Clinical Decision Support Systems and AI Regulation: Balancing Innovation, Patient Safety, and Legal Responsibility

Abstract

Artificial intelligence (AI)-based Clinical Decision Support Systems (CDSS) are changing the face of healthcare by offering evidence-based information to improve the quality of diagnosis and treatment planning. Nevertheless, the fast adoption of AI in clinical practice poses some serious issues concerning patient safety, ethical duty, and legal liability. This study will be based on the regulatory frameworks of AI-enabled CDSS, and the way in which innovation can be achieved in balance with risk management and compliance needs. By comparing the available regulations, case analyses on the clinical implementation, and the opinions of the experts, the research points out the missing links in the current oversight systems and suggests the methods of responsible AI implementation in medicine. The results will inform the policymakers, healthcare professionals and developers in terms of ensuring that AI based decision support systems can drive innovative approaches in medical care without jeopardizing the well-being of patients and the legal requirements.