Edition in 2013

Chapter I General principles

1. The Regulation aims to strengthen medical records management in medical institutions, ensuring medical quality and safety and safeguarding the legitimate rights and interests of doctors and patients.

2. Medical records refer to the sum of texts, symbols, graphics, images and slides produced in medical activities by medical personnel, including outpatient (emergency) and hospitalization medical records. Medical records are filed to be medical history.

3. This regulation shall apply to medical record management in all kinds of medical institutions at all levels.

4. Medical records can be categorized into paper and electronic medical records. Electronic and paper records have the same effect.

5. Medical institutions shall establish and improve the medical record management system, set up the medical record management department or assign specific professional staff to be responsible for medical record management.

Medical institutions shall establish regular medical record quality inspection, evaluation and feedback system. The medical departments in medical institutions should be responsible for management quality of medical record.

6. Medical institutions and medical staff shall strictly protect patient privacy. Any leakage of patients’ medical records for non-medical, non-teaching or non-research purposes is forbidden.

Chapter II Medical record establishment

7. Medical institutions should set up a numbering system for outpatient (emergency) and hospitalization medical records to establish a unique identification number for each patient. Medical institutions that have established electronic medical records shall associate the medical record identification number with a patient’s ID number so that either number can access the patient’s medical records.

Outpatient (emergency) and hospitalization medical records should be marked with page numbers physically or electronically.

8. Medical personnel shall take medical records in accordance with the Basic Medical Record Taking Standard, the Basic Traditional Chinese Medicine Medical Record Taking Standard, the Basic Electronic Medical Records Standard (Trial) and the Basic Traditional Chinese Medicine Electronic Medical Record Taking Standard (Trial).

9. Hospitalization medical records shall be in line with the following order: temperature chart, doctor’s advice record, resident admittance note, record on course of disease, preoperative discussion record, operation agreement, anesthesia agreement, pre-anesthesia visiting record, operation safety verification record, inventory record, anesthesia record, operation record, post-anesthesia visiting record, record on post-operation course of disease, seriously ill (dying) patients’ nursing records, discharge record, death record, blood transfusion informed consent letter, special examination (special treatment) consent letter, consultation record, critically ill notice, pathological files, auxiliary examination report, and medical imaging examination data.

A medical record shall be bound and saved in the following order: home page of hospitalization medical record, record on course of disease, preoperative discussion record, operation agreement, anesthesia agreement, pre-anesthesia visiting record, operation safety verification record, inventory record, anesthesia record, operation record, post-anesthesia visiting record, record on post-operation course of disease, discharge record, death record, death case discussion record, blood transfusion informed consent letter, special examination (special treatment) consent letter, consultation record, critically ill notice, pathological files, auxiliary examination report, medical imaging examination data, temperature chart, doctor’s advice record, and seriously ill (dying) patient nursing records.

Chapter III Medical record keeping

10. In theory, outpatient (emergency) medical records should be kept by patients. Medical institutes that have established an outpatient (emergency) medical record room or electronic medical record can take care of medical records after getting approval of patients or their legal representatives.

Hospitalization medical records should be kept by medical institutes.

11. Medical institutes should hand test results over to patients if patients are holding the outpatient (emergency) medical record.

12. Medical institutes should add test results in outpatient (emergency) medical record within 24 hours and put the record on file the first working day after the diagnosis and treatment, if they keep the record.

13. The medical record should be kept by the inpatient department during hospitalization. The inpatient department should assign specific staff to carry and take care of the medical records if they have to be taken away from the jurisdictions of inpatient department for medical activities or work reasons.

The medical institution shall add test results and related information on hospitalized patients in hospitalization medical records within 24 hours after receiving them.

Hospitalization medical records should be kept and managed by the medical records management department or professional (part-time) employees after patients are discharged.

14. Medical institutions shall conduct strict management on medical record. No one can arbitrarily alter, fake, conceal, destroy, rob or steal medical records.

Chapter IV Medical record lending and replication

15. No organization or individual shall have access to a patient’s medical record, except medical staff providing medical services to patients, the health and family planning authorities, Traditional Chinese Medicine authorities, or medical record management and personnel authorized by medical institutions.

16. Other medical institutions and medical personnel that need to read and borrow medical records for scientific research and teaching purposes shall apply to medical institutions. They should return medical records in three working days. The borrowed medical information should not be taken away from the medical institution.

