Abstract
This chapter introduces the concept of a learning health care system (LHCS) and discusses the ethical issues that arise within the LHCS context. The LHCS has gained attention as an organizational innovation to improve the quality and efficiency of health care. In an LHCS, knowledge generation is built into the ongoing practice of clinical care, and findings based on this knowledge are continuously fed back to improve care delivery. The goals of an LHCS are arguably consistent with the moral obligation of health systems to improve quality, safety, and justice in health. However, the LHCS model also presents potential ethical challenges. This article discusses challenges related to continuous data generation, including maintaining privacy and confidentiality; obligations related to data on cost and quality; transparency to patients and other stakeholders; and data interoperability. It also describes issues related to the continued appropriateness of the research-practice distinction and implications for ethical oversight.
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