Telemedicine providers and vendors doing business in China, whether based in China, the United States, or elsewhere, received new guidance on the use of telemedicine in China. On August 29, 2014, the National Health and Family Planning Commission of the People's Republic of China (NHFPC) published Interpretations (interpretive guidance) and associated guidelines regarding telemedicine services in China. (The Opinions are dated August 21, 2014.) These documents were released to the public shortly thereafter. The documents include the Interpretation and the "Opinions of the National Health and Family Planning Commission Regarding Promoting Medical Institutions' Telemedicine Services," reflect China's efforts to promote the adoption and use of telemedicine in the country. Access a copy of the new Opinions and Interpretation, along with an English language translation, here.
The new Opinions represent the first official telemedicine guidance published since the former Ministry of Health's brief but notable document, "Notice on Strengthening the Administration of Telemedicine Consultation" promulgated more than 15 years ago on January 4, 1999. The Opinions serve as an essential update to the 1999 Notice, including greater detail and representing important step forward in China's policy position and regulatory expectations for telemedicine providers.The Opinions are divided into four major opinions or "chapters," and key sections in those chapters are as follows:
I. Enhance overall coordination and actively promote the development of telemedicine services
This section provides that administrative authorities in charge of health and family planning at various local levels should include the construction of a telemedicine service system in their regional health plan and medical institution setup plan. The NHFPC instructs local health officials to actively coordinate with financial authorities in order to provide appropriate funding, support and safeguarding for the development of telemedicine services and coordinate with relevant authorities. The intent is to create and foster an appropriate policy environment for the development of telemedicine services.
II. Clarify service items and ensure the quality and safety of telemedicine services
The second chapter includes two subsections:
1. In one subsection, the chapter clarifies the definition and content of telemedicine services, and includes in the definition medical activities whereby a "host" medical institution allows other "invited" medical institutions to use communications and information technologies to provide technical support in the diagnosis and treatment of patients in the "host" institutions. Telemedicine services also include: direct-to-patient telemedicine diagnostic and treatment services provided by "host" institutions, remote pathological diagnosis, remote medical imaging diagnosis (including imaging, ultrasound, nuclear medicine, electrocardiograms, electromyography and electroencephalograms), remote patient monitoring, remote outpatient services and remote case discussions and other items provided by administrative authorities above the provincial levels in charge of health and family planning.
2. In the other subsection, the chapter sets forth certain regulatory compliance expectations. During the performance of telemedicine services, medical institutions must strictly comply with China's laws, regulations, information standards and technical practices, ensuring the quality and safety of medical services and protecting the legal interest of patients. Notably, the Opinion states that non-medical institutions are not authorized to provide telemedicine services. While the scope of the term "medical institutions" might on initial read appear to focus on domestic (Chinese) health providers/institutions, it is notable that the NHFPC in the next-to-last sentence of the Opinions provides that when telemedicine services are performed between medical institutions [in China] and medical institutions outside China, reference should be made to The Opinions. By this sentence, the authorities are acknowledging the rapidly growing role of foreign health providers in the market in China and clarifying the applicability of the Opinions to foreign medical institutions providing telemedicine services in China.
III. Perfect the service process and ensure the high quality and efficiency of telemedicine services
The third chapter includes seven sections, focused primarily on operational and compliance expectations:
1. Medical institutions must possess the required diagnostic and treatment technology and expertise required to perform telemedicine services, including the appropriately qualified personnel, equipment and facilities. This may include designating a dedicated department or personnel responsible for testing, registrations, maintenance, modifications and upgrades of the instruments, equipment, facilities and information systems used in telemedicine services. Medical institutions must ensure their telemedicine service systems (hardware and software) are in standard operation and meet the relevant health information standards and privacy and security provisions related to telemedicine services.
