Protecting a connected implant means protecting the whole system around it—not just the device inside the body. Patients and caregivers should use only manufacturer- or clinician-approved connections, keep equipment physically secure, install manufacturer-recommended updates, and ask the care team what applies to their exact device. Do not change radio, pairing, programmer, or network settings or try internet-sourced fixes without direction from the manufacturer or care team.
What an implant network can include
Some medical devices communicate wirelessly or through wired connections with phones, home monitors, clinic programmers, hospital networks, or other equipment. Each connection can create cybersecurity considerations, but not every implant has the same features or connections. The device’s instructions and care team are the authority on what applies to a particular system.
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For a connected implant, the relevant system may include the implanted component and the equipment or software used to monitor, program, or support it. Protecting one part alone may not address risks involving another part.
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What patients and caregivers can do
Use only approved connections and software
Connect the device only to equipment, apps, or software that the manufacturer or healthcare provider has approved for that device. Do not add a phone, accessory, app, or other connection just because it appears compatible, and do not change pairing or network settings on your own.
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Secure accounts and equipment
- If a device account or connected piece of equipment offers password protection, use a unique password rather than reusing one from another account.
- Keep the monitor, programmer, phone, or other supporting equipment under your physical control, following the manufacturer’s instructions for safe storage and use.
- Register the device with its manufacturer so the company can send important device information.
Install updates only as directed
Keep the device and its supporting software up to date with updates or patches supplied or recommended by the manufacturer. Ask the care team or manufacturer how updates are delivered and whether you need to take any action. Do not download unofficial software or apply a fix found online.
Ask for device-specific instructions
Ask your care team or the manufacturer which connections are approved, which alerts matter, how updates are handled, and whom to contact if something seems wrong. Instructions differ among devices, so general advice should not replace the labeling or guidance for your model.
What to do about unusual behavior or an alert
If the implant system behaves unexpectedly, displays an unfamiliar alert, or a connected monitor or app stops working as expected, contact the device team or manufacturer for guidance. Do not try to diagnose a cybersecurity problem or make technical changes yourself. If you have an urgent health concern, follow your care team’s instructions for getting medical help; cybersecurity troubleshooting is not a substitute for medical care.
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What healthcare delivery organizations should do
Responsibility is shared among healthcare organizations and device manufacturers. The FDA advises healthcare delivery organizations to evaluate and protect their networks, while organizations and manufacturers coordinate mitigations that address patient-safety risks and preserve device performance.
For an organization, practical starting points include identifying the networked systems that support care, evaluating their security in the context of local clinical workflows, and coordinating vulnerability response and mitigations with the manufacturers of the devices in use. The FDA material does not prescribe one universal network layout or technical control for every facility; decisions need to account for the exact device inventory, manufacturer instructions, and the organization’s risk assessment.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What manufacturers and system owners are responsible for
FDA treats cybersecurity as a lifecycle issue for medical devices. Its postmarket guidance, issued in 2016, discusses attention to cybersecurity from design and development through production, distribution, deployment, and maintenance. That guidance provides lifecycle context; it is not a patient configuration guide.
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The FDA’s February 2026 final premarket cybersecurity guidance supersedes its June 2025 guidance. It addresses recommendations for device design, labeling, and premarket submission content, including Section 524B. These are manufacturer-facing recommendations and should not be read as instructions for patients to configure an implant.
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A free scan shows the junk files, broken settings and background clutter dragging Windows down - then fixes them in one click.Free scan · Windows 10 & 11Section 524B applies to qualifying “cyber devices,” as defined by law. FDA describes manufacturer requirements that include plans to monitor, identify, and address postmarket vulnerabilities; secure development and maintenance processes; postmarket updates and patches; and a software bill of materials. These requirements concern qualifying devices and regulatory submissions, not direct consumer obligations.
Why device-specific instructions matter
In a March 21, 2019 safety communication concerning certain Medtronic implantable cardiac-device systems, the FDA addressed vulnerabilities involving wireless telemetry between devices, clinic programmers, and home monitors. The FDA’s index said users should continue intended use and follow device labeling. That dated example illustrates why cybersecurity can involve the supporting equipment as well as an implant; it is not a universal instruction for current products. For a specific device, check the current FDA communication and manufacturer notice before taking action.
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