INDONESIAN MINISTRY OF HEALTH'S REGULATORY SANDBOX POLICY ON DIGITAL HEALTH INNOVATION

Abstract

The collaborative approach to regulatory development is known as the Regulatory Sandbox, a regulatory development approach designed to encourage more adaptive regulations for digital innovation. The Regulatory Sandbox is designed to test digital innovation products or business models in a limited environment (sandbox) with direct government oversight. However, since the implementation of the regulatory sandbox for digital health innovation in 2023, no specific regulations have been established for digital health innovation. The purpose of this study is to inventory the legal basis for digital health innovation in health legislation and analyze their synchronization. This study uses a normative juridical method with specifications for legal inventory and legal synchronization. The results of this study indicate that the Decree of the Minister of Health Number HK.01.07/MENKES/1280/2023 concerning the Development of a Digital Health Innovation Ecosystem Through a Regulatory Sandbox is not in sync with Government Regulation No. 28 of 2024 concerning the Implementing Regulations of Law No. 17 of 2023 concerning Health, so it is necessary to immediately formulate regulations in the form of a Regulation of the Minister of Health that regulates the regulatory sandbox for digital health innovation with a new term, namely health technology innovation.