VB Group Interview No.11: Liu Jian of Shanghai Hongkang Information Technology on the Role of ECG in Mobile Healthcare Development

Guest of this issue: Liu Jian, General Manager of Shanghai Hongkang Information Technology
Time: 2015.09.23 20:00–21:30
Host: Zhao Zhanshi


Topic Sharing

The Development of Mobile Health

Mobile healthcare has evolved from telemedicine, which was already being practiced in the 1980s. At that time, telemedicine was primarily limited to interactions between medical institutions or to remote guidance provided by physicians to their patients at home. This scope also aligns with the current regulations on telemedicine issued by the National Health and Family Planning Commission of China.

Mobile healthcare utilizes existing mobile networks to replace traditional wired interaction methods. It typically connects intelligent sensing devices to smartphones or terminals, enabling access to medical and health services through remote guidance from hospital physicians via the network. This approach facilitates more proactive human intervention, allowing patients and users in need to receive assistance across a wider range of locations and environments.

Difficulty in accessing medical care and high healthcare costs are prevalent issues today. It is extremely challenging for patients to seek diagnosis and treatment from specialists at reputable hospitals. For personal health, not only is professional medical consultation crucial, but also out-of-hospital self-monitoring and preventive measures play a vital role. Mobile healthcare is primarily applicable to out-of-hospital settings, effectively breaking down the barriers of traditional hospital care. Its target customers are often individuals with sub-optimal health conditions or chronic diseases. By facilitating early disease screening and monitoring the progress of rehabilitation, mobile healthcare helps improve their health outcomes and reduce medical expenses.

Mobile healthcare primarily encompasses three core components: monitoring, assessment, and guidance. From the perspective of monitoring, appropriate medical devices are required to acquire medical data; in the realm of electrocardiography (ECG), this is mainly achieved through ECG monitors. Regarding assessment, only physicians are qualified to perform this task, as relevant regulations mandate that final diagnoses must be made by licensed physicians. Furthermore, since most individuals cannot interpret ECG tracings, professional physician interpretation is essential. In terms of guidance, recommendations can be provided by physicians or generated through intelligent algorithms. Many companies compile statistics on common patient cases, conduct data analysis, and offer corresponding guidance.

Many health management companies are currently providing post-discharge care for patients. After discharge, physicians often struggle to effectively monitor and manage their former patients due to a lack of access to medical data. Although patients, concerned about their health, frequently pose questions to their doctors verbally or in writing, physicians cannot provide accurate diagnoses without supporting medical data throughout this process. For instance, when a patient visits a hospital, a physician will not—and indeed cannot—issue a diagnosis without conducting examinations and obtaining clinical test results.

Market Access and Key Considerations for the ECG Device Industry

Objectively speaking, mobile healthcare comprises two components: mobility and healthcare. The primary regulatory authorities are the China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC). Additionally, individual hospitals and physicians adhere to their own specific medical service regulations.

Regarding product development, if you intend to market your product as a medical device, it must obtain certification from the National Medical Products Administration (NMPA). Electrocardiogram (ECG) devices are classified as Class II medical devices, for which certification can be completed directly at the provincial level.
Medical services must be approved by the National Health and Family Planning Commission and require collaboration with hospitals or physicians to secure their support. With the development of internet-based mobile healthcare, some physicians within the public healthcare system are now providing online medical and health services through platforms such as Chunyu Yisheng (Spring Rain Doctor) and Haodafu Online, offering guidance and recommendations to patients. However, these online consultation services still rely on medical data; without such data, even the most skilled physicians cannot accurately assess a patient’s condition. Furthermore, variations in physicians’ experience levels raise concerns about how to mitigate risks for patients.

The key distinction between medical devices and other digital products lies in whether they have obtained medical device registration approval. Products that fail to secure such certification are definitively not classified as medical devices, and this determination is made by the food and drug regulatory authorities. For example, the Apple Watch features high-quality pulse and heart rate sensors, and Apple has long sought to integrate these capabilities with iPhones or iPads for heart rate monitoring. To this end, Apple’s senior executives engaged in multiple discussions with the U.S. Food and Drug Administration (FDA). However, these efforts were ultimately unsuccessful. The FDA responded that while the product could be marketed as a general wellness device without issue, it could not be labeled or used as a heart rate monitor unless it obtained FDA clearance, since heart rate monitors are classified as Class II medical devices.

