sharing powers rather than intrusive powers. Given that the main international norms have arguably designated the WHO as a “non-authoritarian” authority aiming at the highest possible level of health for individuals, the paper suggests that sharing of administrative powers should be incentivised by involving all the relevant actors in the decision-making process, namely through the participation in proceedings of all actors involved in the decision-making, namely governments, national health authorities, and other non-state actors.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45035529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Telemedical and Self-Managed Abortion: A Human Rights Imperative?","authors":"Zoe L. Tongue","doi":"10.1163/15718093-bja10092","DOIUrl":"https://doi.org/10.1163/15718093-bja10092","url":null,"abstract":"\u0000Early into the COVID-19 pandemic, abortion rights advocates highlighted the importance of maintaining access to abortion through telemedicine. It was argued that telemedical and self-managed abortion was, in the pandemic context, a human rights imperative. This article argues that providing for telemedical and self-managed abortion remains a human rights imperative beyond the duration of the pandemic. Telemedical and self-managed abortion is safe and effective, supports the pregnant person’s preferences and reproductive autonomy, and minimises many of the physical and structural barriers faced by pregnant people in accessing abortion services. International and European human rights standards access to abortion require states to take positive measures to guarantee access to abortion, and this article argues that such measures include telemedical and self-managed abortion.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45516398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Evolution of Whistleblowing Protection in Healthcare on a European Level","authors":"Paulien Walraet, Sofia Palmieri, T. Goffin","doi":"10.1163/15718093-bja10091","DOIUrl":"https://doi.org/10.1163/15718093-bja10091","url":null,"abstract":"\u0000 The protection of whistleblowers in healthcare is necessary to ensure quality of care by raising concerns about suspected breaches of human rights and Union law. This protection has evolved over the years through initiatives from the European Council, which were also taken into account in two rulings of the European Court of Human Rights, and the European Parliament. However, these initiatives implement a general framework rather than focussing directly on healthcare. This article therefore starts from analysing the general protection. Hereinafter, the relevance for the healthcare sector will be examined for each of the involved initiatives.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49641877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"European Court of Human Rights.","authors":"Joseph Dute,&nbsp;Tom Goffin","doi":"10.1163/15718093-bja10090","DOIUrl":"https://doi.org/10.1163/15718093-bja10090","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-11"},"PeriodicalIF":0.8,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10015078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Problematic Path of Fundamental Rights in the European Union: Continuing the Journey on the Regulation on Clinical Trials","authors":"Caterina Di Costanzo","doi":"10.1163/15718093-bja10089","DOIUrl":"https://doi.org/10.1163/15718093-bja10089","url":null,"abstract":"\u0000In this paper I have tried to identify and analyse some critical points that Regulation No. 526 of 2014 on clinical trials still presents. I have seen that in the face of a long gestation, the criticisms that have been made of the regulation have been various. If we think of the first criticism identified in the regulation, the so-called law shopping, we must affirm that the subject of experimentation is a very delicate matter since it has a direct and frontal impact on the guarantee of the right to health of European citizens and the use of law shopping does not provide adequate guarantees for the protection of the rights of those participating in a trial. Secondly, the marginalisation of the Ethics Committees whose role is decided at the level of the single national legal system does not ensure that components of independence and representation of the point of view of patients and their associations are guaranteed. This aspect is undoubtedly an important criticism of the regulation as the importance of the role played by the Ethics Committees in the assessment procedures for authorisation applications is not taken into fully consideration. Also, in this case, the economic need for simplification and speed of the evaluation procedure seem to prevail over the need to ensure a thorough and independent scientific and ethical review of authorisation applications. We believe that in the case of Regulation No. 536 of 2014, greater awareness of risks and opportunities will be achieved only by verifying in practice the possible distortions to which this legislation can lead. Only through serious monitoring and reporting of the effects of the regulation on the protection of patients’ rights will it be possible to identify and indicate targeted changes to the rules contained therein and, of course, to adopt the consequent measures to reduce possible damages. In this sense, also on the basis of a possible and foreseeable future phase of gestation of Regulation No. 534 of 2014, we believe that in the European area, in the field of clinical trials but not exclusively, that trend, developed above all in the French context, of the “experimentation of laws” should be further cultivated.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45115000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Legal Challenges to Restrictions on Assistance in Suicide in Italy, Germany and Austria: An Ethico-Legal Analysis.","authors":"David Albert Jones, Laura Palazzani, Franz-Josef Bormann, Stefan Hofmann","doi":"10.1163/15718093-bja10086","DOIUrl":"10.1163/15718093-bja10086","url":null,"abstract":"<p><p>This paper deals with a series of legal cases in Italy, Germany, and Austria, between September 2019 and December 2020, which ruled that laws prohibiting or restricting assistance in suicide were unconstitutional. There are similarities between these three cases, all of which are influenced by the practice of assisted suicide in Switzerland, but also differences, not least because of the antecedent legal contexts. Each case is based on flawed reasoning. They have in common an exaggerated account of autonomy or self-determination, insufficiently qualified by the duty to protect human life or by other ethical constraints. The Italian and Austrian Courts also appeal to the principle of equality and to a supposed analogy with refusal of life-sustaining treatments, both of which raise concerns in relation to further expansion of the provisions. In responding to these flawed judgements, legislators should favour proposals that prevent the normalisation of assisted and non-assisted suicide.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-25"},"PeriodicalIF":0.8,"publicationDate":"2022-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48963808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}