Operationalizing "One Health" as "One Digital Health" Through a Global Framework That Emphasizes Fair and Equitable Sharing of Benefits From the Use of Artificial Intelligence and Related Digital Technologies.

The operationalization of One Health (OH) through digitalization is a means to deploy digital technologies (including Artificial Intelligence (AI), big data and related digital technologies) to better capacitate us to deal with growing climate exigency and related threats to human, animal and plant health. With reference to the concept of One Digital Health (ODH), this paper considers how digital capabilities can help to overcome 'operational brakes' in OH through new and deeper insights, better predictions, and more targeted or precise preventive strategies and public health countermeasures. However, the data landscape is fragmented and access to certain types of data is increasingly restrictive as individuals, communities and countries seek to assert greater control over data taken from them. This paper proposes for a dedicated global ODH framework-centered on fairness and equity-to be established to promote data-sharing across all the key knowledge domains of OH and to devise data-driven solutions to challenges in the human-animal-ecosystems interface. It first considers the data landscape in relation to: (1) Human and population health; (2) Pathogens; (3) Animal and plant health; and (4) Ecosystems and biodiversity. The complexification from the application of advance genetic sequencing technology is then considered, with focus on current debates over whether certain types of data like digital (genetic) sequencing information (DSI) should remain openly and freely accessible. The proposed ODH framework must augment the existing access and benefit sharing (ABS) framework currently prescribed under the Nagoya Protocol to the Convention on Biological Diversity (CBD) in at least three different ways. First, the ODH framework should apply to all genetic resources and data, including DSI, whether from humans or non-humans. Second, the FAIRER principles should be implemented, with focus on fair and equitable benefit-sharing. Third, the ODH framework should adopt multilateral approaches to data sharing (such as through federated data systems) and to ABS. By operationalizing OH as ODH, we are more likely to be able to protect and restore natural habitats, secure the health and well-being of all living things, and thereby realize the goals set out in the post-2020 Global Biodiversity Framework under the CBD.

A Call for an Ethics and Governance Action Plan to Harness the Power of Artificial Intelligence and Digitalization in Nephrology.

Digitalization in nephrology has progressed in a manner that is disparate and siloed, even though learning (under a broader Learning Health System initiative) has been manifested in all the main areas of clinical application. Most applications based on artificial intelligence/machine learning (AI/ML) are still in the initial developmental stages and are yet to be adequately validated and shown to contribute to positive patient outcomes. There is also no consistent or comprehensive digitalization plan, and insufficient data are a limiting factor across all of these areas. In this article, we first consider how digitalization along nephrology care pathways relates to the Learning Health System initiative. We then consider the current state of AI/ML-based software and devices in nephrology and the ethical and regulatory challenges in scaling them up toward broader clinical application. We conclude with our proposal to establish a dedicated ethics and governance framework that is centered around health care providers in nephrology and the AI/ML-based software to which their work relates. This framework should help to integrate ethical and regulatory values and considerations, involve a wide range of stakeholders, and apply across normative domains that are conventionally demarcated as clinical, research, and public health.

Engaging publics in biobanking and genetic research governance - a literature review towards informing practice in India.

Background: There is growing interest in advancing biobanking and genetic research in many countries, including India. Concurrently, more importance is being placed on participatory approaches involving the public and other stakeholders in addressing ethical issues and policymaking as part of a broader governance approach. We analyse the tools, purposes, outcomes and limitations of engaging people towards biobanking and genetic research governance that have been undertaken worldwide, and explore their relevance to India. Methods: Papers to be reviewed were identified through a targeted literature search carried out using ProQuest and PubMed. Retrieved papers were analysed with the Rpackage for Qualitative Data Analysis using inductive coding and thematic analysis, guided by the Framework Method. Results: Empirical studies on public and community engagement in the context of biobanking and or genetic research show a predominance towards the end of the last decade, spanning 2007 to 2019. Numerous strategies-including public meetings, community durbars, focus group discussions, interviews, deliberations, citizen-expert panels and community advisory boards-have been used to facilitate communication, consultation and collaboration with people, at the level of general and specific publics. Engagement allowed researchers to understand how people's values, opinions and experiences related to the research process; and enabled participants to become partners within the conduct of research. Conclusions: Constructs such as 'co-production', 'engagement of knowledges', 'rules of engagement' and 'stewardship' emerge as significant mechanisms that can address the ethical challenges and the governance of biobanking and genetic research in India. Given the inherent diversity of the Indian population and its varying cultural values and beliefs, there is a need to invest time and research funds for engagement as a continuum of participatory activity, involving communication, consultation and collaboration in relation to biobanking and genetic research. Further research into these findings is required to explore their effective employment within India.