2. When medical institutions perform telemedicine services among themselves, they should execute a telemedicine cooperation agreement. The agreement should covenant items such as the purpose of the agreement, conditions of cooperation, processes for the telemedicine services, the rights and obligations of the parties and risk sharing regarding liability and responsibilities.
3. The "host" medical institution should fully inform patients and obtain their written consent to telemedicine services. When it is not appropriate to offer an explanation to the patient (e.g., in minor patient situations), the written consent of the guardian or a close relative of patients should be obtained.
4. When the "host" medical institution needs to discuss individual patient cases regarding telemedicine services, it must submit a request to the "invited" medical institution. The guidance describes the elements required in that request, as well as the process the two medical institutions must follow. The "host" medical institution has the right of medical disposal with respect to the patients and should, based on the clinical information on the patients and with reference to the diagnostic opinions of the "invited" medical institution, have ultimate authority for final diagnostic and treatment decisions.
5. The "host" and "invited" medical institutions should jointly complete medical record information in accordance with laws regarding completion and safekeeping of medical records. The guidance describes specifics regarding storage and ownership of original copies, as well as expectations regarding electronic transmission of medical records and signature requirements.
6. The "host" and "invited" medical institutions should set up matching support or another kind of partnership relationship. The guidance discusses situations when telemedicine services and the process used must be reflected in the parties' telemedicine cooperation agreement.
7. In arrangements where healthcare professionals provide direct-to-patient telemedicine services outside their medical institution, they should first obtain the permission of the medical institution(s) where they are registered to practice. When providing these services, the professionals should utilize the health information platforms established by the medical institutions when providing diagnostic and treatment services for patients.
IV. Enhance supervision and management and guarantee the legitimate interests of both physicians and patients
The fourth chapter includes four sections, focused primarily on management and oversight compliance expectations:
1. Without the approval of the NHFPC, no medical institution performing telemedicine services should include in their name "China," "Chinese" and "National" or other alternative names or names that imply a nationwide or interprovincial scope or imprimatur.
2. Medical institutions offering telemedicine services must take steps to control safety risks, including planning for emergencies and serious adverse consequences directly related to the telemedicine services. If such occurs, telemedicine services should be stopped immediately and a report should be filed with the administrative authorities.
3. When administrative authorities discover quality and safety concerns related to telemedicine, they will immediately commence an investigation into the practices of the related medical institutions. The guidance describes sanctions and corrective actions that may be applied to noncompliant medical institutions.
4. In the event of any medical dispute regarding the telemedicine services, the "host" and "invited" medical institutions should handle the matter in accordance with the applicable laws and regulations and the telemedicine cooperation agreement. The guidance also describes sanctions for noncompliance with medical licensing and practice standards in China.
5. As mentioned earlier, this section also clarifies that references should be made to the Opinions in telemedicine service performance situations involving China-based and non China–based medical institutions.
Technological advances are driving increased demand for telemedicine services in China, particularly in fields that support China's underserved "primary and secondary" hospital facilities in rural areas, such as radiology, pathology, and expert consults. China's healthcare sector continues to grow at an exponential rate, and there is a recent government push for telemedicine, which has been identified as essential to China's healthcare delivery systems. Opportunities for U.S.-based healthcare providers to provide telemedicine services in China abound.
The 1999 Notice alluded to the "infancy" of the telemedicine service system and the need for, among other things, the strengthening of regulations. The release of the Opinions highlights the challenges U.S.-based providers face with the application of rapidly evolving technology and service platforms in a more slowly evolving regulatory system. However, more positively, the Opinions reflect regulatory authority recognition of this situation and the need for further guidance. U.S.-based providers with existing or contemplated telemedicine arrangements in China should pay close attention to the new Opinions, but must also take the time to learn how these rules will be enforced and applied by China government regulators to their particular telemedicine service models.
Access a copy of the new Opinions and Interpretation, along with an English language translation, here.
Foley & Lardner will be offering a complimentary Web Conference on October 6, 2014 to further explore this topic. For more information and to register, visit our website.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.