GB/T 48666-2026 电子病历版式文档技术要求

ICS35.240.30

CCSL67

中华人民共和国国家标准

GB/T48666—2026

电子病历版式文档技术要求

Technicalrequirementsforelectronicmedicalrecordfixed⁃layoutdocument

2026⁃09⁃28发布2027⁃04⁃01实施

国家市场监督管理总局

国家标准化管理委员会发布

GB/T48666—2026

目次

前言··························································································································Ⅲ

引言··························································································································Ⅳ

1范围·······················································································································1

2规范性引用文件········································································································1

3术语和定义··············································································································1

4缩略语····················································································································3

5总体要求·················································································································3

5.1适用场景···········································································································3

5.2应用框架···········································································································3

5.3总体应用要求·····································································································4

6基础格式要求···········································································································5

6.1基础格式···········································································································5

6.2文件命名要求·····································································································6

6.3签名或签章要求··································································································8

7医疗应用要求···········································································································8

7.1基本结构要求·····································································································8

7.2资源文件要求·····································································································9

7.3数据内容要求·····································································································9

7.4附件要求···········································································································9

7.5机读信息要求····································································································10

7.6版本要求··········································································································10

8安全要求···············································································································10

9软件要求···············································································································10

9.1生成软件··········································································································10

9.2阅读软件··········································································································10

参考文献····················································································································12

Ⅰ

GB/T48666—2026

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规定

起草。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由国家密码管理局提出并归口。

本文件起草单位：国家卫生健康委统计信息中心、中国电子技术标准化研究院、中国医学科学院阜

外医院、上海交通大学医学院附属瑞金医院、南京鼓楼医院。

本文件主要起草人：舒婷、赵韡、刘贤刚、董建、夏霁、李红霞、陈亚军、袁靖、林劼、张静、王凯、褚丹奇、

胡伟国、杨郁青、赵艳、苏逸飞、鲍瀛、白松涛、韩志国、王雷、郑艳方、张鹏、林佳乔、申建刚。

Ⅲ

GB/T48666—2026

引言

电子病历是电子文件在医疗卫生行业应用的主要形态。该行业亟需将分散存储于各业务系统中

的高价值电子病历数据，转换为符合国家档案管理要求、具备技术中立性且便于交换的电子病历，以实

现其长期保存和利用。这些文件在脱离操作系统、数据库和业务信息系统等运行环境后，仍能保持其

真实性、完整性，并具备长期可读、可理解和可用的特性。

电子文件作为信息载体，可支撑电子病历数据在异构信息系统之间的流通交换。通过以电子文件

形式交付、流转和再加载数据，能够实现分散医疗数据的有效共享与融合利用，同时为系统间的数据交

换与应用提供信任凭证。本文件提出了一种以文件为纽带连接医疗卫生行业异构信息系统的新框架，

一方面借助版式文档提升阅读便利性，另一方面通过文件中的结构化数据更好地对接计算机处理。倡

导医疗机构各类业务信息系统在业务流程中生成可携带、可交付的电子文件，更好地支持医疗数据跨

机构流转，保障患者和相关用户的数据权利。各类需求方通过归集和整合这些电子病历，实现医疗机

构内部、机构之间乃至区域医疗联合体的数据整合和利用。

Ⅳ

GB/T48666—2026

电子病历版式文档技术要求

1范围

本文件提出了电子病历的应用参考框架，并规定了电子病历版式文档的总体要求，以及基础格式、

医疗应用、安全和软件等要求。

本文件适用于指导医疗信息系统生成、存储和处理电子病历版式文档，也适用于电子病历的归档

和共享应用。

2规范性引用文件

下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文

件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适用于

本文件。

GB18030信息技术中文编码字符集

GB/T33190电子文件存储与交换格式版式文档

GB/T33560网络安全技术密码应用标识

GB/T35275网络安全技术SM2密码算法加密签名消息格式

GB/T38540信息安全技术安全电子签章密码技术规范

GB/T42133信息技术OFD档案应用指南

3术语和定义

下列术语和定义适用于本文件。

3.1

文件records

组织或个人在履行法定义务或办理业务过程中生成、接收并作为凭证保存的信息。

3.2

电子文件electronicrecords

通过计算机等电子设备生成或办理的文件。

3.3

版式文档fixed⁃layoutdocument

呈现效果固定、独立于软硬件环境的文档形态。

注1：版式文档在各类屏幕、打印机等设备呈现效果一致。

注2：开放版式文档（OFD）是一种版式文档格式标准。

3.4

病历medicalrecord

医疗机构的医务人员在门诊、住院患者临床诊疗和指导干预等医疗活动过程中形成的，记录服务

对象的基本信息、病情、病史、检查检验、诊断、处方、治疗、护理等过程或结果信息的文件。

注：病历归档后称为病案。

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