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    Interoperability

    Ability of devices and systems to exchange and use information.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 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.
    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.

    Related terms

    Shared paths + category
    Software & AI
    Software as a Medical Device(SaMD)

    Software intended for medical purposes that performs without being part of a hardware device.

    SaMD & AI/ML Devices
    Cybersecurity
    Premarket Cybersecurity Submission

    The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.

    Software & AI
    Good Machine Learning Practice(GMLP)

    Guiding principles for the development of AI/ML-enabled medical devices.

    SaMD & AI/ML Devices · adjacent
    Software & AI
    Clinical Decision Support(CDS)

    Software providing healthcare professionals with knowledge and patient-specific information.

    SaMD & AI/ML Devices
    Software & AI
    Predetermined Change Control Plan(PCCP)

    FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.

    SaMD & AI/ML Devices
    Software & AI
    Software in a Medical Device(SiMD)

    Software embedded in or required to operate a hardware medical device.

    SaMD & AI/ML Devices

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    Primary references

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

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