The Ministry of Health and Welfare will overhaul the electronic medical record (EMR) system certification program. The aim is to integrate the split framework to reduce administrative burdens on medical institutions.
The ministry said on the 7th that it has finalized and will implement the revised notice on the operation of the EMR system certification program.
An EMR is a system that records and manages patient information and diagnosis, prescription, and test results in electronic document form. Until now, it has been operated in two categories: "product certification" and "use certification." Product certification is a process that evaluates the EMR system itself, while use certification examines whether a medical institution uses the certified system without functional changes.
However, there have been continued criticisms that use certification substantially overlaps with product certification in review items and imposes a heavy procedural burden. In practice, the participation rate for product certification was about 82%, while use certification remained at 11%.
The ministry decided to unify the certification framework as "EMR system certification." Going forward, system developers or medical institutions that develop their own systems can apply for integrated certification to the Korea Health Information Service (KHIS).
It also specified the criteria for change reviews. Previously, the rules required reporting in the event of a "material change," but the revision clarifies this as "changes to or deletion of functions related to the certification criteria."
The post-management framework will also be strengthened. If it is determined that system functions have changed after certification or that an inspection is necessary, the certification body may require the submission of self-inspection results. If materials are not submitted, on-site inspections are also possible.
The ministry expects the overhaul to increase participation in EMR certification. The Korea Health Information Service (KHIS) plans to hold a briefing session on the revision in May.