New NHFPC Electronic Medical Record Guidelines Unveiled: Three Key Regulatory Shifts Signal Major Industry Transformation
On February 22, the National Health and Family Planning Commission issued new《Administrative Specifications for the Application of Electronic Medical Records (Trial)》It has been seven years since the promulgation of the “Basic Specifications for Electronic Medical Records (Trial)” in 2010.
Compared with the previous version of the "Specifications", this revision has three significant changes, the first being“Electronic Signature”, secondly“Sharing”IIIYes"Uniqueness"。
Electronic Signature
Article 9 and Article 10 of the previous version of the "Specifications" stipulate:
After medical personnel log in to the electronic medical record system using their credentials, complete various documentation and other operations, and confirm them,The system shall display the electronic signatures of medical personnel.。
Medical records documented by intern medical personnel and medical personnel during their probationary period shall be reviewed by medical personnel legally practicing at the medical institution.Revised and confirmed with electronic signature。
In Article 10 of the "New Edition," the provision has been revised to:Medical institutions with the necessary conditions may use electronic signatures for identity authentication in their electronic medical record systems. Reliable electronic signatures have the same legal validity as handwritten signatures or seals.。
This revision is more practical than the previous version. Given the low adoption rate of electronic signatures in hospitals across China, changing the mandatory requirement to an optional one is a relatively appropriate approach.
Share
The notice on the issuance of the new version of the “Specifications” explicitly mentions promoting the effective sharing of electronic medical records.“The Guidelines” also emphasize this point in the main text.As stipulated in Article 8 of Chapter II,Promoting Effective Sharing of Electronic Medical Record Information Under the Premise of Ensuring Information Security. This content was not included in the previous version of the Guidelines.
Furthermore, the patient's electronic medical recordReplicable ObjectsThere are also some changes in the new edition of the "Guidelines."
Article 26 of the previous version of the Standards stipulates that medical institutions shall accept applications from the following individuals or entities for photocopying or duplicating electronic medical record data:
(1) The patient themselves or their authorized representative;
(2) Close relatives of the deceased patient or their agents;
(3) Paying for patients' expensesBasic Medical Security Administration and Handling Agencies；
(4) Patient Authorization and EntrustmentInsurance Institutions。
However, the new version of the Regulations does not mention insurance institutions or basic medical security management and operating agencies; it onlyArticle 21 mentions:Medical institutions shall provide applicants with copying services for electronic medical records.Medical institutions can provide medical records in electronic or printed format.
Medical institutions with the necessary conditions may provide patients withMedical Imaging, Surgical Videos, Interventional Procedure VideosElectronic data copying services.
The narrowing scope of replicable objects indicates that the National Health and Family Planning Commission has imposed stricter restrictions on the privacy of electronic medical records.Medical Consortiums and Patients Themselves, or will become the core channel for the sharing and use of electronic medical records. Furthermore,Electronic Medical RecordsThe enhancement of the level of sharing, forThe impetus from big data in healthcare is also a clear positive.
Uniqueness
Article 11 of the previous version of the Specifications states：Electronic medical record systems shall establish a personal information database for patients (including name, gender, date of birth, ethnicity, marital status, occupation, employer, address, valid identity document number, social security number or health insurance number, contact telephone number, etc.),Assign a unique identifier and ensure it corresponds to the patient's medical records.。
In Article 13 of the new version of the Guidelines, this sentence has been revised to:Medical institutions shall assign a unique patient identity identifier to patients' electronic medical records.to ensure the authenticity, consistency, continuity, and completeness of patients’ basic information and their medical records.
One corresponds to traditional medical records, while the other explicitly designates electronic medical records as the patient’s unique identifier, making their increased importance self-evident.
The following is the original text of the "Specifications":
No. 8 [2017] of the General Office of the National Health Commission
Health and Family Planning Commissions, Traditional Chinese Medicine Administrations of all provinces, autonomous regions, and municipalities directly under the Central Government; Health Bureau of the Xinjiang Production and Construction Corps:
To implement the spirit of the National Health and Wellness Conference and the requirements for deepening the reform of the medical and healthcare system, standardize the clinical use and management of electronic medical records (EMRs), promote the effective sharing of EMRs, and advance the informatization construction of medical institutions, the National Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine have jointly formulated the “Specifications for the Application and Management of Electronic Medical Records (Trial).” These Specifications are hereby issued to you (available for download from the “Medical Administration and Hospital Management” section of the official website of the National Health and Family Planning Commission) and shall be implemented accordingly.
