DECISION

PROMULGATING INTERIM GUIDELINES AND REGULATIONS FOR ORGANIZATION OF REMOTE MEDICAL EXAMINATION AND TREATMENT CONSULTATIONS AND ADVISING

MINISTER OF HEALTH

Pursuant to the 2009 Law on Medical Examination and Treatment;

Pursuant to the 2006 Law on Information Technology No. 67/2006/QH11;

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

Pursuant to the Circular No. 49/2017/TT-BYT dated December 28, 2017 by the Minister of Health on telemedicine;

At the request of the Head of the Medical Services Administration,

HEREBY DECIDES:

Article 1. Promulgated together with this Decision are the interim guidelines and regulations for organization of remote medical examination and treatment consultations and advising (hereinafter collectively referred to as “teleconsultation”), with the following contents:

1. Teleconsultation room establishment guidelines;

2. Guidelines for confidentiality in teleconsultation;

3. Teleconsultation procedures.

Article 2. Interim guidelines and regulations for organization of teleconsultation are applicable to healthcare establishments having registered for remote medical examination and treatment across Vietnam.

Article 3. This Decision takes effect from the date on which it is signed.

Article 4. Head of the Ministry Office; Chief Inspector of the Ministry of Health; heads of affiliates of the Ministry of Health; Directors of Departments of Health; directors of hospitals affiliated to the Ministry of Health and heads of health units of other ministries shall implement this Decision./.

GUIDELINES

TELECONSULTATION ROOM ESTABLISHMENT

(Promulgated together with Decision No. 4054/QD-BYT dated September 22, 2020)

I. OVERVIEW

A teleconsultation between healthcare establishments means a medical consultation between a hospital providing high level of care (hereinafter referred to as “high-level hospital”) and a hospital providing low level of care (hereinafter referred to as “low-level hospital”) organized via information technology platforms at the request of the low-level hospital and with the agreement of the high-level hospital to advise on the diagnosis and orientation for treatment for each individual patient.

II. REGULATIONS

1. Teleconsultation rooms:

- Standards for provision of teleconsultation services

+ Hardware: low-level hospitals shall prioritize use of their existing equipment

+ Software: low-level hospitals shall use the following 2 types of software:

- Television conference software, which shall be used to connect and discuss with the high-level hospital over the internet.

- Software for connection with the Telehealth platform, which shall be used to connect and upload patient’s data to the Telehealth platform to send to the high-level hospital.

+ Patient’s data shall be collected from the following sources:

- Medical record summary: a doctor of the low-level hospital shall perform a physical examination and obtain the patient’s medical history.

- DICOM and nonDICOM images directly collected using imaging equipment available at the healthcare establishment.

- Data collected using handheld medical IoT equipment (if necessary).

+ Images and sound must be transmitted in real time.

2. Facilities and equipment of teleconsultation rooms

2.1. For high-level hospitals

- A meeting room with area of at least 20m2 and yellow light

- 02 table and chairs sets (with size depending on room area), one to be used as the conference table with 5-7 chairs (depending on number of participating experts and room size) and the other to be used as the tech table with 2-3 chairs.

- 02 computer sets (desktop/laptop), one for setting up the television conference and the other for making diagnosis and displaying the patient’s medical record. Recommended configuration: PC Dell Vostro 3671 42VT370049 Mini Tower: CPU intel core i5 9400, RAM 8GB, HDD 1TB.

- 1 laptop used to control connected points with CPU I7, Ram 8G, SSD 256

- 02 55 inch televisions, one for displaying the low-level hospital side and the other for displaying the patient’s medical record and images.

- 01 camera with Pan Tilt Zoom functionality

- 01 set of omnidirectional microphone and speaker

- Internet connection of at least 50 Mbps to connect with the Telehealth platform and the television conference

- Connections linked to and cameras in operating rooms, endoscopy rooms, outpatient department or departments participating in teleconsultation.

2.2. For low-level hospitals

- A meeting room with area of at least 20m2 and yellow light

- 1 table and chairs set (1 table, 5-7 chairs)

- 01 computer set used to set up the television conference, connect to the Telehealth platform and upload patient’s data to the platform

- 01 55 inch television used to display the high-level hospital side

- 01 camera with Pan Tilt Zoom functionality

- 01 set of omnidirectional microphone and speaker

- 01 patient bed

- Internet connection of at least 50 Mbps to connect with the Telehealth platform and the conference

- Connections linked to and cameras in operating rooms, endoscopy rooms, outpatient department or departments requiring teleconsultation.

3. Positions of chair of teleconsultation, participating experts and equipment according to layout:

3.1. High-level hospital/hospital presiding over the teleconsultation

3.2. Low-level hospital/healthcare establishment requiring teleconsultation

III. IMPLEMENTING RESPONSIBILITIES

- Directors of low-level hospitals and high-level hospitals shall upgrade facilities or provide new ones and furnish all necessary equipment according to regulations.

