ORCID Profile
0000-0001-6448-4954
Current Organisations
University of Queensland
,
University of Adelaide
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In Research Link Australia (RLA), "Research Topics" refer to ANZSRC FOR and SEO codes. These topics are either sourced from ANZSRC FOR and SEO codes listed in researchers' related grants or generated by a large language model (LLM) based on their publications.
Applied Ethics | Bioethics (human and animal) | Professional Ethics (incl. police and research ethics) | Law and Society | Law And Society | Human Bioethics | Applied Ethics (Incl. Bioethics And Environmental Ethics) |
Law, Politics and Community Services not elsewhere classified | Bioethics | Justice and the law not elsewhere classified | Bioethics | Public Health (excl. Specific Population Health) not elsewhere classified | Health not elsewhere classified | Health policy evaluation
Publisher: CSIRO Publishing
Date: 2016
DOI: 10.1071/AH15081
Abstract: Objective This paper aims to demonstrate that any suggestion that there is a need for specific innovation laws is flawed. Innovation is central to good medical practice and is adequately supported by current law. Methods The paper reviews the nature of medical innovation and outlines recent attempts in the UK to introduce specific laws aimed at ‘encouraging’ and ‘supporting’ innovation. The current legal framework is outlined and the role of the law in relation to medical innovation explored. Results The analysis demonstrates the cyclic relationship between medical advancement and the law and concludes that there is no requirement for specific innovation laws. Conclusions The law not only supports innovation and development in medical treatment but encourages it as central to a functioning medical system. There is no need to introduce specific laws aimed at medical innovation to do so represents an unnecessary legal innovation and serves to complicate matters. What is known about the topic? Over recent months, there has been a great deal of discussion surrounding the law in the context of medical innovation. This was driven by the attempts in the UK to introduce specific laws in the Medical Innovation Bill. The general subject matter – negligence and the expected standard of care in the provision of treatment – is very well understood, but not in cases where the treatment can be described as innovative. The general rhetoric in both the UK and Australia around the Medical Innovation Bill demonstrates a lack of understanding of the position of the law with regards to innovative treatment. What does this paper add? This paper adds clarity to the debate. It presents the law and explains the manner in which the law can operate around innovative treatment. The paper asserts that medical innovation is both supported and encouraged by existing legal principles. What are the implications for practitioners? The paper presents an argument that can guide the policy position in this area. It also provides clarity around the legal position and expected standard of care for those who are introducing innovative medical treatment.
Publisher: Springer Science and Business Media LLC
Date: 04-01-2014
Publisher: Springer Berlin Heidelberg
Date: 2013
Publisher: Springer Science and Business Media LLC
Date: 20-04-2017
Publisher: Springer Science and Business Media LLC
Date: 15-10-2010
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2017
Publisher: Springer Science and Business Media LLC
Date: 06-2020
Publisher: Springer Science and Business Media LLC
Date: 23-06-2017
Publisher: Springer Science and Business Media LLC
Date: 03-2020
Publisher: Springer Science and Business Media LLC
Date: 09-2019
Publisher: Oxford University Press (OUP)
Date: 21-01-2017
Publisher: Springer Science and Business Media LLC
Date: 10-07-2015
Publisher: Springer Science and Business Media LLC
Date: 24-01-2013
Publisher: Springer Science and Business Media LLC
Date: 13-05-2015
Publisher: Springer Science and Business Media LLC
Date: 12-10-2012
Publisher: MDPI AG
Date: 03-03-2020
DOI: 10.3390/JCM9030681
Abstract: Breast density, also known as mammographic density, refers to white and bright regions on a mammogram. Breast density can only be assessed by mammogram and is not related to how breasts look or feel. Therefore, women will only know their breast density if they are notified by the radiologist when they have a mammogram. Breast density affects a woman’s breast cancer risk and the sensitivity of a screening mammogram to detect cancer. Currently, the position of BreastScreen Australia and the Royal Australian and New Zealand College of Radiologists is to not notify women if they have dense breasts. However, patient advocacy organisations are lobbying for policy change. Whether or not to notify women of their breast density is a complex issue and can be framed within the context of both public health ethics and clinical ethics. Central ethical themes associated with breast density notification are equitable care, patient autonomy in decision-making, trust in health professionals, duty of care by the physician, and uncertainties around evidence relating to measurement and clinical management pathways for women with dense breasts. Legal guidance on this issue must be gained from broad legal principles found in the law of negligence and the test of materiality. We conclude a rigid legal framework for breast density notification in Australia would not be appropriate. Instead, a policy framework should be developed through engagement with all stakeholders to understand and take account of multiple perspectives and the values at stake.
Publisher: Springer Science and Business Media LLC
Date: 23-03-2022
DOI: 10.1186/S12910-022-00771-2
Abstract: The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.
