Anne van Dalen

1 Legal perspectives on black box recording devices in the operating environment I 35 INTRODUCTION The number of healthcare professionals using an audio, video or complete data recorder in the surgical environment, sometimes referred to as a medical data recorder (MDR) or ‘black box’, is increasing. 1–3 An MDR is able to record operational data (for example from overview cameras, laparoscopic cameras, anaesthetic and environmental equipment), enabling analysis of technical and non-technical elements. 4 It provides theatre staff the opportunity to learn from their performance or suboptimal situations to enhance team performance. 5–11 Surgical procedures may be recorded for purposes of education, research and quality improvement. 3,12 Although this has been associated with a reduction in errors, there are concerns about the adequacy of implementation related to privacy, ownership of data and medical negligence. 4,8,10,13,14 Understandably, medical practitioners fear that an MDR could be misused for punitive or controlling purposes, a situation that inevitably leads to scepticism, user resistance and loss of autonomy. 7,13,15 These very real medicolegal concerns are hindering the optimal use of the MDR. 3,5 Other high-risk industries such as aviation (flight data recorder), offshore oil platforms and maritime transport (voyage data recorder) have used black boxes to analyse suboptimal situations and errors for quite some time16. In these industries, they have been embedded in legal and operational frameworks that are sorely lacking in the surgical environment. 7,17 This study reviewed the privacy law concerns, medicolegal considerations and universal legal requirements regarding MDR use.