Circular No. 49/2017/TT-BYT dated December 28, 2017 of the Ministry of Health on tele-medicine

THE MINISTRY OF HEALTH

Circular No. 49/2017/TT-BYT dated December 28, 2017 of the Ministry of Health on telemedicine

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

At the request of the Director of Department of Information Technology,

The Minister of Health promulgates a Circular on telemedicine.

Article 1. Scope and regulated entities

1. This Circular deals with telemedicine, including: telemedicine consultation; remote consultation on medical examination and treatment; teleradiology; remote anatomy consultation; remote surgery consultation and training in telemedicine technology transfer.

2. This Circular applies to health facilities and authorities, organizations and individuals (hereinafter referred to as "organizations and individuals") related telemedicine in the territory of Vietnam, including overseas organizations and individuals when connecting telemedicine with health facilities in Vietnam.

Article 2. Definitions

For the purposes of this Circular, the terms below shall be construed as follows:

1. “telemedicine” means exchange of information related to a patient’s health between such patient and a health care provider or among health care providers in distant areas through the use of information technology (IT) and telecommunication.

2. "connecting point" is the place where IT equipment provides telemedicine.

3. "central control point” is the place where a multi-point management device is installed to control connecting points through the line system.

Article 3. Rules for providing telemedicine

1. Telemedicine shall be provided on the principle of voluntary between participants.

2. Distributed clients shall decide and take responsibility for the use of consulting contents provided by consultants and shall inform consultants of telemedicine results.

Article 4. IT requirements for telemedicine

Telemedicine shall be provided when the organization/individual satisfies the following IT requirements:

1. IT infrastructure and measures to ensure confidentiality of information satisfy all the provisions of Article 3 and Article 4 of the Circular No. 53/2014/TT-BYT dated December 29, 2014 by the Ministry of Health on requirements for providing health care services through the Internet.

2. The consultant and the distributed client ensure continuous transmission during the telemedicine is provided.

3. The data recording system has the minimum storage capacity of 10 years.

4. The IT system is operated by a qualified IT operator.

5. Regulations on management of telemedicine are approved by the head of the health facility.

Article 5. General requirements for telemedicine

The telemedicine shall only be provided in the health facility responsible for disease prevention or having the license for medical examination and treatment in accordance with regulations of the Law on Medical examination and treatment and other relevant legislative documents.

Article 6. Telemedicine consultation

1. Remote consultation on disease prevention

Consultants providing remote consultation on disease prevention shall only consult the contents in compliance with their qualifications and take responsibility for their consultation contents.

2. Telemedicine consultation

Consultants providing telemedicine consultation shall only consult the contents in compliance with their qualifications mentioned in their certificates of medicine examination and treatment according to regulations of law on medicine examination and treatment and take responsibility for their consultation contents.

Article 7. Holding of telemedicine consultation

The health facility holding telemedicine consultation shall satisfy the rules and requirements mentioned in Articles 3, 4 and 5 and Clause 2 Article 6 herein and the following requirements:

1. The health facility fulfills regulations and procedures for holding consultation issued by the Ministry of Health.

2. The health facility ensures that there is at least 1 connecting point having the data recording system. If the telemedicine consultation requires remote monitoring of patients, the medical monitoring device shall be connected to the telemedicine system.

3. The health facility requesting holding of telemedicine consultation shall conclude clearly each problem and record such problems into a telemedicine consultation record provided in the specimen of Appendix I attached hereto.

Article 8. Holding of teleradiology consultation

The health facility providing teleradiology consultation shall satisfy the requirements mentioned in Article 7 herein and the following requirements:

1. There is a system sending or receiving medical data and images of patients among connecting points involving in the process of teleradiology consultation in accordance with the Digital Imaging and Communications in Medicine (DICOM) standard from the Hospital Information System (HIS).

