I Introduction
Digital technologies are integrated into all areas of life. The field of health is no exception. Some of the earliest uses of digital technology for health can be dated back to the 1960s.Footnote 1 In its 2005 resolution, the World Health Assembly (WHA) acknowledged the value of digital health and encouraged its member states to incorporate digital technologies into their health systems.Footnote 2 The important role of digital health was reiterated in the 2018 resolution, in which the WHA urged member states to prioritize the development and greater use of digital technologies for promoting equitable, affordable, and universal access to health for all.Footnote 3 During the COVID-19 pandemic, many countries have accelerated the utilization and development of digital health so as to guarantee the continued provision of health services with minimum in-person contact. As a result, there is now a growing consensus among countries that digital health has the potential to strengthen health systems and improve access to health.Footnote 4
China embraced the new digital technology and attempted to use it for health as early as the 1990s.Footnote 5 As will be discussed in the following sections, the government, encouraged by the rapid development of internet technology in China, has made great efforts to support digital health in the past three decades for solving the problem of uneven geographic and health resources distribution. In 2018, the General Office of the State Council released an overarching document, entitled Opinions on Promoting the Development of “Internet Plus Health Care,” with an aim to promote the innovative integration of digital technologies into the health system as a means of improving equitable, affordable, and universal access to health.Footnote 6 The term “internet plus health care” (IPHC) was introduced as a blanket term to mean the use of digital technologies in support of the delivery of health care and health-related services, such as internet-based diagnosis, treatment, and medicine, and internet hospitals. In this article, we use IPHC as an umbrella term for general discussion and refer to specific terms such as internet-based diagnosis where necessary.
This article intends to provide an overview of the development of IPHC in China, from its origins to its widespread use during the COVID-19 pandemic, with focuses on its regulatory landscape and, particularly, on digital diagnosis. In Section III, we identify three major regulatory challenges to IPHC. We conclude with a few recommendations for furthering the development and implementation of IPHC in the post-COVID-19 era.
II Landscape Analysis of “Internet Plus Health Care”
A The Development of “Internet Plus Health Care” in China
China’s health system has long been criticized for its inequitable distribution of health resources and unequal access to health care. To address these deeply rooted problems, particularly the weak provision of primary health care at grassroots level, the Chinese central government initiated a new round of health reform in 2009. Digital technologies, across a range of measures, have been employed as a feasible modern channel for promoting equitable, affordable, and universal access to health for all.Footnote 7
As far back as the 1990s, some of the first attempts at using digital technologies to improve access to quality health services were initiated. In 1988, the first remote consultation center was founded, which enabled the discussion of neurosurgery cases between Chinese and German hospitals via satellite.Footnote 8 With the development of information technology (IT), many medical institutions in urban areas started to establish remote consultation centers for exchanging knowledge and sharing experience with lower-level medical institutions. More importantly, the government made special efforts to support remote diagnosis in rural and mountainous regions as a means of addressing geographic barriers to access health care services. For example, many village clinics were equipped with computer terminals, despite the then poor IT infrastructure in these regions. As a result, a relatively robust physical and IT infrastructure was deployed for IPHC.
Since the beginning of the twenty-first century, a variety of regulatory and policy instruments have been adopted to facilitate the development of IPHC. With supportive policies, giant IT companies such as Alibaba and Tencent began to leverage their advances in digital technologies to establish online platforms and mobile applications to provide health-related services. In the meantime, public medical institutions also started to establish their own internet platforms. In 2012, the first public online hospital platform was founded in Guangdong Province.Footnote 9 Provinces with scarce health resources took the initiative to issue favorable policies to attract medical companies to set up internet hospitals as a means of improving access to health for their residents. The favorable policies and innovative technologies have stimulated the rapid development of IPHC during this period. In 2018, the aforementioned Opinions on Promoting the Development of “Internet Plus Health Care” (Opinions) document was released, with an overall aim to promote IPHC and guarantee equitable, affordable, and universal access to health for all. For quality assurance purposes, platform-based internet hospitals with no offline facilities were no longer allowed. In particular, this document required authorities to develop implementation rules and action plans for governing IPHC. A preliminary regulatory framework was thus established (see details in Section II.B). In September 2018, the National Health Commission (NHC) and the Government of Ningxia Hui Autonomous Region signed a strategic agreement to establish the first national IPHC pilot demonstration area, and in May 2019, the NHC signed similar agreements with another ten provinces and municipalities. In short, tremendous efforts had been made to promote the development and use of IPHC before the COVID-19 pandemic. However, the use of IPHC remained limited in practice due to regulatory restrictions and poor technical maintenance.
