ISO/TR 18727:2026

Technical
Report
ISO/TR 18727
First edition
Health informatics — Quality
2026-01
management of health data in the
real world — A case study
Reference number
© ISO 2026
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 1
3.1 Terms and definitions .1
3.2 Abbreviations .2 ®
4 MID-NET system overview . 2
4.1 General .2
4.2 EMR .3
4.3 Medical information storage at medical sites .4
4.4 Integrating medical information (central data centre) .4
4.5 Onsite centre .4
5 Stakeholders . 4
5.1 Project owners .4
5.2 Medical sites .4
5.3 EMR and LIS vendors .4
5.4 Development and maintenance of standard codes .4
5.5 Organization governance to ensure data quality .5 ®
5.6 MID-NET stakeholders.5
6 Quality management overview . 5
6.1 General .5
6.2 Standardization .6
6.3 Data mapping .7
6.4 Data validation .7
6.5 Governance .8
6.5.1 General .8
6.5.2 Real-time validation tool (RTVT) .8
6.5.3 Tool to check the syntax of HL7 V2.5 messages in the files contained in the
folders of the storage hierarchical structure (MSVT) .8
6.5.4 Governance centre operations .8
7 Conclusion . 9
Annex A (informative) Standard code mapping table . 10
Annex B (informative) Data consistency in data categories .11
Annex C (informative) Tools for data consistency .12
Bibliography .16

iii
Foreword
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iv
Introduction
Medical data is extensively used worldwide. Furthermore, data-driven business initiatives based on real-
world data (RWD) are becoming more critical. Expectations for RWD usage to improve the efficiency of
clinical research and the process of the development of new drugs are increasing.
RWD refers to medical data captured in daily medical practice. The pieces of scientific evidence obtained
[4]
by analysing RWD are known as real-world evidence (RWE). High-quality RWD ensures RWE validity.
However, collecting high-quality data is costly and time-consuming. Systematic and standard procedures
have not sufficiently demonstrated how to validate and manage data quality. Existing frameworks often lack
consistent validation rules and practical guidance for routine use.
This document describes a specific case study of the Japanese experience in obtaining RWD through the ®
implementation of quality management, as part of MID-NET Project sponsored by the Ministry of Health,
Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. This experience has demonstrated
a reduction in both costs and time, and dramatically improved data reliability. The project has shown that
the implementation of quality management can reduce cost and time, maintain data reliability, and be
applied in a standardized fashion. The lessons learned in Japan can apply anywhere in the world, and the
case study described in this document is meant to provide an example to the global community. ®
The methodology used in the MID-NET Project can be applied to any project in any country or region.
This document is intentionally based on the following fundamental principles:
— applicability to any medical site;
— reduction of costs for introduction and implementation;
— no dependence on any particular technology or products belonging to any specific company;
— easy to understand and implement.

v
Technical Report ISO/TR 18727:2026(en)
Health informatics — Quality management of health data in
the real world — A case study
1 Scope
This document presents a case study of a quality management process to support the integration of medical
information storage within a hierarchical storage structure, across multiple medical sites. This case study
® [5]
examines how it was used within the MID-NET Project, utilizing the hierarchical storage structure
conformant with ISO/TS 24289.
This document does not address issues related to the protection of patient privacy, network security, or the
management of patient identifiers and information processes.
2 Normative references
There are no normative references in this document.
3 Terms, definitions and abbreviations
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 Terms and definitions
3.1.1
real-world data
RWD
data relating to patient health status or the delivery of health care, or both, routinely collected from a variety
of sources
Note 1 to entry: RWD is collected from electronic medical records (3.1.2), claims data or registries.
Note 2 to entry: Adapted from Reference [4].
3.1.2
electronic medical record
EMR
electronic record derived from a computerized system used primarily for delivering patient care in a clinical
setting
[SOURCE: ISO/TR 24291:2021, 3.3]
3.1.3
electronic health record
EHR
repository of information regarding the health status of a subject of care, in computer processable form
Note 1 to entry: EHR is a broad concept that includes various types of medical information such as EMRs, administrative
claims, and data from departmental systems.

