FDA Medical Device Plan: a Baby Step in the Right Direction

An industry perspective from Synopsys authors evaluating the FDA's Medical Device Safety Action Plan: the article notes useful proposals (software bill of materials, stronger premarket requirements, coordinated vulnerability disclosure, and a proposed CyberMed Safety Analysis Board) but argues these measures are unlikely to quickly resolve systemic issues—legacy devices, limited resources, long device lifecycles, and government-held vulnerabilities remain major challenges; the piece cites WannaCry as an example of how ransomware can impact patient safety.