The COVID-19 outbreak has become a turning point in this area. The Chinese government has made several regulatory changes to make IPHC more widely used and to ensure the continued provision of health care when in-person services were not available during the health emergency. These changes include the relaxation of limitations on the scope of IPHC services and the expansion of health insurance coverage. The NHC also issued guidelines urging public hospitals to introduce or further develop IPHC as a means of relieving pressure on overloaded offline facilities. As a result, IPHC has obtained greater acceptance and its use surged during the pandemic. Statistical reports show that, by 2021, the number of licensed internet hospitals in China exceeded 1,600, while the user size of IPHC amounted to 298 million, accounting for 28.9 percent of all Internet users.Footnote 10
B Current Regulatory Framework of “Internet Plus Health Care”
In 2018, the NHC and National Administration of Traditional Chinese Medicine (NATCM) issued three consecutive normative documents for trial implementation as a response to the requirements of the Opinions mentioned above: The Administrative Measures for Internet-based Diagnosis and Treatment (AMIDT), Administrative Measures for Internet Hospital (AMIH), and Administrative Regulations on Remote Medical Service (ARRMS).Footnote 11 The AMIDT and ARRMS provide norms and guidelines for the provision of “internet-based diagnosis and treatment” and “remote diagnosis and treatment.”Footnote 12 These two documents also make it clear that medical institutions and qualified health personnel are eligible to provide such services. According to the AMIH, there are two different operating models of internet hospitals. The AMIH stipulates stringent licensing and operation requirements for each type of internet hospital. It also sets out registration and practicing requirements for physicians who practice at internet hospitals.
In addition, as will be discussed further in Section III.C, the National Health Security Administration (NHSA) issued a series of guidance documents regarding the reimbursement and coverage of internet-based medical services during the pandemic, so as to make IPHC more widely affordable to patients.
Safety is at the heart of health care services, and internet-based diagnoses are no exception. After three years of trial implementation, the NHC published its Regulatory Rules on Internet-based Diagnosis and Treatment in March 2022, with an aim to reinforce governance structures and oversight mechanisms for internet-based diagnosis as well as the related medical institutions and health personnel.Footnote 13 The new Regulatory Rules set out guiding principles for the supervision of internet-based diagnosis and outlined explicit regulatory requirements for medical institutions providing such services. This regulatory document requires provincial health administrations to establish their own regulatory platforms and implement real-time supervision of medical institutions that provide internet-based diagnosis within their jurisdiction, to ensure that internet-based diagnoses meet the same quality as in-person services. Built on these documents, a preliminary regulatory framework for IPHC has been created. Table 11.1 summarizes the legal and policy documents that have an impact on IPHC.
C Types of “Internet Plus Health Care” Services
i Internet-Based Diagnosis
Internet-based diagnosis, or online diagnosis, is a particular type of medical service precisely defined by the AMIDT as “a follow-up diagnosis for some common and chronic diseases delivered by a medical institution’s own registered physicians via internet or other digital technologies.”
Several restrictions in the AMIDT have been imposed on internet-based diagnosis for quality assurance purposes. First, only medical institutions with valid licenses and registered physicians with more than three years of independent clinical practice are qualified to provide internet-based diagnoses. Second, the scope of diseases is limited to certain common and chronic diseases. The types of chronic disease are determined by provincial health commissions and health security administrations, and generally include hypertension, coronary heart disease, diabetes, epilepsy, and so on. Third, a first diagnosis or diagnoses of sophisticated diseases are not permitted. This means that if a person becomes ill and in need of medical services, the person has to have a face-to-face diagnosis first. A physician in an offline hospital should diagnose that the patient has a common or chronic disease, then follow-up diagnoses and treatment can be given online. First diagnoses or patients with no medical records are not eligible for an internet-based diagnosis. Requiring an in-person diagnosis for a first diagnosis is a particular procedural and institutional requirement for safety assurance in the field of digital health.
