Rules for adopting electronic medical records in Vietnam

Rules for adopting electronic medical records in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Rules for adopting electronic medical records in Vietnam

Whenadopting electronic medical records, it is necessary to follow the principles specified in Article 3 of Circular 46/2018/TT-BYT as follows:

- Each patient’s EMR shall be issued with the unique ID number for the purposes of management and storage at a health facility.

- An EMR is required to meet the following requirements:

+ It must contain all required information as a paper medical record.

+ It must be digitally signed by the person in charge of data entered into the EMR.

+ It must comply with provisions on protection of personal information in Section 2 Chapter II of the Law on Cyberinformation Security.

- Health facilities are allowed to use and retain EMRs instead of paper medical records upon their satisfaction of requirements in Circular 46/2018/TT-BYT.

2. Requirements for electronic medical record software

According to Article 8 of Circular 46/2018/TT-BYT, EMR software is required to meet the following requirements:

- It must conform to provisions on healthcare information technology standards and shared lists relating to EMRs as prescribed in Article 14 and Article 15 of Circular 46/2018/TT-BYT and relevant regulations adopted by the Minister of Information and Communications and the Minister of Health.

- Control of access by users (including IT employees and healthcare workers) must be ensured at any time. To be specific:

+ Ensure user verification capacity and grant of access rights to users.

+ Ensure the right to privacy, confidentiality and traceability.

- EMR software must be capable of exporting electronic files in XML format, including:

+ Summarized EMRs.

+ Information relating to management, assessment and reimbursement of costs of medical services covered by health insurance fund in accordance with the Decision 4210/QD-BYT dated September 20, 2018 of the Minister of Health.

+ Information relating to personal health records as regulated in the Decision 831/QD-BYT dated March 11, 2017 of the Minister of Health.

- It must be capable of displaying medical records on the computer monitor or other electronic devices in prescribed formats.

- It must be capable of exporting medical records in prescribed formats to printers, where necessary.

- 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 54/2017/TT-BYT.

3. Cases in which electronic medical records are allowed to be exploited

The use and exploitation of electronic medical records shall comply with the provisions of Clauses 4 and 5, Article 59 of the Law on Medical Examination and Treatment 2009.

Specifically, the head of a medical examination and treatment establishment shall permit the use of case history dossiers in the following cases:

- Trainee students, researchers and practitioners of medical examination and treatment establishments borrowing case history dossiers for on-the-spot reading or for copying for research or professional purposes;

- Representatives of health state management agencies that directly manage medical examination and treatment establishments, investigative agencies, procuracies, courts, health inspectors, insurance agencies, forensic and mental forensic examination organizations and lawyers borrowing case history dossiers for on-the-spot-reading or for copying for performance of their assigned tasks according to their vested powers:

- Patients or their representatives receiving brief summaries of case history dossiers under Clause 1. Article 11 of the Law on Medical Examination and Treatment 2009.

A summarized EMR shall contain information fields as per the form provided in the Appendix No. 4 enclosed with the Circular 56/2017/TT-BYT dated December 29, 2017 of the Minister of Health.

(Article 7 of Circular 46/2018/TT-BYT)

Thanh Rin

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