Singapore revises healthcare AI guidelines, attains WHO top rating for medical device regulation

The recognition enables HSA to serve as a global reference for other regulators worldwide. Read more at straitstimes.com.

SINGAPORE – Singapore has revised its healthcare AI guidelines to enable more innovations to augment the healthcare workforce and new drugs to reach patients faster, Minister for Health Ong Ye Kung said on March 10.

The Health Sciences Authority (HSA) has also become the first national regulatory authority to attain the World Health Organization’s (WHO) highest level of medical device regulation, he said. The recognition enables HSA to serve as a global reference for other regulators worldwide.

Speaking at the opening of the International Medical Device Regulators Forum at NTUC Centre, Mr Ong said the Ministry of Health (MOH) and HSA co-developed and launched the revised healthcare AI framework that addresses developments in artificial intelligence, such as generative AI, to better support innovation, while ensuring safety and quality.

In his speech, Mr Ong said regulatory sandboxes will facilitate the evaluation of AI solutions in real-world healthcare settings, ensuring that AI tools are built using quality, real-life data.

He added that HSA has not received any registration application for AI-developed drugs, but it would welcome such applications in the near future.

AI is revolutionising the drug development process, as simulated laboratory data is being used to replace traditional early-phase clinical trials, which are costly and time-consuming.