In July 2023, the United States and the European Union introduced the Data Privacy Framework (DPF), introducing the third generation of cross-border data transfer agreements constituting adequacy with respect to personal data transfers under the General Data Protection Regulation (GDPR) between the European Union (EU) and the US. This framework may be used in cross-border healthcare and research relationships, which are highly desirable and increasingly essential to innovative health technology development and health services deployment. A reliable model meeting EU adequacy requirements could enhance the transfer of patient and research participant data. While the DPF might present a familiar terrain for US organizations, it also brings unique challenges. A notable concern is the ability of individual EU Member States to establish individual and additional requirements for health data that are more restrictive than GDPR requirements, which are not anticipated by the DPF. This article highlights the DPF’s potential impact on the healthcare and research sectors, finding that the DPF may not provide the degree of lawful health data transfer desirable for healthcare entities. We examine the DPF against a background of existing Health Insurance Portability and Accountability Act obligations and other GDPR transfer tools to offer alternatives that can improve the likelihood of reliable, lawful health data transfer between the US and EU.

Background: Operating-room audiovisual recording is increasingly proposed, although its ethical implications need elucidation. The aim of this systematic review was to examine the published literature on ethical aspects regarding operating-room recording. Methods: MEDLINE (via PubMed), Embase, and Cochrane databases were systematically searched for articles describing ethical aspects regarding surgical (both intracorporeal and operating room) recording from database inception to the present (the last search was undertaken in July 2022). Medical subject headings used in the search included ‘operating room’, ‘surgery’, ‘video recording’, ‘black box’, ‘ethics’, ‘consent’, ‘confidentiality’, ‘privacy’, and more. Title, abstract, and full-text screening determined relevance. The quality of studies was assessed using Centre for Evidence-Based Medicine grading and no formal assessment of risk of bias was attempted given the theoretical nature of the data collected. Results: From 1048 citations, 22 publications met the inclusion criteria, with three more added from their references. There was evident geographical (21 were from North America/Europe) and recency (all published since 2010) bias and an exclusive patient/clinician perspective (25 of 25). The varied methodology (including ten descriptive reviews, seven opinion pieces, five surveys, two case reports, and one RCT) and evidence level (14 level V and 10 level III/IV) prevented meaningful systematic grading/meta-analysis. Publications were narratively analysed for ethical thematic content (mainly education, performance, privacy, consent, and ownership) that was then grouped by the four principles of biomedical ethics of Beauchamp and Childress, accounting for 63 distinct considerations concerning beneficence (22 of 63; 35 per cent), non-maleficence (17 of 63; 27 per cent), justice (14 of 63; 22 per cent), and autonomy (10 of 63; 16 per cent). From this, a set of proposed guidelines on the use of operative data is presented. Conclusion: For a surgical video to be a truly valuable resource, its potential benefits must be more fully weighed against its potential disadvantages, so that any derived instruments have a solid ethical foundation. Universal, ethical, best-practice guidelines are needed to protect clinicians, patients, and society.