JMIR Publications

ABSTRACT

Clinical decision-making is a critical process where physicians balance risks and benefits. Clinical Decision Support Tools (CDSTs) are increasingly used to help in this process. The regulatory landscape for CDSTs is evolving significantly, with the new European Medical Device Regulation (MDR) now requiring, CE certification for certain CDSTs. This shift poses challenges for healthcare providers to develop CDSTs in an effective and useful manner while adhering to regulations. This viewpoint explores the development of CDSTs across three key phases: scientific development, regulatory assessment, and clinical implementation. Using three tools (the Early Onset Sepsis Calculator, Feverkidstool), and Neonatal Procalcitonin Intervention Study algorithm) as examples, this viewpoint illustrates the diverse challenges and solutions in developing a reliable, well integrated and practical tool for clinical use. Successful integration of CDSTs into clinical practice requires a comprehensive understanding of the interconnections between these phases. Phases must be navigated strategically, as decisions made in one phase, such as algorithm validation and platform selection in the scientific phase, influence decisions in further phases. While regulations focus on technical safety, ensuring scientific validity is critical for the long-term success of CDSTs. Developers and clinicians must rigorously validate their tools to ensure they are based on robust evidence and effective for clinical use. To achieve this, they should address the challenges outlined in this review, considering both regulation requirements and clinical needs, to create CDSTs that are not only compliant but also adaptable to the rapidly changing healthcare landscape.