Circular No. 49/2017/TT-BYT on remote healthcare activities

CIRCULAR

REGULATIONS ON REMOTE HEALTHCARE ACTIVITIES

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

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

THE MINISTER OF HEALTH Issuing this Circular to regulate remote healthcare activities.

Article 1. Scope of Regulation and Applicability

1. This Circular regulates remote healthcare activities, including: Remote medical consultation; remote consultation for diagnosis and treatment; remote consultation for imaging diagnosis; remote consultation for pathological diagnosis; remote consultation for surgery; and remote training and technology transfer for diagnosis and treatment.

2. This Circular applies to healthcare facilities and agencies, organizations, and individuals (hereinafter referred to collectively as organizations and individuals) related to remote healthcare activities within the territory of Vietnam, including organizations and individuals abroad when connecting with remote healthcare activities at healthcare facilities in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Remote Healthcare refers to the exchange of information related to individual health between healthcare professionals and such individuals or among healthcare professionals located at different places through information and communication technologies.

2. Connection Point is the location where information technology equipment participating in remote healthcare is installed.

3. Central Control Point is the location where multi-point management equipment is installed to control connection points through transmission systems.

Article 3. Principles of Remote Healthcare Activities

1. Remote healthcare activities are carried out on the principle of voluntariness of the parties involved.

2. The person requesting advice decides and is responsible for using the advisory content provided by the advisor, and must inform the advisor of the results of implementation.

Article 4. Technical Requirements for Information Technology in Remote Healthcare Activities

Remote healthcare activities shall be conducted when organizations and individuals meet the following technical requirements for information technology:

1. The technical infrastructure for information technology and measures to ensure information security must fully comply with the provisions of Articles 3 and 4 of Circular No. 53/2014/TT-BYT dated December 29, 2014 of the Ministry of Health on conditions for conducting healthcare activities over the internet.

2. Both the advisor and the party seeking advice must ensure uninterrupted and continuous connectivity during remote healthcare activities.

3. The data recording system must have a minimum storage capacity of ten years.

4. The information technology system must be operated by persons trained or educated in operating information technology systems.

5. There must be a regulation on managing remote healthcare activities approved by the head of the healthcare facility.

Article 5. General Professional Requirements for Remote Healthcare Activities

Remote healthcare activities may only be conducted at healthcare facilities with functions and tasks related to disease prevention or at healthcare facilities providing diagnosis and treatment services that have obtained a license according to the Law on Diagnosis and Treatment and other relevant legal regulations.

Article 6. Remote Medical Consultation

1. Remote Disease Prevention Consultation

The person conducting remote disease prevention consultation may only provide advice within their professional expertise and is responsible for the content of the advice given.

2. Remote Diagnosis and Treatment Consultation

The person conducting remote diagnosis and treatment consultation may only provide advice within the scope of their professional practice as recorded in their medical practice certificate according to the laws on diagnosis and treatment and is responsible for the content of the advice given.

Article 7. Remote Consultative Medical Examination and Treatment Rounds

Medical examination and treatment facilities conducting remote consultative medical examination and treatment rounds must comply with the principles and requirements stipulated in Articles 3, 4, 5, Clause 2 of Article 6 of this Circular and meet the following requirements:

1. Adhere to the regulations and procedures for specialized consultative rounds set forth by the Ministry of Health.

2. Ensure at least one connection point equipped with a data recording system. In cases where remote consultative medical examination and treatment rounds involve physical examinations on patients, the medical equipment used for such examinations must be capable of connecting to the remote healthcare system.

3. The medical examination and treatment facility requesting remote consultative medical examination and treatment rounds must clearly conclude each issue during the consultative round and record it in the Consultative Round Minutes according to the model prescribed in Appendix I attached to this Circular.

Article 8. Remote Consultative Radiological Diagnosis

Medical examination and treatment facilities conducting remote consultative radiological diagnosis must comply with the requirements stipulated in Article 7 of this Circular and meet the following requirements:

1. Between the connection points participating in the remote consultative radiological diagnosis process, ensure integration of a system supporting functions for sending and receiving medical information and image data according to the Digital Imaging and Communications in Medicine (DICOM) standard from the hospital information management system (HIS).

2. Have a data compression and decompression system that meets the standards for medical images.

3. After the doctor at the consulting facility reads and diagnoses the patient's medical images, they must automatically store them in the database at the consulting facility, while this data is also stored at the receiving facility.

