In her DOTmed News byline, Medcrypt’s Naomi Schwartz explores how the recent Baxter Life2000 Class I recall marks a pivotal shift in the FDA’s treatment of cybersecurity vulnerabilities. Once considered primarily technical concerns, such vulnerabilities are now recognized as direct threats to patient safety.
Naomi argues that healthcare organizations must rethink how they assess and manage cyber risk — not as an IT issue, but as an integral part of patient care. She calls for a more coordinated approach between AI governance and cybersecurity, ensuring that devices are built with secure-by-design principles, maintain up-to-date SBOMs, and follow robust postmarket response protocols.
Her insights resonate strongly with DOTmed’s readership of healthcare leaders, biomedical engineers, and IT security professionals, positioning Medcrypt as a trusted thought leader at the intersection of regulation, innovation, and patient safety.
Read the full article: Cybersecurity as a Patient Safety Imperative – DOTmed
