ISO Standards in Healthcare Organizations: Research Evolution and Trends from a Bibliometric Analysis

Abstract

This study provides an overview of trends and evolution in International Organization for Standardization (ISO) implementation in healthcare over the past three decades, useful for researchers, practitioners, and policymakers in the sector. As an additional contribution, we propose the NU-index, which allows the evaluation of authors’ scientific output in a comprehensive way that will be valuable for researchers, institutions, and funding agencies seeking to assess researcher performance more accurately and understandably. A bibliometric analysis of 476 scientific articles from the Scopus Database was conducted, examining the scientific output, key authors, high-impact journals, and frequent keywords using VOSviewer, Bibliometrix library, and statistical analysis. Results reveal a significant increase in publications on ISO standards in healthcare since 2009, particularly in areas such as telemedicine, artificial intelligence, and information security. The emergence of ISO 11073 (health informatics) and ISO 13606 (electronic health records) highlights a growing trend towards information and communication technologies. Despite reported implementation barriers, such as lack of top management commitment and associated costs, adoption of these standards is increasing due to the demand for high-quality healthcare services and the need to comply with regulatory requirements.