Bridging the Gap: Understanding System Limitations in Secure Connectivity for Medical Devices

Even when medical devices support secure communication protocols like HL7, DICOM, or ASTM, real-world implementation often falls short—leaving vulnerabilities that aren't addressed during FDA review. This white paper explores the systemic disconnects between device vendors, hospitals, and regulators that lead to insecure deployments. We examine why secure connectivity remains elusive, highlight the technical and organizational barriers within HDOs, and offer actionable recommendations to align stakeholders and improve cybersecurity outcomes.