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Multisite medical data sharing is critical in modern clinical practice and medical research. The challenge is to conduct data sharing that preserves individual privacy and data utility. The shortcomings of traditional privacy-enhancing technologies mean that institutions rely upon bespoke data sharing contracts. The lengthy process and administration induced by these contracts increases the inefficiency of data sharing and may disincentivize important clinical treatment and medical research. This paper provides a synthesis between 2 novel advanced privacy-enhancing technologies—homomorphic encryption and secure multiparty computation (defined together as multiparty homomorphic encryption). These privacy-enhancing technologies provide a mathematical guarantee of privacy, with multiparty homomorphic encryption providing a performance advantage over separately using homomorphic encryption or secure multiparty computation. We argue multiparty homomorphic encryption fulfills legal requirements for medical data sharing under the European Union’s General Data Protection Regulation which has set a global benchmark for data protection. Specifically, the data processed and shared using multiparty homomorphic encryption can be considered anonymized data. We explain how multiparty homomorphic encryption can reduce the reliance upon customized contractual measures between institutions. The proposed approach can accelerate the pace of medical research while offering additional incentives for health care and research institutes to employ common data interoperability standards.

Background Increasingly, hospitals and research institutes are developing technical solutions for sharing patient data in a privacy preserving manner. Two of these technical solutions are homomorphic encryption and distributed ledger technology. Homomorphic encryption allows computations to be performed on data without this data ever being decrypted. Therefore, homomorphic encryption represents a potential solution for conducting feasibility studies on cohorts of sensitive patient data stored in distributed locations. Distributed ledger technology provides a permanent record on all transfers and processing of patient data, allowing data custodians to audit access. A significant portion of the current literature has examined how these technologies might comply with data protection and research ethics frameworks. In the Swiss context, these instruments include the Federal Act on Data Protection and the Human Research Act. There are also institutional frameworks that govern the processing of health related and genetic data at different universities and hospitals. Given Switzerland’s geographical proximity to European Union (EU) member states, the General Data Protection Regulation (GDPR) may impose additional obligations. Methods To conduct this assessment, we carried out a series of qualitative interviews with key stakeholders at Swiss hospitals and research institutions. These included legal and clinical data management staff, as well as clinical and research ethics experts. These interviews were carried out with two series of vignettes that focused on data discovery using homomorphic encryption and data erasure from a distributed ledger platform. Results For our first set of vignettes, interviewees were prepared to allow data discovery requests if patients had provided general consent or ethics committee approval, depending on the types of data made available. Our interviewees highlighted the importance of protecting against the risk of reidentification given different types of data. For our second set, there was disagreement amongst interviewees on whether they would delete patient data locally, or delete data linked to a ledger with cryptographic hashes. Our interviewees were also willing to delete data locally or on the ledger, subject to local legislation. Conclusion Our findings can help guide the deployment of these technologies, as well as determine ethics and legal requirements for such technologies.

Assistance dog refusals and misunderstandings about their legal status occur in all aspects of public life. Emergency services agencies are not immune to this problem, given the quick decisions that need to be made under duress.

Australian public sector agencies want to improve access to public sector data to help conduct better informed policy analysis and research and have passed legislation to improve access to this data. Much of this public sector data also contains personal information or health information and is therefore governed by state and federal privacy law which places conditions on the use of personal and health information. This paper therefore analyses how these data sharing laws compare with one another, as well as whether they substantially change the grounds on which public sector data can be shared. It finds that data sharing legislation, by itself, does not substantially change the norms embedded in privacy and health information management law governing the sharing of personal and health information. However, this paper notes that there can still be breaches of social licence even where data sharing occurs lawfully. Further, this paper notes that there are several inconsistencies between data sharing legislation across Australia. This paper therefore proposes reform, policy, and technical strategies to resolve the impact of these inconsistencies.

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.

Digital innovation is ever more present and increasingly integrated into citizen science research. However, smartphones and other connected devices come with specific features and characteristics and, in consequence, raise particular ethical issues. This article addresses this important intersection of citizen science and the Internet of Things by focusing on how such ethical issues are communicated in scholarly literature. To answer this research question, this article presents a scoping review of published scientific studies or case studies of scientific studies that utilize both citizen scientists and Internet of Things devices. Specifically, this scoping review protocol retrieved studies where the authors had included at least a short discussion of the ethical issues encountered during the research process. A full text analysis of relevant articles conducted inductively and deductively identified three main categories of ethical issues being communicated: autonomy and data privacy, data quality, and intellectual property. Based on these categories, this review offers an overview of the legal and social innovation implications raised. This review also provides recommendations for researchers who wish to innovatively integrate citizen scientists and Internet of Things devices into their research based on the strategies researchers took to resolve these ethical issues.

In this paper, we compare four patient rights regarding data stored in NEHRs under nine European and Asia-Pacific jurisdictions. We aim to ascertain whether the success and failure of NEHR implementations could be attributable to differences in patient rights. We note that while there is a convergence of access controls, there is a divergence with respect to controlling third-party access and modifying patient data. Analysing these divergences through four bioethical principles defined by Beauchamp and Childress, we find claims of patient empowerment mask a neoliberal perspective of outsourcing responsibility to patients. Likewise, refusing sufficient granular control can contribute to patient mistrust.We argue that it is important to conceptualise NEHRs as a public good and design regulatory frameworks accordingly.

Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.

Abstract Research in biomedical and health sciences using data-intensive methods increasingly involve multi-party cross-border institutional collaborations. Regulatory complexities governing international data flow remain challenging to navigate, particularly where differing legal standards in relation to data and privacy protections exist in the respective jurisdictions. In this paper, we use the example of a use case from a joint health research program between Singapore and Switzerland to illustrate the possibility of cross-border data flow for these two jurisdictions with no reciprocal adequacy recognition standards. We have therefore compared data privacy and biomedical research ethics laws in both jurisdictions to help determine when cross-border data sharing could occur that are compliant with data privacy laws. Our comparison makes reference to when technical and organizational measures including privacy enhancing technologies are appropriate to support data sharing. This paper has the potential to inform researchers collaborating with international institutions in navigating similar privacy regulatory considerations in their research and in developing their collaborative agreements.

Abstract This article posits that Australia, as an affluent country with increasing capacity to manufacture vaccines, has an obligation to assist its regional (and global) counterparts in implementing vaccination programs that protect their populations. First, the article explores the capacity of high-income nations to meet their obligations, assist their neighbours and refrain from vaccine nationalism. This inquiry involves an analysis of the optimal ethical strategy for distributing vaccines globally, and the role that Australia might play in this distribution strategy. Secondly, the article examines the intellectual property landscape for vaccines in Australia, focusing on the patents that cover vaccine compositions and manufacturing techniques (recognizing the potential for know-how and access to materials as well as patents to affect manufacturing capacity). This article then discusses the strategies the Australian Government has at its disposal to counter potential intellectual property impediments whilst complying with existing obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), as an ethically appropriate response to the pandemic. This article also considers whether a so-called TRIPS waiver could provide better options and concludes that the challenge of compelling disclosure of know-how remains.