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Oftmals ist KI f\u00fcr Arbeitsplatzfunktionen im B\u00fcrobereich wie z.\u202fB. in Spracherkennungssoftware verf\u00fcgbar, teilweise auch in Personal- und Ressourcen-Optimierungssoftware. Das Spektrum reicht speziell im medizinischen Bereich von datengetriebenen Analysen und Informationsunterst\u00fctzungssystemen bis hin zur Generierung von Diagnose- und Therapievorschl\u00e4gen f\u00fcr das medizinische Personal. Jedoch sind vielen Akteuren in den Spit\u00e4lern der Umfang und die Auswirkung von KI-Technologien gar nicht wirklich bewusst. Noch weniger bekannt sind dabei die regulatorischen Vorgaben in Kombination mit dem Einsatz von Maschinellem Lernen (ML). Basierend auf einer repr\u00e4sentativen Befragung von allgemeinen Spit\u00e4lern in der Schweiz wurde der aktuelle Stand der KI-Nutzung erhoben. Auf dieser Basis werden die Anforderungen an ML-Systeme in Bezug auf die Medizinprodukteverordnung und deren Auswirkung in Hinblick auf den konformen Einsatz von medizinischer Software analysiert. Wir pr\u00e4sentieren einen Vorschlag, wie ML-Systeme besser mit den Regulatorien in Einklang gebracht werden k\u00f6nnen. Im Ausblick wird auf die m\u00f6glichen Grenzen und Notwendigkeiten f\u00fcr zuk\u00fcnftige Weiterentwicklungen eingegangen.<\/jats:p>","DOI":"10.1365\/s40702-024-01048-5","type":"journal-article","created":{"date-parts":[[2024,2,25]],"date-time":"2024-02-25T22:01:59Z","timestamp":1708898519000},"page":"503-518","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Auswirkungen der Medizinprodukteverordnung auf ML-L\u00f6sungen in Schweizer Spit\u00e4lern","Effects of the Medical Device Regulation on ML Solutions in Swiss Hospitals"],"prefix":"10.1365","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-1337-9765","authenticated-orcid":false,"given":"Christian","family":"Russ","sequence":"first","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9910-3733","authenticated-orcid":false,"given":"Philipp H.","family":"Stalder","sequence":"additional","affiliation":[]},{"given":"Stefanie","family":"Rufinatscha","sequence":"additional","affiliation":[]},{"given":"Tibor","family":"Pimentel","sequence":"additional","affiliation":[]},{"given":"Lukas","family":"Geissmann","sequence":"additional","affiliation":[]}],"member":"93","published-online":{"date-parts":[[2024,2,25]]},"reference":[{"key":"1048_CR1","volume-title":"Die Inverkehrbringung von auf K\u00fcnstlicher Intelligenz basierender Software unter der Medical Device Regulation","author":"R Ab\u00e4cherli","year":"2022","unstructured":"Ab\u00e4cherli\u00a0R (2022) Die Inverkehrbringung von auf K\u00fcnstlicher Intelligenz basierender Software unter der Medical Device Regulation. 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