Interpretation of the 2024 International Society of Hypertension Position Paper on Innovations in Blood Pressure Measurement and Reporting Technology and Its Implications for China

ZHANG Ying¹,², LIAO Xiaoyang¹, YANG Hanfei³, YU Yongjun⁴, LIU Lidi¹, JIA Yu¹, SHEN Can¹, LI Xiao⁵, HUANG Chuanying⁶, YANG Rong¹*

¹General Practice Ward/International Medical Center Ward/Teaching & Research Section/General Practice Research Institute, General Practice Medical Center, West China Hospital, Sichuan University, Chengdu 610000, China
²West China School of Nursing, West China Hospital, Sichuan University, Chengdu 610000, China
³National Engineering Research Center for Cryptography Technology, Sichuan University, Chengdu 610000, China
⁴West China Clinical Medicine College, Sichuan University, Chengdu 610000, China
⁵Department of Dietary Center, West China Hospital, Sichuan University, Chengdu 610000, China
⁶Department of Emergency, West China Hospital, Sichuan University, Chengdu 610000, China

Corresponding author: YANG Rong, Attending physician; E-mail: 976925601@qq.com

【Abstract】 Hypertension is the leading modifiable risk factor for cardiovascular disease morbidity and mortality, and accurate blood pressure measurement is a cornerstone of hypertension management. Conventional blood pressure monitoring is limited by its intermittent and static nature, and inability to capture readings during daily activities. Emerging blood pressure measurement technologies are rapidly being integrated into clinical practice; however, their adoption is hindered by the lack of international consensus regarding validation criteria for accuracy, usability, acceptability, and reliability. In response, this article convenes expert interpretation of the latest International Society of Hypertension Position Paper on Innovations in Blood Pressure Measurement and Reporting Technology, aiming to inform evidence-based recommendations for community-based hypertension prevention and control strategies in China.

【Key words】 Hypertension; Cardiovascular diseases; Blood pressure measurement technologies; Digital intervention; Guidelines interpretation

1 Background

Hypertension is the leading risk factor for cardiovascular disease [2], and accurate blood pressure measurement is a critical component of blood pressure management. Conventional blood pressure measurement methods are limited by their intermittent and static nature, and inability to capture real-time blood pressure during daily activities, making precise blood pressure management difficult. With the accelerated普及 of digital technologies, new blood pressure measurement technologies and devices are attempting to enter clinical practice, promising to address the shortcomings of traditional methods. However, the application of these new technologies lacks international consensus, including how to measure, validate, and ensure the safety and reliability of these technologies. For these reasons, the International Society of Hypertension convened a "Blood Pressure Measurement Innovation" expert working group comprising hypertension specialists from 11 countries to introduce and discuss new blood pressure measurement technologies and their existing evidence, validation and reliability of new technologies, monitoring systems utilizing digital technology, and digital interventions, to provide more in-depth information than existing guidelines and reach consensus on the current situation to promote precise blood pressure management. The "Position Paper" has been reviewed and approved by the World Hypertension League, European Society of Hypertension (ESH), Asian Pacific Society of Hypertension, and Latin American Society of Hypertension.

