ArticleJournal of medical Internet research2023
Introducing a Regulatory Sandbox Into the Indonesian Health System Using e-Malaria as a Use Case: Participatory Action Study.
Article in Journal of medical Internet research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRegulatory sandboxes offer an alternative solution to address regulatory challenges in adopting disruptive technologies. Although regulatory sandboxes have been widely implemented in the financial sector across more than 50 countries, their application to the health sector remains limited.
objectiveThis study aims to explore stakeholders' perspectives on introducing a regulatory sandbox into the Indonesian health system using e-malaria as a use case.
methodsUsing a participatory action research approach, this study conducted qualitative research, including desk reviews, focus group discussions, and in-depth interviews with stakeholders. This study sought to understand stakeholders' concerns and interests regarding the regulatory sandbox and to collaboratively develop a regulatory sandbox model to support the malaria program.
resultsThe study revealed that most stakeholders had limited awareness of the regulatory sandbox concept. Concerns have been raised regarding the time required to establish regulations, knowledge gaps among stakeholders, data protection issues, and limited digital infrastructure in malaria endemic areas. Existing regulations have been found to be inadequate to accommodate disruptive healthtech for malaria. Nevertheless, through a collaborative process, stakeholders successfully developed a regulatory sandbox model specifically for e-malaria, with the crucial support of the Ministry of Health.
conclusionsThe regulatory sandbox holds the potential for adoption in the Indonesian health system to address the limited legal framework and to facilitate the rapid and safe adoption of disruptive healthtech in support of the malaria elimination program. Through stakeholder involvement, guidelines for implementing the regulatory sandbox were developed and innovators were successfully invited to participate in the first-ever trial of a health regulatory sandbox for e-malaria in Indonesia. Future studies should provide further insights into the challenges encountered during the e-malaria regulatory sandbox pilot study, offering a detailed account of the implementation process.
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