Chapter I General Provisions
Article 1 In order to standardize the management of electronic medical records in medical institutions and protect the legitimate rights and interests of both doctors and patients, this Code is formulated in accordance with the Law of People's Republic of China (PRC) Municipality on Medical Practitioners, Regulations on the Administration of Medical Institutions, Regulations on Handling Medical Accidents, Regulations on Nurses and other laws and regulations.
Article 2 This Code is applicable to the establishment, use, preservation and management of electronic medical records in medical institutions.
Article 3 Electronic medical records refer to medical records that can be stored, managed, transmitted and copied by medical personnel using digital information such as words, symbols, charts, graphs, data and images generated by the information system of medical institutions during medical activities. This is a medical record.
The medical records edited and printed by word processing software do not belong to the electronic medical records referred to in this specification.
Article 4 The construction of electronic medical record system in medical institutions shall meet the needs of clinical work, follow the medical workflow, and ensure medical quality and safety.
Chapter II Basic Requirements of Electronic Medical Records
Article 5 Electronic medical record entry shall follow the principles of objectivity, truthfulness, accuracy, timeliness and completeness.
Article 6 Electronic medical records shall be entered in Chinese and medical terms, requiring accurate expression, fluent sentences and correct punctuation. Commonly used foreign language abbreviations and names of symptoms, signs and diseases without official Chinese translation can be used in foreign languages. The recording date shall be in Arabic numerals, and the recording time shall be in 24-hour system.
Article 7 Electronic medical records include outpatient (emergency) electronic medical records, inpatient electronic medical records and other electronic medical records. The content of electronic medical records shall be implemented in accordance with the Basic Standards for Medical Records Writing of the Ministry of Health, and the name, format and content of the project uniformly formulated by the Ministry of Health shall not be changed without authorization.
Article 8 The electronic medical record system shall provide operators with exclusive means of identification and marking, and have corresponding authority; Operators are responsible for the use of their identities.
Article 9 After medical personnel log in to the electronic medical record system through identity identification and complete various records and other operations and confirm, the system shall display the electronic signature of the medical personnel.
Article 10 The electronic medical record system shall set the authority and time limit for medical personnel to consult and modify. Medical records recorded by interns and trainee medical personnel shall be reviewed, revised and confirmed by electronic signatures of medical personnel who are legally practicing in this medical institution. When medical personnel modify, the electronic medical record system should identify itself, save the traces of previous modifications, and mark the accurate modification time and the information of the modifier.
Article 11 The electronic medical record system shall establish a database of patients' personal information (including name, gender, date of birth, nationality, marital status, occupation, work unit, address, valid ID number, social security number or medical insurance number, contact telephone number, etc.). ), grant a unique identification number and ensure that it corresponds to the patient's medical record.
Twelfth electronic medical record system should have strict copy management function. The same information of the same patient can be copied, and the copied content must be proofread, and the information of different patients cannot be copied.
Thirteenth electronic medical record system should comply with the national information security level protection system and standards. It is strictly prohibited to tamper with, forge, conceal, rob, steal and destroy electronic medical records.
Article 14 The electronic medical record system shall provide technical support for medical record quality monitoring, medical and health service information, data statistical analysis and medical insurance expense audit, including statistics of medical quality control indicators such as classified inquiry of medical expenses, operation grading management, clinical pathway management, single disease quality control, average hospitalization days, preoperative average hospitalization days, bed utilization rate, rational drug use monitoring, and the proportion of drugs in total income. Using medical quality evaluation system to improve work efficiency, ensure medical quality and standardize diagnosis and treatment behavior.
Chapter III Basic Conditions for Implementing Electronic Medical Records
Fifteenth medical institutions to establish an electronic medical record system shall meet the following conditions:
(a) there are specialized management departments and personnel responsible for the construction, operation and maintenance of the electronic medical record system.
(2) Having the information technology, equipment and facilities for operating and maintaining the electronic medical record system to ensure the safe and stable operation of the electronic medical record system.
(three) to establish and improve the relevant systems and processes for the use of electronic medical records, including personnel operation, system maintenance and change management procedures, and emergency plans when the system fails.
Article 16 The operation of the electronic medical record system of medical institutions shall meet the following requirements:
(a) there are systems and measures to ensure the safety of electronic medical record data, and there is a data backup mechanism. Conditional medical institutions should establish a disaster backup system for information systems. Should be able to implement the emergency plan when the system fails, to ensure the continuity of electronic medical record business.
(two) to manage the authority of the operators at different levels to protect the privacy of patients.
(3) Having the ability to create, edit and file electronic medical records.
(4) Terms, codes, templates and standard data used in electronic medical records shall meet the requirements of relevant specifications.
Chapter IV Management of Electronic Medical Records
Seventeenth medical institutions should set up an electronic medical record management department, equipped with full-time personnel, specifically responsible for the collection, preservation, access and replication of electronic medical records of emergency and inpatient departments.
