Article 1 In order to standardize the management of electronic medical records in medical institutions, to ensure the legitimate rights and interests of doctors and patients, according to the "People's Republic of China *** and the State Practitioners Law", "Regulations on the Administration of Medical Institutions", "Regulations on the Handling of Medical Accidents", "Regulations on Nurses" and other laws and regulations, to formulate this specification.
Second This specification applies to the establishment, use, preservation and management of electronic medical records in medical institutions.
Article 3 of the electronic medical record refers to the medical staff in the process of medical activities, the use of medical institutions, information systems generated by the text, symbols, charts, graphs, data, images and other digitized information, and can realize the storage, management, transmission and reproduction of the medical record is a form of record of the medical record.
The use of word processing software to edit, print the medical record document, does not belong to the electronic medical records referred to in this specification.
Article IV of the electronic medical record system of medical institutions should meet the needs of clinical work, follow the medical workflow, to protect the quality of medical care and medical safety. Article electronic medical record entry should follow the objective, true, accurate, timely and complete principle.
Article VI of the electronic medical record entry should be used in Chinese and medical terminology, the requirements of the expression of accurate, fluent, correctly punctuated. Common foreign abbreviations and no official Chinese translation of the symptoms, signs, disease names can be used in foreign languages. Record date should use Arabic numerals, record time should be used 24-hour system.
Article VII of the electronic medical records, including outpatient (emergency) electronic medical records, hospitalization electronic medical records and other electronic medical records. Electronic medical records should be in accordance with the Ministry of Health, "the basic specification for medical records", the use of the Ministry of Health unified project name, format and content, shall not be changed without authorization.
Article VIII of the electronic medical record system should provide operators with proprietary identification and means of identification, and set up the appropriate authority; operators are responsible for the use of their own identification.
Article IX of the medical staff to use identification logging in the electronic medical record system to complete the records and other operations and confirmation, the system should display the electronic signature of the medical staff.
Article X of the electronic medical record system should be set up to review the medical staff, modify the authority and time limit. Internship medical personnel, probationary medical personnel record of the medical record, should be legally practicing in this medical institution medical personnel review, modify and confirm the electronic signature. Medical personnel to modify, the electronic medical record system should be identified, save traces of previous modifications, marking the exact time of modification and modification of human information.
Article XI of the electronic medical record system should be established for the patient's personal information database (including name, gender, date of birth, ethnicity, marital status, occupation, work unit, address, valid identity document number, social security number or health insurance number, contact telephone number, etc.), granting a unique identification number and ensure that the patient's medical records correspond to.
Article XII of the electronic medical record system should have a strict copy management function. The same patient the same information can be copied, copy the content must be proofread, different patient information shall not be copied.
Article XIII of the electronic medical record system should meet the national information security level protection system and standards. It is strictly prohibited to tamper with, falsify, conceal, seize, steal and destroy electronic medical records.
Article XIV of the electronic medical record system shall provide technical support for the quality monitoring of medical records, medical and health service information and statistical analysis of data and review of health insurance costs, including medical cost classification query, surgical classification management, clinical path management, quality control of a single disease, average hospitalization days, the average length of stay in the hospital before the operation, the average hospitalization day, the bed utilization rate, the monitoring of rational use of medication, the proportion of drugs to the total income and other healthcare Quality management and control indicators of statistics, the use of system advantages to establish a medical quality assessment system, improve efficiency, ensure medical quality, standardize diagnosis and treatment behavior, and improve the level of hospital management. Article XV of the medical institutions to establish an electronic medical record system shall have the following conditions:
(a) a specialized management department and personnel, responsible for the construction, operation and maintenance of electronic medical record system.
(b) have electronic medical record system operation and maintenance of information technology, equipment and facilities to ensure the safe and stable operation of the electronic medical record system.
(C) the establishment and improvement of the use of electronic medical records of the relevant systems and procedures, including personnel operation, system maintenance and change of management procedures, emergency plans in the event of system failure.
Article XVI of the medical institutions electronic medical record system operation should meet the following requirements:
(a) with the system and measures to ensure data security of electronic medical records, data backup mechanism, the conditions of the medical institutions should be set up information systems disaster recovery system. Should be able to implement the system failure contingency plan to ensure the continuity of electronic medical records business.
(ii) the implementation of hierarchical management of the operator's authority to protect the privacy of patients.
(C) have the ability to trace back operations such as creation, editing, and archiving of electronic medical records.
(D) electronic medical records using terminology, coding, templates and standard data should be in line with the relevant normative requirements. Article XVII of the medical institutions should be set up electronic medical records management department and full-time staff, specifically responsible for the organization's outpatient (emergency) electronic medical records and inpatient electronic medical records collection, preservation, access, copying and other management.
Article XVIII of the electronic medical record system should ensure that the medical staff to access the needs of the medical record, can provide timely and complete presentation of the patient's electronic medical record information.