ii Remote Diagnosis
In the Chinese context, remote diagnosis is a type of medical service provided by two or more medical institutions that are generally in the same medical consortium. According to the ARRMS, one medical institution can invite another to provide technical support for the diagnosis of its patients by means of digital technologies. In practice, normally the inviter is a community-level medical institution that has a close partnership (e.g., medical consortium) with the invitee, which, in most cases, is a top-tier medical institution. The invited medical institution will provide remote diagnosis on the basis of physical examinations and diagnostic tests, such as X-ray, ultrasound, and electrocardiogram, conducted by the inviting institution. For example, a township-level medical center may be equipped with an X-ray unit but lack the expertise to diagnose on the basis of an X-ray film. If a person living in this kind of rural area breaks a leg, they can still visit the center, the physician there will upload the X-ray film to the invited medical institution, and the diagnosis will be conducted remotely. If the center is equipped with a portable X-ray unit, then the patient can be diagnosed at home. Remote medical services promote the intra-group sharing of expertise and ensure that patients living in rural and remote areas have access to the same standards of medical care as those living in urban areas.
iii Online Consultation
Online consultation is the most common type of IPHC provided for first-visit patients with common conditions. Patients can consult physicians or other health professionals at any location about personal medical or psychiatric conditions, or simply seek advice on routine health management, healthy lifestyle, and so on through digital technologies. Online consultation enables patients to receive ongoing care where face-to-face or internet-based diagnoses are not necessary or easily accessible. It is worth pointing out that, while online consultation has much in common with online diagnosis, it lies outside the scope of internet-based diagnosis in the Chinese context. If an online consultation involves diagnosis-making or drug prescriptions, it is indeed classed as an internet-based diagnosis.
Due to space constraints, other IPHC services, such as online health management, electronic medical records management, appointment scheduling, and online payment are not elaborated here.
III Remaining Challenges
Despite considerable progress, the widespread implementation of IPHC remains difficult in practice. Regulatory challenges include restrictions on internet-based diagnosis, physicians practicing at multiple medical institutions, and medical insurance coverage and reimbursement. Technology-related barriers include digital literacy and internet infrastructure, among others. Due to space constraints, the following sections focus on the regulatory challenges.
A Restrictions on Internet-Based Diagnosis
As internet-based diagnosis is a brand-new model of medical service delivery, the NHC has taken a deliberate approach and limited it to “follow-up” diagnoses for “common diseases” and “chronic diseases” in the interests of patient safety and quality of care. Yet, after years of trial implementation, this restriction has raised considerable controversy.
First, the definition and scope of common and chronic diseases is not clear. The AMIDT stipulates that internet-based diagnosis is restricted to “certain” common and chronic diseases, without specifying which diseases fall within that scope. Even though detailed implementation plans of the AMIDT were formulated by provincial health administrations, the wording remained the same. In real practice, the interpretation of this guidance depends largely on the discretion of physicians due to the lack of legal clarity.
Second, it is difficult to verify whether a common or chronic disease was first diagnosed in an offline hospital. According to the AMIDT and other provincial implementation plans, internet hospitals should request to see medical records directly from patients or from other medical institutions with patients’ authorization before diagnosis. Yet, for information security, internet hospitals are less likely to access other institutions’ EMR databases, unless there is a preexisting partnership (e.g., a medical consortium). Patients, in particular the elderly, may neither reserve paper medical records nor understand how to upload their records onto the Internet. In practice, physicians collect patient medical records simply to fulfil regulatory requirements. It is not feasible for them to authenticate patients’ first in-person diagnoses. During the COVID-19 emergency, the NHC lifted the requirement for first in-person diagnoses. Patients with suspected coronavirus symptoms would have an internet-based diagnosis before going to the hospital. This gives rise to the question: Is it still necessary to prohibit internet hospitals from providing a first diagnosis, even just for common or chronic diseases?
