Connecting for surgery: The Belgian use case on the legal aspects of the digital operating room

Abstract

Telecommunications technology is making its way into operating rooms by new developments in e-health. How- ever, conflicts arise with existing legal principles regarding data protection. This paper deals with key elements of the in- teractions between data protection and evolution in e-health. The scope will be the digital operating room, where differ- ent health services and activities converge through networked technology, raising a number of privacy-related issues. For instance, the patient's health records and tools for recording surgical procedures could be integrated within the same plat- form, potentially leading to sensitive personal data linkage. Also the possible duration and reason of storage of surgical recordings, is a matter that remains largely unresolved in cur- rent practice. First, this paper will analyze the data exchanges of the digital operating room. As these will include personal patient data, it must be assessed whether and how the Euro- pean framework on data protection can apply. Second, the regulatory regime of the manufacturers of the devices of the digital operating room will be analyzed. Can the current legal framework relating to e-health provide for suitable regulation for such devices? Drawing from experience gained in research projects, this paper aims to provide practical answers to often theoretical questions.