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    Interoperability

    Ability of devices and systems to exchange and use information.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

    Definition

    Interoperability is the ability of two or more medical devices, products, technologies, or systems to exchange and use information with consideration for safety, effectiveness, and security. For devices, interoperability needs to be designed in: manufacturers should define the purpose of each interface, the data exchanged, the standards used (such as HL7 FHIR, DICOM or IEEE 11073) and the limits of what connected systems can safely do. FDA's 2017 guidance on interoperable medical devices recommends describing interfaces in labeling and addressing interface-related risks, including cybersecurity, in the risk analysis.
    What the regulation says
    Regulators emphasize interoperability for safe and effective healthcare. The FDA, in its guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," highlights the importance of addressing interoperability risks, particularly regarding cybersecurity. The EU MDR (Regulation (EU) 2017/745) also implicitly addresses interoperability through its essential requirements for safety and performance, which can be impacted by how devices exchange and use information.

    What this means in practice

    FDA's interoperability guidance recommends defining the purpose of an electronic interface, anticipated users, risk management, validation, and labeling.

    Examples

    • A continuous glucose monitor (CGM) wirelessly transmitting blood glucose levels to an insulin pump for automated dose adjustments, demonstrating device-to-device interoperability.
    • An electronic health record (EHR) system integrating data from various hospital departments, such as labs, pharmacies, and imaging, to provide a comprehensive patient view, illustrating system-level interoperability.
    • A diagnostic imaging device sending images in a DICOM (Digital Imaging and Communications in Medicine) format to a picture archiving and communication system (PACS) for storage and review, showcasing adherence to specific communication standards.
    Common pitfalls
    • •Ignoring cybersecurity risks associated with data exchange can lead to vulnerabilities and patient harm.
    • •Failing to validate interoperable systems as a whole can result in unidentified functional or safety issues.
    • •Assuming that all interconnected devices will seamlessly exchange data without explicit interface requirements is a common mistake.
    • •Neglecting to define clear use cases and expected performance for an interoperable system can lead to design flaws and regulatory non-compliance.

    Frequently asked questions

    Interoperability is crucial for enabling seamless data exchange among devices and systems, which can improve patient care, streamline workflows, and enhance the utility of health information technology. It supports coordinated care and efficient clinical decision-making.

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 2Regulator guidance and consensus· 3
    Link health: 3 verified· last checked 2026-06-20
    1. 1
      FDA Interoperability Guidance
      Tier 2 Verified
      FDAfda.gov
    2. 2
      FDA - Software as a Medical Device (SaMD)
      Tier 2 Verified
      FDAfda.gov
    3. 3
      FDA - AI/ML-Enabled Medical Devices
      Tier 2 Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.