As early as June 2014, Apple Watch leveraged HealthKit to introduce the “wearable devices + health cloud platform” model, revealing Apple’s ambition to build a comprehensive solution for mobile health and mobile medicine.
This year, Apple Watch has expanded heart rate monitoring to fetuses through the mobile health app AirStrip, directly entering the maternal and infant health sector and drawing significant attention from the mobile healthcare industry.
Generally, self-monitoring is not recommended for pregnant women before 15 weeks of gestation. For those between 15 and 28 weeks, it is safe to monitor three times daily, with each session lasting one minute. After 28 weeks, as fetal development is more advanced, the duration and frequency of monitoring can be increased. For high-risk pregnant women after 35 weeks (e.g., those with complications such as pregnancy-induced hypertension or hyperthyroidism), continuous fetal heart rate monitoring using a cardiotocograph should be conducted in a hospital setting; if necessary, prolonged continuous monitoring (exceeding one hour) may be performed.
In the past, the medical community primarily relied on prescribed medical devices, such as Doppler ultrasound monitors, to assess fetal well-being. Whether continuous long-term monitoring has any impact on the fetus remains unproven. The introduction of this application means that pregnant women can monitor their unborn baby’s heart rate at any time using an Apple Watch, allowing them to check on the baby’s condition and avoid the hardship of frequent hospital visits during pregnancy.
Home medical and health devices are being replaced by smart wearable hardware, which will become increasingly miniaturized in the future. Not long ago, Mengdong’s fetal monitoring patch, specializing in fetal monitoring, launched on Indiegogo (a U.S.-based crowdfunding platform), bringing a monitoring approach distinctly different from that of the Apple Watch to the U.S. market.
The Mengdong Fetal Monitoring Patch can simultaneously detect fetal movement and fetal heart rate. It consists of two components: first, a wearable device designed specifically for pregnant women, with a diameter of approximately 40 mm, a thickness of 6 mm, and a weight of 15 g; it features medical-grade silicone adhesive (3M standard) and a low-power battery that supports up to seven days of continuous use. Second, a connected mobile app records the data collected by the device, generates authentic fetal heartbeat sounds, and also tracks maternal parameters including heart rate, physical activity, sleep, and respiratory rate.
The team behind this product is from China’s Chuanshi Weilai. Its founder, Ma Jiliang, graduated with a degree in Industrial Systems Engineering from the University of Wisconsin–Madison in the United States. He was a founding member of “Mobvoi” and was primarily responsible for voice search products for wearable devices.
It is understood that the fetal heart rate monitoring employed by Apple utilizes ultrasound principles to monitor the fetus’s condition in utero. Fetal heart rate is regulated by the sympathetic and parasympathetic nervous systems. By plotting instantaneous changes in fetal heart rate into a monitoring waveform, clinicians can assess fetal heart responses during fetal movement and uterine contractions, thereby inferring whether the fetus is experiencing intrauterine hypoxia.
During fetal heart rate monitoring, the detection of abnormal fetal heart rate patterns is often used to indicate fetal heart rate abnormalities. In most cases, these abnormalities signify intrauterine fetal hypoxia; the greater the severity of the abnormality, the more severe the fetal hypoxia tends to be. However, not all fetal heart rate abnormalities are caused by hypoxia.
Chuan Shi Wei Lai employs “passive monitoring” technology, which acquires fetal and maternal heart rates without emitting signals, relying solely on high-sensitivity sensors and intelligent algorithms, thereby ensuring safe and non-invasive monitoring. According to Ma Jiliang, the technical principle involves detecting micro-vibrations in the air caused by sounds emitted by the fetus, combined with an algorithm for recognizing fetal movement patterns. The product has undergone clinical testing; while the national standard allows for an error margin of 2 BPM, Mengdong’s error margin is only 1 BPM. In terms of wearability, Mengdong is positioned closer to the fetal heart than the Apple Watch, facilitating more accurate data acquisition. This “passive monitoring” technology enables users to receive instant alerts regarding changes in fetal heart rate directly through the app.
Integration with Traditional Medicine
However, Chuanshi Future faces the same bottleneck as Apple: how to break through in integrating with traditional healthcare. A small hardware device attached to the mother’s abdomen can continuously record fetal movement data, generating substantial amounts of data to assist clinicians in making diagnostic judgments. In the future, these data could even be used to build predictive models for early warning of abnormal conditions, thereby reducing the rate of stillbirth.
