1 A Sociotechnical Approach to Electronic Health Record-related Safety 1 Dean F. Sittig, PhD and Hardeep Singh, MD, MPH Abstract Electronic health records (EHRs) have greatly improved the safety and quality of health care delivery by increasing access to information, reducing illegibility, and enabling closer oversight of the clinical care process. EHR implementation involves developing and connecting a complex set of electro-mechanical devices designed to collect, store, and transmit information, at speed, within an existing complex adaptive sociotechnical system. The sociotechnical system consists of all the hardware and software required to run the EHR along with the interactions between the people, their clinical and administrative workflows and communication processes, and the internal organizational structures, culture and the physical environment in which the clinical work takes place. These widespread EHR implementations have resulted in many unintended and unanticipated adverse events that have significantly affected patient safety. The goal of this chapter is to introduce readers to some of the key theoretical models, conceptual approaches, tools, and strategies to help us understand and address the complex, yet vitally important sociotechnical impacts of these devices on the safety of the health care delivery system and the implementation/adoption process. Keywords: Electronic Health Records (EHRs), Patient safety, Sociotechnical methods, Health IT Policy, EHR-related safety The Need for a Sociotechnical Approach to EHR Safety The modern information and communications technology (ICT)-enabled healthcare delivery system epitomizes a complex adaptive sociotechnical system in which individuals’ actions in relation to the EHR are based on often unpredictable physical, psychological, or social rules rather than constraints imposed by someone, or something, that is “in-charge”. 1 Individuals’ needs, desires, and actions are often not homogeneous even within their work groups which often leads to goals and behaviors that are in conflict. Over the past 10 years, many healthcare delivery systems around the world have added an enormously complex set of interconnected, often externally developed, software applications that together create an electronic health record (EHR). These EHRs were designed to improve the quality and safety of the care delivered while also reducing its cost. Addressing the safe and effective design, development, implementation, and use of state-of-the-art EHRs requires a sociotechnical approach since focusing on the technology alone has not worked well. Briefly, the sociotechnical approach regards individual system components (e.g. the people, their culture, organizational structures and processes, and technology) as a single, complex adaptive system in which the technology changes the way some people organize and conduct their work and the way some people change the technology. In other words, the various human and technical components 1 Draft Chapter from “Key Advances in Clinical Informatics: Transforming Health Care through Health Information Technology” eds. Bates, Kresswell, Sheikh, Wright; 2017.