Legal perspectives on black box recording devices in the operating environment

Abstract

Background A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review. Methods A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre. Results After removing duplicates, 116 citations were retrieved and abstracts screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record. Conclusion Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.

Development of a Model for Video-Assisted Postoperative Team Debriefing

“…20 The study subjects were voluntarily asked to give their formal written informed consent before participation. 19,21 The OR Black Box obtained all intraoperative data feeds, including audiovisual recordings in the OR, and depersonified patient physiological data. 22 The data feed combined views of the surgical field, nursing station, laparoscopic camera, and anesthesia station, including the anesthesia patient-monitoring device.…”

“…This may help participants to open up and speak their mind freely. 21,37 An independent moderator to lead team debriefing may be key, safeguarding aforementioned conditions.…”

Machine Learning and Learning Machines: KI in der Aus- und Weiterbildung

“…Hierbei werden alle Daten im OP-Saal aufgenommen und können bei Bedarf z. B. zur Fehleranalyse ausgewertet werden, ähnlich einem Flugschreiber im Flugzeug [10][11][12][13]. Andererseits können Daten auch prospektiv aufgenommen und analysiert werden, um Voraussagen treffen zu kön-nen über mögliche Fehlerquellen und Trainingsmöglichkeiten bzw.…”

This month on Twitter

“…One of the most discussed papers this month was on the legal implications of black box recording devices in the operating theatre. Overall, black box use seemed to be a popular concept, providing privacy was implemented appropriately.…”