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Notice of the Ministry of Health on Issuing the Basic Norms for Electronic Medical Records (for Trial Implementation)
(No. 24 [2010] of the Ministry of Health)
The health departments and bureaus of all provinces, autonomous regions and municipalities directly under the Central Government, and the Health Bureau of Xinjiang Production and Construction Corps,
For purposes of implementing the Opinions of the CPC Central Committee and the State Council on Deepening the Reform of the Medical and Health Care System andthe Notice of the General Office of the State Council on Issuing the Work Arrangements for the Reform of the Medical and Health Care System in Five Key Aspects (2009), strengthening the management of electronic medical records in medical institutions of China, regulating the clinical utilization of electronic medical records and promoting the informatization construction in medical institutions, this Ministry organized the formulation of the Basic Norms for Electronic Medical Records (for Trial Implementation) and hereby print and distribute them to you for implementation.
Annex: Basic Norms for Electronic Medical Records (for Trial Implementation)
February 22, 2010
Annex: Basic Norms for Electronic Medical Records (for Trial Implementation)
| | 卫生部关于印发《电子病历基本规范（试行）》的通知
（卫医政发〔2010〕24号）
各省、自治区、直辖市卫生厅局，新疆生产建设兵团卫生局：
为贯彻落实《中共中央 国务院关于深化医药卫生体制改革的意见》和国务院办公厅《关于印发医药卫生体制五项重点改革2009年工作安排的通知》，加强我国医疗机构电子病历管理，规范电子病历临床使用，促进医疗机构信息化建设，我部组织制定了《电子病历基本规范（试行）》，现印发给你们，请遵照执行。
附件：《电子病历基本规范（试行）》
二〇一〇年二月二十二日
附件：电子病历基本规范（试行）
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Chapter I General Provisions
| | 第一章 总则
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Article 1 To regulate the management of electronic medical records in medical institutions and ensure the lawful rights and interests of both the medical institutions and patients, these Norms are formulated in accordance with the Law on Practicing Doctors of the People's Republic of China, Regulation on the Administration of Medical Institutions,Regulation on the Handling of Medical Accidents, Regulation on Nurses, and other laws and regulations.
| | 第一条 为规范医疗机构电子病历管理，保证医患双方合法权益，根据《中华人民共和国执业医师法》、《医疗机构管理条例》、《医疗事故处理条例》、《护士条例》等法律、法规，制定本规范。
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Article 2 These Norms shall apply to the establishment, use, storage and management of electronic medical records in medical institutions.
| | 第二条 本规范适用于医疗机构电子病历的建立、使用、保存和管理。
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Article 3 The term “electronic medical records” refers to such medical records as characters, symbols, diagrams, graphics, data, images and other digital information which are generated by medical institutions' information systems used by medical personnel during their medical activities and which can be memorized, managed, transmitted and recurred. It is a way of keeping medical records.
The files of medical records edited and printed through word processing software are not electronic medical records as mentioned in these Norms.
| | 第三条 电子病历是指医务人员在医疗活动过程中，使用医疗机构信息系统生成的文字、符号、图表、图形、数据、影像等数字化信息，并能实现存储、管理、传输和重现的医疗记录，是病历的一种记录形式。
使用文字处理软件编辑、打印的病历文档，不属于本规范所称的电子病历。
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Article 4 A medical institution's construction of the electronic medical record system shall satisfy the clinical needs, be in line with the medical operating procedures and ensure the medical quality and safety.
| | 第四条 医疗机构电子病历系统的建设应当满足临床工作需要，遵循医疗工作流程，保障医疗质量和医疗安全。
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Chapter II Basic Requirements for Electronic Medical Records
| | 第二章 电子病历基本要求
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Article 5 The principle of objectiveness, genuineness, accuracy, timeliness and completeness shall be followed in inputting electronic medical records.
| | 第五条 电子病历录入应当遵循客观、真实、准确、及时、完整的原则。
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Article 6 The electronic records shall be input in Chinese characters and medical terms and be subject to such requirements as accurate expressions, coherent and smooth writing, and correct punctuations. The commonly used foreign abbreviations and the symptoms, bodily signs, disease names, etc. without formal Chinese equivalents may be in a foreign language. The date of record shall be in Arabic numerals and the time of record shall be written in the 24-hour system.
| | 第六条 电子病历录入应当使用中文和医学术语，要求表述准确，语句通顺，标点正确。通用的外文缩写和无正式中文译名的症状、体征、疾病名称等可以使用外文。记录日期应当使用阿拉伯数字，记录时间应当采用24小时制。
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Article 7 The electronic medical records include the electronic medical records of outpatient (emergency) treatments, hospitalization, etc. The contents of the electronic medical records shall conform to the Basic Norms of the Ministry of Health for Writing Medical Records, shall be in line with the item names, formats and contents uniformly provided for by the Ministry of Health and shall not be changed without permission.
| | 第七条 电子病历包括门（急）诊电子病历、住院电子病历及其他电子医疗记录。电子病历内容应当按照卫生部《病历书写基本规范》执行，使用卫生部统一制定的项目名称、格式和内容，不得擅自变更。
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Article 8 The system of electronic records shall provide exclusive identity signs and identifying means to the operators and set corresponding authority to them. An operator shall be responsible for the use of his own identity sign.
| | 第八条 电子病历系统应当为操作人员提供专有的身份标识和识别手段，并设置有相应权限；操作人员对本人身份标识的使用负责。
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Article 9 After any of the medical personnel logs into the electronic medical record system, finishes all records and other operations and makes a confirmation, the system shall show his electronic signature.
| | 第九条 医务人员采用身份标识登录电子病历系统完成各项记录等操作并予确认后，系统应当显示医务人员电子签名。
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Article 10 The electronic medical record system shall set the review and revision authority and time period for the medical personnel. The medical records prepared by the medical interns and medical personnel during the probation period shall be reviewed, revised and confirmed with electronic signatures by lawful practicing medical personnel of the present medical institution. When any of the medical personnel revises the relevant information, the system of medical records shall identify him, keep the revisions made every time, and mark the accurate revision time and the information about the reviser.
．．．．．． | | 第十条 电子病历系统应当设置医务人员审查、修改的权限和时限。实习医务人员、试用期医务人员记录的病历，应当经过在本医疗机构合法执业的医务人员审阅、修改并予电子签名确认。医务人员修改时，电子病历系统应当进行身份识别、保存历次修改痕迹、标记准确的修改时间和修改人信息。
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