Why can't hospitals just use standard IT security tools for medical devices?

Most medical devices run legacy operating systems, use proprietary protocols, and cannot accept security agents without voiding warranties or disrupting clinical use. Dedicated medical device security platforms are built to work without agents and to understand clinical communication formats.

What does the FDA require for medical device cybersecurity?

The FDA requires device manufacturers to submit a Software Bill of Materials, a vulnerability disclosure policy, and a cybersecurity management plan as part of the premarket submission process. Post-market, manufacturers must monitor for vulnerabilities and communicate risks to customers.

How is medical device security different from IoT security?

IoT security platforms cover a broad range of connected devices across many industries. Medical device security tools are specifically built for clinical environments, with support for healthcare protocols like DICOM and HL7, FDA compliance workflows, and risk scoring that accounts for patient safety impact.

What is Medical Device Security?

Q: What is medical device security?

Medical device security is the set of practices and tools used to protect networked clinical devices, such as infusion pumps, MRI machines, and patient monitors, from cyberattacks. It covers asset discovery, vulnerability management, network monitoring, and regulatory compliance for both hospitals and device manufacturers.

Medical Device Security is the practice of identifying, monitoring, and protecting networked clinical devices such as infusion pumps, imaging systems, and patient monitors from cyber threats. It covers the full device lifecycle, from manufacturer risk assessment through hospital deployment and decommissioning.

What it does

Medical device security platforms give healthcare organizations and device manufacturers visibility and control over connected clinical equipment. Core capabilities include:

Asset discovery: Automatically finding every connected device on a clinical network, including devices that cannot run agents.
Vulnerability management: Mapping known CVEs to specific device models and firmware versions, then prioritizing patches based on clinical risk.
Traffic monitoring: Watching network communications to detect anomalous behavior, such as a ventilator initiating outbound connections.
File security: Scanning DICOM imaging files and other medical data formats for malware before they reach internal systems.
PKI and identity: Issuing and managing certificates for device authentication across the device lifecycle.
Compliance reporting: Generating evidence for FDA cybersecurity guidance, HIPAA, and other regulatory requirements.

Why teams buy it

Standard IT security tools were not built for medical devices. Many devices run legacy operating systems that cannot be patched. Others use proprietary protocols. Agents cannot be installed without voiding warranties or disrupting clinical workflows. A compromise of a connected infusion pump or imaging system can directly harm patients, not just expose data. Regulators now require manufacturers to submit a Software Bill of Materials (SBOM) and a cybersecurity plan before FDA clearance. Both hospital security teams and device manufacturers face distinct but overlapping pressure to act.

What to look for

Does the platform understand clinical protocols such as HL7, DICOM, and proprietary device communication formats?

What is Medical Device Security?

What it does

Why teams buy it

What to look for

Common confusions

Medical Device Security tools

Frequently asked questions