17. Medical institutions should accept applications from the following personnel and organizations for copying or reading medical records, and offer medical record copying and reference services in accordance with relevant provisions:

a. Patients or their legal representatives

b. Dead patient’s legal heir or agent

18. Medical institutions shall assign a specific department or personnel to deal with applications for medical record replication. They should ask applicants to provide required materials and review them when dealing with the application.

a. If the applicant is a patient, valid proof of patient’s identity is required.

b. If applicant is a patient’s agent, valid proof of patient and agent identities, as well as a legal proof on the relationship between the patient and agent and authorization letter, are required.

c. If applicant is a dead patient’s legal heir, a death certificate, valid proof of the heir’s identity, as well as evidentiary materials proving the dead patient and their legal heir relationship are required.

4. If applicant is agent of a dead patient’s legal heir, a death certificate, valid proof of the heir’s and agent’s identities, as well as evidentiary materials proving the relationship between dead patient and their legal heir and that between the legal heir and agent and authorization letter are required.

19. Medical institutes can replicate medical records for applicants, including temperature chart, doctor’s advice note, resident admit note, operation agreement, anesthesia agreement and record, operation record, seriously ill (dying) patients‘ nursing records, discharge record, blood transfusion informed consent letter, special examination (special treatment) consent letter, pathological and test report, and medical imaging examination data.

20. Government authorities of public security, justice, human resources and social security, insurance, medical accident technical appraisal and commercial insurance companies are entitled to ask for some or all medical records for the purpose of dealing with criminal cases, conducting professional and technical appraisal, and examing the claim of commercial medical insurance after submitting the following evidentiary materials:

a. Administrative and judicial government departments, insurance or medical accident technical appraisal departments provide evidentiary materials for reading and copying medical records

b. Applicant’s own ID proof

c. Applicant’s work certificate (in line with administrative and judicial government departments, insurance or medical accident technical appraisal departments)

Insurance companies should also provide a copy of the insurance contract and evidentiary materials which shows patients or their agents’ agreement on the insurance companies’ application for borrowing the medical record when applying for reading or copying medical records for commercial insurance claim examine. If patients are dead, the insurance contract and evidentiary materials which shows the legal heirs or their agents’ agreement on the insurance companies’ application for borrowing the medical record are required, unless contract or law stipulates otherwise.

21. As required by the Basic Medical Record Taking Standard and the Basic Traditional Chinese Medicine Medical Record TakingStandard, if a medical record has not yet been completed, the applicant can only copy the part that has been completed. After medical staff complete the medical record, the applicant can copy the newly finished part.

22. Medical institutions should assign a specific department or personnel to inform medical record management department or personnel and send record copies to a designated place within a regulated period of time. The copy should be made with applicants on hand. Copies will be stamped after applicants and medical institutes confirm the whole operation.

23. Medical institutes can charge fees for costs of copying medical records.

Chapter V: Medical record sealing and unsealing

24. Medical institutions or their authorized agents, patients or their agents should be present, jointly confirm medical records, and sign and seal medical record copy if the record needs to be sealed.

When applying to seal medical records, medical institutions should inform patients or their agents to jointly carry out the sealing action. If patients or their agents refuse or give up sealing medical records, medical institutions can confirm medical records with the presence of notary organizations, which sign and seal medical record copies.

25. Medical institutes are responsible for taking care of medical record copies.

26. The original copy can continue to be used after sealed.

As required by the Basic Medical Record Taking Standard and the Basic Traditional Chinese Medicine Medical Record Taking Standard, if medical records have not yet been completed, only the part that has been completed can be sealed. After medical staff complete the medical record, the newly finished part can be sealed.

27. All parties at the scene of signing and sealing medical records should be present when unsealing the record.

Chapter VI Medical record preservation

28. Medical institutions can use micrographics technology that meets file management requirements to deal with paper medical records before preserving them.

29. Preservation time for outpatient (emergency) medical records in medical institutes should be no less than 15 years from the last time patients seek consultation and treatment on. Preservation time for hospitalization medical records should be no less than 30 years since the last time patients are discharged.

30. If a medical institution changes its name, its medical records shall be kept by the medical institution with the new name.

If a medical institution is revoked, its medical records should be handed over to the provincial health and family planning authorities, traditional Chinese medicine administrative authorities, or assigned institutes for preservation.

Chapter VII Bylaws

31: The provisions are explained by the National Health and Family Planning Commission.

32. The regulation takes effect on Jan 1, 2014. The Regulation on Medical Record Management at Medical Institutes issued by the defunct Ministry of Health and the State Administration of Traditional Chinese Medicine (No 193) in 2002 have been abolished.