ARTICLE SUMMARY:
In this month’s spotlight from Pathways’ Document Depot, a consultation from Singapore introducing a novel ratings-based approach to embedding better cybersecurity protections into medical devices. (Photo: Singapore HSA headquarters)
Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
Singapore’s January 25 consultation document on a “Proposed Cybersecurity Labelling Scheme for Medical Devices, CLS (MD)” caught our attention this month for a couple of reasons.
First, it’s a highly collaborative document, with four different agencies on the authoring line, hinting at a novel cross-cutting approach to medical technology oversight. Unsurprisingly, one of the agencies is the Health Sciences Authority, which serves as a primary regulator of medical devices in Singapore (akin to the US FDA), and another is its parent, the Ministry of Health. But also helping lead the joint initiative is the Cyber Security Agency of Singapore (CSA, which operates out of the Ministry of Communications and Information) and the Integrated Health Information Systems, a government-formed health IT technology developer.
Second, the proposal strikes an interesting balance between leveraging regulatory requirements and instituting voluntary testing standards to potentially create new market incentives.
