JMIR Publications

ABSTRACT

Background:

Regulatory sandbox is an alternative solution to solve the bottleneck of the existing regulation to adopt disruptive technologies. While more than 50 countries have implemented a regulatory sandbox on financial sector, limited examples are available in the health sector.

Objective:

Using e-malaria as a use case, this study aims to explore the stakeholders’ perspectives to introduce regulatory sandbox in Indonesian health system.

Methods:

This operational study applies qualitative approach through focus group discussions (FGD) and desk reviews to explore the concerns and interest of stakeholders with regard to the introduction of regulatory sandbox and its implementation to adopt disruptive technologies to support malaria program. Given the pandemic situation, most FGDs were conducted virtually.

Results:

This study was in line with digital transformation program started by the Indonesian Ministry of Health during the pandemic. However, existing regulations were not ready to adopt disruptive health technologies, especially for malaria. Most of the stakeholders were not aware about regulatory sandbox although it has been implemented by the Indonesian Financial Authority since 2018. Several concerns were raised by stakeholders, including: the amount of time needed to create a regulation, gap of knowledge between stakeholders, the protection of sensitive data, and limited digital infrastructure in the malaria endemic area.

Conclusions:

Regulatory sandbox is potential to be adopted in Indonesian health system to fill the limited legal basis and accelerate the adopting of a safe and well-tested disruptive health technologies to support the malaria elimination program. By involving the stakeholders, we have developed guideline to implement regulatory sandbox and successfully invited innovators to participate in the first ever trial of health regulatory sandbox in Indonesia for e-malaria.