The Health Sciences Authority (HSA) has released findings from its public consultation on the regulation of artificial intelligence (AI) software used in healthcare, particularly software classified as medical devices. The consultation, conducted from May to June 2025, proposed the introduction of a regulatory “sandbox” that would allow selected AI medical software developed within public healthcare institutions to be deployed under controlled conditions without requiring full licensing or product registration. This approach aims to accelerate innovation and enable wider adoption of AI solutions while maintaining appropriate oversight.
The framework focuses on lower-risk AI applications and includes safeguards such as clinical oversight, quality management requirements, and institutional accountability prior to deployment. Healthcare institutions will also be required to notify the regulator, ensure transparency to patients, and comply with ongoing monitoring and reporting obligations.
Feedback from the public consultation was generally supportive of a more flexible and innovation-friendly regulatory approach. Respondents recognized the potential benefits of AI in improving healthcare outcomes and operational efficiency, while also emphasising the importance of maintaining strong safeguards.
Overall, the initiative reflects Singapore’s efforts to balance innovation with patient safety by creating a structured pathway for testing and scaling AI-driven healthcare solutions. The regulator is expected to monitor outcomes from this approach and refine the framework over time to support broader adoption of AI technologies across the healthcare system.
(Source: Baker McKenzie)
