Singapore’s national HealthTech agency (Synapxe) has joined forces with the Global Digital Health Partnership (GDHP) to launch a new cybersecurity framework aimed at protecting medical devices worldwide. The GDHP Guidance for Medical Device Cybersecurity (GMDC), introduced at the GovWare Healthcare Forum 2024, establishes comprehensive guidelines for medical device manufacturers (MDMs) and healthcare delivery organizations (HDOs). The goal is to ensure that medical devices, which handle sensitive data like personal identifiable information (PII) and clinical data, are secure from cybersecurity threats. This collaboration underscores the growing importance of cybersecurity in safeguarding the healthcare sector’s digital infrastructure.
The GMDC framework, developed by GDHP’s Cyber Security Work Stream and Synapxe, is designed to standardize cybersecurity protocols for medical devices on a global scale. It features four levels of security requirements, with higher levels demanding more stringent assessments. Adapted from Singapore’s Cybersecurity Labelling Scheme for Medical Devices (CLS[MD]), the GMDC framework offers manufacturers a clear path to developing “secure-by-design” products. This initiative aims to address the challenges faced by manufacturers who struggle with varying security standards across countries, providing them with consistent guidelines to follow.
Synapxe, a key player in the global health cybersecurity landscape, is dedicated to leveraging technology to enhance healthcare. As the national HealthTech agency in Singapore, Synapxe plays a critical role in advancing the nation’s digital health ecosystem through innovation and collaborative initiatives. Their involvement in the GMDC reflects a commitment to ensuring that healthcare systems worldwide can adopt effective cybersecurity measures. This framework will assist hospitals and healthcare providers in selecting medical devices that meet high security standards, promoting patient safety and operational resilience.
At the launch, leaders like Lisa Lewis Person, US Deputy Assistant Secretary for Technology Policy, emphasized that cybersecurity must be ingrained in every aspect of healthcare. The GMDC encourages manufacturers and healthcare providers to prioritize security from the outset. Fuller Yu, Chief Information Security Officer at the Hong Kong Hospital Authority, noted that cybersecurity is not a “one-off exercise,” stressing the importance of ongoing maintenance and updates to protect against evolving threats. By introducing the GMDC, Synapxe and GDHP are leading a global effort to protect medical devices and the healthcare systems they support, paving the way for a safer, more resilient future in digital health.
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