Learning to Regulate Learning Healthcare Systems

Abstract

Abstract:It is commonplace to observe that science often outstrips the ability of society to monitor, supervise and regulate it. A recent challenge in this regard concerns Learning Healthcare Systems, an initiative to collect data and test hypotheses across clinical settings, and therefore to a larger degree than before. Some argue that the line between research and clinical practice is becoming blurred, and that existing regulation seems to obstruct low risk research. They propose the creation of a new ethical framework for Learning Healthcare Systems, to speed up research. This paper opposes that view, and argues that Learning Healthcare Systems do not blur or remove the line between research and practice, and will not result in a single set of regulations for all kinds of biomedical research. The authors suggest that a large proportion of Learning Healthcare System activities resemble public health surveillance to a significant extent. Therefore, they propose that these activities should be organized in accordance with the same ethical principles as public health surveillance, specifically that Learning Healthcare Systems should rest on the principles of comprehensiveness, transparency, and public accountability.