776 resultados para Health Law and Policy


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This report provides an analysis of the cultural, policy and legal implications of ‘mash-ups’. This study provides a short history of mash-ups, explaining how the current ‘remix culture’ builds upon a range of creative antecedents and cultural traditions, which valorised appropriation, quotation, and transformation. It provides modern examples of mash-ups, such as sound recordings, musical works, film and artistic works, focusing on works seen on You Tube and other online applications. In particular, it considers - * Literary mash-ups of canonical texts, including Pride and Prejudice and Zombies, The Wind Done Gone, After the Rain, and 60 Years Later; * Artistic mash-ups, highlighting the Obama Hope poster, the ‘Column’ case, and the competition for extending famous album covers; * Geographical mash-ups, most notably, the Google Australia bushfires map; * Musical mash-ups, such as The Grey Album and the work of Girl Talk; * Cinematic mash-ups, including remixes of There Will Be Blood and The Downfall; and This survey provides an analysis of why mash-up culture is valuable. It highlights the range of aesthetic, political, comic, and commercial impulses behind the creation and the dissemination of mash-ups. This report highlights the tensions between copyright law and mash-ups in particular cultural sectors. Second, this report emphasizes the importance of civil society institutions in promoting and defending mash-ups in both copyright litigation and policy debates. It provides a study of key organisations – including: * The Fair Use Project; * The Organization for Transformative Works; * Public Knowledge; * The Electronic Frontier Foundation; and * The Chilling Effects Clearinghouse This report suggests that much can be learnt from this network of organisations in the United States. There is a dearth of comparable legal clinics, advocacy groups, and creative institutions in Australia. As a result, the public interest values of copyright law have only received weak, incidental support from defendant companies – such as Network Ten and IceTV – with other copyright agendas. Third, this report canvasses a succinct model for legislative reform in respect of copyright law and mash-ups. It highlights: * The extent to which mash-ups are ‘tolerated uses’; * The conflicting judicial precedents on substantiality in Australia and the United States; * The debate over copyright exceptions relating to mash-ups and remixes; * The use of the take-down and notice system under the safe harbours regime by copyright owners in respect of mash-ups; * The impact of technological protection measures on mash-ups and remixes; * The possibility of statutory licensing in respect of mash-ups; * The use of Creative Commons licences; * The impact of moral rights protection upon mash-ups; * The interaction between economic and moral rights under copyright law; and * Questions of copyright law, freedom of expression, and political mash-ups.

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This exploratory article examines the phenomenon of the ‘Quantified Self’—until recently, a subculture of enthusiasts who aim to discover knowledge about themselves and their bodies through self-tracking, usually using wearable devices to do so—and its implications for laws concerned with regulating and protecting health information. Quantified Self techniques and the ‘wearable devices’ and software that facilitate them—in which large transnational technology corporations are now involved—often involve the gathering of what would be considered ‘health information’ according to legal definitions, yet may occur outside the provision of traditional health services (including ‘e-health’) and the regulatory frameworks that govern them. This article explores the legal and regulatory framework for self-quantified health information and wearable devices in Australia and determines the extent to which this framework addresses privacy and other concerns that these techniques engender, along with suggestions for reform.

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This workshop is jointly organized by EFMI Working Groups Security, Safety and Ethics and Personal Portable Devices in cooperation with IMIA Working Group "Security in Health Information Systems". In contemporary healthcare and personal health management the collection and use of personal health information takes place in different contexts and jurisdictions. Global use of health data is also expanding. The approach taken by different experts, health service providers, data subjects and secondary users in understanding privacy and the privacy expectations others may have is strongly context dependent. To make eHealth, global healthcare, mHealth and personal health management successful and to enable fair secondary use of personal health data, it is necessary to find a practical and functional balance between privacy expectations of stakeholder groups. The workshop will highlight these privacy concerns by presenting different cases and approaches. Workshop participants will analyse stakeholder privacy expectations that take place in different real-life contexts such as portable health devices and personal health records, and develop a mechanism to balance them in such a way that global protection of health data and its meaningful use is realized simultaneously. Based on the results of the workshop, initial requirements for a global healthcare information certification framework will be developed.

