Artificial Intelligence in Healthcare Guidelines (AIHGle)

The Artificial Intelligence in Healthcare Guidelines (AIHGle) were jointly released in October 2021 by the Ministry of Health (MOH), the Health Sciences Authority (HSA), and the then Integrated Health Information Systems (IHiS, reorganised as Synapxe in 2023). They are Singapore's core non-binding guidance on healthcare AI. Two objectives: support the safe and effective deployment of AI in healthcare, and complement HSA's binding regulation of AI-Medical Devices (AI-MD). The guidelines cover the full lifecycle on both the developer and healthcare-institution sides: evidence of clinical validity at the development stage, integration into clinical workflows and human-in-the-loop at deployment, post-market monitoring and adverse event reporting, and patient communication and informed consent. Together with HSA's medical-device registration requirements under the Health Products Act, AIHGle creates a "soft guidance + hard law" two-layer structure — the compliance baseline beneath national healthcare-AI initiatives like ACE-AI and Synapxe's AI platforms.