Medical device interoperability has become a critical requirement to ensure patient safety, continuity of care, and high-quality clinical data. In an increasingly digital and connected healthcare ecosystem, the ability of systems to exchange health information in a meaningful and structured way is a cornerstone of modern digital health.
In this context, HL7 (Health Level Seven) has emerged as one of the leading standards for clinical data exchange at the application level. From HL7 v2.x and HL7 v3 to the more recent HL7 FHIR (Fast Healthcare Interoperability Resources), the standard has evolved to improve integration, modularity, and compatibility with web-based technologies and connected healthcare platforms.
However, achieving true medical device interoperability cannot rely solely on HL7. The article highlights several limitations of the standard, including partial implementations by manufacturers, variability between systems, and the lack of guidance on infrastructure and cybersecurity layers. Interoperability requires a broader, integrated approach that combines data governance, secure communication protocols, regulatory alignment, and compliance with European frameworks such as the EHDS (read more here).
Understanding the technical and regulatory implications of interoperability is essential for manufacturers, system integrators, and digital health stakeholders.
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