Joel Drittenbass

The use of robotic applications is a growing trend in Switzerland’s healthcare sector. For example, robots have been broadly in use in minimally invasive surgery. Robotic applications in minimally invasive surgery are an information-driven and safety-critical technology governed, amongst others, by data protection as well as medical device regulations. Doctors must make sure they understand how such robots process patient-specific information to comply with the relevant provisions of data protection regulations, which include, in the opinion of the authors, the requirement to seek informed patient consent. Robotic applications in minimally invasive surgery are (normally) medical devices under Swiss law. In this respect, the revised Therapeutic Product Act leads to a tightening of medical device regulations and an increase of the barriers to market entry for medical device manufacturers.

Autonomous medical robots are data-, network- and cloud-based medical devices, which are mainly regulated by data protection and medical device law. They reveal impressive opportunities, but also give rise to considerable risks that are amenable to legal control. This thesis examines the extent to which legal forms and legal instruments of data protection and medical device law are suitable to enable opportunities from autonomous medical robots and at the same time to minimize the risks of autonomous medical robots. This study is thus based on a reciprocal legal concept, which demonstrates the need to supplement the instrumental choice in data protection and medical device law. In fact, the identified deficits (in the form of possible loss of options and/or possible reduction of public welfare) can be transferred to a normative approach. Legal instruments of the Risk-Based Approach, which originates from the «common law», can make a (limited) contribution to overcoming the identified deficits. Therefore, it is not surprising this thesis pleads for the applicability and enactment of risk-based legal instruments in order to facilitate a science-based regulation of autonomous medical robots.