--- title: "Interoperability, Definition | MedTech Terms" description: "Ability of devices and systems to exchange and use information. Plain-English Software & AI definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/interoperability#term", "name": "Interoperability", "description": "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.", "url": "https://medtechterms.com/terms/interoperability", "termCode": "interoperability", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/interoperability#article", "headline": "Interoperability", "description": "Ability of devices and systems to exchange and use information.", "url": "https://medtechterms.com/terms/interoperability", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/interoperability" }, "about": { "@id": "https://medtechterms.com/terms/interoperability#term" }, "articleSection": "Software & AI", "inLanguage": "en", "keywords": "Interoperability, Software & AI, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA Interoperability Guidance", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-and-pre-market-submission-recommendations-interoperable-medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FDA - Software as a Medical Device (SaMD)", "url": "https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FDA - AI/ML-Enabled Medical Devices", "url": "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/samd#term", "name": "Software as a Medical Device", "alternateName": "SaMD", "url": "https://medtechterms.com/terms/samd" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/premarket-cybersecurity#term", "name": "Premarket Cybersecurity Submission", "url": "https://medtechterms.com/terms/premarket-cybersecurity" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Software & AI", "item": "https://medtechterms.com/terms?cat=Software%20%26%20AI" }, { "@type": "ListItem", "position": 4, "name": "Interoperability", "item": "https://medtechterms.com/terms/interoperability" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/interoperability#faq", "mainEntity": [ { "@type": "Question", "name": "Why is interoperability important for medical devices?", "acceptedAnswer": { "@type": "Answer", "text": "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. 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ISO 14971:2019 principles should be applied to assess, control, and monitor these risks throughout the device lifecycle." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. Interoperability [All terms](/terms) Software & AI [Software Lifecycle](/ecosystems/software-lifecycle) # Interoperability Ability of devices and systems to exchange and use information. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/safe-note) 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](/terms/mdr-reporting) (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](/terms/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 Why is interoperability important for medical devices? 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. What are the key regulatory considerations for interoperability? How does risk management apply to interoperability? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd)[ 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. ](/terms/premarket-cybersecurity) ### SaMD & AI/ML Devices · From this learning path [ Software & AI Good Machine Learning Practice(GMLP) Guiding principles for the development of AI/ML-enabled medical devices. Adjacent lesson ](/terms/good-machine-learning-practice?from=samd-and-ai)[ Software & AI Clinical Decision Support(CDS) Software providing healthcare professionals with knowledge and patient-specific information. ](/terms/cds?from=samd-and-ai)[ Software & AI Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. ](/terms/ai-ml-pccp?from=samd-and-ai)[ Software & AI Software in a Medical Device(SiMD) Software embedded in or required to operate a hardware medical device. ](/terms/simd?from=samd-and-ai) ### More in Software & AI · Same category [ Software & AI Software of Unknown Provenance(SOUP) Software not developed for medical device use, or lacking adequate development records, incorporated into a device. ](/terms/soup)[ Software & AI Software Safety Classification IEC 62304 classes A, B, C reflecting potential harm from software failure. ](/terms/software-safety-class) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [SaMD & AI/ML Devices](/paths/samd-and-ai)Lesson 9 of 9 Ecosystems (1) - [Software Lifecycle](/ecosystems/software-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 1. [1 FDA Interoperability Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-and-pre-market-submission-recommendations-interoperable-medical-devices) 2. [2 FDA - Software as a Medical Device (SaMD) Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd) 3. [3 FDA - AI/ML-Enabled Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Software & AI Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=interoperability) Learn in 60 seconds Card Lesson Quiz Ability of devices and systems to exchange and use information. - · FDA's interoperability guidance recommends defining the purpose of an electronic interface, anticipated users, risk management, validation, and labeling. Remember this Watch out: Ignoring cybersecurity risks associated with data exchange can lead to vulnerabilities and patient harm. Related terms - [Software as a Medical Device(SaMD) ](/terms/samd) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) You may also need Auto-suggested from Software & AI and shared keywords. - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [AAMI TIR57 ](/terms/aami-tir57) - [Health Information Sharing and Analysis Center(H-ISAC) ](/terms/h-isac) - [Health Technology Assessment(HTA) ](/terms/hta) - [IEC 80001-1 ](/terms/iec-80001) - [IEC 81001-5-1 ](/terms/iec-81001-5-1) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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