2 Blood Pressure Measurement Technology/Devices

2.1 Traditional Cuff-Based Technology

The core principle of traditional upper-arm cuff-based blood pressure measurement involves inflating a cuff to occlude blood flow and then identifying Korotkoff sounds to determine blood pressure values, known as the auscultatory method. This method was discovered by Russian scholar Nikolai Korotkoff in 1905, which involves wrapping a cuff around the upper arm and inflating it to compress the brachial artery, then gradually deflating it. As pressure decreases, a stethoscope within the cuff can hear friction and impact sounds synchronized with the pulse as blood flow is restored [8]. Korotkoff sounds originate from periodic turbulent vibrations of the arterial wall, and their appearance and disappearance directly reflect hemodynamic status. The auscultatory method is the gold standard for blood pressure measurement, but due to its subjective dependence and limitations in patients with arrhythmias and vascular stiffness, traditional mercury devices have been gradually replaced by electronic sphygmomanometers, though instrument calibration still uses the auscultatory method as the benchmark. The core principle of currently widely used clinical electronic sphygmomanometers is the oscillometric method, which involves inflating the cuff to occlude brachial artery blood flow, then during slow deflation, using high-precision pressure sensors to capture periodic micro-pressure fluctuations within the cuff caused by arterial pulsation, and then using specific algorithms to analyze these fluctuation signals to calculate blood pressure values [9]. However, these blood pressure devices face clinical application challenges, including device validation and calibration, limitations of both auscultatory and oscillometric methods, improper cuff sizes, and discontinuous data [10-12]. Therefore, given China's context of a large population and rapid aging progression, non-invasive blood pressure measurement technologies that can seamlessly integrate into daily life can not only better facilitate blood pressure management but also enable broader and more precise blood pressure intervention measures. Table 1 [TABLE:1] summarizes these new technologies, which are detailed below.

2.2.1 Cuff-Based Wrist Devices

Currently, cuff-based wrist-worn blood pressure monitors primarily operate on the oscillometric method, combined with sensor technology and algorithm optimization to achieve convenient blood pressure monitoring. The Position Paper mentions two relevant devices: the Omron HEM-9601T1 and a wrist blood pressure monitor from China's Huawei company. These devices are particularly suitable for measuring nocturnal blood pressure with minimal sleep disturbance. A study involving 50 patients showed that across 2 nights with 694 paired measurements, the mean difference in systolic blood pressure between upper-arm (Omron HEM-9700T) and wrist devices (Omron HEM-9601T) was only 0.2±10.2 mmHg (1 mmHg=0.133 kPa), demonstrating good agreement [13]. Another Chinese study validated the accuracy of the HUAWEI WATCH for blood pressure monitoring, enrolling 85 patients and comparing measurements with a mercury sphygmomanometer, with results showing high consistency between HUAWEI WATCH readings and reference values [14]. Regarding sleep disturbance assessment, a study presented at the 33rd European Society of Hypertension annual meeting mentioned [15] that 90% of patients showed no EEG evidence of being awakened by the blood pressure measurement process using the Omron HEM-9601T. However, wrist blood pressure monitors remain susceptible to measurement errors due to nocturnal arm movements and temporal variations in hydrostatic height differences between the wrist and heart level [16].

2.2.1.2 Finger Cuff Devices Based on Vascular Unloading Technology

Vascular unloading technology, also known as the volume-clamp method, is a non-invasive approach that indirectly measures blood pressure by dynamically regulating external pressure to maintain arterial vessels at a constant volume. Proposed by Czech physiologist Jan Penaz in 1973 and later improved by Wesseling et al. for application in the Finapres finger cuff device in the 1980s, it became a milestone technology for continuous non-invasive blood pressure monitoring [17-19]. This technology adjusts finger cuff pressure to maintain finger arteries at a constant volume, at which point the transmural pressure of the finger artery is zero, meaning intra-arterial and extra-arterial pressures are equal [20]. Previous studies have validated the feasibility of the Continuous Non-invasive Arterial Pressure (CNAP) system based on vascular unloading technology for continuous non-invasive blood pressure monitoring in emergency departments. Compared with intermittent oscillometric measurements, the CNAP system can more sensitively capture hypotensive events while maintaining consistency with standard methods [21]. This technology is suitable for situations with rapid blood pressure changes, but due to its high sensitivity to motion artifacts, it is not appropriate for precise blood pressure level assessment or hypertension diagnosis.

2.2.2 Cuffless Blood Pressure Monitoring Technology

Many current wearable devices use cuffless blood pressure monitoring technology, which generates blood pressure readings without an inflatable cuff. Cuffless blood pressure monitors employ one or more combined technologies to measure blood pressure, including photoplethysmography (PPG), pulse transit time (PTT), pulse arrival time (PAT), arterial tonometry, electrocardiography, ballistocardiography, electrical impedance, seismocardiography, and ultrasound technology, typically requiring user-specific calibration combined with artificial intelligence and machine learning [22-25].

