LAUSR

This article describes a recent United States (U.S.) government settlement with a company producing clinical decision support software (CDSS) for kickbacks the company received from a pharmaceutical company intended to drive up opioid prescribing. It reflects on the legal avenues pursued by the government in the matter and considers the implications of the case for regulation of clinical software design in the Australian healthcare context. CDSS is medical software that is widely used in both primary care and hospital settings. It is usually integrated within electronic health record (EHR) systems. The software applies algorithms to patient data to generate personalized guidance for a patient’s care that can be utilized by a clinician. CDSS can provide support and reminders to clinicians for decisions about preventative healthcare tasks, prescribing, diagnostic imaging, pathology testing, and many other aspects of a person’s treatment. These systems have been available for over three decades, and there is substantial evidence demonstrating their generally positive effects on care quality, processes, and outcomes. The regulation of CDSS in Australia is somewhat of a grey zone. I will return to this point after outlining the U.S. Practice Fusion case since the case highlights the risks of under-regulation in this arena, particularly in terms of the risks and responsibility it creates for individual clinicians using EHR systems.