2. The system of compressing and decompressing sent and received data ensures standards of medical images.

3. Medical images of patients that have been recorded and diagnosed by the consultant are automatically saved in the database of both the consultant’s and the distributed client’s workplaces.

4. The minimum transmission broadband at connection points involved is 4 Mbps. If the connecting point is a central control point, the minimum broadband is (n-1) x 4 Mbps, where: n: the number of online connecting point.

Article 9. Holding of remote anatomy consultation

The health facility providing remote anatomy consultation shall satisfy the requirements mentioned in Article 7 herein and the following requirements:

1. Holding of remote anatomy consultation with still images satisfies the provision of Clause 1 Article 8 herein.

2. Holding of remote anatomy consultation with moving images satisfies the following requirements: Connecting points that require remote anatomy consultation are equipped with a standard scanner capable of producing real-time anatomical video footage that reaches at least standard high-definition (HD) technology, and the signal is able to connect to the video conferencing system to share medical images with remote meeting participants; the system automatically records and saves the process of holding the consultation.

Article 10. Holding of remote surgery consultation

The health facility providing remote surgery consultation, apart from satisfying the requirements mentioned in Article 7 herein, shall have processing devices that are able to connect multiple video and audio sources from a variety of formats and connect to the video conferencing system; devices are capable of switching between different types of formats.

Article 11. Training in telemedicine technology transfer

The health facility providing training in telemedicine technology transfer shall satisfy the requirements mentioned in Articles 4 and 5 and Clause 2 Article 6 herein and the following requirements:

1. Classrooms or halls are suitable for scale and programs of training in telemedicine technology transfer.

2. IT infrastructure ensures that:

a) The minimum broadband of the line system at each connecting point using HD technology is 2 Mbps. The minimum broadband of the central control point with more than 2 connecting points using HD technology is (n-n1) x 2 Mbps, where: n: the number of online connecting point, n1: the number of connecting point in the internal network, (n-n1): the number of connecting point beyond the internal network;

b) At least 1 connecting point has the data recording system.

Article 12. Costs of providing telemedicine

IT system operating costs and other extra costs serving provision of telemedicine shall be paid in accordance with regulations of law.

Article 13. Effect

1. This Circular takes effect on February 15, 2018.

2. If any reference stated herein is replaced or revised, its latest version shall prevail.

Article 14. Responsibilities for implementation

1. Responsibilities of departments affiliated to the Ministry of Health

a) The Agency of Information Technology shall take charge or cooperate with the Agency of Medical Services Administration in directing, providing guidelines and inspecting implementation of this Circular;

b) The Department of Planning and Finance shall take charge or cooperate with the Agency of Information Technology, the Agency of Medical Services Administration, the Department of Health Insurance and relevant authorities in developing operating costs of the IT system and extra costs in order to request competent authorities for approval;

c) Offices of ministries, departments, agencies, general agencies affiliated to the Ministry of Health and inspectorate of the Ministry of Health shall cooperate with the Agency of Information Technology in implementing state management of telemedicine within their competence.

2. Provincial Departments of Health shall direct, provide guidelines and inspect implementation of this Circular within their competence; make reports on provision and effectiveness of telemedicine in December every year within their competence.

3. Responsibilities of health facilities providing telemedicine

a) Heads of health facilities shall make a decision on providing telemedicine in their facilities when satisfying the provisions state herein and report such decision to superior health authorities in accordance with the specimen provided in Appendix II attached hereto;

b) Health facilities shall develop and issue regulations on management of telemedicine;

c) Telemedicine shall ensure rights and obligations of patients, consultants and distributed clients in accordance with regulations of the Law on Medical examination and treatment and other relevant regulations;

d) Health facilities shall assess effectiveness of providing telemedicine;

dd) Health facilities shall make reports on provision and effectiveness of telemedicine to superior health authorities on December every year.

Any issues arising in the course of implementation shall be promptly reported to the Ministry of Health (Agency of Information Technology).

For the Minister

The Deputy Minister

Le Quang Cuong