UNSTRUCTURED
The fourth industrial revolution is based on cyber-physical systems and the connectivity of devices. It is currently unclear what the consequences are for patient safety as existing digital health technologies become ubiquitous with increasing pace and interact in unforeseen ways. In this paper, we describe the output from a workshop focused on identifying the patient-safety challenges associated with emerging digital health technologies. We present a definition of Patient Safety Informatics that was informed by the workshop and existing literature, discuss the challenges identified in the workshop, and present recommendations to address the patient-safety concerns posed by them. A key implication of considering the challenges and opportunities for Patient Safety Informatics is the interdisciplinary contribution required to study digital health technologies within their embedded context. The principles underlying our recommendations are those of proactive and systems approaches that relate the social, technical and regulatory facets underpinning patient safety informatics theory and practice.