Singapore Health Sciences Authority (HSA) Clarifies Regulatory Framework of Clinical Decision Support Software (CDSS)

With the use of clinical decision support software (CDSS) proliferating among medical providers, Singapore’s HSA has issued guidance on which types of the software technology are subject to the country’s increasingly strict regulations.

The HSA guidance is informational and does not impose any new restrictions or regulations on CDSS software-based products.

The software technology known as CDSS covers a broad range of applications. Some, such as scheduling and software used by medical offices, are benign uses not subject to medical device regulation. Others, such as software used by medical professionals to analyze a patient’s genetic data, or their anatomical features for therapy or surgical removal, are considered medical devices.

The distinction, according to the HSA guidance, rests on whether the CDSS device processes information and data from patients and is used to make recommendations to doctors and other healthcare providers that cannot be independently verified through other means.