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.

Article DOI: 10.1016/j.semnephrol.2021.05.009