Health information was once generally collected and reserved either to inform clinical care, conduct research, or survey the public's health. Today, with digital data infrastructure, health information can technically flow between all of these purposes simultaneously, enabling learning health systems (LHSs) and related enterprises. LHSs are emerging through infrastructural innovation that allows for connectedness in data collection, analytics to transform data to knowledge, and application of that knowledge in practice and in ways that generate new data through evaluation of outcomes (Figure 1).1 LHSs create cycles of continuous improvement that will allow health systems to address well-known, chronic maladies-e.g., high rates of medical error, spiraling costs, the slow rate of translational science, and failure to implement agreed-upon best practices. 2,3 LHSs represent an innovation in health infrastructure such that learning occurs at multiple levels of scale, ranging from individuals, single practices, and systems to systems of systems spanning organizational and geopolitical boundaries.LHSs are successful when platforms and culture support efficient organization of technology, people, processes, and policy. Researchers conducting quality improvement studies rather than research also do not require Institutional Review Board (IRB) oversight.Proponents of LHSs claim a moral imperative, which remains to be empirically tested, for data to be amassed, unencumbered by "outdated" frameworks that hinder the pursuit of knowledge and the timely dissemination of important findings. 7-9 Ruth Faden and colleagues, for example, have offered a widely cited framework that reevaluates the obligations of stakeholders in the context of health as a learning health system as an initial position from which to launch a deeper dialogue and empirical evaluation of alternatives, implementation strategies, as well as the acceptability of this framework to the
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