LawFlash

Overview of China’s Internet-Based Medicine

October 12, 2020

The Chinese government has been actively promoting internet-based medicine in mainland China since 2014. On July 17, 2018, the National Health Committee (NHC) and the State Administration of Traditional Chinese Medicine jointly issued the three fundamental rules that formed the basic legal framework of China’s internet-based medicine:

  • Administrative Measures for Internet-Based Diagnosis (for Trial Implementation) (Measures for Internet-Based Diagnosis)
  • Administrative Measures for Internet Hospitals (for Trial Implementation) (Measures for Internet Hospitals)
  • Good Practices for Telemedicine Services (for Trial Implementation) (Good Practices)

According to the above three rules, internet-based medicine in mainland China is classified into three categories:

  1. Internet-Based Diagnosis

    Domestic medical institution through its registered physicians to provide follow-up consultation for patients with common diseases and/or chronic diseases as well as “Internet+” family doctor engagement services via the internet or other information technologies provided under the Measures for Internet-Based Diagnosis.

  2. Internet Hospitals

    Online extension of services provided by domestic medical institution itself with registered physicians of its own or from other medical institutions; or independent online platform operated by third party entity relying on a group of domestic medical institutions; either way, an operator of an internet hospital shall register with the competent health administration.

  3. Telemedicine Services

    Medical activities where a domestic medical institution, either directly sends out the invitation by itself or indirectly through third party virtual healthcare matching platforms, to invite one or more other domestic medical institutions to provide technical support for diagnosis and treatment of patients of the inviting domestic medical institution using information technologies.

At the current stage, all three categories of the internet-based medicine under the existing People’s Republic of China (PRC) laws are dependent on physical medical institutions established within mainland China. The main responsible parties with respect to internet-based medicine under the current PRC laws are domestic medical institutions and/or other domestic entities (e.g., third party matching platforms).

Further, the existing PRC laws still require that physicians must conduct in-person consultation and examination on patients in their first visits to physical hospitals before the online follow-up consultation. That said, this restriction may be lifted in the future given a new policy document released on April 7, 2020 explicitly mentioned promoting the development of internet-based first consultation, but detailed implementation rules are yet to be seen.

The Chinese government keeps adjusting regulations on internet-based medicine as there are still many issues that have not yet been addressed under the existing legal framework. For instance, requirements on internet-based cross-border medicine are still unclear because the existing legal framework only focuses on regulating internet-based medicine provided by domestic entities and physicians. For foreign investors who are interested in China’s internet-based medicine market, the following may need to be taken into consideration as a preliminary risk assessment when contemplating relevant investment plans:

  • Overseas-based foreign medical institutions and/or physicians may be allowed to provide non-diagnostic consultation between Chinese patients and foreign physicians through online platforms, which should only act as reference opinions rather than specific diagnosis or treatment plan for specific patients. Such online platform may need to apply for relevant license required under PRC telecommunication laws.
  • Overseas-based foreign medical institutions and/or physicians may not be able to directly make diagnosis decisions and give instructions/prescriptions to Chinese domestic patients with respect to specific medication or treatment, as only medical institutions and physicians with appropriate practice licenses are allowed to carry out diagnosis and treatment activities in mainland China.
  • Under PRC law, only physicians duly registered and approved by competent Chinese health administration have the right to prescribe. Prescriptions of a foreign medical institution are considered invalid and will not be recognized by Chinese medical institutions.
  • Involvement of domestic hospitals may potentially create a shield over foreign medical institutions and its physicians as relevant legal and compliance obligations under the current PRC legal framework on internet-based medical activities are mainly on domestic entities, especially domestic medical institutions.

HOW WE CAN HELP

Telehealth is a highly regulated field and legal issues can vary across payers, across states, and even across countries. Morgan Lewis provides companies around the world with integrated legal guidance related to telehealth and digital health technologies. Our lawyers work seamlessly together to advise and represent telehealth provider networks, hospitals and healthcare providers, digital health, life sciences and technology companies, employers, investors, and other telehealth stakeholders.

CONTACTS

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the authors or any of the following Morgan Lewis lawyers:

Shanghai
Todd Liao
Fan Shi

Abu Dhabi
Mark Gilligan

Boston
Mark Stein

Frankfurt
Dr. Joachim Heine

Singapore
Bernard Lui*
Wai Ming Yap*

Washington, DC
Michele Buenafe
Dr. Axel Spies
Jacob Harper

*A solicitor of Morgan Lewis Stamford LLC, a Singapore law corporation affiliated ‎with Morgan, Lewis & Bockius LLP