The use of digital technology is increasing rapidly across surgical specialities, yet there is no consensus for the term ‘digital surgery’. This is critical as digital health technologies present technical, governance, and legal challenges which are unique to the surgeon and surgical patient. We aim to define the term digital surgery and the ethical issues surrounding its clinical application, and to identify barriers and research goals for future practice. 38 international experts, across the fields of surgery, AI, industry, law, ethics and policy, participated in a four-round Delphi exercise. Issues were generated by an expert panel and public panel through a scoping questionnaire around key themes identified from the literature and voted upon in two subsequent questionnaire rounds. Consensus was defined if >70% of the panel deemed the statement important and <30% unimportant. A final online meeting was held to discuss consensus statements. The definition of digital surgery as the use of technology for the enhancement of preoperative planning, surgical performance, therapeutic support, or training, to improve outcomes and reduce harm achieved 100% consensus agreement. We highlight key ethical issues concerning data, privacy, confidentiality and public trust, consent, law, litigation and liability, and commercial partnerships within digital surgery and identify barriers and research goals for future practice. Developers and users of digital surgery must not only have an awareness of the ethical issues surrounding digital applications in healthcare, but also the ethical considerations unique to digital surgery. Future research into these issues must involve all digital surgery stakeholders including patients.
BACKGROUND The United Kingdom originally joined the early incarnation of the EU (the European Community or Common Market) in 1973. 2 This was confirmed by popular consent in the referendum of 1975. 3 At the time, the organisation consisted only of Western European countries. Greece joined in 1981, followed by Portugal and Spain in 1986. The 1990s saw the addition of Austria, Sweden and Finland. Finally, many of the countries of Eastern Europe joined in two batches-2004 (8 countries) and 2007 (Bulgaria and Romania). The last country to join was Croatia in 2013. LEGISLATIVE FRAMEWORK The EU directive (PQD) 2005/36 EC 4 (recently incorporated into UK law 5) on the recognition of professional qualifications for dentists, allows dentists to freely work in other member states subject to approval by the local competent authority; in the case of the UK, that is the GDC. The term EEA (European Economic Area) includes the countries of Norway, Iceland and Lichtenstein who have similar rights of access but are not EU members. The terms EU and EEA are used interchangeably here.
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