Explainable AI for Regulatory-Compliant Clinical Decision Support

Abstract

Explainable AI for Regulatory-Compliant Clinical Decision Support

 - Design and Evaluation of a Framework for Structured Medical Data Processing under EU MDR, FDA SaMD, and AI Act Requirements -

This dissertation shall develop and evaluate a design science–based framework for the explainable and regulatory-compliant processing of unstructured medical data using artificial intelligence. It shall investigate how clinical NLP and explainable AI can be integrated with process optimization, risk management, and lifecycle governance to generate traceable and auditable clinical decision-support artifacts. The framework shall be designed to enable deployment as Software as a Medical Device (SaMD) under the EU Medical Device Regulation, relevant FDA guidance, and the EU Artificial Intelligence Act. A prototype-based evaluation shall demonstrate both clinical usability and regulatory feasibility within compliance-critical healthcare workflows.