4. The minimum bandwidth of the transmission network at the participating connection points is 4Mbps. For the central connection point, the minimum bandwidth requirement is: (n-1) x 4Mbps, where n is the number of online connection points.

Article 9. Remote Consultative Pathology Rounds

Medical examination and treatment facilities conducting remote consultative pathology rounds must comply with the requirements stipulated in Article 7 of this Circular and meet the following requirements:

1. Remote consultative pathology rounds involving static image sources must comply with the provisions of Clause 1 of Article 8 of this Circular.

2. Remote consultative pathology rounds involving dynamic image sources must meet the following requirements: The connection point requesting remote consultative pathology rounds must be equipped with a slide scanner capable of real-time video output of the pathologist's actions, meeting at least high-definition (HD) technology standards, and this signal must have the capability to connect to the video conferencing system to share medical images with remote consultation participants; there must be an automatic recording and storage system for the consultative round process.

Article 10. Remote Consultative Surgical Rounds

Medical examination and treatment facilities conducting remote consultative surgical rounds, in addition to complying with the provisions of Article 7 of this Circular, must have equipment capable of connecting multiple image and audio sources from different formats and able to connect to the video conferencing system; these devices must be able to convert between different types of formats.

Article 11. Training for Remote Medical Examination and Treatment Technology Transfer

Healthcare facilities responsible for training to transfer remote medical examination and treatment technology must comply with the provisions set out in Articles 4 and 5, Clause 2 of Article 6 of this Circular, and the following requirements:

1. There must be a room or auditorium suitable for the scale and content of the remote medical examination and treatment technology transfer training.

2. The information technology infrastructure must ensure:

a) The minimum bandwidth of the transmission system at each connection point using HD technology is 2Mbps. The minimum bandwidth of the central control point with more than two connection points using HD technology is (n-n1) x 2Mbps, where n is the number of online connection points, n1 is the number of connection points within the internal network, and (n-n1) is the number of connection points outside the internal network;

b) At least one connection point must have a data recording system.

Article 12. Costs of Remote Healthcare Activities

Operating costs of the information technology system and additional costs incurred to implement remote healthcare activities shall be reimbursed in accordance with the provisions of the law.

Article 13. Effective Date

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

2. In cases where the referenced documents in this Circular are replaced or amended, they shall be applied according to the replacement document or the amended document.

1. The Minister, Heads of Ministries equivalent to ministries, Heads of government agencies, Chairmen of provincial People's Committees under the central government, and related agencies, units, and individuals are responsible for implementing this Circular.

1. Departments and Bureaus under the Ministry of Health

a) The Department of Information Technology shall take the lead and coordinate with the Department of Medical Examination and Treatment to direct, guide, and inspect the implementation of this Circular;

b) The Department of Planning and Finance shall take the lead and coordinate with the Department of Information Technology, the Department of Medical Examination and Treatment, the Department of Health Insurance, and related units to develop operating costs of the information technology system and additional costs, and report to the competent authority for approval;

c) The Office of the Ministry, Departments, Bureaus, and General Departments under the Ministry of Health and the Inspectorate of the Ministry of Health shall cooperate with the Department of Information Technology to participate in state management of remote healthcare activities according to their assigned functions and tasks.

2. Provincial Health Departments and health departments of ministries and sectors shall be responsible for directing, guiding, inspecting, and auditing the implementation of this Circular within their management authority; annually in December, they shall compile and report to the Ministry of Health (Department of Information Technology) on the operation and effectiveness of remote healthcare activities of units under their management.

3. Healthcare facilities implementing remote healthcare activities

a) The head of the healthcare facility shall decide to implement remote healthcare activities at the facility when complying with the provisions of this Circular, and simultaneously report to the higher-level health administration agency according to the model prescribed in Appendix II issued together with this Circular;

b) Establish and promulgate regulations on managing remote healthcare activities at the healthcare facility;

c) Remote healthcare activities must ensure the rights and obligations of patients, consultants, and those seeking consultation advice in accordance with the Law on Medical Examination and Treatment and other relevant regulations;

d) Organize the evaluation of the effectiveness of remote healthcare activities to adjust appropriately and promptly;

đ) Annually in December, report to the higher-level health administration agency on the operation and effectiveness of remote healthcare activities. During the implementation process, if there are difficulties or obstacles, they should promptly reflect to the Ministry of Health (Department of Information Technology) for consideration and resolution./.