Towards the integration of the notion of «just culture» into positive law on the basis of bioethical and normative considerations founded on patient safety

Abstract

The improvement of patient safety in modern healthcare systems is inextricably linked to the implementation of certain technical structures, among which adverse event reporting systems are particularly important as they are essential tools for the learning of professionals. In this sense, the aforementioned reporting implies certain institutional conditions and legal guarantees for the different actors involved, in the absence of which the communication of incidents in the health sector is no longer feasible. In line with the above, the concept of “just culture” has been coined for more than two decades as one of the central notions for enabling the reporting of incidents and near-misses by healthcare professionals. This paper analyses the connection between the implementation of a patient safety culture and the model of responsibility (insofar as it involves a transition from a blaming culture to a systemic approach in dealing with adverse events). Furthermore, the article discusses the bioethical foundations of policies aimed at patients' safety (and, in particular, of adverse events reporting systems), and establishes the guidelines for the integration of the notion of “just culture” in the framework of positive law.