Article 19 of the patient diagnosis and treatment activities in the process of non-textual information (CT, magnetic *** vibration, ultrasound and other medical imaging information, electrocardiograms, audio, video, etc.) should be included in the electronic medical record system management, should ensure that at any time access to the contents of the complete.
Article 20 of the outpatient electronic medical records in the outpatient (emergency) clinic records to the receiving physician to enter the confirmation that is filed, filed shall not be modified.
Article 21 of the inpatient electronic medical records with patients discharged by the superior physician in the patient's discharge audit confirmed that the archives, archived by the management of electronic medical records management department.
Article 22 of the implanted materials can not be electronically bar code, informed consent and other medical information, measures can be taken to make the information digitized into the electronic medical records and retain the original.
Article 23 of the archived electronic medical records using electronic data preservation, if necessary, can print a paper version, print the paper version of the electronic medical records should be uniform specifications, fonts, formats.
Article 24 of the electronic medical record data should be kept back up, and regular recovery tests on the backup data to ensure that the electronic medical record data can be recovered in a timely manner. When the electronic medical record system is updated, upgraded, should ensure the inheritance and use of the original data.
Article 25 of the medical institutions shall establish electronic medical record information security and confidentiality system, set the medical staff and the relevant hospital management personnel to access, copy, print the electronic medical records of the appropriate authority to establish an electronic medical record logbook, record the use of personnel, operating time and content. Without authorization, any unit or individual shall not access, copy electronic medical records.
Article 26 The medical institutions shall accept the following persons or institutions to copy or copy the application of electronic medical record information:
(1) the patient himself or his agent;
(2) the next of kin of the deceased patient or his agent;
(3) for the patient to pay for the cost of the basic medical care insurance management and management agencies;
(4) the patient authorized to entrust the insurance agency.
Article 27 Medical institutions shall designate specialized agencies and personnel responsible for accepting applications for copying or reproducing electronic medical record information, and retain copies of the applicant's valid identification and its statutory supporting materials, insurance contracts and other copies. When accepting the application, the applicant shall be required to provide materials in accordance with the following requirements:
(1) If the applicant is the patient himself, he shall provide his own valid identification;
(2) If the applicant is the patient's agent, he shall provide the patient's and his agent's valid identification, and the applicant's statutory proof of his relationship with the patient's agent;
(3) If the applicant is the The next of kin of the deceased patient, shall provide the patient's death certificate and his next of kin's valid identification, the applicant is the next of kin of the deceased patient's statutory evidence;
(d) the applicant is the agent of the next of kin of the deceased patient, shall provide the patient's death certificate, the next of kin of the deceased patient and his agent's valid identification, the deceased patient and his next of kin's relationship with the applicant's statutory evidence and the deceased patient's next of kin agent of the relationship between the statutory evidence;
(e) the applicant for the basic medical insurance management and handling organizations, shall be implemented in accordance with the relevant provisions of the corresponding basic medical insurance system;
(f) the applicant for the insurance agency, shall provide a copy of the insurance contract, the contractor's valid proof of identity, the patient himself or her agent agreed to the statutory evidence; the death of the patient, shall provide a copy of the insurance contract, valid proof of identity, the patient himself or her agent agreed to the statutory evidence; the death of the patient, should be provided. Proof of the patient's death, shall provide a copy of the insurance contract, the contractor's valid proof of identity, the death of the patient's next of kin or his agent agreed to the statutory documents. The contract or the law provides otherwise, except.
Article 28 of the public security, judicial organs for handling cases (matters), the need to collect, access to electronic medical records, medical institutions should be in the public security, judicial organs issued by the legal proof and the implementation of the validity of the identity of the official personnel truthfully provided.
Article 29 of the medical institutions can copy or copy the scope of electronic medical record information for the applicant in accordance with the Ministry of Medical Records Management Regulations.
Article 30 The medical institution accepts the application for copying or reproduction of electronic medical records, medical staff shall complete the medical records in accordance with the prescribed time limit before providing.
Article 31 The copy or reproduction of the medical record information by the applicant to verify that there is no error, the medical institution shall be in the electronic medical record paper version of the seal of proof, or to provide a locked and unchangeable electronic version of the medical record.
Article 32 of the occurrence of medical malpractice disputes, should be in the presence of both doctors and patients to lock the electronic medical records and produce identical paper version for sealing, sealing of paper medical records by the medical institution for safekeeping. Article 33 of the provincial health administrative departments can be based on this specification to develop the relevant implementation of this jurisdiction.
Article 34 of the basic norms of electronic medical records of traditional Chinese medicine by the State Administration of Traditional Chinese Medicine formulated separately.
Article 35 The Ministry of Health shall be responsible for the interpretation of this specification.
Article 36 These norms shall come into force on April 1, 2010, and shall be implemented.