Scientific medical decision-making is grounded in evidence-based medicine; without data-driven proof, clinical actions cannot be taken. Furthermore, such evidentiary data must be clinically valuable; otherwise, it will not benefit patients. Regarding medical practice, the National Health and Family Planning Commission has an additional regulation stipulating that medical activities must be conducted within medical institutions. In other words, diagnosis and treatment must take place in a hospital, regardless of its size, provided it is a recognized hospital. Currently, however, private physicians and family doctors are emerging under contractual authorization. If the development of private and family practice progresses favorably in the future, medical services may be delivered in patients’ homes.

One important point to note is that medical data obtained by a professional healthcare provider through the correct operation of medical equipment is considered credible within the hospital. In contrast, if a patient performs an electrocardiogram (ECG) on their own and brings the results to the hospital, physicians will not use it as the sole basis for a final diagnosis. However, it can serve as a reference for further examination, as it is impossible to determine whether the patient strictly followed the correct procedures for data acquisition or whether the data is valid. These considerations are crucial for the development and positioning of our devices.

Healthcare is an inelastic demand, but it lacks strong stickiness, as individuals are not perpetually ill. We can enhance user retention by integrating health-related factors into medical services. Currently, health products do not require registration with the National Medical Products Administration (NMPA). Mobile healthcare must extend beyond hospital settings. We provide mobile medical devices that capture diagnostic data and transmit it to cloud-based physicians, who then offer professional health guidance based on this information. This model aligns well with the concepts of mobile healthcare or personalized telemedicine.

Cardiac examinations vary by purpose. In hospital electrophysiology departments, electrocardiogram (ECG) machines and Holter monitors are commonly used, complementing each other through short-term and long-term monitoring. Imaging modalities such as ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and digital subtraction angiography (DSA) can also be employed for cardiac assessment. Patients cannot take large-scale hospital equipment outside the facility; these devices are restricted to use within hospitals or medical examination centers, and laypersons lack the professional expertise required to operate them. Therefore, based on product characteristics, operational complexity, and intended use, only ECG devices are currently suitable for application as mobile medical products outside hospital settings. Their ease of operation, portability, and relatively low cost meet the needs of general users in out-of-hospital environments. Of course, these devices cannot replace hospital-grade ECG machines and Holter monitors, as data obtained by professionally operated hospital equipment is more comprehensive, precise, and authoritative. From an application perspective, mobile medical devices typically feature functions such as data acquisition, display, intelligent ECG analysis with alerts, personal information storage, and transmission/reception of ECG data for remote analytical recommendations.

Entrepreneurship Recommendations for an ECG Equipment Company

From the perspective of data value, I recommend using a higher sampling rate for ECG machines. If the sampling rate is too low, the utility of the ECG data in clinical applications will be limited. Since the 1990s, guidelines in Europe and the United States have recommended an actual sampling rate of above 500 Hz, which allows ECG data to reveal fine details and thus enhances its value.
We can transmit data through our own app, and it should also be possible to share data via other instant messaging channels, thereby making it more convenient for users and doctors to utilize the product.

Medical product development cycles are relatively long. Even with accelerated R&D speeds, it typically takes two to three years or more from the initiation of a product’s development to obtain regulatory approval. Therefore, it is critical to strategically manage timelines to navigate these extended cycles while closely monitoring capital operations to mitigate financial risks.

In the field of mobile health, particularly in electrocardiography (ECG), it is crucial to recognize the high risks associated with acute or high-risk patients, who require hospital-based diagnosis and treatment. Our primary focus, however, is on individuals with chronic diseases or those in a sub-health state, as this is where mobile health products truly demonstrate their value in healthcare.

Starting a business is inherently challenging, and launching a venture in the healthcare industry is even more difficult due to the numerous regulations that must be strictly adhered to. Any misstep can render a company’s products non-operational. In this landscape, entrepreneurs are better off collaborating with industry peers to achieve win-win outcomes and mutual support, thereby enhancing their chances of sustainable growth. Of course, the high barrier to entry in this sector is a double-edged sword.

