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.