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Background: Digital health innovations can improve health system performance, yet previous experience has shown that many innovations do not advance beyond the pilot stage to achieve scale. Vietnam's National Immunization Information System (NIIS) began as a series of digital health pilots, first initiated in 2010, and was officially launched nationwide in 2017. The NIIS is one of the few examples of an electronic immunization registry (EIR) at national scale in low- and middle-income countries.Objective: The aim of this study was to understand the determinants of scale-up of the national EIR in Vietnam.Methods: This qualitative study explored the facilitators and barriers to national scale-up of the EIR in Vietnam. Qualitative data were collected from October to December 2019 through in-depth key informant interviews and desk review. The mHealth Assessment and Planning for Scale (MAPS) Toolkit guided the development of the study design, interview guides, and analytic framework. MAPS defines the key determinants of success, or the "axes of scale," to be groundwork, partnerships, financial health, technology and architecture, operations, and monitoring and evaluation.Results: The partnership and operations axes were critical to the successful scale-up of the EIR in Vietnam, while the groundwork and monitoring and the evaluation axes were considered to be strong contributors in the success of all the other axes. The partnership model leveraged complementary strengths of the technical working group partners: the Ministry of Health General Department of Preventive Medicine, the National Expanded Program on Immunization, Viettel (the mobile network operator), and PATH. The operational approach to introducing the NIIS with lean, iterative, and integrated training and supervision was also a key facilitator to successful scale-up. The financial health, technology and architecture, and operations axes were identified as barriers to successful deployment and scale-up. Key barriers to scale-up included insufficient estimates of operational costs, unanticipated volume of data storage and transmission, lack of a national ID to support interoperability, and operational challenges among end users. Overall, the multiple phases of EIR deployment and scale-up from 2010 to 2017 allowed for continuous learning and improvement that strengthened all the axes and contributed to successful scale-up.Conclusions: The results highlight the importance of the measured, iterative approach that was taken to gradually expand a series of small pilots to nationwide scale. The findings from this study can be used to inform other countries considering, introducing, or in the process of scaling an EIR or other digital health innovations. [ABSTRACT FROM AUTHOR]