After many years of IPHC development, there are plenty of discussions in academia and industry about relaxing the restrictions on the scope of internet-based diagnosis. Arguably, internet hospitals have an obvious limitation: Medical services, such as physical examinations and diagnostic tests, must be conducted in-person in offline hospitals. Therefore, because of quality and safety concerns, strict measures have been taken to regulate the operation of internet hospitals. Prior to the COVID-19 pandemic, internet hospitals just served as a supplement to offline hospitals. Yet the demand for IPHC significantly increased during the health emergency. As such, national and provincial health administrations have issued a number of guidance documents to provide temporary regulatory flexibility, so as to make internet hospitals more widely accessible. Internet hospitals have now become a part of mainstream medical service delivery, and the NHC, in its newly released National Health Informatization Program in the Fourteenth Five-year Plan, intends to set up electronic health files and electronic medical records for every citizen. These provide a good opportunity to conduct further research on the potential and proper trades-offs between convenience of access to health care and safety of service and privacy, while loosening the regulations on internet-based diagnosis.
B Physician Multi-site Practicing
Physician multi-site practicing (PMP) is expected to advance the implementation of IPHC.Footnote 14 PMP is designed as a mechanism to address health professional shortages and improve efficient and equitable allocation of medical resources.Footnote 15 For example, as Haodaifu (“good doctor” in Mandarin) Online (one of the biggest platform-based internet hospitals in China) claims, there are more than 240,000 physicians registered on its platform, more than 70 percent of whom are from tertiary hospitals across the country.Footnote 16 PMP makes it possible for patients living in remote rural areas to receive internet-based diagnoses provided by physicians in big cities, such as Beijing and Shanghai, at home.
PMP needs regulatory clarification. Since the new round of health system reforms in 2009, the Chinese government has issued various guidance documents to encourage physicians to practice at multiple sites. In 2017, the Administrative Measures for the Registration of Practicing Medical Doctors took effect and released limitations on the number and geographic location of medical institutions at which a physician is permitted to practice.Footnote 17 More importantly, the measures simplified the registration procedures for PMP. Approval from the primary practice institution is no longer necessary. Nevertheless, this requirement was once again included in the 2018 Administrative Measures for Internet-based Diagnosis and Treatment. As a result, physicians have to obtain the approval from their primary practice institution before practicing at any internet hospital. Therefore, further clarification is needed regarding the regulation of PMP.
To a lesser extent, even though prior approval would not be necessary for multi-practicing online, it does not mean that the primary practice institution has no de facto discretion when it comes to PMP. In China, most physicians are hired by medical institutions (in most instances their primary practice institution) and are, thus, subject to the personnel management of the institution. Physicians are the most valuable medical resources and the core competence of any medical institution. Arguably, PMP would have a considerable impact on the operation of the primary practice institution. Also, given the high workload in public medical institutions and especially tertiary hospitals, some institutions may take administrative measures to restrict de facto PMP, except for in their affiliated online or offline institutions.
There are also concerns over the affordability and quality of care regarding PMP. On the one hand, prices for medical services provided by public medical institutions, whether online or offline, are capped by governments, while those provided by non-public medical institutions (e.g., platform-based internet hospitals) are self-determined. In addition, as will be discussed further in the next section, medical services provided by non-public medical institutions are generally not covered by the country’s mandatory basic medical insurance (BMI) schemes, unless these institutions choose to negotiate prices and sign contracts with local health insurance bureaus (i.e., insurers).Footnote 18 Consequently, the service fees charged by non-public medical institutions are higher than public ones and patients have to pay all the service fees out-of-pocket, unless the patient has extra commercial insurance to cover all or parts of the expenses. For instance, for the same specialist, the outpatient service fee charged by the aforementioned Haodaifu Online could be ten times higher than that of the tertiary hospital. On the other hand, physicians are better paid under this circumstance. Financial incentives could motivate them to allocate more (free) time to platform-based internet hospitals, and waiting times for hospital admission would, thus, be significantly reduced. However, there is a dilemma for patients: PMP at platform-based internet hospitals makes medical services provided by specialists more accessible, yet less affordable. In other words, patients need to pay more money in exchange for a shorter waiting time for specialist medical services. PMP may also have a negative impact on the quality of care provided by the specialist’s primary practice institution. Therefore, national and provincial health administrations have made some principal guidelines on PMP, requiring physicians to give priority to the work at their primary practice institution. It would thus be important for policy makers to consider complementary measures to encourage as well as to regulate PMP, so as to further improve the accessibility, affordability and quality of health care.
