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

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dc.contributor.authorRodríguez Vergara, Carla
dc.contributor.authorValdés-González, Héctor
dc.contributor.authorReyes-Bozo, Lorenzo
dc.contributor.authorVidal, Juan Carlos
dc.date.accessioned2025-09-02T21:04:23Z
dc.date.available2025-09-02T21:04:23Z
dc.date.issued2024
dc.description.abstractThis 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
dc.description.versionVersión publicada
dc.format.extent9 p.
dc.identifier.citationC. Rodríguez Vergara, H. Valdés-González, L. Reyes-Bozo, J. C. Vidal, “Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations”, Revista Facultad de Ingeniería, vol. 33, no. 69, e18045, 2024. https://doi.org/10.19053/01211129.v33.n69.2024.18045
dc.identifier.doihttps://doi.org/10.19053/01211129.v33.n69.2024.18045
dc.identifier.urihttps://hdl.handle.net/11447/10252
dc.language.isoen
dc.subjectACROCHI
dc.subjectEstándares FDA
dc.subjectEstandarización de procesos
dc.subjectGestión de datos sensibles
dc.subjectRegistros electrónicos
dc.titleConceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations
dc.title.alternativeModelo Conceptual para la Transformación Digital de Historias Clínicas en Chile: Un enfoque estandarizado de acuerdo con las regulaciones de la FDA
dc.typeArticle
dcterms.accessRightsAcceso abierto
dcterms.sourceRevista Facultad de Ingeniería
dspace.entity.typePublication

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