Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations

This study addresses the management of medical information in Chile from the perspective of digital transformation. The objective of this study is to propose a standardized conceptual model for the digital transformation of medical records according to the FDAframework to reduce operating times and add value to clinical research in Chile. A semi-structured qualitative methodology was employed; insights from 39 health professionals, including researchers and industry members, were gathered through convenience sampling. Findings suggest that the digital transformation process can be standardized using a conceptual map, which wouldreduce data loss and operational inefficiencies while fostering the development of new research projects. The study concludes that implementing standardized electronic medical records in compliance with FDA guidelines is feasible and could significantly enhance the quality of medical care, support clinical research, and attract pharmaceutical investments.