Key takeaways
The Singapore regulatory landscape has been evolving rapidly in relation to digital health and AI in healthcare issues. The government has been pushing for the increased adoption of such capabilities into its healthcare ecosystem to augment the delivery of healthcare services.
Companies involved in the manufacture and distribution of such digital health systems and/or services, especially AI-SaMDs, should stay aware of the latest developments to ensure that they are aligned with all regulatory requirements and recommended best practices.
In more detail
Currently, specified healthcare service licensees that develop an AI-SaMD for in-house use (i.e., for their own patients) are exempted from requirements for a manufacturer's license and product registration. This exemption is designed to minimize the regulatory burden on the licensees, so that patients' clinical needs can be addressed more efficiently. The exempted licensees are still subject to existing clinical governance frameworks, safety protocols and oversight in the use of the AI-SaMDs.
Under the proposed amendments, the MOH Office for Healthcare Transformation (MOHT), Synapxe and public healthcare clusters and institutions will be included as exempted healthcare service licensees. These entities play a key role in scaling the use of AI across multiple institutions by leveraging technology to develop AI-SaMDs customized for public healthcare institutions. The proposed exemptions aim to create a regulatory sandbox for deploying AI-SaMDs developed by and for public healthcare institutions. This sandbox will serve as a testing ground to assess the effectiveness and impact of AI in public healthcare.
Proposed exemption under the Act
The proposed exemption will expand the current exception to include AI-SaMDs that meet the following requirements:
- Developed by MOHT, Synapxe and public healthcare clusters and institutions
- Classified as class A (low risk) or class B (moderately low risk) under the Third Schedule of the Regulations
- Developed under the supervision and oversight of a clinician employed in a public healthcare institution holding the position of consultant or higher
- Only for in-house use by public healthcare licensees
- Notified to the HSA at the point of deployment
Proposed additional safeguards and controls
The HSA has proposed the following safeguards and controls for MOHT, Synapxe and public healthcare clusters and institutions that develop the AI-SaMDs:
- Self-attest annually to a quality management system (ISO 13485), and check against an internal product control checklist.
- Continue to adhere to internal governance controls for public healthcare institutions, including cyber and data security requirements.
- Ensure that the AI-SaMD is endorsed by the chair of the medical board or the chief executive officer of the public healthcare licensee before use.
- Report any adverse effect to the HSA.
Post-market controls, including adverse effect reporting requirements, will continue to apply, where breaches may be liable to fines of up to SGD 20,000 (approximately USD 15,000) and/or imprisonment for up to 12 months.
The HSA will monitor the proposed exemption for 12 months to evaluate the regulatory sandbox. If there are not enough indicators or AI-SaMDs developed during this period, the duration may be extended for a more robust assessment.
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