Collaborative and Cooperative Hospital “In-House” Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values

Anett Schönfelder   ¹ , MBA ;   Maria Eberlein-Gonska   ² , Prof Dr ;   Manfred Hülsken-Giesler   ³ , Prof Dr ;   Florian Jovy-Klein   ⁴ , MSc ;   Jakob Nikolas Kather   ^{1, 5, 6, 7} , Prof Dr ;   Elisabeth Kohoutek   ⁸ , RA ;   Thomas Lennefer   ⁹ , Dr rer nat, MSc ;   Elisabeth Liebert   ¹⁰ , MA ;   Myriam Lipprandt   ¹¹ , Prof Dr ;   Rebecca Mathias   ¹ , MSc ;   Hannah Sophie Muti   ^{1, 12} , MD, Dr med ;   Julius Obergassel   ¹³ , MD, MHBA ;   Thomas Reibel   ⁴ , MSc ;   Ulrike Rösler   ¹⁴ , PhD ;   Moritz Schneider   ¹⁵ , MSc ;   Larissa Schlicht   ¹⁶ , MSc ;   Hannes Schlieter   ¹⁷ , Prof Dr ;   Malte L Schmieding   ¹⁸ , MD, MSc ;   Nils Schweingruber   ¹³ , MD ;   Martin Sedlmayr   ¹⁹ , Prof Dr ;   Reinhard Strametz   ²⁰ , Prof Dr ;   Barbara Susec   ²¹ , BA ;   Magdalena Katharina Wekenborg   ¹ , Dr rer nat ;   Eva Weicken   ²² , MD ;   Katharina Weitz   ²² , Dr rer nat ;   Anke Diehl   ^{10 *} , Dr med, MD ;   Stephen Gilbert   ^{1, 17 *} , Prof Dr

¹ Else Kroener Fresenius Center for Digital Health, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Saxony, Germany

² University Hospital Carl Gustav Carus, Dresden, Germany

³ Department of Nursing Science, Institute of Health Research and Education, University of Osnabrück, Osnabrück, Germany

⁴ Institute for Technology and Innovation Management (TIM), RWTH Aachen University, Aachen, Germany

⁵ Department of Medicine I, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Saxony, Germany

⁶ Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany

⁷ Pathology & Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, United Kingdom

⁸ Luther Rechtsanwaltsgesellschaft mbH, Cologne, Germany

⁹ Department for Prevention, AOK Federal Association, Berlin, Germany

¹⁰ Department for Digital Transformation, University Medicine Essen, Essen, Germany

¹¹ Institute of Medical Informatics, University Hospital RWTH Aachen, Aachen, North Rhine-Westphalia, Germany

¹² Department for Visceral, Thoracic and Vascular Surgery, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany

¹³ University Medical Center Hamburg - Eppendorf, Hamburg, Germany

¹⁴ Federal Institute for Occupational Safety and Health, Berlin, Germany

¹⁵ Institute for Occupational Safety and Health of the German Social Accident Insurance, Sankt Augustin, Germany

¹⁶ Faculty of Humanities and Social Sciences, Karlsruhe Institute of Technology, Karlsruhe, Germany

¹⁷ Faculty of Business and Economics, TUD Dresden University of Technology, Dresden, Germany

¹⁸ German Federal Ministry of Health, Berlin, Germany

¹⁹ Institute for Medical Informatics and Biometry, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany

²⁰ Wiesbaden Institute for Healthcare Economics and Patient Safety (WiHelP), Wiesbaden, Germany

²¹ ver.di, Berlin, Germany

²² Department of Artificial Intelligence, Fraunhofer Heinrich Hertz Institute, Berlin, Germany

*these authors contributed equally