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Medical Devices · Cyber Insurance

Specialty Cyber Insurance.

Coverage for data breaches, network security incidents, and cyber-related events affecting medical device companies.

02 · Coverage overview

About cyber insurance.

Cyber insurance responds to data breaches, network security incidents, and the business interruption that follows. For a device manufacturer the exposure has two halves: the company's own systems, and the connected devices it has placed in the field.

That second half is what separates device cyber from generic technology cyber. A vulnerability in a connected device can produce a regulatory response, a field correction, and in some cases a claim involving patient harm. This page covers what the policy responds to, where device cyber differs from standard cyber, and what underwriters now expect from a manufacturer.

What Cyber Insurance Covers

A cyber policy typically funds breach response: forensics, legal counsel, notification, credit monitoring where required, and restoration of data and systems. It also responds to business interruption when an incident stops operations, and to extortion events.

Most forms include some regulatory defense and penalty coverage. For a device company that handles protected health information or operates in regulated environments, that section deserves attention, because the size of the sub-limit rarely matches the scale of a real regulatory response.

Where Device Cyber Differs From Standard Cyber

Most cyber policies were written around data and network events, and many exclude bodily injury. A connected device that harms a patient through a security failure can fall into the space between a cyber policy that excludes bodily injury and a products liability policy that was not drafted with software in mind.

Closing that gap is a deliberate exercise. It means reading the cyber form and the products form side by side, finding the line where a device compromise causing injury would fall, and confirming that one of them clearly answers it.

What Underwriters Expect From Manufacturers

Underwriting questions have become specific to devices. Expect to be asked for a software bill of materials, a postmarket vulnerability management process, a coordinated disclosure policy, and a patch cadence, all of which now sit inside FDA cybersecurity expectations for connected devices.

Enterprise controls still matter too. Multi-factor authentication, network segmentation, backup and recovery testing, and a documented incident response plan are the baseline, and a company that cannot evidence them is harder to place on competitive terms.

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03 · Common questions

Frequently Asked Questions

Does Cyber Insurance Cover Patient Harm From A Device Compromise?

Often it does not. Bodily injury is commonly excluded from cyber forms, and a products liability policy written for hardware may not contemplate a security failure. This is the most important gap for a connected-device manufacturer to close deliberately.

Do We Need Cyber Insurance If Our Device Is Not Connected?

The device-specific exposure is smaller, but the company still holds data, depends on systems, and works with vendors. The enterprise exposure remains, and most customer and investor requirements do not distinguish.

What Is A Software Bill Of Materials And Why Do Underwriters Ask For It?

It is an inventory of the software components inside the device, including third-party and open-source code. Underwriters use it to judge vulnerability exposure, and FDA cybersecurity requirements for connected devices expect manufacturers to maintain one.

Does Cyber Cover A Field Correction Caused By A Vulnerability?

Usually not. The cost of notifying customers and retrieving or correcting devices in the field generally sits in recall coverage, which is a separate placement and frequently missing from device programs.

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