Promulgated by: National Health and Family Planning Commission and State Administration of Traditional Chinese Medicine. Document No.: Guo Wei Yi Fa [2013] No. 31 (国卫医发〔2013〕31号). Adopted and promulgated on November 20, 2013. Effective January 1, 2014.
Article 1. These Provisions are formulated in order to strengthen the administration of medical records of medical institutions, safeguard the quality and safety of medical care, and protect the lawful rights and interests of both medical institutions and patients.
Article 2. A medical record (病历) refers to the totality of written materials, symbols, charts, images, tissue sections, and other information generated by medical personnel in the course of medical activities, and includes outpatient (including emergency) medical records and inpatient medical records. A medical record becomes a medical case archive (病案) upon archiving.
Article 3. These Provisions apply to the administration of medical records by medical institutions of all levels and types.
Article 4. Medical records may be distinguished, according to their format, as paper medical records and electronic medical records. Electronic medical records have the same legal effect as paper medical records.
Article 5. A medical institution shall establish and improve a medical record administration system, set up a medical case management department or appoint dedicated (or part-time) personnel, responsible for the administration of medical records and medical case archives.
A medical institution shall establish a system of regular inspection, evaluation, and feedback on the quality of medical records. The medical affairs department of the medical institution is responsible for the quality management of medical records.
Article 6. Medical institutions and their medical personnel shall strictly protect patients’ privacy and shall not disclose patients’ medical record materials for any purpose other than medical treatment, teaching, or research.
Article 7. A medical institution shall establish a numbering system for outpatient (including emergency) medical records and inpatient medical records, and shall assign each patient a unique identification number. A medical institution that has established electronic medical records shall associate the medical record identification number with the patient’s identity document number, so that the medical record may be retrieved using either the identification number or the identity document number.
Outpatient (including emergency) medical records and inpatient medical records shall be marked with page numbers or electronic page numbers.
Article 8. Medical personnel shall write medical records in accordance with the requirements of the Basic Norms for Medical Record Writing, the Basic Norms for Traditional Chinese Medicine Medical Record Writing, the Basic Norms for Electronic Medical Records (Trial), and the Basic Norms for Traditional Chinese Medicine Electronic Medical Records (Trial).
Article 9. Inpatient medical records shall be arranged in the following order: temperature chart, physician’s order sheet, admission record, progress notes, pre-operative discussion record, surgical consent form, anesthesia consent form, pre-anesthesia visit record, surgical safety checklist, surgical instrument count record, anesthesia record, operative record, post-anesthesia visit record, post-operative progress notes, nursing records for critically (or seriously) ill patients, discharge record, death record, blood transfusion treatment informed consent form, special examination (special treatment) consent form, consultation record, critical (serious) illness notification, pathology materials, auxiliary examination reports, and medical imaging examination materials.
Medical case archives shall be filed and retained in the following order: inpatient case archive cover sheet, admission record, progress notes, pre-operative discussion record, surgical consent form, anesthesia consent form, pre-anesthesia visit record, surgical safety checklist, surgical instrument count record, anesthesia record, operative record, post-anesthesia visit record, post-operative progress notes, discharge record, death record, death case discussion record, blood transfusion treatment informed consent form, special examination (special treatment) consent form, consultation record, critical (serious) illness notification, pathology materials, auxiliary examination reports, medical imaging examination materials, temperature chart, physician’s order sheet, and nursing records for critically (or seriously) ill patients.
Article 10. Outpatient (including emergency) medical records shall in principle be kept by the patient. Where a medical institution has established an outpatient (including emergency) medical record archive or has established outpatient (including emergency) electronic medical records, the outpatient (including emergency) medical records may be kept by the medical institution with the consent of the patient or the patient’s legal representative.
Inpatient medical records shall be kept by the medical institution.
Article 11. Where outpatient (including emergency) medical records are kept by the patient, the medical institution shall promptly deliver examination and laboratory results to the patient for safekeeping.
Article 12. Where outpatient (including emergency) medical records are kept by the medical institution, the medical institution shall, within 24 hours of receiving examination and laboratory results, incorporate or record such results into the outpatient (including emergency) medical record, and shall file the outpatient (including emergency) medical record on the first working day following the conclusion of each medical encounter.
Article 13. During a patient’s hospitalization, inpatient medical records shall be kept uniformly by the ward in which the patient is located. Where it is necessary for medical or operational reasons to take inpatient medical records off the ward, dedicated personnel designated by the ward shall be responsible for transporting and keeping the records.
A medical institution shall, within 24 hours of receiving examination and laboratory results and related materials for an inpatient, incorporate or record such materials into the inpatient medical record.
After the patient is discharged, inpatient medical records shall be uniformly preserved and managed by the medical case management department or dedicated (or part-time) personnel.
Article 14. Medical institutions shall administer medical records strictly; no person may alter medical records without authorization; forgery, concealment, destruction, seizure, or theft of medical records is strictly prohibited.
Article 15. No institution or individual other than medical personnel providing medical treatment services to the patient, and departments or personnel authorized by the health administration authority, the traditional Chinese medicine administration authority, or the medical institution to be responsible for medical case administration or medical administration, may examine a patient’s medical records without authorization.
Article 16. Other medical institutions and medical personnel who need to examine or borrow medical records for scientific research or teaching purposes shall submit an application to the medical institution at which the patient received treatment, and may examine or borrow the records only after approval and completion of the relevant procedures. Records shall be returned immediately after examination; borrowed medical records shall be returned within three working days. Examined medical record materials may not be taken off the premises of the medical institution at which the patient received treatment.
Article 17. A medical institution shall accept applications from the following persons and institutions to copy or examine medical record materials, and shall provide medical record copying or examination services in accordance with the applicable rules:
(1) the patient personally, or the patient’s authorized agent; and
(2) the statutory heir of a deceased patient, or such heir’s agent.
