Promulgated by: General Office of the National Health and Family Planning Commission; Office of the State Administration of Traditional Chinese Medicine. Document No.: 国卫办医发〔2017〕8号. Adopted February 15, 2017. Effective April 1, 2017.
关于印发电子病历应用管理规范（试行）的通知
国卫办医发〔2017〕8号
各省、自治区、直辖市卫生计生委、中医药管理局，新疆生产建设兵团卫生局：
为贯彻落实全国卫生与健康大会精神及深化医药卫生体制改革有关要求，规范电子病历临床使用与管理，促进电子病历有效共享，推进医疗机构信息化建设，国家卫生计生委、国家中医药管理局组织制定了《电子病历应用管理规范（试行）》。现印发给你们，请遵照执行。
国家卫生计生委办公厅
国家中医药管理局办公室
2017年2月15日
电子病历应用管理规范（试行）
第一章 总则
Article 1. These Specifications are formulated in accordance with the Law of the People’s Republic of China on Licensed Physicians, the Electronic Signature Law of the People’s Republic of China, the Regulations on the Administration of Medical Institutions, and other laws and regulations, in order to regulate the application and administration of electronic medical records (including traditional Chinese medicine electronic medical records; the same applies below) in healthcare institutions, to meet the needs of clinical work, to safeguard the quality of and safety in medical care, and to protect the lawful rights and interests of both medical personnel and patients.
Article 2. These Specifications apply to healthcare institutions that implement electronic medical records, with respect to the creation, recording, modification, use, storage, and administration of their electronic medical records.
Article 3. An electronic medical record refers to a form of medical record in which medical personnel, in the course of medical activities, use information systems to generate digitized information such as text, symbols, charts, graphics, numbers, and images, which can be stored, administered, transmitted, and reproduced. Electronic medical records include outpatient (emergency) records and inpatient records.
Article 4. An electronic medical record system refers to a computer information system within a healthcare institution that supports the collection, storage, and access of electronic medical record information and provides online assistance, and that offers information-processing and intelligent service functions oriented toward improving the quality of medical care, safeguarding the safety of medical care, and enhancing the efficiency of medical care.
Article 5. The National Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine are responsible for providing guidance on the nationwide application and administration of electronic medical records. Local health and family planning administrative authorities at all levels (including traditional Chinese medicine administration departments) are responsible for supervising and administering the application of electronic medical records within their respective administrative regions.
第二章 电子病历的基本要求
Article 6. A healthcare institution applying electronic medical records shall meet the following conditions:
(1) it possesses dedicated technical support departments and personnel responsible for the construction, operation, and maintenance of electronic medical record-related information systems, and possesses dedicated administration departments and personnel responsible for the business supervision of electronic medical records;
(2) it has established and improved the relevant rules and procedures for the use of electronic medical records;
(3) it possesses a security administration system and security safeguard mechanism for electronic medical records;
(4) it possesses the capability to trace creation, modification, and archiving operations on electronic medical records; and
(5) it meets other conditions prescribed by relevant laws, regulations, normative documents, and the provincial-level health and family planning administrative authorities.
Article 7. The Provisions on the Administration of Medical Records of Healthcare Institutions (2013 Edition), the Basic Norms for Medical Record Writing, and the Basic Norms for Traditional Chinese Medicine Medical Record Writing apply to the administration of electronic medical records.
Article 8. The terminology, coding, templates, and data used in electronic medical records shall comply with the requirements of relevant industry standards and specifications. On the premise of safeguarding information security, the effective sharing of electronic medical record information shall be promoted.
Article 9. An electronic medical record system shall provide operating personnel with exclusive identity credentials and identification means, and shall set corresponding access rights. Operating personnel shall be responsible for the use of their own identity credentials.
Article 10. Healthcare institutions with the necessary capabilities may use electronic signatures in their electronic medical record systems for identity authentication. A reliable electronic signature shall have the same legal effect as a handwritten signature or seal.
Article 11. An electronic medical record system shall use an authoritative and reliable time source.
第三章 电子病历的书写与存储
Article 12. Healthcare institutions using electronic medical record systems for medical record writing shall follow the principles of being objective, truthful, accurate, timely, complete, and standardized.
The content of outpatient (emergency) medical record writing includes: the outpatient (emergency) medical record cover page, medical record entries, laboratory reports, medical imaging examination materials, and the like.
The content of inpatient medical record writing includes: the inpatient case summary cover page, admission records, progress notes, surgical consent forms, anesthesia consent forms, blood transfusion treatment informed consent forms, special examination (special treatment) consent forms, critical illness (serious condition) notification forms, physician order sheets, supplementary examination report forms, temperature charts, medical imaging examination reports, pathology report forms, and the like.
Article 13. A healthcare institution shall assign a unique patient identifier to each patient’s electronic medical record so as to ensure the authenticity, consistency, continuity, and completeness of the patient’s basic information and medical records.
Article 14. An electronic medical record system shall identify operating personnel and shall preserve imprints of all previous operations, marking the time of each operation and the information of the operating personnel, and shall ensure that all previous operation imprints, marked operation times, and operating personnel information are queryable and traceable.