General Office of the National Health and Family Planning Commission General Office of the State Administration of Traditional Chinese Medicine
February 15, 2017
Administrative Specifications for the Application of Electronic Medical Records (Trial)
Chapter I General Provisions
Article 1 These Provisions are formulated to regulate the application and management of electronic medical records (including traditional Chinese medicine electronic medical records, hereinafter referred to as such) in medical institutions, meet clinical work requirements, safeguard medical quality and safety, and protect the legitimate rights and interests of both medical providers and patients, 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 relevant laws and regulations.
Article 2 This Standard shall apply to the creation, documentation, modification, use, storage, and management of electronic medical records in medical institutions that implement electronic medical record systems.
Article 3 Electronic medical records refer to medical records generated by medical personnel using information systems during medical activities, in the form of digitized information such as text, symbols, charts, graphics, numbers, and images, which can be stored, managed, transmitted, and reproduced. They are a form of medical record documentation, including outpatient (emergency) medical records and inpatient medical records.
Article 4 An electronic medical record (EMR) system refers to a computer information system within a medical institution that supports the collection, storage, access, and online assistance of EMR information, and provides information processing and intelligent service functions aimed at improving medical quality, ensuring medical safety, and enhancing medical efficiency.
Article 5 The National Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine shall be responsible for guiding the application and management of electronic medical records nationwide. Local health and family planning administrative departments at all levels (including traditional Chinese medicine management departments) shall be responsible for the supervision and administration of the application of electronic medical records within their respective administrative areas.
Chapter 2 Basic Requirements for Electronic Medical Records
Article 6 Medical institutions applying electronic medical records shall meet the following conditions:
(1) There shall be dedicated technical support departments and personnel responsible for the construction, operation, and maintenance of information systems related to electronic medical records; there shall also be dedicated management departments and personnel responsible for business supervision and other related tasks concerning electronic medical records.
(2) Establish and improve the relevant systems and procedures for the use of electronic medical records;
(3) Possess a security management system and security assurance mechanisms for electronic medical records;
(4) Possess the capability to trace operations such as the creation, modification, and archiving of electronic medical records;
(V) Other conditions stipulated by relevant laws, regulations, normative documents, and the provincial health and family planning administrative department.
Article 7 The Provisions on the Administration of Medical Records in Medical Institutions (2013 Edition), the Basic Standards for Medical Record Writing, and the Basic Standards for Traditional Chinese Medicine Medical Record Writing shall 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 norms, and promote the effective sharing of electronic medical record information under the premise of ensuring information security.
Article 9 The electronic medical record system shall provide operators with unique identity identifiers and authentication methods, and assign corresponding access privileges. Operators shall be responsible for the use of their own identity identifiers.
Article 10 Electronic medical record systems of healthcare institutions with the requisite conditions may use electronic signatures for identity authentication. Reliable electronic signatures shall have the same legal validity as handwritten signatures or seals.
Article 11 The electronic medical record system shall adopt an authoritative and reliable time source.
Chapter 3 Writing and Storage of Electronic Medical Records
Article 12 Medical institutions using electronic medical record systems for medical record documentation shall adhere to the principles of objectivity, authenticity, accuracy, timeliness, completeness, and standardization.
The content of outpatient and emergency medical records includes the cover page of outpatient and emergency medical records, medical record entries, laboratory test reports, medical imaging examination data, etc.
The contents of inpatient medical records include the inpatient medical record face sheet, admission note, progress notes, surgical consent form, anesthesia consent form, informed consent for blood transfusion therapy, consent form for special examinations (special treatments), critical illness notification form, physician order sheet, auxiliary examination reports, temperature chart, medical imaging reports, and pathology reports.
Article 13 Medical institutions shall assign a unique patient identifier to each patient’s electronic medical record to ensure the authenticity, consistency, continuity, and integrity of the patient’s basic information and medical records.
Article 14 The electronic medical record system shall authenticate the identity of operators, retain audit trails of all operations, and log operation timestamps and operator information, ensuring that such audit trails, timestamps, and operator information are queryable and traceable.
Article 15 After medical personnel log in to the electronic medical record system using their identity credentials to perform operations such as documentation, review, and modification, and confirm these actions, the system shall display the name of the medical personnel and the time of completion.
