Developing Clinical Decision (Support) Systems Combining the Scientific and Regulatory Perspective: European Insights on Challenges, Requirements, and Practical Guidance.

Abstract

Clinical decision-making is a critical process where physicians balance risks and benefits. Clinical Decision Support Systems (CDSSs) are increasingly used to help in this process. The regulatory landscape for CDSSs is evolving significantly, with the new European Medical Device Regulation (MDR) now requiring, CE certification for certain CDSSs. This shift poses challenges for health care providers to develop CDSSs in an effective and useful manner while adhering to regulations. This viewpoint c