Analysis and evaluation of the Electronic Health Record standard in China: A comparison with the American national standard ASTM E 1384

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Abstract

Objective

To analyze and evaluate the newly issued Electronic Health Record (EHR) Architecture and Data Standard of China (Chinese EHR Standard) and identify areas of improvement for future revisions.

Design

We compared the Chinese EHR Standard with the standard of the American Society for Testing and Materials Standard Practice for Content and Structure of Electronic Health Records in the United States (ASTM E 1384 Standard).

Methods

The comparison comprised two steps: (1) comparing the conformance of the two standards to the international standard: Health Informatics—Requirements for an Electronic Health Record Architecture (ISO/TS 18308), and showing how the architectures of the two standards satisfy or deviate from the ISO requirements and (2) comparing the detailed data structures between the two standards.

Results

Of the 124 requirement items in ISO/TS 18308, the Chinese EHR Standard and the ASTM E 1384 Standard conformed to 77 (62.1%) and 111 (89.5%), respectively. The Chinese EHR Standard conformed to 34 of 50 Structure requirements (68.0%), 22 of 24 Process requirements (91.7%), and 21 of 50 Other requirements (42.0%). The ASTM E 1384 Standard conformed to 49 of 50 Structure requirements (98.0%), 23 of 24 Process requirements (95.8%), and 39 of 40 Other requirements (78.0%).

Conclusions

Further development of the Chinese EHR Standard should focus on supporting privacy and security mechanism, diverse data types, more generic and extensible lower level data structures, and relational attributes for data elements.

Highlights

► We compared the Chinese EHR Standard with ASTM E 1384 Standard. ► We compared the conformance of the two standards to ISO/TS 18308. ► We find that the Chinese EHR Standard lacks sufficient support for secondary uses. ► It is necessary to follow ISO standards to build a EHR standard. ► The EHR standard should be generic and flexible.

Introduction

China issued a trial version of Electronic Health Record (EHR) Architecture and Data Standard (Chinese EHR Standard) within the China Healthcare Information Infrastructure in December 2009 [1]. According to the recent five-year strategy of China's Healthcare System Reform, three fundamental standards (Longitudinal Health Record Architecture and Data Standard, EHR Architecture and Data Standard, and National Healthcare Data Dictionary) will be developed and implemented. The longitudinal healthcare record is defined as a regulatory and scientific record of an individual's lifetime health management process in the Longitudinal Healthcare Record Architecture and Data Standard. It is similar to the longitudinal summary or longitudinal health record in the American Society for Testing and Materials Standard Practice for Content and Structure of Electronic Health Records (ASTM E 1384 Standard) [2]. The EHR is defined as a complete collection of digital clinical information documenting the clinical care rendered to an individual in the Chinese EHR Standard.

A well-developed EHR can support both present and future care as well as secondary uses [3]. The newly published EHR standard in China will accelerate efficient care management and reuse of the clinical information, which will benefit clinic practices in China and other countries Using the international standard: Health Informatics—Requirements for an Electronic Health Record Architecture (ISO/TS 18308) [4] as the optimal criteria, we compared the Chinese EHR Standard to the ASTM E 1384 Standard and suggested improvements to the Chinese EHR Standard.

Section snippets

Chinese EHR architecture

The Chinese EHR Standard consists of two parts: the Basic Architecture and the Data Standard. The Basic Architecture concerns basic information on EHR concepts, contents and source. The content is derived from the Basic Specification for Writing Medical Record [5] and the Basic Specification for Writing Medical Record on Chinese Traditional Medicine or Integration of Traditional and Western Medicine [6], and organized into clinical summary, outpatient (emergency) medical record, inpatient

Evaluation methods

The newly issued Chinese EHR Standard demonstrates substantial progress in electronic healthcare service in China that can be continuously improved in practical application. The aim of the study is to identify the deficiencies or problem areas for future revisions of the Chinese EHR Standard. A comparative research method was performed by using the ASTM E 1384 Standard as a control.

The ASTM E 1384 Standard was originally approved in 1991. With decades of development and revisions, it is now

Discussions and conclusions

China produces a huge amount of clinical documentation every year. The efficient management and reuse of the clinical documents will benefit both Chinese people and people all over the world. China has made the first step towards achieving these benefits by developing an EHR standard. Based on traditional medical record regulations in China and referenced international and Australian standards, it meets the basic requirements for an EHR architecture.

The design philosophy of the Chinese EHR

Authors’ contributions

Wei Xu is responsible for designing the study, reviewing and analyzing the standards, and drafting the article, and revising the manuscript. Zhiyu Guan is responsible for revising the article critically for important content and final approval of the version to be submitted. Hongxin Cao is responsible for analyzing the data. Haiyan Zhang is responsible for collecting the data. Min Lu is responsible for collecting the data. Tiejun Li is responsible for reviewing and analyzing the standards, and

Conflict of interest statement

There are no conflict of interest.

Acknowledgements

This study was sponsored by National Nature Science Foundation of China (No. 30972549). We also thank Fu Wentao for reviewing the paper.

Summary points

What was already known on the topic?

  • Many countries have developed EHR standards.

  • There are International Standards, such as ISO/TS 18308 and ISO/IEC 11179, helping to develop content and structure of the EHR.

What this study added to our knowledge?

  • ISO/TS 18308 can be used to assess conformance of EHR models to this standard.

  • The Chinese EHR Standard

References (20)

There are more references available in the full text version of this article.

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