What is the Ministry of Health's Regulatory Sandbox and what are its stages?

The Ministry of Health's Regulatory Sandbox is a safe testing environment to evaluate digital health innovations at a limited scale under official Ministry of Health supervision. Generating empirical evidence for future health tech regulations. Governed by Minister of Health Decree Number HK.01.07/MENKES/1280/2023 (effective 4 April 2023), its operational guidelines lay out five key stages. Registration, recording, testing, recommendation, and guidance.

Eligible participants and innovation clusters

Participants are digital health innovation (IDK) operators that modernize healthcare delivery processes or business models through digital ecosystems. Eligible participants must be non-individual corporate entities (such as a limited liability company / PT or cooperative). Operate across at least two Indonesian provinces, and deploy technologically complex solutions. Hospitals and clinics frequently participate as healthcare trial partners.

The Ministry identifies eight innovation clusters, led by three top priorities: telehealth, pharmacy and medical device digital services, and health marketplaces. Artificial intelligence represents a high-potential cluster evaluated as the sandbox framework expands.

Five operational sandbox stages

1. Registration: Applicants submit corporate documentation, including incorporation deeds, Business Identification Number (NIB), tax ID (NPWP), Kominfo PSE registration proof, self-assessment forms, and non-disclosure agreements.
2. Recording: The Ministry verifies documentation. Verified applicants receive an official registration number and obtain Recorded (Tercatat) status.
3. Testing: Selected participants receive Supervised (Diawasi) status. This phase involves business model analysis, scenario stress-testing (security, privacy, interoperability), and live clinical pilots at designated healthcare facilities.
4. Recommendation: The evaluation panel issues one of three formal outcomes: recommended, conditionally recommended (with up to 3 months for remediation), or not recommended.
5. Guidance: Successfully recommended participants receive Guided (Dibina) status. The Ministry monitors regular operational reports for ongoing oversight and policy integration.

Three participant statuses and official logo rules

The Ministry publicly discloses participant status across three transparent tiers:

• Recorded (Tercatat): Verified in initial administration, but strictly prohibited from displaying the Ministry of Health logo.
• Supervised (Diawasi): Actively undergoing live trial testing. Required to display the Ministry logo with the caption "Supervised by the Ministry of Health of the Republic of Indonesia."
• Guided (Dibina): Successfully recommended following testing. Required to display the Ministry logo with the caption "Guided by the Ministry of Health of the Republic of Indonesia."

For hospital and clinic leaders, a "Guided" status provides objective regulatory proof that a digital health vendor has successfully passed Ministry of Health sandbox evaluation.

Legal basis

• Minister of Health Decree Number HK.01.07/MENKES/1280/2023 on the Development of Digital Health Innovation Ecosystems through Regulatory Sandbox: Dictums 1–3 and Dictum 8.
• Annex I of KMK HK.01.07/MENKES/1280/2023 (Health Regulatory Sandbox Guidelines): Chapters I–III.