- Any difficulty arising during the implementation of these guidelines should be reported to the Ministry of Health (Medical Services Administration).

GUIDELINES

CONFIDENTIALITY IN TELECONSULTATION

Pursuant to the Law on Medical Examination and Treatment No. 40/2009/QH12;

Pursuant to the Law on Information Technology No. 67/2006/QH11 dated 29/6/2006;

Pursuant to the Law on Cyberinformation Security No. 86/2015/QH13 dated 19/11/2015;

Pursuant to the Cybersecurity Law No. 24/2018/QH14 dated June 12, 2018;

1. Objectives and requirements

a) These guidelines provide for preservation of confidentiality in teleconsultation.

b) Teleconsultation shall be carried out in compliance with regulations in Article 8 of the Law on Medical Examination and Treatment, which provides for the patient’s right to privacy, including:

- Keep confidential information on the patient’s health condition and private life available in their medical record.

- Information on the patient’s health condition and private life available in their medical record shall only be disclosed with the patient’s consent or shared between professionals directly treating the patient for the purpose of improving quality of diagnosis, care and/or treatment provided for the patient or disclosed in other cases as per the law.

2. Regulated entities

a) Healthcare establishments involved in teleconsultation

b) Officials and health professionals of healthcare establishments involved in remote medical examination and treatment, health experts involved in remote medical examination and treatment

c) Students learning about and involved in teleconsultation

d) Patients and families of patients participating in teleconsultation

dd) Organizations, individuals and enterprises involved in management, provision, operation, use and application of information technology in remote medical examination and treatment

3. Information permitted to share during teleconsultation

- Summary of the medical record and developments of the case requiring consultation, including medical history, past medical history, results of physical examination and paraclinical tests, preliminary diagnosis, treatment process, consultation requirements and other information used for diagnosis and treatment purposes.

- Consultation record after the consultation ends

4. Measures to limit sharing of patient's personal information during remote medical examination and treatment

- Do not share the patient’s personal information such as their full name, address, images of their face and body or information that can be used to identify the patient in any shape or form (images, documents, audio recordings, etc.).

- In case a consultation requires the patient’s presence, take technical measures to cover or blur the patient’s face.

- Do not live stream teleconsultations on social network sites or in any other form that might reveal personal information, face and health condition of the patient and teleconsultation participants.

5. Responsibilities of organizations and individuals involved in teleconsultation

a) Directors of healthcare establishments:

- Follow procedures for organization of teleconsultations;

- Promulgate internal regulations for their healthcare establishments on organization of teleconsultations, management of system login, copying teleconsultation data, confidentiality, antimalware, and emergency response to security breaches and attacks on information systems, which shall specify the responsibility of each individual and unit for preservation of patient and teleconsultation participant confidentiality in accordance with regulations of these guidelines;

- Lists of organizations and individuals participating in teleconsultations must be approved by heads of healthcare establishments. Healthcare establishments participating in a teleconsultation shall record and retain list of participating officials and experts.

- Ensure required equipment and documents are available to provide all information related to each teleconsultation.

- Properly manage computer equipment that retains data and do not allow the equipment to be moved without permission from the competent person.

- Manage and authorize suitable persons to access application software and databases.

- Adopt mechanisms for protecting private networks and ensuring information safety when private networks are connected to public networks such as the internet or networks of other organizations; implement private network security systems such as firewalls, systems preventing unauthorized access, etc.

- Develop and take protective measures, monitor and record activities, and manage technical infrastructure and information systems to prevent and detect unauthorized access early on.

- Equip officials in charge of information technology in regulatory bodies and units with computer and technical equipment necessary for their work; and enable managerial officials and officials in charge of technology to join all training and refresher courses on cyberinformation security.

- Provide advice and instructions on signing teleconsultation participation agreements for patients before taking any action.

b) Healthcare officials participating in teleconsultations

- Keep confidential and do not share information on the patient and teleconsultation participants while taking part in a teleconsultation;

- Strictly comply with these guidelines and internal regulations of their workplaces.

c) Patients and patient families

- A patient or authorized legal representative of a patient who agrees to participate in a teleconsultation shall not disclose the patient’s identity and other personal information during the teleconsultation process.

- Comply with guidelines from the healthcare establishment during the teleconsultation process.

d) Organizations, individuals and enterprises involved in management, provision, operation, use and application of information technology in remote medical examination and treatment shall perform the following tasks:

- Have backup mechanisms for software system and databases, store data copies in a safe place, and inspect these copies regularly to ensure that they are ready for recovery in case of a cyberinformation security breach.

- Ensure safety and security of data in storage and teleconsultation according to the State's regulations.

- Database management software must have a mechanism for automatic installation of patches from the manufacturer.

- Closely cooperate with healthcare establishments involved in teleconsultation in protecting personal information and medical information of patients participating in teleconsultation.

- Take responsibility before the law in the event of unauthorized disclosure of personal information and medical information of a patient participating in teleconsultation.