Article 16 The electronic medical record (EMR) system shall establish permissions and time limits for the creation, review, and modification of records by medical personnel. Medical records documented by intern medical personnel or medical personnel during their probationary period shall be reviewed, modified, and confirmed by supervising medical personnel who hold practicing qualifications at the respective medical institution. When supervising medical personnel review, modify, and confirm the content of electronic medical records, the EMR system shall perform identity verification, retain logs of all historical operations, and accurately record the timestamps and operator information for each action.
Article 17 Electronic medical records shall be assigned an archival status. Medical institutions shall, in accordance with relevant regulations on medical record management, timely convert electronic medical records to archival status after the completion of a patient’s outpatient or emergency visit or upon discharge. Once archived, electronic medical records shall not be modified in principle; where modification is indeed necessary under special circumstances, it shall be carried out only upon approval by the medical affairs department of the medical institution, and all modification traces shall be preserved.
Article 18 Medical institutions may print electronic medical records and merge them with non-electronic materials to form medical records for archival purposes. Medical institutions with the necessary capabilities may digitize non-electronic materials, such as informed consent forms and barcodes of implanted materials, incorporate them into the electronic medical record system for management, and properly store the original documents separately.
Article 19 Where outpatient and emergency electronic medical records are kept by medical institutions, 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.
Chapter 4 Use of Electronic Medical Records
Article 20 The electronic medical record (EMR) system shall establish access permissions for medical records, ensure that healthcare professionals’ needs for accessing medical records are met, and provide timely and complete presentation of the patient’s EMR data. The displayed EMR shall include the patient’s personal information, diagnosis and treatment records, date and time of documentation, name of the documenting personnel, and name of the supervising reviewer.
Article 21 Medical institutions shall provide applicants with copying services for electronic medical records. Medical institutions may provide medical records in either electronic or printed format. The copied electronic medical record documents shall be independently readable, and the printed paper version of the electronic medical records shall bear the special seal for medical record management of the medical institution.
Article 22 Medical institutions with the necessary conditions may provide patients with copying services for electronic materials, such as medical imaging examination images, surgical videos, and interventional procedure videos.
Chapter 5 Sealing of Electronic Medical Records
Article 23 Where it is necessary to seal electronic medical records in accordance with the law, the electronic medical records shall be jointly verified by both parties—namely, the medical institution or its entrusted agent, and the patient or their agent—in the presence of both parties. The records shall then be copied and sealed. The sealed copy of the electronic medical records may be in electronic form; alternatively, a printed paper version may be photocopied, stamped with the medical record management seal, and then sealed.
Article 24 The sealed copies of electronic medical records shall meet the following technical conditions and requirements:
(1) Stored on independent and reliable storage media, and jointly sealed by both the medical provider and the patient or their respective agents;
(2) Can be read within the original system, but cannot be modified;
(3) Operational traces, operation times, and operator information shall be queryable and traceable;
(4) Other conditions and requirements stipulated by relevant laws, regulations, normative documents, and the provincial health and family planning administrative departments.
Article 25 The original electronic medical records may continue to be used after being sealed. Where the electronic medical records are incomplete and need to be sealed, the completed portions may be sealed first; after the medical personnel complete the remaining portions in accordance with regulations, the newly completed portions shall then be sealed.
Chapter VI Supplementary Provisions
Article 26 The term “electronic signature” as used in these Specifications refers to the data contained in or attached to a data message in electronic form, as prescribed in Article 2 of the Electronic Signature Law, which is used to identify the signatory’s identity and to indicate the signatory’s approval of the content therein. A “reliable electronic signature” refers to an electronic signature that meets the conditions specified in Article 13 of the Electronic Signature Law.
Article 27 The term "electronic medical record (EMR) operators" as used in these Specifications refers to medical personnel who use the EMR system, technical staff responsible for maintaining and managing the EMR information system, and administrative personnel tasked with implementing quality supervision of electronic medical records.
Article 28 The term "electronic medical record documentation" as used in these Specifications refers to the act by which medical personnel use an electronic medical record system to summarize, analyze, and organize relevant information obtained through medical activities such as history taking, physical examination, auxiliary tests, diagnosis, treatment, and nursing care, thereby forming records of medical activities.
Article 29 Provincial health and family planning administrative departments may formulate detailed implementation rules in accordance with these Specifications.
Article 30 The Basic Standards for Electronic Medical Records (Trial) (Wei Yi Zheng Fa [2010] No. 24) and the Basic Standards for Traditional Chinese Medicine Electronic Medical Records (Trial) (Guo Zhong Yi Yao Fa [2010] No. 18) shall be repealed simultaneously.
Article 31 These Specifications shall come into force as of April 1, 2017.