Hagiwara, YukiYukiHagiwaraEspinoza, DelfinaDelfinaEspinozaSchleiß, PhilippPhilippSchleißMata, NúriaNúriaMataDoan, Nguyen Anh VuNguyen Anh VuDoan2024-02-122024-02-122023https://publica.fraunhofer.de/handle/publica/46202810.1109/MetroXRAINE58569.2023.10405816Computer-Aided Diagnosis (CADx) systems are safety-critical systems that provide automated medical diagnoses based on their input data. They are Artificial Intelligence based systems which make use of Machine Learning or Deep Learning techniques to differentiate between healthy and unhealthy medical images, as well as, physiological signals acquired from patients. Although current CADx systems offer many advantages in diagnostics, validation is still a challenge, i.e. ensuring that no false negative happens while limiting the occurrence of false positives. This is a major concern since such safety-critical systems have to be verified before deployment into a clinical environment. For that reason, this paper aims to improve the reliability of the CADx systems by adding a Human Machine Interface (HMI) component to enhance the data acquisition process and providing a safety-related framework which includes the HMI/CADx system life cycle to bridge the identified gaps.encomputer-aided diagnosisdeep learningDLhuman machine interfaceHMImachine learningMLsafetycomputer aided diagnosisCADxmedical imagehealthsafety-criticalconference paper