C Affordability of IPHC
Affordability is one of the key determinants of IPHC. The NHSA has, therefore, issued a series of policies to make IPHC more affordable to patients. In 2019, the NHSA announced for the first time that all eligible “internet plus” medical services would gradually be covered by medical insurance in the Guiding Opinions on Improving the “Internet Plus” Medical Service Price and Medical Insurance Coverage Policy.Footnote 19 This document authorizes provincial health insurance bureaus to set prices for internet-based diagnoses and other medical services provided by public medical institutions, while non-public medical institutions are allowed to set their own service prices. Nevertheless, prior to the COVID-19 pandemic, internet-based medical services had not started to be covered by BMI schemes.
In response to the COVID-19 outbreak, the NHSA and NHC issued their Guiding Opinions on Promoting “Internet Plus” Medical Insurance Service during the Prevention and Control of COVID-19, expanding the BMI coverage to make internet-based diagnosis and other medical services more affordable.Footnote 20 The pricing policy remains unchanged in this guidance document. BMI programs would cover and reimburse internet-based diagnoses for common and chronic diseases provided by designated public medical institutions that voluntarily signed a supplementary contract with local health insurance bureaus. Internet-based diagnoses provided by designated non-public medical institutions would also be reimbursed, but at the same rate as public medical institutions if non-public institutions choose to provide such services. Multiple provinces and municipalities have also taken actions to temporarily broaden provincial BMI schemes to cover internet-based diagnoses, as well as expand the types of internet hospitals which may provide such services.
Several months later, the NHSA issued another document, Guiding Opinions on Actively Promoting Medical Insurance Coverage of “Internet Plus” Medical Service, establishing concrete measures to promote the reimbursement and coverage of internet-based medical services.Footnote 21 The new Guiding Opinions make clear that a voluntary supplementary contract between designated medical institutions and local health insurance bureaus is a prerequisite for BMI coverage. Payment parity is granted, which means that internet-based diagnoses will be reimbursed at the same rate as the equivalent in-person services provided by public medical institutions offline. However, this document does not require service parity. Provincial health insurance bureaus are authorized to determine the coverage of services in their own insurance plans. Research suggests that twenty-one Chinese provinces have so far expanded their provincial BMI coverage of internet-based diagnoses, while the scope of coverage varies from province to province.Footnote 22 In addition, as just explained, non-public medical institutions could set their own pricing for medical services, no matter whether they are provided online or offline. Such services will not be covered nor reimbursed by BMI schemes, unless these institutions choose to negotiate prices and sign contracts with local health insurance bureaus.Footnote 23
To sum up, affordability was, is, and may still be a major barrier for the utilization of IPHC. Although the NHSA has issued a number of polices to expand coverage, most of them only provide principal guidelines, without an integrated regulatory framework for “internet plus” health insurance coverage and reimbursement.
IV Conclusion: The Way Forward
IPHC has proven to be critical and full of potential for strengthening the Chinese health system, transforming health care services, and improving equitable, affordable, and universal access to health. The Chinese government has taken a variety of measures to accelerate the utilization of IPHC before, during, and after COVID-19, such as the establishment and revision of regulations, the removal of restrictions, and adjustments to reimbursement mechanisms. However, gaps remain in the legal and regulatory framework for governing the use of IPHC. Many of the reimbursement mechanisms have been established as exceptions rather than permanent changes. Also, most IPHC-related regulations are still in trial the phases of implementation. Therefore, it is necessary to develop a clear legal and regulatory framework for supporting the development and sustained use of IPHC, and for eventually developing an “internet plus” health ecosystem in the post-COVID-19 era. Additional research on the potential trades-offs in loosening the regulations on internet-based diagnoses, as well as PMP, is needed. In addition, the use of digital technologies for health helps to improve geographic access to health, yet it may exacerbate other inequalities due to digital literacy. For example, the elderly living alone face greater challenges when it comes to using digital technologies to access internet hospitals. Further research should pay particular attention to the special needs of vulnerable groups and focus on how to improve their digital literacy and access to the Internet. Also, additional studies on how to strike the balance between data sharing and privacy protection are much needed.
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