Proceedings of Toward Electronic Patient Record'97 (Nashville), pp370-373, 1997.

Harmonization for standardization
-- A Japanese Approach

Hiroshi Takeda (Osaka University Medical School),
Youichi Satomura (Chiba University School of Medicine)
Michio Kimura (Hamamatsu University School of Medicine)

Introduction

Owing to the advancement in information processing and communication technology, computer application in medical care has become very common. Most hospitals in Japan has been installing hospital information systems (HIS) [1] [2]which feature physicians' order entry. Some leading hospitals started to install Picture Archiving and Communication Systems (PACS) [3] [4]and Electronic Patient Record (EPR) systems [5] in an institutional level.

The Ministry of Health and Welfare (MHW) in Japan has decided its mind to admit Electronic Patient Record systems and Telemedicine as one of deregulation procedures of the government , and organized four working groups (WG) for the development of EPR systems at the national level. The technological WG-1 proposed a data model of the EPR system as DTD (Data-type definition) and MML (Medical Markup Language) which is medical version of SGML (Standard Generalized Markup Language) and . From the standpoint of a standard view, the WG is defining the content and the data exchange standard of Japanese EPR system. The WG-2 has developed a thesaurus and medical terms /vocabulary standardization. The WG-3 targeted with the clinical pathway or navigation care map which may standardize clinical process and may provide a basis for case mix control. The WG-4 contracted with JAHIS (the Japanese Association of Healthcare Information Systems Industry) to develop security issues on the EPR system.

The main purpose of this paper is to introduce an approach to terms/vocabulary standards for electronic patient record system in Japan.

Toward standardization for terms/vocabulary standards in Japan

Before the EPR development has started in Japan, needs for terms standards were restricted to billing/accounting system standard, since medical care insurance cover whole nations and the work load for making bills and checking the contents is huge enough to employ thousands of people. Therefore, a kind of national standards exists for handling billing /accounting and receipt. The standards are considered to be independent of EPR system and description of clinical processes.

The standards development was led by the Insurance Division of MHW. On the other hand, the Japanese Medical Information Association (JMIA) organized a committee to promote standardization in the field of medical informatics. The committee (JMIASC) dose not develop any standard directly but monitor and integrate existing standards by domestic and foreign standards development organizations (SDO). The WG-3 of the EPR project by MHW has been in cooperation with JMIASC since 1995.and proposed a key concept of a thesaurus for Japanese EPR system.

In the thesaurus, the subject domain concept is adopted. Tentative structure of the thesaurus is composed of ten elements: EPR terms code, Japanese term (2 bytes code), Japanese reading (2 bytes code), English term (full spelling, capital letter, ASCII code), English abbreviation, SNOMED code, relation code 1, code 2, code 3 and code 4. For example, "gastrectomy" is described as follows: D130005| (Japanese term) | (Japanese reading) | GASTRECTOMY| GASTREC| P155330| ICD9CM:439|

The WG has made thesaurus table as trial basis in accordance with DTD which was proposed by the WG-1 of the EPR project. In order to test whether we will create a suitable first-phase set of codes for the EPR system by borrowing from many different existing code systems, major subjects domains terms / codes standardization in Japan are surveyed. The results are as follows; General Terms:

1) Medical vocabulary dictionary (Japanese Medical Association)

Diagnoses:

1) ICD10 based diagnosis table (Medical Information System Development Center)

2) Code for Medical Care Receipt (Div. Of Insurance, MHW) Clinical tests:

1) Test code (Japanese Association of Clinical Pathology)

Drugs :

1) Brand name code (Div. of Economics, MHW)

2) Chemical name code (Div. of Safety, MHW)

3) Drug codes for Medical care Receipt (Div. of Insurance, MHW)

4) JAN drug codes (Pharmaceutical Industry Association)

5) Classification for drug effect (Div. of Economics, MHWj

6) Drug ID code (Div. of Investigation, MHW)

Medical devices:

1) Brand name code (Div. of Economics, MHW)

2) Code for Medical Care Receipt (Division of Insurance, MHW)

3) JMENET code (Japanese Medical Devices Marketing & Industry Association)

Operating devices :

1) Devices code (Medical Instrument Society of Japan)

Care procedures:

1) Procedures code for Medical Care Receipt (Div. of Insurance, MHW)

In some subject domains, the development is under way. For symptoms, findings, anatomical sites and other clinical observations, SNOMED international is tentatively proposed as standardization. Patient outcome variables, functional status and other management related subject domains are not decided yet. After the survey on the state of the art of standardization, authors (member of the WG-3) have proposed as follows;

1) Japanese standards for codes/terminology are an essential requirement for a computer stored medical record that exchange data among providers.

