One of the core goals of Digital Health Technologies (DHT) is to transform healthcare services and delivery by shifting primary care from hospitals into the community. However, achieving this goal will rely on the collection, use and storage of large datasets. Some of these datasets will be linked to multiple sources, and may include highly sensitive health information that needs to be transferred across institutional and jurisdictional boundaries. The growth of DHT has outpaced the establishment of clear legal pathways to (...) facilitate the collection, use and transfer of potentially sensitive health data. Our study aimed to address this gap with an ethical code to guide researchers developing DHT with international collaborative partners in Singapore. We generated this code using a modified Policy Delphi process designed to engage stakeholders in the deliberation of health data ethics and governance. This paper reports the outcomes of this process along with the key components of the code and identifies areas for future research. (shrink)

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: impacts on healthcare costs, the outsourcing of expertise and 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. (shrink)

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. (shrink)

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.

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. (shrink)

Respect for autonomy has become a fundamental principle in human research ethics. Nonetheless, this principle and the associated process of obtaining informed consent do have limitations. This can lead to some groups, many of them vulnerable, being left understudied. This book considers these limitations and contributes through legal and philosophical analyses to the search for viable approaches to human research ethics. It explores the limitations of respect for autonomy and informed consent both in law and through the examination of cases (...) where autonomy is lacking (infants), diminished (addicts), and compromised (low socio-economic status). It examines alternative and complementary concepts to overcome the limits of respect for autonomy, including beneficence, dignity, virtue, solidarity, non-exploitation, vulnerability and self-ownership. It takes seriously the importance of human relationality and community in qualifying, tempering and complementing autonomy to achieve the ultimate end of human research - the good of humankind. (shrink)

Demands for improved access to innovative therapies have prompted a discourse that claims patients have rights to access treatments that may be of benefit, even if evidence that demonstrates safety and efficacy is lacking. This rights-based discourse is grounded in accounts of autonomy and assertions claiming that the state ought to not interfere with the free choices of patients and clinical decision-making. In this essay, we scrutinise these arguments to defend the ethical and legal permissibility of interference in contexts where (...) the uncertainty of benefit and potential for harm creates vulnerabilities that undermine patient capacity for self-determination. In support of this argument, we draw on two theoretical approaches to explore the limits of autonomy in innovative contexts and analyse the legal bases of the rights-based discourse. We then apply this analysis to the case example of stem cell transplantation as an innovative treatment for multiple sclerosis. (shrink)

Considering the “Born-Alive” Rule and Possession of Sperm Following Death Content Type Journal Article Category Recent Developments Pages 323-327 DOI 10.1007/s11673-011-9324-0 Authors Bernadette Richards, Law School, The University of Adelaide, South Australia, Australia Bill Madden, School of Law, University of Western Sydney, Sydney, NSW, Australia Tina Cockburn, School of Law, Queensland University of Technology, Brisbane, Qld, Australia Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 8 Journal Issue Volume 8, Number 4.

Property in Human Tissue It seems that a recurring theme in our Recent Developments is the issue of property rights in tissue . This has most commonly been associated with access to reproductive material and begins from the presumption of no property in tissue. A recent decision for the Superior Court of Justice, Ontario, whilst unsuccessful on largely procedural grounds, warrants a brief note because it adds to the general discourse on property in tissue and adopts a different approach. Piljak (...) Estate v Abraham 2014 ONSC 2893 addressed the question of whether or not the family of a deceased person could access liver tissue for genetic testing. The property question arose because the family applied for access to the tissue under Rule 32.01 and in order for the tissue to fall within the ambit of the Rule it must be defined as real or personal property.Background .. (shrink)

Recent Developments Content Type Journal Article Pages 113-119 DOI 10.1007/s11673-011-9300-8 Authors Bernadette Richards, University of Adelaide, Adelaide, South Australia Bill Madden, School of Law, University of Western Sydney, Sydney, NSW, Australia Tina Cockburn, School of Law, Queensland University of Technology, Brisbane, Qld, Australia Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 8 Journal Issue Volume 8, Number 2.

Untangling the Surrogacy WebSurrogacy agreements represent unique legal questions that must be answered with great care. In Australia we had the recent “Baby Gammy” scandal that involved an international surrogacy agreement and claims of abandonment of a child with Down’s syndrome. This story served to reinforce concerns that surrogacy turns children into a commodity that can be put to one side if expectations are not met. Of course, surrogacy agreements do not always end in this manner and often the outcome (...) is positive. There are, however, underlying legal questions regarding the status of the child, with some children, born as the result of international surrogacy agreements, being practically stateless when the nation of the commissioning parents refuses to issue passports to allow the children to return “home” with their “parents.” Where the relationship is local, however, and there is clear legislation, the issues can be less problematic but can become complex where a party wishes .. (shrink)

Sale of Sperm, Health Records, Minimally Conscious States, and Duties of Candour Content Type Journal Article Category Recent Developments Pages 7-14 DOI 10.1007/s11673-011-9347-6 Authors Cameron Stewart, Centre for Health Governance, Law and Ethics, Sydney Law School, University of Sydney, Sydney, NSW, Australia 2006 Bernadette Richards, Law School, University of Adelaide, Adelaide, SA, Australia 5005 Richard Huxtable, Centre for Ethics in Medicine, University of Bristol, Bristol, BS8 1TH UK Bill Madden, School of Law, University of Western Sydney, Sydney, NSW, Australia Tina (...) Cockburn, School of Law, Queensland University of Technology, Brisbane, QLD, Australia Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 9 Journal Issue Volume 9, Number 1. (shrink)