Validation of a usability scale based on ISO 25010 for electronic health records in the Peruvian healthcare system: a human factors study (Preprint)

BACKGROUND The usability of electronic health record (EHR) systems is crucial for patient safety and clinical efficiency, particularly in developing countries such as Peru, where challenges in implementing these technologies persist. OBJECTIVE To develop and validate an instrument based on the ISO 25010 standard to evaluate the usability of the EHR module, integrated with the requirements of the Peruvian Technical Health Standard (NTS). METHODS A methodological study was conducted in three phases: (1) Development of the instrument by integrating 23 items organized into seven usability dimensions; (2) Content validation with 10 experts using Aiken's V coefficient; and (3) Psychometric validation with 115 users using confirmatory factor analysis and reliability calculation. The study evaluated a HCE module implemented in a Peruvian health institution. RESULTS The instrument demonstrated excellent psychometric properties: content validity (V=0.95), model fit (CFI=1.000, TLI=1.001), and high reliability (α=0.968). Overall usability was perceived as "very high" (81.7%) and "high" (18.3%). The module met 80% of the NTS requirements. Certain differences were identified, but they were not significant between clinical and administrative professionals in terms of perceived usability. CONCLUSIONS This study provides the first validated instrument in Spanish for evaluating the usability of information systems that integrates ISO 25010, SUS, and other theoretical foundations. The results highlight the importance of considering both international standards and local regulatory requirements (NTS) in the design of digital health systems. The instrument is applicable in Spanish-speaking contexts and can serve as a reference for future usability evaluations in the region.