Thông tư 46/2018/TT-BYT quy định về hồ sơ bệnh án điện tử do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

PRESCRIBING ELECTRONIC MEDICAL RECORDS

Pursuant to the Law on Medical Examination and Treatment No. 40/2009/QH12 dated November 23, 2009 of the National Assembly;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of Information Technology Department and the Director of Legal Department;

The Minister of Health promulgates a Circular prescribing electronic medical records.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides for the preparation, use and management of electronic medical records (EMRs) at health facilities issued with operating license in accordance with the Law on Medical Examination and Treatment.

Article 2. Legal validity of electronic medical records

If EMRs are prepared, updated, expressed, digitally signed and retained by electronic means and comply with regulations herein, they shall have the same legal validity as paper medical records prescribed in Article 59 of the Law on Medical Examination and Treatment.

Article 3. Rules for adopting electronic medical records

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

2. An EMR is required to meet the following requirements:

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

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

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

3. Health facilities are allowed to use and retain EMRs instead of paper medical records upon their satisfaction of requirements herein.

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.

Chapter III

RESPONSIBILITY FOR IMPLEMENTATION

Article 16. Responsibility of units affiliated to Ministry of Health

1. The Information Technology Department shall play the leading role and cooperate with the Vietnam Administration of Medical Services, the Traditional Medicine Administration of Vietnam and the Maternal and Child Health Department in:

a) directing, instructing and inspecting the implementation of this Circular nationwide.

b) publishing health facilities adopting EMRs instead of paper medical records, those employing storage and transmission of medical images instead of hard-copy films, and those storing laboratory test-related information instead of printing of paper documents on the web portal of the Ministry of Health and website of the Information Technology Department (http://ehealth.gov.vn).

2. The Vietnam Administration of Medical Services shall play the leading role and cooperate with the Traditional Medicine Administration of Vietnam, the Maternal and Child Health Department, the Information Technology Department and relevant authorities and organizations in adding and completing forms of paper medical records, personal health records and hospital discharge summaries, and then submitting them to the Minister of Health for promulgation.

3. The Health Insurance Department shall play the leading role and cooperate with relevant authorities and organizations in completing output data standards used in management, assessment and reimbursement of costs of medical services covered by health insurance fund.

4. The Ministry Office, Ministry Inspectorate and other Departments/General Departments affiliated to the Ministry of Health shall cooperate with the Information Technology Department in developing shared lists in each specialized sector and performing state management of application of information technology within the ambit of their assigned functions, duties and powers.

Article 17. Responsibility of Provincial Departments of Health and health agencies affiliated to Ministries

1. Direct, instruct and inspect the implementation of this Circular within their competence.

2. Prepare and submit consolidated reports on the implementation of this Circular to the Ministry of Health in December annually.

Article 18. Responsibility of health facilities

1. Head of each health facility shall proactively formulate and implement its plans for adoption of EMRs in accordance with regulations herein.

2. Head of each health facility shall, by consulting its specialized council as prescribed in Article 19 hereof or an independent consultancy unit, decide its management and retention of EMRs instead of paper medical records, storage and transmission of medical images instead of hard-copy films, and storage of laboratory test-related information instead of printing of paper documents.

3. The head of each health facility shall, before retaining EMRs instead of paper medical records, storing and transmitting medical images instead of hard-copy films, and storing laboratory test-related information instead of printing of paper documents, notify the Information Technology Department affiliated to the Ministry of Health in writing for publishing relevant information on the web portal of the Ministry of Health and its website.

Article 19. Specialized councils

1. Specialized councils shall be established by heads of health facilities and take charge of providing advice for such heads of health facilities about the use and retention of EMRs instead of paper medical records, storage and transmission of medical images instead of hard-copy films, and storage of laboratory test-related information instead of printing of paper documents.

2. Each specialized council is comprised of at least 07 members, including a Chairperson, a member who also holds the Clerk position, and other members, and among them there are members specialized in information technology and healthcare sectors.

3. A specialized council shall operate by following collective discussion and majority rules, and shall be automatically dissolved upon the completion of assigned duties.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 20. Road map for implementation

1. In 2019 – 2023 period:

a) Health facilities of rank I or higher shall proactively upgrade their information technology systems to develop and adopt EMRs according to regulations herein.

b) Other health facilities shall, based on their actual demand and capacity, make necessary preparations for adopting EMRs and apply EMRs upon their satisfaction of relevant requirements set forth herein.

2. In 2024 – 2028 period:

a) All health facilities nationwide are expected to apply EMRs.

b) In case other health facilities affiliated to the Ministry of Health, or another Ministry, do not yet apply EMRs, they must submit reports thereof to the Ministry of Health; health facilities under the management of Provincial Departments of Health shall submit reports to relevant Provincial Departments of Health if they do not yet apply EMRs. Such report must indicate reasons for failure to apply EMRs and the road map for applying EMRs which must be completed by December 31, 2030.

Article 21. Terms of reference

If any legislative documents referred to in this Circular are superseded or amended, the new ones shall apply.

Article 22. Transition

Health facilities must store paper medical records which are prepared before EMRs are applied in accordance with Clause 3 Article 59 of the Law on Medical Examination and Treatment.

Article 23. Effect

This Circular comes into force as from March 01, 2019.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (via the Information Technology Department) for consideration.