Medical Device Cybersecurity Interoperability Considerations

Updated October 26, 2024

The Federal Drug Administration (FDA) created medical device cybersecurity standards with its new guidance published in 2023. The agency delivered explicit requirements and additional best practices within these new rules. One area of concentration was interoperability.

So, how does interoperability play into these new medical device cybersecurity standards?

Key Takeaways

• FDA guidance emphasizes secure interoperability for medical devices.
• Devices must exchange data securely with other healthcare systems.
• Interoperability involves risks like unauthorized access and data errors.
• Implement strong authentication and encryption for all transmissions.
• Ongoing risk analysis and testing are crucial throughout device lifecycle.
• Consider interoperability in cybersecurity planning for varied environments.

Table of Contents

• Key Takeaways
• The Role of Interoperability in Medical Device Cybersecurity
• Medical Device Cybersecurity Standards and Controls for Interoperability
• What Other Risks Are Inherent with Interoperable Medical Devices?
• Staying on Course: What to Do About Interoperability and Medical Devices

Why this matters

The FDA's Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (Feb 3, 2026 final guidance) made cybersecurity documentation a gating criterion for clearance under Section 524B of the FD&C Act. Reviewers now apply this guidance to medical device cybersecurity interoperability considerations the same way they apply software lifecycle expectations from IEC 62304 and security risk-management expectations from AAMI TIR57 and ANSI/AAMI SW96:2023.

Gaps in this area are the single most common driver of first-cycle cybersecurity Additional Information (AI) requests. The FDA's FY2024 CDRH performance reports show cybersecurity is among the top deficiency categories cited in 510(k) and PMA AI letters, behind only software documentation and clinical evidence. Treating it as a checklist exercise rather than a design-controlled engineering artifact is what creates the gap.

The Role of Interoperability in Medical Device Cybersecurity

Interoperability within healthcare ecosystems has long been a need, ensuring that different software can exchange information. It’s also been an area of great complexity and concern. The FDA highlighted this area in its guidance.

They defined interoperability considerations as including the ability to interface between:

• Medical devices and accessories
• Functions identified in the Multiple Function Device Products
• General purpose platforms
• Other healthcare software systems (e.g., EHRs, medical imaging systems)

Medical devices must be able to interact with other applications. A key example is transmitting information from the device to a patient’s electronic health record. This information is valuable for providers in developing patient care plans.

Interoperability has many security issues, and medical device cybersecurity must consider that. Manufacturers must ensure interoperability is possible in the design of the devices but not allow it to become an exploitable weakness.

Medical devices cannot fully support patient care and outcomes in isolation.

Medical Device Cybersecurity Standards and Controls for Interoperability

The FDA urges medical device companies to implement controls to ensure products are cyber-secure. However, when considering controls, you also have to ensure they don’t cause issues with accessibility and usability.

One area to concentrate on is the technology that enables interoperability, including Bluetooth and network protocols. Heightening the security controls around these, which the organization covers further in their interoperable recommendations. Interoperability considerations create a new subset of protocols focused on interoperability, including:

• Performing a risk analysis
• Extended or expanded testing
• Defining potential misuses and their impact on security
• Verification and validation controls required for integration
• Providing interoperability cybersecurity best practices for providers

These can all be a foundation and would likely be part of the FDA’s other medical device cybersecurity standards for monitoring, identifying, and addressing cyber risk.

What Other Risks Are Inherent with Interoperable Medical Devices?

See also: SPDF and IEC 62304 Mapping: FDA Cyber Guide, FDA Penetration Testing Requirements for Medical Devices, and Letter to File vs New 510(k) for Cybersecurity Changes.

Interoperable medical devices have many shades of risk. They are susceptible to breaches and unauthorized access like any system. What makes it even more concerning is that the other systems could be how hackers gain access. It’s not a closed system, so there must be emphasis on:

• Strong authentication protocols
• Encryption in all communication transmissions

Another potential issue is if a medical device receives the wrong data from another device. This could lead to providers making inaccurate diagnoses and may also be considered a HIPAA violation. For this risk category, you must consider data privacy rules and how they impact interoperability.

Staying on Course: What to Do About Interoperability and Medical Devices

Interoperability is one element of the many things you, as a manufacturer, must consider in cybersecurity planning. It’s critical, as every medical device must connect to other systems. Those connections can occur within a provider network or at the patient’s residence, so you deal with unknowns. You can be reasonably sure that provider networks are secure, but less so with patients.

This increased risk is something you must take into account when creating controls and guidance for the devices once they are in use.

How can you put devices in the best position to be interoperable and secure? Invest in assessments and medical device pen testing throughout the product lifecycle. This doesn’t end once it’s on the market.

It’s an ongoing process, and one that our team has substantial expertise. If you’re concerned about interoperability or any other FDA medical device cybersecurity standards, schedule a discovery session today.

How Blue Goat approaches this

Blue Goat Cyber's medical device practice is led by engineers with CISSP, OSCP, and prior military red-team backgrounds. We treat cybersecurity documentation as design-controlled engineering output, not a submission template, every artifact (threat model, SBOM, security risk assessment, penetration test, labeling) traces back to a controlled requirement and a verified result.

Our engagements deliver the full Feb 3, 2026 guidance documentation set scoped to the device's risk profile, integrated with the existing IEC 62304 software lifecycle and ISO 14971 risk file. See our medical device cybersecurity services for the full scope. If the FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost.

FAQ

What is medical device interoperability?

Medical device interoperability refers to the ability of different medical devices, accessories, and healthcare IT systems (like EHRs) to exchange and use information seamlessly. This facilitates coordinated patient care and data flow within healthcare ecosystems.

How does the FDA address interoperability in its cybersecurity guidance?

The FDA's February 3, 2026 final guidance highlights interoperability as a key cybersecurity consideration. It requires manufacturers to balance functional connectivity with strong security measures to prevent exploitation of these interfaces.

What are common risks with interoperable medical devices?

Common risks include unauthorized access, data breaches, and the transmission of incorrect data between systems. These can compromise patient privacy, lead to inaccurate diagnoses, or result in HIPAA violations.

What security controls are needed for interoperable devices?

Manufacturers should implement strong authentication protocols, encryption for all data transmissions, thorough risk analyses, and expanded testing. Controls specific to technologies like Bluetooth and network protocols are also essential.

Does interoperability testing end after device release?

No, cybersecurity for interoperable medical devices is an ongoing process. Continuous assessments and penetration testing throughout the product lifecycle are necessary to address evolving threats and maintain security.

Related: Medical Device Cybersecurity: A Complete Lifecycle Guide

About the author

Christian Espinosa, CISSP, Founder, Blue Goat Cyber. Christian leads a team focused exclusively on medical device cybersecurity for FDA premarket submissions and postmarket compliance. Read more about Christian.