JMIR Publications

ABSTRACT

Background:

Electronic medical record (EMR) certification programs have traditionally focused on product-level requirements such as interoperability, security, and core functionality. However, growing evidence suggests that many patient safety risks associated with EMRs arise after implementation, and are closely related to system configuration, workflow integration, and real-world use. Despite the presence of a national EMR product certification system in Korea, a systematic evaluation of the implementation and use of certified systems in clinical practice is lacking.

Objective:

This study aimed to develop and validate a self-assessment checklist for EMR -use certification focused on patient safety–critical functions and to evaluate its content validity and practical applicability across healthcare institutions of different sizes.

Methods:

A convergent mixed methods design was used. A self-assessment checklist comprising ten patient safety–related EMR functions was developed by adapting the United States Office of the National Coordinator for Health Information Technology self-assessment templates to the Korean EMR certification context. Content validity was quantitatively assessed using the content validity index across four dimensions (relevance, usefulness, clarity, and importance) by a panel of 24 experts with experience in EMR implementation and certification. Qualitative feedback was collected through open-ended survey questions to examine the feasibility, anticipated challenges, and differences between product and use certifications across tertiary hospitals, general hospitals, and clinics.

Results:

The overall scale-level content validity index was 0.92, indicating strong content validity of the proposed checklist. While most items demonstrated high agreement, lower ratings were observed for certain functions, particularly in clinical settings, reflecting structural and resource-related constraints rather than limited recognition of patient safety priorities. The qualitative findings highlighted challenges related to staffing, system governance, and the feasibility of assembling multidisciplinary assessment teams in smaller institutions.

Conclusions:

These findings support the feasibility and relevance of EMR-use certification as a complement to product certification. A context-sensitive, tiered certification approach, with scenario-based evaluation tools and policy-level support, may promote safe and effective EMR use across diverse healthcare settings. This study provides empirical evidence for the development of EMR-use certification frameworks aimed at strengthening patient safety in real-world clinical environments.