Regulation of Medical Robots in Switzerland: The Example of Robotic Applications in Minimally Invasive Surgery
Journal
Juristische Zeitschrift für Pharma, Biotech und Medtech (Life Science Recht)
Type
journal article
Date Issued
2020-03
Author(s)
Abstract
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.
Language
English
HSG Classification
contribution to practical use / society
HSG Profile Area
LS - Business Enterprise - Law, Innovation and Risk
Refereed
Yes
Publisher
Stämpfli
Publisher place
Bern
Volume
LSR 2020
Number
1
Start page
11
End page
19
Pages
9
Subject(s)
Eprints ID
260207
File(s)![Thumbnail Image]()
Name
LSR 01_2020_Regulation of Medical Robots in Switzerland.pdf
Size
6.61 MB
Format
Adobe PDF
Checksum (MD5)
fc9fe76c96c1c5878aa3171066f61b2a