2.2.2.1 Cuffless Wrist-Worn Devices

Currently available cuffless wrist-worn blood pressure monitors measure blood pressure based on pulse wave analysis, primarily by monitoring the correlation between pulse wave propagation characteristics and blood pressure. The core technologies involve PTT, PAT, and multimodal signal fusion algorithms. Pulse waves are pressure waves formed when blood ejected during cardiac contraction impacts the arterial wall, and their propagation velocity is directly related to vascular elasticity and blood pressure. When blood pressure increases, arterial wall tension increases, pulse wave velocity accelerates, and PTT shortens, and vice versa. PAT represents the time difference between the R-wave peak of the ECG signal and the arrival of the pulse wave at a peripheral site. Through precise measurement of PTT/PAT and algorithm optimization, blood pressure estimation based on pulse wave analysis can be achieved [26]. Pulse wave signals can be obtained through PPG and ultrasound technologies. The Position Paper mentions the Aktiia bracelet and Samsung Galaxy Watch, as well as China's Huawei Watch D, which utilize pulse wave analysis technology. Cuffless wrist-worn blood pressure monitors still face challenges regarding calibration frequency, measurement accuracy, and systematic bias, though large cohorts have already employed this technology [27,28].

2.2.2.2 Smart Rings

Smart rings measure blood pressure based on PPG, an optical principle-based non-invasive physiological parameter detection technology that obtains dynamic information about the cardiovascular system by measuring blood volume changes. PPG irradiates the skin with LED light of specific wavelengths, and photoelectric sensors detect changes in reflected or transmitted light intensity. Since hemoglobin in blood has different absorption rates for different wavelengths, periodic changes in blood volume caused by cardiac pulsation alter light absorption, forming PPG signals containing both pulsatile and static components [26,29]. A 2024 prospective, single-arm, first-in-human pivotal trial evaluated the accuracy of smart ring blood pressure measurement, showing strong correlations between the device and reference systolic blood pressure (r=0.94, P<0.001) and diastolic blood pressure (r=0.95, P<0.001) [27]. However, this device relies on traditional cuff-based equipment for calibration, which may introduce systematic errors, and the entire testing protocol did not follow the latest ESH validation protocol specifically designed for cuffless devices.

2.2.2.3 Smartphone-Based PPG

Smartphones can also perform pulse wave analysis by acquiring PPG signals, typically using the LED light adjacent to the phone's camera as the light source, with the finger covering the camera and flash to monitor reflected light changes and form PPG waveforms [30]. The OptiBP application introduced in the Position Paper employs this method, utilizing the process of light penetrating the fingertip, reflecting off tissues, and transmitting to the phone's camera image sensor to analyze blood pressure using image data generated from blood volume changes. Studies comparing blood pressure values obtained via the smartphone OptiBP application with auscultatory measurements demonstrated that the app can accurately measure blood pressure at the finger [31]. Currently, similar applications such as JD Health's "Mobile Blood Pressure Measurement" and Health Snap's "Contactless Blood Pressure Measurement" have been launched in China, obtaining PPG signals from fingers or facial measurements to derive blood pressure values. However, validation studies for this technology were conducted with participants in a sitting position and the smartphone at left ventricular level, without assessing the ability of calibration parameters to remain stable over time [32]. Additionally, blood pressure measurements from users' faces appear to have significant systematic errors [32].

