China’s NHFPC issues Opinions on Promotion and Administration of Telemedicine Services
On 29 August 2014, the National Health and Family Planning Commission released on its official website its opinions on the promotion and administration of telemedicine services in China, which took effect on 21 August 2014.
In recent years, China’s central government has made substantial investments to support the development of telemedicine. According to statistics from the National Health and Family Planning Commission (NHFPC), there were 2,057 medical institutions providing telemedicine services in China in 2013. However, with the rapid development of information technology and the widespread use of telemedicine, the old regulatory requirements specified in the Notice Regarding Strengthening the Administration on Telemedicine Consultation issued by the Ministry of Health in 1999 (the Old Notice) needed to be updated. In order to boost the sustainable development of telemedicine and to optimize the allocation of medical resources, the NHFPC issued the Opinions of the National Health and Family Planning Commission Regarding Promoting Medical Institutions’ Telemedicine Services (the Opinions) on the promotion and administration of telemedicine services in China, which are also applicable to telemedicine services between Chinese and foreign medical institutions.
Government Promotion of the Development of Telemedicine Services
According to the Opinions, local administrative authorities of health and family planning at various levels should actively promote the development of telemedicine by:
Integrating the construction of telemedicine service systems into local-level plans for health care and the establishment of medical institutions
Coordinating with the finance department at the same administrative level to provide financial support for the development of telemedicine
Coordinating with other relevant local authorities (including the administrative authorities of development and reform, price control, human resources and social security) to create an optimal environment for the development of telemedicine
Local authorities are also encouraged to explore the possibility of establishing the telemedicine service platform based on the health information platform of the local population.
Clarification on the Definition and Scope of Telemedicine Services
The Opinions for the first time clarify the definition and scope of telemedicine services. Telemedicine services mean, where by the use of information technologies: (1) one medical institution (the inviter) invites another medical institution (the invitee) to provide relevant technical support in the diagnosis and treatment of its patients; or (2) one medical institution provides medical services directly to patients who are offsite. The first model is the main form of telemedicine services, though the second model is also permitted as it has been adopted by some medical institutions in practice.
The scope of telemedicine services includes: tele-pathlogical diagnosis, tele-medical imageology, tele-monitoring, tele-consultation, tele-outpatient services, tele-case discussion and other services as specified by the local administrative authorities of health and family planning at the provincial level.
Basic Requirements for Providing Telemedicine Services
Non-medical institutions are prohibited from providing telemedicine services. Chinese non-medical institutions are required to obtain the Practice License of Medical Institution before providing telemedicine services. The Opinions do not clearly set forth relevant requirements for foreign medical institutions. According to the authors’ informal inquiries with the NHFPC, cooperation agreements between Chinese and foreign medical institutions are not required to be submitted to the NHFPC for filing, and the NHFPC will not review the qualifications of foreign medical institutions. Nevertheless, before signing any telemedicine cooperation agreement with a foreign medical institution, the Chinese medical institution will have to ensure the foreign medical institution has obtained the relevant qualifications or licenses that are appropriate and adequate for the contemplated telemedicine services.
According to the Opinions, medical institutions should also have medical services, personnel, technologies, equipment and facilities that are appropriate and adequate for the provision of telemedicine services.
Medical institutions are required to immediately stop providing telemedicine services and report to local administrative authorities: (1) when there is any change to the main technical personnel, key equipment or facilities, or other conditions arise that cause it to be unable to adequately provide telemedicine services; (2) when there are any problems with the quality and safety of the telemedicine services; and/or (3) when there are other serious adverse consequences directly related to the telemedicine services.
During the provision of telemedicine services, medical institutions should strictly comply with relevant laws, regulations, information standards and technical rules. At the same time, they should also establish relevant management systems to ensure the quality and safety of telemedicine services and protect the privacy of patients. In addition, absent the NHFPC’s approval, medical institutions providing telemedicine services cannot have in their names the words “China”, “National” or other similar words that mean “national” or “inter-provincial”.
Relationship between Participating Parties
In accordance with the Old Notice, the relationship between the inviter and the invitee was deemed to be a form of medical consultancy. There was no direct physician-patient relationship between the invitee and the patients, and the inviter was responsible for the clinical diagnosis and treatment of the patients.
It appears that the Opinions have adopted a more flexible relationship between the inviter and the invitee. According to the Opinions, medical institutions participating in telemedicine services should enter into cooperation agreements that spell out the purposes, conditions, scope of cooperation, process of providing telemedicine services, rights and obligations, assumption of risks and liabilities arising from medical malpractice and other important matters. By doing so, the inviter and the invitee should be able to handle any dispute arising from the provision of telemedicine services and assume relevant liability in accordance with the law, regulations and telemedicine cooperation agreement between the two parties.
Nevertheless, the Opinions stipulate that the inviter has the right to make final decisions on the diagnosis and treatment of a patient. However, they also provide that such decisions be made with due consideration of and reference to the opinions of the invitee, which must be issued in writing and signed off by the invitee.
In keeping with the Old Notice, the Opinions also confer on patients the right to be fully informed of the telemedicine services they are receiving. The inviter must also obtain written consent from the patients or their guardians or immediate relatives before providing telemedicine services.
It is also noteworthy that medical personnel have to obtain the consent of their employers (i.e., the medical institutes where they are registered for practice) and use the information platform established by their employers before they may provide telemedicine services directly to patients of other medical institutions.
Telemedicine has long been considered one of the most effective approaches to improving the quality of medical services and facilitating better access to care for people living in remote areas in China. The Opinions, together with other previously issued policies, underscore the great importance China’s central government has placed on further promoting the development of telemedicine services under enhanced government supervision.