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Child sexual abuse is a major global public health concern, affecting one in eight children and causing massive costs including depression, unwanted pregnancy and HIV. The gravity of this global issue is reflected by the United Nations’ new effort to respond to sexual abuse in the 2015 Sustainable Development Goals. The fundamental policy aims are to improve prevention, identification and optimal responses to sexual abuse. However, as shown in our literature review, policymakers face difficult challenges because child sexual abuse is hidden, psychologically complex, and socially sensitive. This article contributes significant new ideas for international progress. Insights about required strategies are informed by an innovative multidisciplinary analysis of research from public health, medicine, social science, psychology, and neurology. Using an ecological model comprising individual, institutional and societal dimensions, we propose that two preconditions for progress are the enhancement of awareness of child sexual abuse, and of empathic responses towards its victims.

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McInnes, C., Lee, K. (2006). Health, security and foreign policy. Review of International Studies, 32 (1), 5-23. RAE2008

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The Lisbon Agenda places Europe in a uniquely difficult position globally, most particularly as an example of a social and regulatory experiment which many consider to be doomed to failure. The drive towards economic competitiveness has led to a focus on regulation and its effect on entrepreneurship, productivity and business growth but assessing this relationship is complex for a number of reasons. First, not all regulatory effects can be predicted precisely in relation to behavioural outcomes. Path-dependency scholars have also demonstrated that the regulation will have varying effects depending on context. Second, theoretically it is clear that many non-regulatory factors may contribute to economic and competitive success. Third, there is evidence of internal conflict within the Commission as to the relative importance of the Lisbon goals. Finally, the experience of distinct Member States presents challenges both for assessment and prescriptive remedies. The Commission has estimated that the cost of regulatory compliance obligations on businesses in the EU is between 4% and 6% of gross domestic product and that 15% of this figure is avoidable 'red tape' (the term used specifically to signify unnecessary compliance burdens). This article proposes to assess the likely outcomes of de-regulation as we rapidly approach 2010, the year for attainment of the Lisbon goals.

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This thesis examines the tension between patent rights and the right to health and it recognizes patent rights on pharmaceutical products as one of the factors responsible for the problem of lack of access to affordable medicines in developing countries. The thesis contends that, in order to preserve their patent policy space and secure access to affordable medicines for their citizens, developing countries should incorporate a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws. The thesis provides a systematic analysis of court decisions from four key developing countries (Brazil, India, Kenya, and South Africa) and it assesses how the national courts in these countries resolve the tension between patent rights and the right to health. Essentially, this thesis demonstrates how a model of human rights can be incorporated into the adjudication of disputes involving patent rights in national courts. Focusing specifically on Brazil, the thesis equally demonstrates how policy makers and law makers at the national level can incorporate a model of human rights into the design or amendment of their national patent law. This thesis also contributes to the ongoing debate in the field of business and human rights with regard to the mechanisms that can be used to hold corporate actors accountable for their human rights responsibilities. This thesis recognizes that, while states bear the primary responsibility to respect, protect, and fulfil the right to health, corporate actors such as pharmaceutical companies also have a baseline responsibility to respect the right to health. This thesis therefore contends that pharmaceutical companies that own patent rights on pharmaceutical products can be held accountable for their right to health responsibilities at the national level through the incorporation of a model of civic participation into a country’s patent law system.

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Maps the research agenda that underpinned the edited collection 'European Law and New Health Technologies', that this pieces introduces.

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End of award report for the funded research seminar series of the same name.

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Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money.

To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation.

This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.

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The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before 28 May 2016, provides an opportunity to review the legal and political context within which this important aspect of research law and policy sits and to reflect on the implications for public health. My aim in this article is to relate the context to the key purposes and aims of EU law and policy on clinical trials in order to explain and clarify its orientation. On that basis, I argue that the CTR and the changes it introduces to the law on clinical trials are part of the EU's continued focus on market optimisation. It is this focus that orients and directs the wider pharmaceutical development pipeline, but that undermines the achievement of key public health objectives.