Chapter II
MANAGEMENT OF ELECTRONIC MEDICAL RECORDS
Article 4. Types and contents of electronic medical records
1. EMRs include inpatient medical records, outpatient medical records and other medical records as regulated by the Ministry of Health.
2. An EMR must contain sufficient information fields as per the forms of medical records used in health facilities provided in the Decision No. 4069/2001/QD-BYT dated September 28, 2001 of the Minister of Health, the Circular No. 50/2017/TT-BYT dated December 29, 2017 of the Minister of Health, the Decision No. 4604/QD-BYT dated November 29, 2010 of the Minister of Health, the Decision No. 999/QD-BYT dated April 05, 2011 of the Minister of Health, the Decision No. 3443/QD-BYT dated September 22, 2011 of the Minister of Health, the Decision No. 1456/QD-BYT dated May 04, 2012 of the Minister of Health and relevant provisions.
Article 5. Preparing and updating electronic medical records
1. EMRs shall be prepared and updated in accordance with Article 4 hereof and Article 59 of the Law on Medical Examination and Treatment.
2. An EMR must be updated within 12 hours from the issuance of a physician order. If medical examination and treatment lasts for more than 12 hours or the IT system fails, the time limit for updating the EMR may be extended but shall not exceed 24 hours.
Article 6. Storing electronic medical records
A health facility is allowed to retain EMRs instead of paper medical records upon its satisfaction of the following requirements:
1. Its EMR software meets advanced–level requirements set forth in the Circular No. 54/2017/TT-BYT dated December 29, 2017 of the Minister of Health.
2. The capacity of its storage devices must be large enough to keep EMRs for the retention period for medical records prescribed in Clause 3 Article 59 of the Law on Medical Examination and Treatment.
3. EMRs shall be backed up in a data center that meets requirements adopted by the Minister of Information and Communications. EMRs of heath facilities under the management of the Ministry of National Defence shall be backed up in accordance with provisions of the Minister of National Defense.
4. In case of merger of health facilities, EMR data must be transferred to the acquiring health facility. If a health facility is dissolved bankrupt, its EMR data must be transferred to its supervisory authority before being declared bankrupt.
5. Health facilities shall back up their EMRs as regulated in Clause 3 of this Article on a weekly basis.
Article 7. Using and accessing electronic medical records
1. The use and access to EMRs shall conform to Clause 4 and Clause 5 Article 59 of the Law on Medical Examination and Treatment.
The access to EMRs shall be subject to the permission given by the health facility’s head in the following circumstances:
a) Trainees, researchers and practitioners working at a health facility may be allowed to access EMRs on the spot or make electronic copies of EMRs for the purposes of research or specialized operations;
b) Representative of the supervisory authority of a health facility, investigation authorities, People’s Procuracies, courts, healthcare inspectors, insurance offices, providers of forensic examination and forensic psychiatric assessment, and lawyers may be allowed to access EMRs on the spot or make hard copies of EMRs with certification of the head of that health facility for the purpose of fulfilling their assigned duties;
c) Patients or their representatives may be allowed to receive summaries of EMRs or paper medical records at their request as prescribed in Clause 1 Article 11 of the Law on Medical Examination and Treatment. A summarized EMR shall contain information fields as per the form provided in the Appendix No. 4 enclosed with the Circular No. 56/2017/TT-BYT dated December 29, 2017 of the Minister of Health.
2. The entities in Clause 1 of this Article must keep confidentiality of information included in EMRs and only use that obtained information for the purposes stated in their request and approved by heads of health facilities.
Article 8. Electronic medical record software
EMR software is required to meet the following requirements:
1. It must conform to provisions on healthcare information technology standards and shared lists relating to EMRs as prescribed in Article 14 and Article 15 hereof and relevant regulations adopted by the Minister of Information and Communications and the Minister of Health.
2. Control of access by users (including IT employees and healthcare workers) must be ensured at any time. To be specific:
a) Ensure user verification capacity and grant of access rights to users.
b) Ensure the right to privacy, confidentiality and traceability.
