This case study was developed to highlight health data governance success stories and illustrate how the Health Data Governance Principles can be applied in a national context with support from Fondation Botnar. This information was compiled by Central American Health Informatics Network (RECAINSA) through desk research and interview with local digital health experts. It highlights the progress around data governance—including health—that Ecuador has made aligned with the eight Health Data Governance Principles1:
In recent years, Ecuador has made significant progress in the implementation of laws and government regulations for data governance, including health data. This has encouraged both local and international academic institutions to generate scientific articles and innovation initiatives that address the issue of data governance of individuals and the health sector, as well as promote open data initiatives. These efforts are happening in tandem with an overall digital transformation in healthcare in Ecuador, including the digitization of medical records.
Since 2010, Ecuador has had a national system for registering public data2 that regulates the registration and management of personal identification data through the National Directorate of Public Data Registration.
In May 2021, the Organic Law on the Protection of Personal Data entered into force in Ecuador, thus achieving the most important advance in personal data privacy, security, and confidentiality. This law regulates the treatment that state institutions must give to personally identifiable information and associated personal data, empowering individuals to express their will for the processing of their data, reflecting their rights of access to information, data updating, and elimination.3 Articles 30, 31, and 32 of the law specifically regulate health data.
Ecuador has implemented the Open Government Initiative, which has the following pillars: transparency and access to public information, integrity and accountability, citizen participation, and public collaboration and innovation.4 The first Open Government action plan proposes a co-creation process, with citizens participating through a web portal and co-creation roundtables. According to the official report, in the first stage of this process, 335 citizen proposals were received, 6.27 percent of which can be classified as Health and Welfare.5
Within the Open Government action framework, Ecuador has promoted the Dialogue initiative, which consists of a web platform where citizens have access to suggest, review, and support government proposals and citizen initiatives, as well as debate on new regulatory proposals and participate in polls on government actions.6 This provides an opportunity to increase citizen participation in public health regulations and policies.
Ecuador has observed the regulations and norms that accompany each initiative for the registration of personal data and open data through the Organic Law on the Protection of Personal Data and the ministerial agreement of the Ministry of Telecommunications and Information Society, which monitors the open data policy through the regulations and its implementation guide. 7This law includes technical details on the correct disclosure and safeguarding of data, and a revision to include specific guidelines for patient data is being encouraged. Currently, the main initiatives complying with the above regulations and norms are the e-government platform,8 the single portal for citizen proceedings,9 and the civil registry with electronic proceedings.10
There is a government project to strengthen the health services network and improve quality, which includes the implementation of a single computerized information system (Integrated Health Management Information System) as one of the crosscutting aspects.12 Although there is no information about the implementation or progress of this project, important steps have been taken toward the implementation of electronic health records and institutionalization of the Health Level 7 (HL7) interoperability standard in the country, in addition to implementation of personal data protection regulations and planning of the National Conference on Health Information Systems.
The National Health Council has also developed a standardized digital clinical history record that can be used by both the public and private sectors.
Ecuador currently has regulations that seek to institutionalize the adoption of the HL7 standard in the country. With this, the Pan American Health Organization has officially established a project that seeks to provide the MOPH with the knowledge and technical capacity necessary for the development and implementation of electronic clinical documents (HL7, Fast Healthcare Interoperability Resources/FHIR, Clinical Document Architecture). This project will result in the empowerment of civil society, academia, and public and private institutions through the constitution of a National Network of Health Information Systems.13 This network will hold a multi-sectoral national conference to build further awareness and knowledge around state-of-the-art health information systems in the country.
In Ecuador, the governing and supporting body for the implementation of technological innovation is the Ministry of Telecommunications and Information Society. This agency has promoted various regulatory initiatives that promote the adoption of innovation in the collection and dissemination of data for decision-making, as well as for the implementation of innovation projects, such as the ministerial agreement for the adoption of the HL7 standard, the open data policy, and the e-government platform.
Recently, Ecuador has implemented the SaludEc14 app, in coordination with the MOPH and the Ministry of Telecommunications and Information Society. One of the objectives of this app for mobile devices is to become a channel for the delivery of telemedicine services.
In recent years, Ecuador has shown interest in advancing equitable health promotion. To this end, it has created an Education and Communication for Health Promotion Manual15 that seeks to promote the participation and empowerment of individuals, families, communities, and social actors and to influence the social, personal, environmental, economic, and political determinants of health. This approach favors the equitable dissemination of health information to all people in Ecuador.
Regarding data collection, in 2018 the National Survey of Health and Nutrition16 was conducted, the objective of which was to generate indicators on the main problems and the health situation in the country. The expected benefit of having these indicators is to generate the necessary public policies to address nutrition problems.
