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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., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Technological advances in big data (large amounts of highly varied data from many different sources that may be processed rapidly), data sciences and artificial intelligence can improve health-system functions and promote personalized care and public good. However, these technologies will not replace the fundamental components of the health system, such as ethical leadership and governance, or avoid the need for a robust ethical and regulatory environment. In this paper, we discuss what a robust ethical and regulatory environment might look like for big data analytics in health insurance, and describe examples of safeguards and participatory mechanisms that should be established. First, a clear and effective data governance framework is critical. Legal standards need to be enacted and insurers should be encouraged and given incentives to adopt a human-centred approach in the design and use of big data analytics and artificial intelligence. Second, a clear and accountable process is necessary to explain what information can be used and how it can be used. Third, people whose data may be used should be empowered through their active involvement in determining how their personal data may be managed and governed. Fourth, insurers and governance bodies, including regulators and policy-makers, need to work together to ensure that the big data analytics based on artificial intelligence that are developed are transparent and accurate. Unless an enabling ethical environment is in place, the use of such analytics will likely contribute to the proliferation of unconnected data systems, worsen existing inequalities, and erode trustworthiness and trust., ((c) 2020 The authors; licensee World Health Organization.)

The text discusses the governance of medical artificial intelligence (AI) devices in Hong Kong. The Medical Device Division (MDD) of the Department of Health has issued technical guidance on AI medical devices, which are defined as medical devices integrated with AI software. The guidance extends the registration regime for medical devices to AI devices with continuous learning capability. Data governance is also emphasized, with providers required to maintain data integrity and follow good practice recommendations. The text highlights the importance of stakeholder involvement and addresses concerns related to personal data and equity. The special issue includes articles on responsibility, trust, jurisdiction-specific governance, data governance, and stakeholder involvement. It concludes with discussions on equity and the environmental impact of AI devices. [Extracted from the article]