Computational medicine promises significant advancements in healthcare, using physics-based simulations and artificial intelligence to optimise disease diagnosis, personalise treatment strategies and accelerate medical innovation. Biomedical research efforts are developing a growing number of computational models of human pathophysiology and medical treatments, with advanced applications in areas such as cardiovascular diseases, orthopaedics and cancer diagnosis. However, the widespread adoption of these instruments is hindered¬¬ by technological and regulatory barriers. This paper provides an overview of the potential impact, needs and challenges of the adoption of in silico medicine in the healthcare ecosystem, with a focus on the European Union’s regulatory framework and initiatives to sustain this technology. The paper introduces the concept of the "computational model lifecycle" as a framework to describe the stages from academic research to pre-clinical and clinical applications, analysing key opportunities and challenges in translating these technologies at each stage. These challenges are associated with data management, standards for model credibility assessment, transparency of regulatory frameworks, and clinical integration. The paper focuses on the European Union's regulatory environment and initiatives such as the European Health Data Space and the Virtual Human Twins (VHT) Initiative, aimed at fostering the development and application of computational medicine in healthcare.

BRIDIO Sara;  DECEUNINCK Pierre;  WHELAN Maurice;  WORTH Andrew; 

2025-10-03

SAGE PUBLICATIONS LTD

JRC140417

2047-7163 (online),   

https://journals.sagepub.com/doi/10.1177/00368504251344145,    https://doi.org/10.1177/00368504251344145,    https://publications.jrc.ec.europa.eu/repository/handle/JRC140417,   

10.1177/00368504251344145 (online),