[SOURCE: ISO/TR 20514:2005, 2.11, modified — Note 1 to entry was changed.]
3.1.4
laboratory information system
LIS
software system that records, manages, and stores data for clinical laboratories
Note 1 to entry: Adapted from Reference [6].
3.2 Abbreviations
JANIS Japan Nosocomial Infections Surveillance
MEDIS-DC Medical Information System Development Center
MHLW Ministry of Health, Labour and Welfare
PMDA Pharmaceuticals and Medical Devices Agency
® ®
MID-NET medical information database network
RTVT real-time validation tool
MSVT message syntax verification tool ®
4 MID-NET system overview
4.1 General
® ®
Figure 1 shows an overview of the MID-NET system. The MID-NET Project adopts a common data model
that stores a wide variety of electronic health record (EHR) such as electronic medical records (EMRs) and ®
administrative claims. EMRs constitute a particularly important component of the MID-NET system. As
described in the ISO/TS 24289, storage with a hierarchical structure of HL7 Message Files is constructed by ®
first extracting and standardizing data from EMRs at each medical site that participates in the MID-NET
Project. Data extracted from each medical site is anonymized and sent to the “common data model database”
in the central data centre for further analysis. Users in the onsite centre are able to access and send queries
to the common data model database for remote viewing and analysis, and summarized data is available as
output from the common data model database and sent to the requestors at the onsite centre.
Figure 1 shows the implementation of components, allowing medical information storage using a hierarchical
structure. Data extraction and standardization processes from various EMRs in numerous medical sites,
together with their subsequent integration across multiple medical sites, are integral components of the ®
MID-NET Project.
Continuous quality management supports the process of standardizing data across each system.
®
Figure 1 — MID-NET system overview
4.2 EMR ®
For each of the EMR systems participating in the MID-NET Project, coded data are extracted to construct a
hierarchical structure for medical information storage in each medical site, as follows:
— patient basic information;
— diseases;
— prescription order;
— injection order;
— reception information;
— order information of admission, discharge, and ward change;
— meal;
— laboratory examination;
— bacteriological examination;
— radiological examination;
— physiological examination.
Input data quality is maintained within the EMRs through the use of data coding and mapping of local codes
to standardized codes to ensure data standardization.

4.3 Medical information storage at medical sites
Varying codes used in data extracted from EMR sites are harmonized and converted to standard codes
prior to transfer to the central medical information storage. Medical information is maintained within
the hierarchical structure, such as HL7 message files (see ISO/TS 24289), and hierarchical structures and
standardized codes are consistently applied across all medical sites.
Data quality is maintained by verification of the hierarchical file structure and syntax of HL7 V2.5 messages.
4.4 Integrating medical information (central data centre)
Individual-level data are automatically anonymized to protect patient privacy by designating new patient
identification numbers and deleting personally identifiable information, as follows:
— Patient ID Number: Conversion of local patient ID into a new ID number;
— Name: Deleted;
— Address: Deleted;
— Postal Code: A seven-digit number without the exact address.
4.5 Onsite centre
Onsite centre users can access and send queries to the common data model database for remote viewing and
analysis. The onsite centre users are required to meet certain safety management conditions with security
prior to application and approval of access. Aggregated data corresponding to the conditions determined
by users are output from the common data model database in the central data centre. The onsite centre is
a workroom outfitted with security management. Approved users can enter the onsite centre when it is
locked; surveillance cameras are installed.
5 Stakeholders
5.1 Project owners
Project owners include government agencies, regulatory authorities, academic societies, medical sites and
institutions, pharmacological companies, contract research organizations, and laboratories for clinical
examinations. Project owners manage all processes to develop systems which integrate EMR and related ®
medical data, such as the MID-NET system, for inclusion in the common data model database.
5.2 Medical sites
Medical sites provide EMR data that is used to construct hierarchical structures for medical information
storage with standardized data for integrated data systems.
5.3 EMR and LIS vendors
Medical sites request EMR vendors to construct hierarchical structures for medical information storage
with standardized data for integrated data systems. LIS vendors do the same in their laboratories for clinical
examinations.
5.4 Development and maintenance of standard codes
Organizations develop and maintain standard codes of department names, diseases, drugs, laboratory
examinations, and bacteriological examinations. These organizations also publish updates and ensure
version control of codes.
5.5 Organization governance to ensure data quality
A dedicated external organization functions as the governance centre to ensure data quality. Because the
organization is external, its governance is neutral and without bias. ®
5.6 MID-NET stakeholders
Stakeholders in MID-NET® Project are shown in Table 1. ®
Table 1 — Stakeholders in MID-NET Project ®
Stakeholder Organization in MID-NET
Project owners MHLW and PMDA
Medical sites 23 medical sites from 10 healthcare organizations
EMR vendors Selected by each medical site
Organization for standard codes MHLW, MEDIS-DC, and JANIS
Organization for governance Governance centre
6 Quality management overview
6.1 General
Quality management processes are applied to ensure data integrity, quality, accuracy, and completeness.
In this project, data for a selected reference month are extracted from a sampling of EMRs, along with the
corresponding data stored within the common data model database. These datasets are compared for
accuracy and consistency.
...