The National Academy of Medicine and others advocate the development of learning health systems (LHSs). Ideal LHSs integrate observational data, quasi-experimental designs, and pragmatic trials to track care, test interventions to improve care, implement successes, and share findings. This integration of learning across the system poses challenges for governance, because traditional governance models impose substantial burdens on activities defined as research, while failing to ensure participant protection in other learning activities. Although governance of learning is central to the missions of LHSs, we know little about how they carry it out or engage patients and families in the process.
