I dati dei dispositivi medici e della In Vitro Diagnosis (IVD)

Abstract

The clinician’s view of digital data management in the medical laboratory is undoubtedly more important for quality and patient safety than that of the laboratory itself. This is clear from international standards: European standards such as the International Patient Summary (IPS) and the Pharmacotherapy Decision Support System (CEN ISO/TS 22756:2020), alongside numerous international standards. The relevant ISO document families originated in the 1980s. The ISO Open Systems Interconnection (ISO-OSI) model is the basis for the standards on system interconnection. Attention was then directed to the functional content of interconnections, i.e. interoperability. ISO has provided standards for interoperability in various fields, such as drugs and various objects. CLSI recently published the document AUTO17, dedicated to semantic interoperability for in vitro diagnostic systems.