Anne van Dalen

262 I Summary and General Discussion GENERAL DISCUSSION Legal and privacy concerns As is often the case with relatively new technology, legal guidelines on the use of a Black Box are currently lacking. 46 Lessons are learned from the aviation industry, and the main issues that should be addressed are related to the privacy and legislation perspectives. Regardless of the national differences in legislation, the importance of the general privacy principles, to ensure clear consensus and openness between participants and researchers about the methods and purpose of the Black Box, are to be underlined. The key dimensions to address are; “what is the purpose?’, “who and what to the data cover?”, “what about the privacy and privacy-by-design-principles?’, “who is responsible for the data?”, and “which format should the data be in?”. Most importantly, written informed consent does not necessarily have to be obtained from the patients. That their safety and personal privacy is protected needs to be pointed out, ensuring full transparency of the methods used. 46 This thesis concluded that the fear that a Black Box bears an increased risk of medical negligence litigation, limited performance or loss of professional status is unjustified, as long as good professional standards of patient medical record keeping and reporting of adverse events are maintained. To help dissipate any remaining fear, resistance or doubt, an official agreement on confidentiality can be signed and supported by the hospital directorate. The researchers and the institute are then, in accordance with the official agreement, bound to refuse the disclosure of any data obtained by the Black Box. Yet, it is important to emphasize that, if a severe adverse event occurs, video recordings usually help rather than harm the healthcare professionals involved. The chain of (re)actions and decisions resulting in the unwanted event are better understood with the objective help of the Black Box, as it helps in augmenting the analysis of a calamity or near miss when constructing a public calamity report. 10 26 The data source itself is protected by law. Besides, if the healthcare professional has provided reasonable quality standard of care, no punitive measures can be imposed anyway. 46 67 68