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

Autores:: Rodríguez-Vergara, Carla
Valdés-González, Héctor
Reyes-Bozo, Lorenzo
Vidal, Juan-Carlos

Tipo de recurso:: Article of journal

Fecha de publicación:: 2024

Institución:: Universidad Pedagógica y Tecnológica de Colombia

Repositorio:: RiUPTC: Repositorio Institucional UPTC

Idioma:

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dc.title.en-US.fl_str_mv	Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations
title	Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations
spellingShingle	Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations Electronic records FDA standards Process standardization Sensitive data management Estándares FDA Estandarización de procesos Gestión de datos sensibles Registros electrónicos
title_short	Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations
title_full	Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations
title_fullStr	Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations
title_full_unstemmed	Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations
title_sort	Conceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA Regulations
dc.creator.fl_str_mv	Rodríguez-Vergara, Carla Valdés-González, Héctor Reyes-Bozo, Lorenzo Vidal, Juan-Carlos
dc.contributor.author.eng.fl_str_mv	Rodríguez-Vergara, Carla Valdés-González, Héctor Reyes-Bozo, Lorenzo Vidal, Juan-Carlos
dc.subject.none.fl_str_mv	Electronic records FDA standards Process standardization Sensitive data management Estándares FDA Estandarización de procesos Gestión de datos sensibles Registros electrónicos
topic	Electronic records FDA standards Process standardization Sensitive data management Estándares FDA Estandarización de procesos Gestión de datos sensibles Registros electrónicos
publishDate	2024
dc.date.accessioned.none.fl_str_mv	2024-08-29 21:27:51 2026-04-16T17:47:36Z
dc.date.available.none.fl_str_mv	2024-08-29 21:27:51
dc.date.issued.none.fl_str_mv	2024-08-29
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dc.relation.references.none.fl_str_mv	E. Monaghesh, A. Hajizadeh, “The role of telehealth during COVID-19 outbreak: a systematic review based on current evidence”, BMC Public Health, vol. 20, e1193, 2020. https://doi.org/10.1186/s12889-020-09301-4 S. B. Love, E. Armstrong, C. Bayliss, M. Boulter, L. Fox, J. Grumett, P. Rafferty, B. Temesi, K. Wills, A. Corkhill, “Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic”, Trials, vol. 22, e279, Apr. 2021. https://doi.org/10.1186/s13063-021-05225-5 L. L. Fragidis, P. D. Chatzoglou, “Implementation of a nationwide electronic health record (EHR): The international experience in 13 countries”, International Journal of Health Care Quality Assurance, vol. 31, no. 2, pp. 116-130, 2018. https://doi.org/10.1108/ijhcqa-09-2016-0136 Electronic code of Federal Regulations, title 21, CFR, Part 11, 2020. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11 W. Ricciardi, P. Pita Barros, A Bourek, W. Brouwer, T. Kelsey, L. Lehtonen, “How to govern the digital transformation of health services”, European Journal of Public Health, vol. 29, no. 3, pp. 7-12, 2019. https://doi.org/10.1093/eurpub/ckz165 S. N. Haque, “Telehealth beyond COVID-19”. Psychiatric Services, vol. 72, no. 1, pp. 100-103, Jan. 2021. https://doi.org/10.1176/appi.ps.202000368 M. P. Colás Bravo, T. González Ramírez, R. García Pérez, M. A. Rebollo Catalán, Técnicas de recogida de información, Sevilla: Kronos, 1993. J. Murillo Torrecilla, La entrevista, Madrid, España: Universidad Autónoma de Madrid, 2006. http://www2.uca.edu.sv/mcp/media/archivo/f53e86_entrevistapdfcopy.pdf A. Rodríguez, M. E. Viñar, M. Reyno, M. De Luca, M. N. Sosa Gonzalez, M. P. Martínez Rubio, S. Sena, M. V. Blanco Latierro, “La ética en el encuentro. Reflexiones a partir de la instrumentación del Consentimiento Informado en investigaciones cualitativas”, Psicología, Conocimiento y Sociedad, vol. 10, no. 1, pp. 261-291, 2020. https://doi.org/10.26864/PCS.v10.n1.12 J. Escobar-Pérez, A. Cuervo-Martínez, “Validez de contenido y juicio de expertos: una aproximación a su utilización”, Avances en medición, vol. 6, no. 1, pp. 27-36, 2008. E. A. Taylor, S. H. Fischer, T. Gracner, I. Tejeda, A. Y. Kim, E. R. Chavez-Herrerias, F. Hoces de la