In China, most mobile health companies currently on the market have yet to address a core issue: whether for chronic disease management or providing telemedicine services to clients, the ultimate recipient of all data should be physicians. However, due to the fact that doctors in public hospitals in China have not been fundamentally liberated from their heavy workloads, it remains difficult for them—especially those at tertiary Grade A hospitals—to provide detailed and sufficient professional advice to patients through these mobile health devices and apps.
For medical-grade wearable devices to be officially deployed, manufacturers must first obtain regulatory approval. However, regulators tend to exercise extreme caution when faced with such entirely innovative medical technologies. Currently, these devices remain in the experimental stage and are far from being ready for clinical use.
As product capabilities continue to deepen, can Apple propel wearable medical devices from being “nice but useless” toward a genuine mobile health revolution? Before the Apple Watch was released, Malay Gandhi, president of a prominent U.S. digital health incubator, argued that only Apple’s products could truly unlock the digital health app market, encourage consumer trust and engagement in wearable medical technology, and leverage HealthKit to bridge personal data with clinical care.
HealthKit integrates seven major categories of information—body metrics, fitness, personal details, nutrition, lab results, sleep, and organ data—to comprehensively display users’ personal health data. Among these, “Health Data” displays health metrics measured by wearable devices, such as body mass index (BMI), body fat percentage, walking distance, calories burned, and sleep patterns. “Medical ID” primarily stores user information, including name, medical history, allergies, current medications, and emergency contacts, serving as a medical record in emergencies to provide physicians with essential background information.
It is widely believed in the industry that, following Apple’s consistent development trajectory, the Apple Watch will stimulate and establish a standard for fitness and medical monitoring features on wearable electronic devices. Apple will collaborate with healthcare institutions to develop medical systems, enabling hospitals to access health data stored in Health to monitor patients’ physical conditions and, when necessary, utilize this data further in treatment processes.
This is also the key to whether wearable medical devices can truly achieve a breakthrough: first, the maturity of sensors, which will affect the accuracy of the collected data; second, whether the collected data can be integrated with doctors' diagnoses and medical services in hospitals.
Joshua Landy, a Canadian emergency care specialist and Chief Medical Officer at the health startup Figure 1, stated that he reviews patient data displayed on the Apple Watch. “Before purchasing or recommending this smartwatch to colleagues, I need to assess whether its data is useful.” Molly Maloof, a physician expert in the digital health field, remarked, “The accuracy of the Apple Watch’s heart rate monitoring can be described as exciting.” Monitoring heart rate variability is crucial for the treatment of many diseases, as it provides physicians with a more intuitive overview of a patient’s physical condition.
To achieve breakthroughs at the hospital level, Apple is collaborating with numerous health app providers in the United States to establish connections and services for healthcare institutions and iOS 8-enabled smartphones or tablets, including through HealthKit. Currently, more than a dozen top-tier medical institutions in the U.S. have launched pilot programs for HealthKit services to build patient health information databases for hospitals. Meanwhile, over 600 developers have integrated HealthKit into their health and fitness applications.
It is reported that Stanford University Hospital and Duke University Hospital have begun integrating medical devices with the HealthKi platform to track patients’ health status.
Stanford University Hospital primarily uses HealthKit to record blood glucose levels in pediatric patients with diabetes, while Duke University employs HealthKit to track patients’ blood pressure, weight, and other vital signs, thereby assisting in the treatment of more severe conditions such as heart disease and cancer. HealthKit collects data from medical monitoring devices and provides corresponding feedback, allowing user data to be shared with physicians. Furthermore, HealthKit can automatically determine whether a patient’s blood pressure and other vital signs fall within normal ranges and notify hospitals if further examination is required.
If HealthKit merely established a health data platform for ordinary users, healthcare institutions, and developers, then ResearchKit, launched by Apple in March this year, holds far more profound significance. It has truly initiated the mobile health mechanism, enabling physicians and medical researchers to effectively address patient-related issues or propose treatment plans through mobile apps. The substantial impact of ResearchKit stems from its vast user base and open-source nature, welcoming any healthcare institution worldwide to conduct research and provide medical services using the data collected via ResearchKit.
This may be just the beginning of a revolution.
Text/Xin