Heralding the Digitalization of Life in Post-Pandemic East Asian Societies.

Following the outbreak of what would become the COVID-19 pandemic, social distancing measures were quickly introduced across East Asia-including drastic shelter-in-place orders in some cities-drawing on experience with the outbreak of severe acute respiratory syndrome (SARS) almost two decades ago. "Smart City" technologies and other digital tools were quickly deployed for infection control purposes, ranging from conventional thermal scanning cameras to digital tracing in the surveillance of at-risk individuals. Chatbots endowed with artificial intelligence have also been deployed to shift part of healthcare provision away from hospitals and to support a number of programmes for self-management of chronic disease in the community. With the closure of schools and adults working from home, digital technologies have also sustained many aspects of both professional and social life at a pace and scale not considered to be practicable before the outbreak. This paper considers how these new experiences with digital technologies in public health surveillance are spurring digitalization in East Asian societies beyond the conventional public health context. It also considers some of the concerns and challenges that are likely to arise with rapid digitalization, particularly in healthcare.

Pathogens collections, biobanks and related-data in a One Health legal and ethical perspective.

Research on emerging infectious diseases calls for a work on collections of pathogens (including hosts or vectors from which the pathogens were isolated), related to human and animal health, to wildlife or on the environmental material. In this respect, the adoption of a One Health perspective is determined by the need for a common approach to consider the collection, storage and use of pathogens coming from human or non-human sources, and particularly when the same pathogen is taken from different environments. In response to this development, our purpose is to delineate a flexible regulation framework concerning collections of pathogens from various origins or hosts and their associated data in order to facilitate scientific work and research partnerships. The legal and ethical cutting-edge research on Biomedical Big Data is particularly stimulating when it comes to address challenges related to collections or biobanks of pathogens such as prior informed consent and accessibility, Material Transfer Agreement or benefit sharing.

CIOMS guidelines remain conservative about vulnerability and social justice.

This paper begins by considering how the revised CIOMS guidelines have progressed beyond a mere labelling approach in the handling of vulnerability.. However, progress is limited as the guidelines remain fixated on voluntariness and harm reduction or prevention. Although these are important considerations, vulnerability could also serve as a robust analytic for the evaluation of situational and pathogenic (or structural) contributions to susceptibilities to harm. They could also provide better guidance on how to differentiate among varying types and degrees of harm, rather than merely noting their presence. The paper concludes by considering vulnerability in relation to especially vulnerable children in health research.

ELSI practices in genomic research in East Asia: implications for research collaboration and public participation.

Common infrastructures and platforms are required for international collaborations in large-scale human genomic research and policy development, such as the Global Alliance for Genomics and Health and the 'ELSI 2.0' initiative. Such initiatives may require international harmonization of ethical and regulatory requirements. To enable this, however, a greater understanding of issues and practices that relate to the ethical, legal and social implications (ELSI) of genomic research will be needed for the different countries and global regions involved in such research. Here, we review the ELSI practices and regulations for genomic research in six East Asian countries (China, Indonesia, Japan, Singapore, South Korea and Taiwan), highlighting the main similarities and differences between these countries, and more generally, in relation to Western countries. While there are significant differences in ELSI practices among these East Asian countries, there is a consistent emphasis on advancing genomic science and technology. In addition, considerable emphasis is placed on informed consent for participation in research, whether through the contribution of tissue samples or personal information. However, a higher level of engagement with interested stakeholders and the public will be needed in some countries.

Governance of biomedical research in Singapore and the challenge of conflicts of interest.

This article discusses the establishment of a governance framework for biomedical research in Singapore. It focuses on the work of the Bioethics Advisory Committee (BAC), which has been instrumental in institutionalizing a governance framework, through the provision of recommendations to the government, and through the coordination of efforts among government agencies. However, developing capabilities in biomedical sciences presents challenges that are qualitatively different from those of past technologies. The state has a greater role to play in balancing conflicting and potentially irreconcilable economic, social, and political goals. This article analyzes the various ways by which the BAC has facilitated this.