Singapore’s Health Sciences Authority (HSA) is inviting public feedback on a proposed regulatory exemption that could pave the way for more widespread use of AI-powered medical software in the public healthcare system. This public consultation runs from 19 May to 19 June 2025.
Why It Matters
Artificial Intelligence – Software as a Medical Device (AI-SaMD) is already being developed by institutions like MOH Office for Healthcare Transformation (MOHT), Synapxe, and various public healthcare clusters to support better patient care. However, under current regulations, these AI tools can only be used within the institution that developed them, limiting their scalability and impact across Singapore’s healthcare system.
What’s Being Proposed
To address this, HSA is proposing a regulatory sandbox that would allow certain AI medical software tools to be exempt from licensing and product registration requirements, making it easier for them to be used across multiple public healthcare institutions.
The exemption would apply only to AI-SaMDs that meet all of the following conditions:
Developed by MOHT, Synapxe, or public healthcare institutions
Classified as Class A (low risk) or Class B (moderately low risk) devices
Built under the oversight of a senior clinician (Consultant level or higher)
Intended strictly for in-house use within the public healthcare sector
Notified to HSA at the point of deployment
Non-compliance with these requirements could lead to penalties of up to $50,000 or 2 years’ imprisonment under the Health Products Act.
Additional Safeguards
To maintain safety and accountability, institutions participating in the sandbox must:
Conduct annual self-attestation to an ISO 13485 quality management system
Use internal product control checklists
Maintain strict cybersecurity and data protection protocols
Obtain approval from the institution’s Chairman Medical Board or CEO
Even with the exemption, existing rules around adverse event reporting will remain in place. HSA will monitor the sandbox over 12 months, with the option to extend the trial period if needed.
Share Your Views
HSA is welcoming feedback from the public, industry stakeholders, and healthcare professionals. If you’d like to share your thoughts on this initiative, you can do so through the official form at the link below before 19 June 2025:
For confidentiality, contributors may request that their feedback not be published if it contains sensitive or proprietary information.
Images: Envato
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