Digital Health Transformation in Indonesia: SATUSEHAT Platform and AI-Based Medical Device Regulation

Abstract

Indonesia’s fragmented healthcare system, stretched across more than 17,000 islands, faces persistent challenges in access, data continuity, and service quality, which were further exposed during the COVID-19 pandemic. In response, the government introduced a national Digital Health Transformation Blueprint and the SATUSEHAT platform to standardize and integrate health data, supported by the citizen-facing SATUSEHAT Mobile application that enables access to personal health records, self-monitoring, and navigation of health services. This thesis analyzes the architecture, governance, and effectiveness of SATUSEHAT as the backbone of Indonesia’s digital health ecosystem, alongside the regulatory framework for AI-based medical software, including risk-based device classification, marketing authorization (IDAK), and Domestic Component Level (TKDN) local-content requirements that shape market access for foreign and domestic companies. Using document analysis of national policies, regulatory guidelines, and recent empirical studies, the research maps key stakeholders, evaluates the completeness and implementation of regulations, and identifies bottlenecks such as interoperability constraints, usability issues in SATUSEHAT Mobile, regulatory capacity limits, and the tension between TKDN targets and globalized supply chains. The findings show that Indonesia has established a comparatively comprehensive legal and technical scaffold for digital health and AI-enabled medical devices, but still needs clearer AI-specific operational standards, improved user experience, and more flexible localization mechanisms to fully unlock innovation and equitable access. The thesis proposes policy and industry recommendations to strengthen regulatory capacity, refine TKDN application for software-based technologies, and support collaborative innovation models that can accelerate safe, inclusive digital health transformation in Indonesia.