Auswirkungen der Medizinprodukteverordnung auf ML-Lösungen in Schweizer Spitälern

Artificial intelligence (AI) has been present in hospitals directly and indirectly for some time. Often AI is available for workplace functions in the office area, such as speech recognition software, and in some cases also in personnel and resource optimization software. In the medical field, specifically, the spectrum ranges from data-driven analyses and information support systems to the generation of diagnostic and therapeutic suggestions for medical personnel. However, many players in hospitals are not aware of the scope and impact of AI technologies. What is not well known are the regulatory requirements in combination with the use of machine learning (ML). Based on a representative survey of general hospitals in Switzerland, the current state of AI usage was determined. On this basis, we analyze the requirements for ML systems with respect to the Medical Device Regulation and their impact with respect to the compliant use of medical software. We present a proposal on how ML systems can be brought more in line with regulations. In the concluding outlook, the possible limitations and necessities for future developments are discussed.