Singapore has created a voluntary scheme to rate medical devices based on their cybersecurity features. The Cybersecurity Labelling Scheme for Medical Devices, which was implemented on October 16, evaluates devices to verify they fulfil requirements for protecting against data breaches and cyber assaults.
At the Singapore International Cyber Week, Senior Minister Dr Janil Puthucheary emphasised the importance of proactive cybersecurity measures as medical devices become more connected to networks, heightening possible risks. Devices must already comply with Health Sciences Authority (HSA) laws, but this new system, designed in collaboration with the Cyber Security Agency (CSA), Ministry of Health, and Synapxe, provides additional precautions.
The scheme applies to a variety of devices, including pacemakers and ventilators, that handle sensitive patient data. Devices are rated on four levels, with higher levels requiring third-party testing and meeting severe standards. A nine-month experiment tested 47 devices, some receiving Level 1 ratings.
TIIM Healthcare’s aiTriage device, which is not internet-enabled, obtained a Level 1 rating. COO Michael Cheng emphasised the company’s Bluetooth capabilities and the need of cybersecurity in securing patient data. Applications for the labelling program are now open on GoBusiness, with labels valid for three years.
Singapore also signed mutual recognition agreements with South Korea and Germany to strengthen international cybersecurity cooperation.