2) Although the goal is to have an acceptable code system for each subject domains. It is not necessary to have all of the codes come from a single master code system.

3) Development of interfaces can integrate multiple code systems easily. a first-stage medical record code system be created by borrowing from existing code systems in order to cover most of the above subjects domains.

4) No existent standard will be made up by using SNOMED international as a central or core system.

5) To facilitate standardization for EPR system, an organization like American National Standards Institute's Healthcare Informatics Standards Planning Panel must be established in Japan.

International Harmonization

USA and EC are leading the standardization in general. As for EPR system development, standards for contents, data exchange and terms/vocabulary must be settled. For example, Standards development organizations in America such as American College of Radiology/National Electric Manufacturers Association (ACR/NEMA), ASTM(American Society for Testing and Materials) E31 Standards Committee on Medical Informatics, Health Industry Business Communication Council (HIBBCC), Health Level 7 (HL7), IEEE, National Council for Prescription Drug Programs (NCPDP) and Accredited Standards Committee X12 (ASC X12) , have been played major roles and American National Standards Institute's Healthcare Informatics Standards Planning Panel (ANSI HISPP) functioned for the coordination among SDOs. Although Japanese situation is not satisfactory for coordinated approach, the EPR development facilitate the standardization and working group has made an action. The committee in Japanese Association of Medical Informatics try to seek to follow up or monitor overseas movement, especially for USA and have an intention to be an interface for international harmonization.

It is the time for international harmonization and the committee for standardization in the JMIA will act as access point for the international cooperation until the Japanese version of HISPP is established. The international harmonization should move on the new stage to make international harmonization panel. Internet technology, especially using mailing list will be important to keep in touch among international standard organizations.

Conclusions

Patient data are of many different kinds and come from various sites; doctors offices, hospitals, nursing homes, public health departments. In order to permit physicians, other care providers, government, medical material suppliers, computer system developers, insurance organizations and patients themselves to share clinical data easily, the international standardization of content, data exchange and terms/ vocabulary is one of urgent and valuable tasks in the health care community.

The development of EPR standards will takes a long time and a lot of resources. While they are not perfect at first, nor are they suitable for all conceivable purposes, we will lose valuable chance for the EPR systems if we start late. The approach toward standardization should be coordinated in each nation and harmonized among countries, especially USA, EC and Japan.

References

[1] Takeda H.,Matsumura Y, Kondo H, Imai K and Inoue M. Development of a totally integrated hospital information system; An intelligent hospital in Osaka university. Proc.MEDINFO92 (Lun KC et al.eds), 241-246, 1992.

[2] Matsumura Y, Takeda H and Inoue M. Implementation of the totally integrated hospital information system (HUMANE) in Osaka University Hospital. Proc. MEDINFO95 (Greenes RA et al.eds), 590-593, 1995.

[3] Takeda H, Matsumura Y, Kondo H, Inoue M, Kondo H, Takeda I and Miyabe S. System design and implementation of HIS, RIS, and PC-based PACS at the Osaka University Hospital. Proc.MEDINFO95 (Greenes RA et al.eds), 430-433, 1995.

[4] Inamura K, Kondo H and Takeda H. Development and operation of PACS/Teleradiology in Japan. IEEE Comm.Magazine (July), 46-51, 1996.

[5] Takeda H, Matsumura Y, Okada T, Kuwata S, Inoue M, Hazumi N and Aoki J. Development of a cardiovascular disease oriented electronic patient record model in a Japanese university hospital. Proc.Toward an Electronic Patient Record'96. 520-523, 1996.