• Jessica Jue, Neal A Shah, and Tim Ken Mackey.
• University of California San Diego, School of Medicine, La Jolla, CA, USA.
• Surg Innov. 2020 Apr 1; 27 (2): 220-228.

AbstractSurgical data recording technology has great promise to generate patient safety and quality data that can be utilized to potentially reduce medical errors. Variations of these systems aim to improve surgical technique, develop better training simulation, and promote adverse event investigation similar to the aims of black box technology utilized in other industries. However, many unknowns remain for surgical data recording utilization in operating rooms and clinical settings in the United States. This includes the need to appropriately design systems so they collect meaningful and useful data that can be discussed by surgical team members in an open and safe environment to optimize clinical care processes. In order to better understand the clinical and regulatory environment for surgical data recording systems, we conducted an interdisciplinary review to identify key technology approaches, and assess legal and regulatory implications associated with this potentially disruptive technology. We found technology ranging from audio and visual data, to systems utilizing mobile applications, and kinematic data capture. The data collected present legal questions over ownership of information and privacy, along with regulatory issues at the federal and state levels. The benefits of these data should be balanced with the need to develop appropriate policies and regulations that protect the interests of both clinicians and patients in order to encourage further innovation and better realize the potential of surgical data recording technology to improve clinical decision making and patient safety outcomes.

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