Foreword

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This document was prepared by Technical Committee ISO/TC 215, Health informatics.

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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 by analysing RWD are known as real-world evidence (RWE).^[4^] 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.

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 examines how it was used within the MID-NET^® Project,^[5^] 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

3 Terms, definitions and abbreviations

3.1 Terms and definitions

3.2 Abbreviations

4 MID-NET^® system overview

4.1 General

4.2 EMR

4.3 Medical information storage at medical sites

4.4 Integrating medical information (central data centre)

4.5 Onsite centre

5 Stakeholders

5.1 Project owners

5.2 Medical sites

5.3 EMR and LIS vendors

5.4 Development and maintenance of standard codes

5.5 Organization governance to ensure data quality

5.6 MID-NET^® stakeholders

6 Quality management overview

6.1 General

6.2 Standardization

6.3 Data mapping

6.4 Data validation

6.5 Governance

7 Conclusion

Bibliography