Article 18 The electronic medical record system of a medical institution shall ensure that medical personnel can consult medical records and provide and present patients' electronic medical records in time.
Nineteenth non-verbal materials (such as CT, magnetic resonance, ultrasound and other medical image information, electrocardiogram, audio and video recording, etc.). ) The contents generated in the process of patients' diagnosis and treatment activities should be included in the management of electronic medical record system, and ensure that the contents can be checked at any time.
Twentieth outpatient electronic medical records in the door (emergency) diagnosis after the attending physician input confirmation is archived, and may not be modified after archiving.
Twenty-first hospital electronic medical records with the patient discharged from the hospital by the superior doctors after the patient discharged from the hospital for inspection and confirmation, and then by the electronic medical record management department for filing.
Twenty-second medical information materials such as bar codes and informed consent forms of implant materials that cannot be digitized at present can be digitized and incorporated into electronic medical records, and the originals can be kept.
Twenty-third archived electronic medical records are saved in the form of electronic data, and paper versions can be printed when necessary. The printed paper version of electronic medical records should be unified in specifications, fonts and formats.
Twenty-fourth electronic medical record data should be backed up and kept, and the backup data should be restored regularly to ensure that the electronic medical record data can be restored in time. When updating and upgrading the electronic medical record system, we should ensure the inheritance and use of the original data.
Article 25 Medical institutions shall establish a security and confidentiality system for electronic medical records, set corresponding rights for medical personnel and hospital-related management personnel to access, copy and print electronic medical records, and establish an electronic medical record log to record users, operation time and contents. Without authorization, no unit or individual may consult or copy electronic medical records without authorization.
Twenty-sixth medical institutions shall accept the following personnel or institutions to copy or duplicate electronic medical records:
(1) The patient himself or his agent;
(2) The close relatives of the deceased patients or their agents;
(three) the basic medical security management and handling institutions that pay for patients;
(4) Insurance institutions authorized by patients.
Twenty-seventh medical institutions shall designate specialized agencies and personnel to be responsible for accepting applications for copying or duplicating electronic medical records, and keep the applicant's valid identity certificate, legal certification materials and copies of insurance contracts. When accepting an application, the applicant shall be required to provide materials in accordance with the following requirements:
(a) if the applicant is the patient himself, he shall provide his valid identity certificate;
(2) If the applicant is the patient's agent, it shall provide the valid identification of the patient and his agent, and the legal proof of the agency relationship between the applicant and the patient;
(3) If the applicant is a close relative of the deceased patient, it shall provide the death certificate of the patient and the valid identity certificate of his close relative, as well as the legal certificate that the applicant is a close relative of the deceased patient;
(4) If the applicant is the agent of the deceased patient's close relatives, it shall provide the death certificate of the patient, the valid identification certificate of the deceased patient's close relatives and their agents, the legal certificate of the relationship between the deceased patient and his close relatives, and the legal certificate of the agency relationship between the applicant and the deceased patient's close relatives;
(five) the applicant is the basic medical security management and handling institutions, in accordance with the relevant provisions of the corresponding basic medical security system;
(six) if the applicant is an insurance institution, it shall provide a copy of the insurance contract, the valid identity certificate of the undertaker, and the legal certification materials agreed by the patient himself or his agent; If the patient dies, it shall provide a copy of the insurance contract, the valid identity certificate of the undertaker, and the legal certification materials agreed by the close relatives of the deceased patient or his agent. Unless otherwise stipulated in the contract or law.
Twenty-eighth public security and judicial organs need to collect and retrieve electronic medical records because of handling cases (events), and medical institutions should provide them truthfully after the public security and judicial organs issue legal certificates and valid identity certificates of public officials.
Twenty-ninth medical institutions can copy or duplicate electronic medical records for applicants in accordance with the provisions of the Ministry of medical records management.
Article 30 After accepting the application for copying or duplicating electronic medical records, medical institutions shall provide them after medical personnel have finished writing medical records within the prescribed time limit.
Article 31 After the copied or duplicated medical records are verified by the applicant, the medical institution shall affix the seal of proof on the paper-based electronic medical records, or provide the locked and unchangeable electronic medical records.
Article 32 When a medical malpractice dispute occurs, the electronic medical record shall be locked in the presence of both doctors and patients, and the same paper version shall be made and sealed, and the sealed paper medical record shall be kept by the medical institution.
Chapter V Supplementary Provisions
Thirty-third provincial health administrative departments may formulate relevant implementation rules in this area according to this specification.
Thirty-fourth basic norms of electronic medical records of traditional Chinese medicine shall be formulated separately by state administration of traditional chinese medicine.
Article 35 The Ministry of Health shall be responsible for the interpretation of this Code.
Article 36 This Code shall come into force on April 1 day, 2065438.