Similarly, there is evidence of a plan to launch the Survey on Health, Well-being, and Aging,17 coordinated by the MOPH and the Ministry of Economic and Social Inclusion.
The participation of nongovernmental organizations has contributed to the promotion of structural changes in health systems and networks to reduce the impact of COVID-19 on the indigenous populations of the Amazon region of Ecuador, Peru, and Brazil through the initiative called the Amazon Indigenous Health Route.18
As mentioned in the previous principles, Ecuador has laws and regulations governing the use of personal data and their management in the public sector, including health. In the Guide for the Treatment of Personal Data in Public Administration, the Organic Law on the Protection of Personal Data, and the open data policy and its guide, the rights of individuals to access, update, and delete their data are clearly established.
Chapter I of the Guide for the Treatment of Personal Data in Public Administration details the rights of citizens to be informed, and these are governed by three main points: Right of Access, Right of Rectification, and Right of Portability.10
Health Data Governance Principles Case Study: Ecuador. Fondation Botnar; 2022.
.Health Data Governance Principles. Foundation Botnar; 2022
1.National Assembly. Organic Law of the National Public Data Registry System. Quito: Republic of Ecuador Ministry of Telecommunications; 2010. https://www.gob.ec/regulaciones/ley-organica-sistema-nacional-registro-datos-publicos#.
2.National Assembly. Organic Law on the Protection of Personal Data. Quito: Republic of Ecuador; 2021. https://www.consejodecomunicacion.gob.ec/wp-content/uploads/downloads/2021/07/lotaip/Ley%20Org%C3%A1nica%20de%20Protecci%C3%B3n%20de%20Datos%20Personales.pdf.
3.Open Government Ecuador website. Home page. https://www.gobiernoabierto.ec/. Accessed March 17, 2022.
4.Open Government Ecuador website. First Action Plan: Co-creation process page. https://www.gobiernoabierto.ec/linea-de-tiempo/. Accessed March 17, 2022.
5.Gobierno del Encuentro (Gob.ec) website. Open Data: Dialogue 2.0 portal. https://aportecivico.gobiernoelectronico.gob.ec/. Accessed March 17, 2022.
6.Ministry of Telecommunications and Information Society. Guide to Open Data. Quito: Republic of Ecuador; 2021. https://www.gobiernoelectronico.gob.ec/wp-content/uploads/2021/03/Guia-Datos-Abiertos-con-portada.pdf.
7.Gobierno del Encuentro (Gob.ec) website. National e-Government Plan page. https://www.gobiernoelectronico.gob.ec/plan-nacional-de-gobierno-electronico/. March 17, 2022.
8.Gobierno del Encuentro (Gob.ec) website. Digital procedures window of Ecuador home page. https://www.gob.ec/. Accessed March 17, 2022.
9.Gobierno del Encuentro (Gob.ec) website. Civil Registry, Identification and Certificate page. https://www.registrocivil.gob.ec/. Accessed March 17, 2022.
10.Gobierno del Encuentro (Gob.ec) website. Ministry of Public Health privacy and data protection policy page. https://www.salud.gob.ec/politica-de-privacidad-y-proteccion-de-datos/. Accessed March 17, 2022.
11.Gobierno del Encuentro (Gob.ec) Ministry of Public Health website. Strengthening the Health Services Network and Quality Improvement project page. https://www.salud.gob.ec/fortalecimiento-de-la-red-de-servicios-de-salud-y-mejoramiento-de-la-calidad/. Accessed March 17, 2022.
12.Pan American Health Organization Information Systems for Health website. Stories page: Ecuador will strengthen Information Systems for Health through the establishment of capacity for the design and implementation of electronic clinical documents and management of interoperability standards in health.
13.Gobierno del Encuentro (Gob.ec) Ministry of Telecommunications website. News page: President Lenín Moreno presented the SaludEc app to the country. https://www.telecomunicaciones.gob.ec/el-presidente-lenin-moreno-presento-al-pais-la-app-saludec/. Accessed March 17, 2022.
14.Ministry of Public Health. Education and Communication for Health Promotion Manual. Quito: Republic of Ecuador; 2019. https://dspace.uniandes.edu.ec/handle/123456789/11811.
15.National Institute of Statistics and Censuses website. National Survey of Health and Nutrition page. https://www.ecuadorencifras.gob.ec/salud-salud-reproductiva-y-nutricion/. Accessed March 17, 2022.
16.National Institute of Statistics and Censuses website. Survey on Health, Well-being, and Aging page. https://www.ecuadorencifras.gob.ec/encuesta-de-salud-bienestar-del-adulto-mayor/. Accessed March 17, 2022.
17.Hivos website. Amazon Indigenous Health Route page. https://america-latina.hivos.org/program/rutadesaludindigenaamazonica/. Accessed March 17, 2022.