Publisher: Springer Science and Business Media LLC
Date: 18-04-2012
Publisher: Springer Science and Business Media LLC
Date: 24-12-2012
DOI: 10.1007/S11673-011-9348-5
Abstract: As rational adults, we are free to elect what is (or is not) done to our bodies. However, this strong freedom does not extend to the borders of life. Control over the uses of our biological material is constrained and uncertain at law. Our article examines the legal condition of embryos and organs: how law conceptualises them and regulates their uses.
Publisher: Springer Science and Business Media LLC
Date: 19-01-2012
Publisher: Springer Science and Business Media LLC
Date: 26-09-2014
Publisher: Springer Science and Business Media LLC
Date: 13-09-2011
Publisher: Wiley
Date: 19-07-1970
DOI: 10.1111/MEDU.14118
Publisher: Springer Science and Business Media LLC
Date: 06-04-2011
Publisher: Springer Science and Business Media LLC
Date: 06-01-2017
Publisher: Elsevier BV
Date: 2018
DOI: 10.2139/SSRN.3138414
Publisher: Elsevier BV
Date: 06-2012
DOI: 10.1016/J.RBMO.2012.01.014
Abstract: Increasingly, important areas of medical therapy and research rely on the donation and use of human embryos. Yet their use is commonly determined by community tolerance and ethico-legal regulation. The aim of this study was to explore the views of an Australian community about what an embryo is, how it should be used and who should make disposition decisions. The findings of a large representative population survey showed that most participants thought of an embryo as human or potentially human but that this did not affect a majority community view that embryos should be used rather than discarded. This study also found ergent views about what the community perceived to be acceptable uses of embryos. The majority perceived the couple as having the authority to make a disposition decision. Women held different views to men across all three questions. The way an embryo was perceived related significantly to how it should be used and who should decide its disposition. These differences and relationships should be considered when developing clinic practices and ethico-legal frameworks to regulate embryo use in science or treatment.
Publisher: Springer Science and Business Media LLC
Date: 05-07-2018
Publisher: Springer Science and Business Media LLC
Date: 08-09-2016
Publisher: BMJ
Date: 04-07-2018
DOI: 10.1136/MEDETHICS-2018-104804
Abstract: Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: (1) impacts on healthcare costs, (2) the outsourcing of expertise and (3) issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries.
Publisher: IEEE
Date: 11-2019
Publisher: Springer Science and Business Media LLC
Date: 04-10-2013
Publisher: Elsevier BV
Date: 02-2020
Publisher: Springer Science and Business Media LLC
Date: 27-05-2019
Publisher: SAGE Publications
Date: 25-02-2015
Abstract: The Medical Innovation Bill continues its journey through Parliament. On 23 January 2015, it was debated for the final time in the House of Lords and with one final amendment, the House moved to support the Bill, which then moved to the House of Commons on 26 January. It will be debated again on 27 February 2015. The Bill’s purpose is to encourage responsible innovation in medical treatment. Although this goal is laudable, it is argued that the Bill is unnecessary and has the potential to undermine the very cause it aims to advance. More useful for encouraging responsible innovation is the continued education of health-care professionals on how the law already supports practitioners who look to improve care through responsible innovation.
Publisher: Springer Science and Business Media LLC
Date: 29-01-2018
Publisher: Springer Science and Business Media LLC
Date: 04-02-2015
Publisher: Springer Science and Business Media LLC
Date: 16-08-2017
Publisher: Queensland University of Technology
Date: 24-05-2022
DOI: 10.5204/LTHJ.2281
Abstract: The introduction of new technologies in medical treatment has led to innovation in medical devices that are highly technical in their application and operation. The medical technology landscape is changeable and healthcare providers often turn to the medical device representatives (MDRs), employed by device manufacturers to help navigate the shifts and uncertainties. While the relationship between MDRs and healthcare providers can be a positive one focusing on appropriate use, selection and safety of devices, it is one that has evolved over time and is not independently regulated. In addition, patients, for the most part, are usually unaware of the involvement of MDRs in their healthcare. It is this knowledge gap with regard to the role of MDRs that is the focus of this paper. We argue that trust is at the heart of healthcare relationships and explore the nature of trust alongside the models of regulation of the medical device industry. We argue that MDRs may currently present a threat to both the interpersonal and the institutional trust of patients, and that regulation and policy responses are appropriate ways to address this risk. We consider potential regulatory frameworks and identify transparency and communication as the crucial characteristics of an appropriate response. We recommend that the polycentric nature of Australian healthcare regulation be cultivated through a multilayered approach, and that a positive obligation to inform the patient of the role of MDRs in their clinical care be established.
Publisher: Springer Science and Business Media LLC
Date: 29-03-2013
Publisher: Queensland University of Technology
Date: 03-02-2014
Start Date: 01-2012
End Date: 12-2015
Amount: $255,000.00
Funder: Australian Research Council
View Funded ActivityStart Date: 03-2020
End Date: 03-2025
Amount: $311,000.00
Funder: Australian Research Council
View Funded ActivityStart Date: 2007
End Date: 12-2012
Amount: $105,000.00
Funder: Australian Research Council
View Funded Activity