Anne van Dalen

42 I Chapter 1 DISCUSSION As is often the case with relatively new technology, legal guidelines on the use of MDRs are currently lacking. However, the general privacy principles are clear on how to design such a system and how to optimize conditions for use. Lessons are learned from the aviation industry, and the main issues that should be addressed are related to the privacy and legislation perspectives. Patients may rely on professional ethics and best judgement in deciding which of the permissive uses of the MDR and disclosures the healthcare professional has to make. 57 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 MDR, are to be highlighted. 2,56,77 Any possible information that might identify the patient or healthcare provider should either be blurred, scrambled or, whenever possible, removed as early as possible and not be reflected in the reporting output. Most importantly, as the patient is not the object of the study itself, patient identifiers should be removed. This means that written informed consent does not necessarily have to be obtained from the patients. 57,78,79 According to the general privacy rules, an opt-out option is sufficient and should be provided to the patient in a timely manner, with their decision clearly noted in the medical record. 3,5,80 As far as the operating theatre staff is concerned, authors recommend that theatre staff, including medical students, are asked formally, upon embarking on such a quality initiative, to volunteer to work with the innovation. 62 An official informed consent stating the purpose of the data recordings, where the data recordings are analysed, what the expected benefits for the participants are, and how the data are stored securely may help in gaining support and momentum for the MDR initiative. 48,81,82 It should be emphasized that their safety and personal privacy is protected, ensuring full transparency of the methods used. 58,80,83–85 Based on this review and the authors’ experience, an overview of the recommended practice and legal guidelines is presented in Table 1. Informing patients about having a MDR that is used solely for the purposes of team debriefing may significantly contribute to the patient’s trust, as most of them value this quality improvement measure. Regardless of this, healthcare professionals