With the use of standalone software as a medical device (SaMD) rising rapidly in Singapore, the country’s health authorities in July unveiled a draft roadmap of regulatory guidelines on software or mobile apps which have a medical purpose and invited public consultation on them.
The draft guidelines published by the Health Sciences Authority (HSA) outline the approach regulators plan to take to determine the risk classification of SaMD. As with other kinds of medical devices, the risk classification system is designed to categorize applications according to the hazard presented by each.
Among the questions to be considered under the draft plan to classify the risk of a particular device is how significant the information provided by the SaMD is to healthcare decision-making and the state of a patient’s healthcare situation. Regulators will also consider to what extent the software is used to drive diagnosis, the course of treatment, or the time at which intervention is needed to ensure patient well-being.
The regulatory approach utilized in the guidance is in line with the framework established by the International Medical Device Regulators Forum, a group of national regulatory authorities collaborating to develop SaMD regulations.