- Do not use images or data obtained from teleconsultation for commercial purpose or other purposes in any shape or form.

TELECONSULTATION PROCEDURES

(Promulgated together with Decision No. 4054/QD-BYT dated September 22, 2020)

I. OVERVIEW

1. The teleconsultation procedures are formulated with the aim of providing healthcare establishments with guidelines on organization of a teleconsultation session with another healthcare establishment via information technology platforms.

2. These procedures are applicable to healthcare establishments nationwide.

II. RULES

1. A teleconsultation shall be held at the request of a healthcare establishment and with the agreement between participating healthcare establishments.

2. Decision on diagnosis and treatment for the patient shall lie with the healthcare establishment where the patient is admitted.

3. Healthcare establishments participating in a teleconsultation must preserve patient confidentiality as prescribed by law.

III. PREPARATION

1. Participants:

- Doctors, nurses, technicians and pharmacists (number and components depend on the characteristics on each case).

- Functional departments: representatives of the general planning department; and the department of training and direction of healthcare activities.

- Official in charge of information technology.

2. Equipment and patient preparation

- Facilities and equipment: prepare all required facilities and equipment according to regulations on facilities and equipment of teleconsultation rooms.

- Medical record: prepare the medical record as per regulations.

- Patient:

+ The patient and/or patient’s guardian shall receive an explanation for the teleconsultation plan and agrees with this plan.

+ The patient is present in the consultation room of the low-level hospital/hospital requiring teleconsultation.

IV. PROCEDURES

Step 1. Identify the need for teleconsultation

- Consultation: a low-level hospital has a difficult case for which an in-hospital consultation has been held and which requires consultation with a high-level hospital.

- Online training: a low-level hospital needs to enrich its knowledge via clinically consulted cases; or a high-level hospital deems that a low-level hospital needs to fill some knowledge gaps identified through consulted cases.

Step 2. Application for teleconsultation

- The low-level hospital shall prepare the medical record and a case summary report of the case requiring consultation. Summary of the medical record and developments of the case requiring consultation includes medical history, past medical history, results of physical examination and paraclinical tests, preliminary diagnosis, treatment process, consultation requirements and other information used for diagnosis and treatment purposes.

- The low-level hospital shall apply for teleconsultation via the web application for teleconsultation.

- Send the patient’s information and medical record summary (including medical history, past medical history, results of physical examination and paraclinical tests, preliminary diagnosis, treatment process and consultation requirements) to the high-level hospital at least 01 day before the consultation takes place (excluding emergency cases). Specify the points requiring the high-level hospital’s advice.

Step 3. Information receipt

- The general planning department (or another functional department assigned by the hospital director) of the high-level hospital shall receive the abovementioned information and inspect the medical record.

- Send points requiring consultation and summary report to provisional participating members and experts of the consultation.

- The general planning department shall receive feedback from the experts and request the low-level hospital to provide more information (if necessary).

Step 4. Schedule arrangement and invitation to consultation

- The general planning department of the high-level hospital shall arrange the schedule, invite experts to the consultation and notify the low-level hospital of the consultation time. In case of emergency, the general planning department of the high-level hospital shall urgently invite the experts and hold the consultation immediately after receiving the request from the low-level hospital.

- The high-level hospital shall invite departments of its hospital relevant to the case requiring consultation.

- The low-level hospital shall notify the patient involved in the consultation, and notify and invite the professionals directly treating the case, relevant departments, general planning department, department of training and direction of healthcare activities, etc.

- The general planning department shall advise the hospital leaders on call center shift schedule, participating experts and official in charge of information technology.

Step 5. Notification and activation of connected points

- Information technology units of both the high-level and low-level hospitals shall directly contact each other to connect and test the connection, ensuring that connection is available before the consultation takes place.

Step 6. Consultation

- The hospital requiring consultation shall report the patient’s condition, illness developments, clinical and paraclinical parameters, etc.

- Provide additional parameters or obtain parameters directly at the request of participating experts.

- Discuss diagnosis based on clinical and paraclinical parameters.

- Provide a detailed diagnosis and orientation for treatment.

Step 7. Consultation conclusion

- The general planning department and treating doctor of the low-level hospital shall draw up a consultation record.

- Send the consultation record to the general planning department of the high-level hospital for approval.

- The low-level hospital shall sign the consultation record. The record must have the following basic contents:

- Evaluation on development of the case

- Diagnosis and orientation for treatment

+ Continue treatment at the low-level hospital

+ Refer to higher level of care

+ Provide training in relevant areas

Step 8. Case development reporting

- Report on the case in the next consultation session

- Urgently report if the case worsens via the hotline number of the general planning department.

V. IMPLEMENTING RESPONSIBILITIES

- Directors of the low-level hospital and high-level hospital shall direct organization of teleconsultations according to regulations in these guidelines.

- Any difficulty arising during the implementation of these guidelines should be reported to the Ministry of Health (Medical Services Administration).

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