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

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 comments on diverse challenges and provides solutions to develop a reliable, well integrated and practical tool for clinical use. Using three tools (the Early Onset Sepsis Calculator, Feverkidstool, and Neonatal Procalcitonin Intervention Study algorithm) as examples, we explore the development of CDSSs across four core characteristics: scientific basis, technical aspects, safety, and sustainability. These characteristics recur across the main development processes; scientific development, regulatory assessment, and implementation in routine practice. Successful integration of CDSSs into clinical practice requires a comprehensive understanding of the interconnections between these processes. For example, decisions on algorithm validation and platform selection in the scientific process influence choices for technical safety during the regulatory process. Developers should consider both regulation requirements and clinical needs, to create CDSSs that are not only compliant but also adaptable to the rapidly changing healthcare landscape. We outline a developer's checklist, for practical guidance, but also appeal for structural support, including national protocols and dedicated hospital roles, to help developers implement CDSSs successfully.