Guardia, Developing a strategic program for Chilean health information technology: Environmental scan and key informant interviews, Santa Monica, CA: RAND Corporation, 2016. https://www.rand.org/pubs/research_reports/RR1358z1.html C.S. Kruse, C. Kristof, B. Jones, E. Mitchell, A. Martinez, “Barriers to electronic health record adoption: A systematic literature review,” Journal of medical systems, vol. 40, e252, Oct. 2016. https://doi.org/10.1007/s10916-016-0628-9 J. Altés, “Papel de las tecnologías de la información y la comunicación en la medicina actual”, Seminarios de la Fundación Española de Reumatología, vol. 14, no. 2, pp. 31-35, 2013. https://doi.org/10.1016/j.semreu.2013.01.005 M. Zahabi, D. B. Kaber, M. Swangnetr, “Usability and safety in electronic medical records interface design: a review of recent literature and guideline formulation,” Human Factors, vol. 57, no. 5, pp. 805-834, Aug. 2015. https://doi.org/10.1177/0018720815576827 S. Kraus, F. Schiavone, A. Pluzhnikova, and A. C. Invernizzi, “Digital transformation in healthcare: Analyzing the current state-of-research”, Journal of Business Research, vol. 123, pp. 557-567, Feb. 2021. https://doi.org/10.1016/j.jbusres.2020.10.030 M. A. Hall “Property, privacy, and the pursuit of interconnected electronic medical records,” Iowa L. Rev., vol. 95, e631, 2009. G. B. Melton, C. J. McDonald, P. C. Tang, G. Hripcsak, “Electronic health records,” in Biomedical Informatics: Computer Applications in Health Care and Biomedicine, 2021, pp. 467-509. https://doi.org/10.1007/978-3-030-58721-5_14 D. Daglish, N. Archer, “Electronic personal health record systems: a brief review of privacy, security, and architectural issues,” in World congress on privacy, security, Trust and the Management of e-Business, 2009, pp. 110-120. I. Keshta, A. Odeh, “Security and privacy of electronic health records: Concerns and challenges,” Egyptian Informatics Journal, vol. 22, no. 2, pp. 177-183, 2001. https://doi.org/10.1016/j.eij.2020.07.003
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dc.relation.citationedition.eng.fl_str_mv	Núm. 69 , Año 2024 : July-September 2024: Open Science at the Service of Engineering
dc.rights.none.fl_str_mv	Carla Rodríguez-Vergara, Héctor Valdés-González, Lorenzo Reyes-Bozo, Juan-Carlos Vidal - 2024
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spelling	Rodríguez-Vergara, CarlaValdés-González, HéctorReyes-Bozo, LorenzoVidal, Juan-Carlos2024-08-29 21:27:512026-04-16T17:47:36Z2024-08-29 21:27:512024-08-290121-1129https://repositorio.uptc.edu.co/handle/001/2158410.19053/uptc.01211129.v33.n69.2024.180452357-5328https://doi.org/10.19053/uptc.01211129.v33.n69.2024.18045application/pdftext/xmlUniversidad Pedagógica y Tecnológica de ColombiaCarla Rodríguez-Vergara, Héctor Valdés-González, Lorenzo Reyes-Bozo, Juan-Carlos Vidal - 2024https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessThis work is licensed under a Creative Commons Attribution 4.0 International License.http://purl.org/coar/access_right/c_abf2https://revistas.uptc.edu.co/index.php/ingenieria/article/view/18045Electronic recordsFDA standardsProcess standardizationSensitive data managementEstándares FDAEstandarización de procesosGestión de datos sensiblesRegistros electrónicosConceptual Model for the Digital Transformation of Medical Records in Chile: A Standardized Approach According to FDA RegulationsArtículo de revistahttp://purl.org/coar/resource_type/c_6501http://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleJournal articleinfo:eu-repo/semantics/publishedVersionTexthttp://purl.org/coar/version/c_970fb48d4fbd8a85E. Monaghesh, A. Hajizadeh, “The role of telehealth during COVID-19 outbreak: a systematic review based on current evidence”, BMC Public Health, vol. 20, e1193, 2020. https://doi.org/10.1186/s12889-020-09301-4S. B. Love, E. Armstrong, C. Bayliss, M. Boulter, L. Fox, J. Grumett, P. Rafferty, B. Temesi, K. Wills, A. Corkhill, “Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic”, Trials, vol. 22, e279, Apr. 2021. https://doi.org/10.1186/s13063-021-05225-5L. L. Fragidis, P. D. Chatzoglou, “Implementation of a nationwide electronic health record (EHR): The international experience in 13 countries”, International Journal of Health Care Quality Assurance, vol. 31, no. 2, pp. 116-130, 2018. https://doi.org/10.1108/ijhcqa-09-2016-0136Electronic code of Federal Regulations, title 21, CFR, Part 11, 2020. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11W. Ricciardi, P. Pita Barros, A Bourek, W. Brouwer, T. Kelsey, L. Lehtonen, “How to govern the digital transformation of health services”, European Journal of Public Health, vol. 29, no. 3, pp. 7-12, 2019. https://doi.org/10.1093/eurpub/ckz165S. N. Haque, “Telehealth beyond COVID-19”. Psychiatric Services, vol. 72, no. 1, pp. 100-103, Jan. 2021. https://doi.org/10.1176/appi.ps.202000368M. P. Colás Bravo, T. González Ramírez, R. García Pérez, M. A. Rebollo Catalán, Técnicas de recogida de información, Sevilla: Kronos, 1993.J. Murillo Torrecilla, La entrevista, Madrid, España: Universidad Autónoma de Madrid, 2006. http://www2.uca.edu.sv/mcp/media/archivo/f53e86_entrevistapdfcopy.pdfA. Rodríguez, M. E. Viñar, M. Reyno, M. De Luca, M. N. Sosa Gonzalez, M. P. Martínez Rubio, S. Sena, M. V. Blanco Latierro, “La ética en el encuentro. Reflexiones a partir de la instrumentación del Consentimiento Informado en investigaciones cualitativas”, Psicología, Conocimiento y Sociedad, vol. 10, no. 1, pp. 261-291, 2020. https://doi.org/10.26864/PCS.v10.n1.12J. Escobar-Pérez, A. Cuervo-Martínez, “Validez de contenido y juicio de expertos: una aproximación a su utilización”, Avances en medición, vol. 6, no. 1, pp. 27-36, 2008.E. A. Taylor, S. H. Fischer, T. Gracner, I. Tejeda, A. Y. Kim, E. R. Chavez-Herrerias, F. Hoces de la Guardia, Developing a strategic program for Chilean health information technology: Environmental scan and key informant interviews, Santa Monica, CA: RAND Corporation, 2016. https://www.rand.org/pubs/research_reports/RR1358z1.htmlC.S. Kruse, C. Kristof, B. Jones, E. Mitchell, A. Martinez, “Barriers to electronic health record adoption: A systematic literature review,” Journal of medical systems, vol. 40, e252, Oct. 2016. https://doi.org/10.1007/s10916-016-0628-9J. Altés, “Papel de las tecnologías de la información y la comunicación en la medicina actual”, Seminarios de la Fundación Española de Reumatología, vol. 14, no. 2, pp. 31-35, 2013. https://doi.org/10.1016/j.semreu.2013.01.005M. Zahabi, D. B. Kaber, M. Swangnetr, “Usability and safety in electronic medical records interface design: a review of recent literature and guideline formulation,” Human Factors, vol. 57, no. 5, pp. 805-834, Aug. 2015. https://doi.org/10.1177/0018720815576827S. Kraus, F. Schiavone, A. Pluzhnikova, and A. C. Invernizzi, “Digital transformation in healthcare: Analyzing the current state-of-research”, Journal of Business Research, vol. 123, pp. 557-567, Feb. 2021. https://doi.org/10.1016/j.jbusres.2020.10.030M. A. Hall “Property, privacy, and the pursuit of interconnected electronic medical records,” Iowa L. Rev., vol. 95, e631, 2009.G. B. Melton, C. J. McDonald, P. C. Tang, G. Hripcsak, “Electronic health records,” in Biomedical Informatics: Computer Applications in Health Care and Biomedicine, 2021, pp. 467-509. https://doi.org/10.1007/978-3-030-58721-5_14D. Daglish, N. Archer, “Electronic personal health record systems: a brief review of privacy, security, and architectural issues,” in World congress on privacy, security, Trust and the Management of e-Business, 2009, pp. 110-120.I. Keshta, A. Odeh, “Security and privacy of electronic health records: Concerns and challenges,” Egyptian Informatics Journal, vol. 22, no. 2, pp. 177-183, 2001. https://doi.org/10.1016/j.eij.2020.07.003e1804569e1804533Revista Facultad de Ingenieríahttps://revistas.uptc.edu.co/index.php/ingenieria/article/download/18045/14946https://revistas.uptc.edu.co/index.php/ingenieria/article/download/18045/14947Núm. 69 , Año 2024 : July-September 2024: Open Science at the Service of EngineeringPublicationOREORE.xmltext/xml2841https://repositorio.uptc.edu.co/bitstreams/496867c3-b3f9-4bf0-a407-91185b16ef04/download4acae3243e1a70f31203d6df86d5c52cMD51falseAnonymousREAD001/21584oai:repositorio.uptc.edu.co:001/215842026-10-29 14:05:13.355https://creativecommons.org/licenses/by/4.0metadata.onlyhttps://repositorio.uptc.edu.coRepositorio Institucional UPTCbdigital@metabiblioteca.com

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

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