Article 15. After medical personnel log in to the electronic medical record system using their identity credentials to complete writing, reviewing, or modifying operations, and confirm such operations, the system shall display the name of the medical personnel and the time of completion.
Article 16. An electronic medical record system shall set out the authority and time limits for medical personnel to write, review, and modify records. Medical records entered by probationary medical personnel or medical personnel in their trial-employment period shall be reviewed, modified, and confirmed by senior medical personnel who hold practice qualifications at the healthcare institution. When senior medical personnel review, modify, and confirm the content of electronic medical records, the electronic medical record system shall perform identity identification, preserve imprints of all previous operations, and mark accurate operation times and operating personnel information.
Article 17. Electronic medical records shall be set to an archiving status. Healthcare institutions shall, in accordance with relevant regulations on medical record administration, convert electronic medical records to archived status at an appropriate time after a patient concludes an outpatient (emergency) visit or is discharged from hospital. In principle, electronic medical records shall not be modified after archiving; in special circumstances where modification is genuinely necessary, the modification shall be carried out upon approval by the medical affairs department of the healthcare institution, and traces of the modification shall be retained.
Article 18. Where necessary for archiving purposes, a healthcare institution may print out electronic medical records and combine them with non-electronic materials to form a case file for preservation. Healthcare institutions with the necessary capabilities may digitally collect non-electronic materials such as informed consent forms and implantable material barcodes and incorporate them into the electronic medical record system for administration; the originals shall be separately preserved in a proper manner.
Article 19. Where outpatient (emergency) electronic medical records are kept by the healthcare institution, the retention period shall be no less than 15 years from the date of the patient’s last visit; the retention period for inpatient electronic medical records shall be no less than 30 years from the date of the patient’s last discharge.
第四章 电子病历的使用
Article 20. An electronic medical record system shall set access rights for viewing medical records, and shall ensure that medical personnel’s need to view medical records is met, and that the patient’s electronic medical record materials can be promptly provided in full. Electronic medical records as presented shall display the patient’s personal information, diagnosis and treatment records, the time of recording, and the names of the recording personnel and their supervising reviewers.
Article 21. A healthcare institution shall provide copying services for electronic medical records to applicants. A healthcare institution may provide electronic or printed copies of medical records. Copied electronic medical record documents shall be independently readable; printed paper copies of electronic medical records shall be stamped with the healthcare institution’s special seal for medical record administration.
Article 22. Healthcare institutions with the necessary capabilities may provide patients with copying services for electronic materials such as medical imaging examination images, surgical recordings, and interventional procedure recordings.
第五章 电子病历的封存
Article 23. Where electronic medical records need to be sealed in accordance with law, the electronic medical records shall be jointly confirmed and then copied and sealed in the joint presence of the healthcare institution or its authorized representative and the patient or the patient’s representative. The sealed copy of the electronic medical records may be in electronic form; alternatively, a printout of the paper version may be photocopied, stamped with the medical records administration seal, and then sealed.
Article 24. Sealed copies of electronic medical records shall meet the following technical conditions and requirements:
(1) they are stored on independent and reliable storage media, and jointly signed and sealed by both the medical and patient parties or their respective representatives;
(2) they can be read within the original system but cannot be modified;
(3) operation imprints, operation times, and operating personnel information are queryable and traceable; and
(4) other conditions and requirements prescribed by relevant laws, regulations, normative documents, and provincial-level health and family planning administrative authorities.
Article 25. After sealing, the original electronic medical records may continue to be used. Where electronic medical records have not yet been completed and need to be sealed, the completed portions of the electronic medical records may be sealed first; once medical personnel have completed the remaining portions in accordance with the regulations, the newly completed portions shall then be sealed.
第六章 附则
Article 26. The “electronic signatures” referred to in these Specifications are those defined in Article 2 of the Electronic Signature Law, namely data contained in or attached to a data message in electronic form that is used to identify the signatory and to indicate the signatory’s approval of the content thereof. A “reliable electronic signature” refers to an electronic signature meeting the relevant conditions set out in Article 13 of the Electronic Signature Law.
Article 27. The “electronic medical record operating personnel” referred to in these Specifications include: medical personnel who use the electronic medical record system; technical personnel who maintain and administer the electronic medical record information system; and administrative management personnel who implement quality supervision of electronic medical records.
Article 28. The “writing of electronic medical records” referred to in these Specifications refers to the act of medical personnel using the electronic medical record system to compile, analyze, and organize information obtained from medical activities such as inquiry, physical examination, supplementary examinations, diagnosis, treatment, and nursing care, so as to form a record of medical activities.
Article 29. Provincial-level health and family planning administrative authorities may formulate implementing rules in accordance with these Specifications.
Article 30. The Basic Norms for Electronic Medical Records (Trial) (Wei Yi Zheng Fa [2010] No. 24) and the Basic Norms for Traditional Chinese Medicine Electronic Medical Records (Trial) (Guo Zhong Yi Yao Fa [2010] No. 18) are hereby simultaneously repealed.
Article 31. These Specifications shall come into force on April 1, 2017.