Legal perspectives on black box recording devices in the operating environment

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 s 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. Antecedentes Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico. Métodos Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano. Resultados Se obtuvieron 1