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Medical Institution File Management System

Legal analysis: On November 20, 2013, the National Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine issued the "Regulations on the Management of Medical Records in Medical Institutions (2013 Edition)". The "Regulations" are divided into general principles, establishment of medical records, custody of medical records, borrowing and copying of medical records, sealing and unsealing of medical records, preservation of medical records, and Supplementary Provisions, Chapter 7 and 32 Articles, and will come into effect on January 1, 2014. The "Regulations on Medical Records Management of Medical Institutions" (Weiyifa [2002] No. 193) promulgated by the former Ministry of Health and the State Administration of Traditional Chinese Medicine in 2002 are abolished.

Legal basis: "Regulations on the Management of Medical Records in Medical Institutions"

Article 10: In principle, patients are responsible for keeping outpatient (emergency) medical records. If a medical institution has established an outpatient (emergency) medical record archive or has established an outpatient (emergency) electronic medical record, with the consent of the patient or his legal representative, the outpatient (emergency) medical records may be kept by the medical institution.

Inpatient medical records are kept by the medical institution.

Article 11: If outpatient (emergency) medical records are kept by the patient, the medical institution shall promptly hand over the examination results to the patient for safekeeping.

Article 12 If outpatient (emergency) clinic medical records are kept by a medical institution, the medical institution shall classify or enter the examination and test results into the outpatient (emergency) clinic within 24 hours after receiving them. Medical records, and file outpatient (emergency) medical records within the first working day after each diagnosis and treatment activity.

Article 13: During the patient’s hospitalization, the hospitalization medical records shall be kept uniformly by the ward. When hospitalization medical records need to be taken out of the ward due to medical activities or work needs, specialized personnel designated by the ward should be responsible for carrying and keeping them.

Medical institutions shall classify or enter the inpatient medical records within 24 hours after receiving the examination results and relevant materials of inpatients.

After the patient is discharged from the hospital, the hospitalization medical records will be uniformly saved and managed by the medical record management department or full-time (part-time) personnel.

Article 14: Medical institutions shall strictly manage medical records. No one may alter medical records at will. It is strictly prohibited to forge, conceal, destroy, rob or steal medical records.