Singapore's rules for health AI: AIHGle 2.0, HSA and the PDPA
Singapore's refreshed AI in Healthcare Guidelines (March 2026), HSA's software medical device guidance and PDPA duties, explained for health AI teams.
- Singapore
Key takeaways
- MOH and HSA launched the refreshed AI in Healthcare Guidelines (AIHGle 2.0) on 10 March 2026.
- AIHGle 2.0 gives practical recommendations for developers, deployers and users, and complements HSA's software medical device guidelines.
- HSA updated its GL-04 guidance for software medical devices in December 2025.
- AI medical devices must still comply with the PDPA, the Healthcare Services Act and the Human Biomedical Research Act.
How does Singapore regulate health AI?
Through layered guidance. The Ministry of Health and the Health Sciences Authority publish the AI in Healthcare Guidelines, HSA regulates AI that is a medical device, and existing laws on personal data, healthcare services and biomedical research continue to apply.
What is AIHGle 2.0?
AIHGle 2.0 is the refreshed AI in Healthcare Guidelines, launched by MOH and HSA on 10 March 2026, developed with Synapxe. It updates the 2021 guidelines with practical recommendations for developers, deployers and users of healthcare AI, aimed at patient safety and trust. MOH treats it as a living document.
When is AI a medical device?
When its intended purpose is medical, such as diagnosis, monitoring or treatment decisions. HSA’s GL-04 guidelines for software medical devices, updated in December 2025, set out what developers must show, including for AI-enabled devices. In 2025 HSA also consulted on exempting some AI devices developed in public healthcare from licensing and registration, with added safeguards.
Which other laws apply?
| Law | Relevance to health AI |
|---|---|
| Personal Data Protection Act | Consent, purpose limitation, protection and breach notification for personal data |
| Healthcare Services Act | Licensing of healthcare services that use AI |
| Human Biomedical Research Act | Research using health data or tissue |
What should teams entering Singapore do?
Decide early whether your product is a medical device, follow AIHGle 2.0’s lifecycle recommendations for testing and monitoring, and design PDPA consent and breach processes. Keep evidence of evaluation for buyers in public healthcare.
Frequently asked questions
Is a health chatbot a medical device in Singapore?
If it is intended to diagnose, treat, monitor or prevent disease, it can be software as a medical device and fall under HSA registration. General wellness information usually does not. Check HSA's GL-04 guidance against your intended use.
Are AIHGle guidelines mandatory?
They are guidelines, not legislation, and MOH describes them as a living document. In practice, public healthcare buyers and partners expect vendors to follow them.
Sources
- Singapore MOH and HSA launch refreshed AI in healthcare guidelinesBaker McKenzie · 2026-03
- Artificial intelligence in healthcareMinistry of Health Singapore
- Digital healthHealth Sciences Authority
- Personal Data Protection ActPersonal Data Protection Commission
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