3. EMR software must be capable of exporting electronic files in XML format, including:
a) Summarized EMRs.
b) Information relating to management, assessment and reimbursement of costs of medical services covered by health insurance fund in accordance with the Decision No. 4210/QD-BYT dated September 20, 2018 of the Minister of Health.
c) Information relating to personal health records as regulated in the Decision No. 831/QD-BYT dated March 11, 2017 of the Minister of Health.
4. It must be capable of displaying medical records on the computer monitor or other electronic devices in prescribed formats.
5. It must be capable of exporting medical records in prescribed formats to printers, where necessary.
6. EMR software must help to manage the provision of healthcare services, administration information and medical records and have other functions as provided for in Table VIII “Electronic medical records (EMR)" provided in the Appendix No. 1 enclosed with the Circular No. 54/2017/TT-BYT.
Article 9. Patient identity information included in EMRs
Patient identity information must be consistently established nationwide in accordance with regulations of the Minister of Health.
Article 10. Confidentiality and privacy of EMRs
1. Access to and sharing of information included in EMRs with relevant regulatory authorities, organizations and individuals shall adhere to Article 7 hereof and relevant regulations issued by the Minister of Health.
2. Health facilities must adopt the following measures:
a) Measures for access control such as user authentication, role-based access control and establishment of time periods for access to EMR software.
b) Measures for protection of EMRs from illegal access.
c) Plans or procedures for data recovery in case IT system encounters problems.
d) Plans for prevention, detection and removal of malware.
3. EMR data must be encrypted in the course of connection and sharing of EMR data between health facilities.
4. Information relating to patients’ medical examination and treatment must be encrypted in accordance with regulations issued by the Minister of Health.
5. EMR software must be capable of logging all transactions and user interaction on the EMR software, including access date and time, new entries, correction, removal or recovery of EMR data.
6. Health facilities shall, pursuant to Clauses 1 through 5 of this Article, promulgate their own regulations on patient privacy and confidentiality.
Article 11. Picture Archiving and Communication System (PACS)
A health facility is entitled to storage and transmission of medical images instead of hard-copy films upon its satisfaction of the following requirements:
1. Its PACS meets advanced-level requirements as prescribed in the Circular No. 54/2017/TT-BYT.
2. The capacity of devices used to store medical images must be large enough to keep such images for the retention period for medical records prescribed in Clause 3 Article 59 of the Law on Medical Examination and Treatment.
Article 12. Laboratory Information System (LIS)
A health facility is entitled to storage of laboratory test-related information instead of printing of hard copies upon its satisfaction of the following requirements:
1. Its LIS meets advanced-level requirements as prescribed in the Circular No. 54/2017/TT-BYT.
2. The capacity of devices used to store laboratory test-related information must be large enough to keep such information for the retention period for medical records prescribed in Clause 3 Article 59 of the Law on Medical Examination and Treatment.
Article 13. Using digital signatures in EMRs
1. Healthcare workers, patients or their representatives may use lawful e-signatures or digital signatures in EMRs.
2. In case the person that enters information or records into an EMR uses e-signature, the health facility’s head or his/her authorized person shall confirm that e-signature by using a lawful digital signature.
3. The head of a health facility shall promulgate its own regulations on use of e-signatures and digital signatures before application. In special cases (such as commitments prepared by patients, vital signs charts, medication treatment sheets kept at the head of patient beds, and alcohol concentration test reports), the health facility's head shall stipulate the signing of paper documents which must be then digitized and attached to EMRs, and also retained as regulated.
Article 14. Health information technology standards
EMRs must apply the following information technology standards:
1. HL7 standard, including HL7 CDA (Clinical Document Architecture) and HL7 FHIR (Fast Healthcare Interoperability Resources).
2. DICOM standard (Digital Imaging and Communications in Medicine) of version 2.0 or later.
3. Healthcare information security standards as regulated by the Minister of Information and Communications and the Minister of Health.
Article 15. Shared listed in EMRs
EMRs shall use shared lists as regulated by the Minister of Health.
Tìm kiếm
Thông tư 46/2018/TT-BYT (Bản Word)
