The Cardiologist Driving Synthetic AI: The TIMA Method for Clinically Supervised Synthetic Data Generation

Background/Objectives: Synthetic artificial intelligence (AI) is increasingly used in cardiovascular medicine to generate realistic clinical data from limited samples while preserving patient privacy. Despite its promise, concerns remain regarding the clinical reliability of synthetic datasets, which hampers their integration into routine practice. This article introduces the TIMA method (Team-Implementation Multidisciplinary Approach), designed to involve clinicians directly in every phase of synthetic data development. The objective of this work is to describe the TIMA framework and to illustrate how structured clinician-data scientist collaboration can enhance the clinical robustness and plausibility of synthetic AI outputs. Methods: The TIMA approach structures the synthetic data generation workflow around continuous interaction between clinicians and data scientists. Cardiologists define clinical constraints, verify inter-variable relationships, and assess the coherence and plausibility of generated records. The framework is illustrated through multiple cardiology use cases, including atrial fibrillation risk prediction and surgical mortality estimation in infective endocarditis, to demonstrate its adaptability across different clinical contexts. Each phase includes iterative validation steps aimed at ensuring alignment with established clinical knowledge rather than reporting quantitative performance outcomes. Results: Application of the TIMA framework supported the development of synthetic datasets that adhered more closely to clinical logic and domain-specific constraints. Clinician-data scientist collaboration enabled early detection of implausible variable interactions, improved interpretability of synthetic data patterns, and enhanced internal consistency across different cardiology-oriented scenarios. Conclusions: TIMA represents a scalable and replicable methodological model for integrating synthetic AI into cardiology by embedding clinical expertise throughout the data generation process. Its structured, multidisciplinary workflow supports the production of synthetic data that is not only statistically coherent but also clinically meaningful, thereby strengthening trust and reliability in AI-assisted cardiovascular research.