Article 18. A medical institution shall designate a department or dedicated (or part-time) personnel to accept applications to copy medical record materials. Upon accepting an application, the medical institution shall require the applicant to provide relevant supporting documents and shall review the formal requirements of the application materials:
(1) where the applicant is the patient personally, a valid identity document of the patient shall be provided;
(2) where the applicant is the patient’s agent, valid identity documents of both the patient and the agent, together with legally prescribed documentary proof of the agency relationship between the agent and the patient and a power of attorney, shall be provided;
(3) where the applicant is the statutory heir of a deceased patient, a death certificate of the patient, a valid identity document of the statutory heir of the deceased patient, and legally prescribed documentary proof of the relationship between the deceased patient and the statutory heir shall be provided; and
(4) where the applicant is the agent of the statutory heir of a deceased patient, a death certificate of the patient, valid identity documents of both the statutory heir of the deceased patient and the agent, legally prescribed documentary proof of the relationship between the deceased patient and the statutory heir, legally prescribed documentary proof of the agency relationship between the agent and the statutory heir, and a power of attorney shall be provided.
Article 19. A medical institution may copy for an applicant the following medical record materials from outpatient (including emergency) medical records and inpatient medical records: temperature chart, physician’s order sheet, inpatient record (admission record), surgical consent form, anesthesia consent form, anesthesia record, operative record, nursing records for critically (or seriously) ill patients, discharge record, blood transfusion treatment informed consent form, special examination (special treatment) consent form, pathology report, laboratory report and other auxiliary examination reports, and medical imaging examination materials.
Article 20. Where public security, judicial, human resources and social security, insurance authorities, or authorities responsible for medical malpractice technical appraisal request to review, examine, or copy medical record materials for the purposes of handling a case, lawfully conducting professional technical appraisal, auditing or arbitrating medical insurance claims, or auditing commercial insurance claims, the medical institution may, upon the case handler’s presentation of the following supporting documents, provide some or all of the patient’s medical records as needed:
(1) legally prescribed proof issued by the relevant administrative authority, judicial authority, insurer, or authority responsible for medical malpractice technical appraisal to retrieve the medical records;
(2) a valid identity document of the case handler personally; and
(3) a valid work credential of the case handler personally (which must correspond to the relevant administrative authority, judicial authority, insurer, or authority responsible for medical malpractice technical appraisal).
Where an insurer requests to review, examine, or copy medical record materials for the purposes of commercial insurance auditing, the insurer shall additionally provide a copy of the insurance contract and legally prescribed documentary proof of the consent of the patient personally or the patient’s agent; where the patient has died, a copy of the insurance contract and legally prescribed documentary proof of the consent of the deceased patient’s statutory heir or such heir’s agent shall be provided. Contracts or laws providing otherwise shall govern.
Article 21. Where a medical record has not yet been completed as required by the Basic Norms for Medical Record Writing and the Basic Norms for Traditional Chinese Medicine Medical Record Writing, and the applicant requests to copy the medical record, the completed portions of the medical record may be copied first; once the medical record has been completed by the medical personnel in accordance with the applicable rules, the newly completed portion may then be copied.
Article 22. After a medical institution accepts an application to copy medical record materials, the designated department or dedicated (or part-time) personnel shall notify the medical case management department or dedicated (or part-time) personnel to deliver the medical record materials to be copied to the designated location within the prescribed time, and to carry out the copying in the presence of the applicant; after the copied medical record materials have been confirmed as accurate by both the applicant and the medical institution, the official seal of the medical institution shall be affixed.
Article 23. A medical institution may charge a cost fee for copying medical record materials in accordance with applicable rules.
Article 24. Where sealing of a medical record is required by law, the medical record shall be jointly confirmed by the medical institution or its authorized agent and the patient or the patient’s agent, and a sealed copy of the medical record shall be signed and sealed in the presence of all parties.
Where the medical institution applies to seal a medical record, the medical institution shall inform the patient or the patient’s agent to jointly carry out the sealing of the medical record; however, where the patient or the patient’s agent refuses or declines to carry out the sealing, the medical institution may, in the presence of a notary public, confirm the medical record and have a copy of the medical record signed and sealed by the notary public.
Article 25. The medical institution is responsible for keeping the sealed copy of the medical record.
Article 26. The original of a sealed medical record may continue to be recorded in and used.
Where a medical record has not yet been completed as required by the Basic Norms for Medical Record Writing and the Basic Norms for Traditional Chinese Medicine Medical Record Writing, and the medical record needs to be sealed, the completed portions may be sealed first; once the physician has completed the medical record in accordance with the applicable rules, the newly completed portion may then be sealed.
Article 27. Opening a sealed medical record shall be carried out in the presence of all parties to the sealing.
Article 28. A medical institution may process paper medical records using microfilming technology that meets archival management requirements and then preserve them.
Article 29. Where outpatient (including emergency) medical records are kept by a medical 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 medical records shall be no less than 30 years from the date of the patient’s last discharge from hospital.
Article 30. Where the name of a medical institution is changed, the medical records held by that institution shall continue to be administered by the renamed medical institution.
After a medical institution is dissolved, the medical records held by that institution may be duly preserved by the provincial-level health administration authority or traditional Chinese medicine administration authority, or by an institution designated by such authorities.
Article 31. These Provisions shall be interpreted by the National Health and Family Planning Commission.
Article 32. These Provisions shall come into force on January 1, 2014. The Provisions on the Administration of Medical Records of Medical Institutions (Wei Yi Fa [2002] No. 193) promulgated by the former Ministry of Health and the State Administration of Traditional Chinese Medicine in 2002 are simultaneously repealed.