Q&A Highlights

1. Will the boundary between health and healthcare narrow, and what is the key driver of this shift?
Liu Jian: The scale will shrink somewhat, but not drastically. Medical services require stringent qualifications, whereas the health sector is subject to much looser regulations. As societal pressure intensifies, regulatory oversight becomes stricter, a trend that is increasingly evident in this area. Nevertheless, the rapidly growing individual demand for medical and health services, along with health management, can help alleviate current doctor-patient conflicts and reduce personal healthcare costs.

II. Could you elaborate on the revenue model? What strategies can be employed to drive sales before obtaining the registration certificate?
Liu Jian: Currently, there are no mobile health companies worldwide that have achieved stable profitability. In my view, the most viable path to profitability in the future will likely lie in integrating individual users, basic medical insurance, commercial insurance, and data applications. In terms of usage, the model should combine medical healthcare services with personal health guidance. Without a medical device registration certificate, products cannot be legally sold on the market. If users are found to be using your unregistered product, you will bear full liability. Recently, Shanghai and Jiangsu provinces shut down dozens of medical device companies for regulatory violations.

III. What are the key areas of auxiliary diagnosis?
Liu Jian: Electrocardiography has evolved for over a century. Today, internet and mobile technologies are extending ECG testing beyond hospital settings, enabling early detection of cardiac abnormalities, reducing missed diagnoses, and facilitating early intervention. This approach helps lower cardiovascular mortality rates and reduces both societal and individual healthcare costs.

IV. How to integrate the ECG laboratory and cardiologists into the operational workflow of mobile ECG services?
Liu Jian: I believe that from an operational and various other perspectives, it is not an issue. The key concern is how to implement quality control over this model if it is conducted under an individual’s name, as this entails risks.

V. Is the user a physician or a wearer? Which is more important, the physician or the user?
Liu Jian: It mainly falls into two aspects: first, who are the users, and second, who are the payers. From the perspective of current internet thinking, users are undoubtedly important. However, physicians, as a critical link in disease diagnosis, are also highly significant; medical devices that lack physician acceptance often struggle to succeed.

6. Which companies does Mobile ECG partner with?
Liu Jian: We should focus on three key aspects. The first is the user, specifically how to acquire paying customers. The second is the payer, which requires greater consideration of internet-centric thinking. The third is data. Data is in demand by medical institutions, pharmaceutical companies, insurance providers, and health supplement companies, among others. Of course, during this process, it is essential to address the standardization of medical privacy risks.

VII. Is this medical diagnostic service subject to fees?
Liu Jian: It is not a medical diagnosis; rather, it primarily involves physicians or institutions providing analytical recommendations remotely, thus constituting a healthcare service. “Health-related, life-entrusted.” Charging fees reflects the value and responsibility involved; if no fees were charged, others would question the credibility of your product. Of course, the issue of who should bear the cost warrants consideration.

8. What are our advantages compared to international brands? What are the payment options?
Liu Jian: The advantage of domestic enterprises lies in their familiarity with the local market, and they aspire to scale up rapidly. International brands are primarily concentrated in specialized medical fields; while transformation is challenging for them, they remain watchful competitors, making speed and market penetration the key differentiators. From a payment perspective, companies with hospital channels can leverage these pathways to reach patients for payment collection. Those without hospital access often rely on crowdfunding, health management firms, community services, or the elderly care sector. However, acquiring users through purely online means remains considerably difficult at present.

9. Can Fully Automated Intelligent Interpretation Be Achieved?
Liu Jian: It is currently unlikely. Even the world’s leading ECG companies can only achieve a certain level of accuracy in intelligent interpretation under controlled conditions. Therefore, it is not feasible at present. Top-tier intelligent interpretation systems can achieve an accuracy rate of 70–80% for standard ECGs under controlled conditions; however, this does not apply to Holter monitoring, which still requires manual intervention.

10. Are most large companies engaged in intelligent analytics?
Liu Jian: Virtually every major company is engaged in intelligent analysis; it is indispensable to offer products with such capabilities, particularly given that most people cannot interpret electrocardiograms (ECGs). It is difficult to determine which company performs best in this area. Some companies are even leveraging ECG signals for biometric fingerprint recognition. Although there is significant inter-individual variability in ECG signals, intelligent analysis can still provide substantial insights.