2.2.2.4 Smartphone-Based Finger Oscillometry

Currently, smartphone applications using finger oscillometry are being developed to measure blood pressure. Users press on the smartphone sensor (typically the camera area), applying external pressure through the finger to gradually compress the superficial palmar arch artery. The phone's built-in pressure sensor monitors the applied finger pressure in real-time, while an optical sensor captures blood volume oscillation signals generated by arterial compression. When the artery is compressed to complete occlusion, blood flow stops; as pressure gradually decreases, blood flow resumes and generates oscillometric waves. By analyzing the characteristics of oscillation amplitude changes with pressure and combining machine learning models, systolic and diastolic blood pressure can be estimated [33]. Study results show that the error range of this method compared to standard cuff devices is within ±3.3 mmHg for systolic pressure and ±5.6 mmHg for diastolic pressure, with accuracy approaching that of finger cuff blood pressure measurement devices.

2.2.2.5 Ultrasound-Based Technology

The principle of using ultrasound technology to measure blood pressure is based on the Doppler effect and hemodynamic analysis, capturing blood flow signals non-invasively and converting them into blood pressure parameters, involving quantitative measurement of vascular diameter changes. The Position Paper notes that its primary value lies in the broad availability of the technology while also enabling assessment of other vascular functional or structural parameters. However, this field has seen limited development, as the technology offers insufficient convenience compared to other cuffless blood pressure monitoring technologies, and has not demonstrated significant advantages over the maturity and portability of existing cuff-based devices [34].

2.2.2.6 Continuous Monitoring Technology

Blood pressure monitoring with output intervals of 30 seconds is defined as continuous blood pressure monitoring, while intervals greater than 30 seconds are defined as intermittent monitoring. Non-invasive methods for continuous blood pressure monitoring include tonometry, volume-clamp method, and pulse wave analysis. This technology is primarily relevant for critical situations with rapid blood pressure changes, such as intensive care and anesthesia, and can also be used for rapid blood pressure changes during sleep in patients with sleep apnea. However, daily life applications face challenges of low usability, patient discomfort, and calibration frequency [35].

2.2.2.7 Devices with Specific Functions

Another innovation in blood pressure monitoring devices lies in integrating additional functions beyond blood pressure measurement. Multi-sensor blood pressure monitoring devices equipped with extra sensors can simultaneously provide physiological, physical, or environmental data, such as blood oxygen saturation, body temperature, ambient humidity, and atmospheric pressure. Furthermore, some automated nocturnal home blood pressure monitoring devices can activate at preset times to achieve non-disruptive nocturnal blood pressure monitoring during sleep [36-38].

2.3 Validation of New Devices

In 2018, the Association for the Advancement of Medical Instrumentation (AAMI), ESH, and the International Organization for Standardization (ISO) jointly developed the globally applicable AAMI-ESH-ISO universal standard (ISO 81060-2:2018) for validating automated cuff-based blood pressure measurement devices [39]. This standard applies only to automated cuff-based devices and not to cuffless blood pressure devices. However, the Institute of Electrical and Electronics Engineers (IEEE 2014), ISO (ISO 81060-3:2022), and the ESH Working Group on Blood Pressure Monitoring and Cardiovascular Variability have developed specialized validation protocols for cuffless devices. Currently, China has not issued national-level validation protocols or standards specifically for cuffless blood pressure devices. Domestic enterprises must obtain medical device registration certification from the National Medical Products Administration (e.g., Class II medical devices) and meet industry standards such as the "Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers" (YY 9706.230-2023), which specify accuracy requirements for blood pressure devices (error ≤5±8 mmHg) and clinical safety requirements. Validation protocols for new cuffless blood pressure monitoring devices are shown in Table 2 [TABLE:2].

2.4 Reliability and Practicality

The market for new blood pressure monitoring devices is growing rapidly. Any new blood pressure monitoring device intended for clinical decision-making must meet three core criteria: accuracy, usability and acceptability, and reliability. Regarding accuracy, new devices must validate that their results are comparable to traditional cuff-based devices, and for health monitoring populations, must also validate the accuracy of derived metrics such as percentage changes in blood pressure during sleep and morning blood pressure surge. For usability and acceptability, usability engineering principles must be applied to identify and reduce predictable human operation errors [44]; since devices generate parameters including blood pressure variability, morning surge, and nocturnal dipping rate whose potential value remains undetermined, acceptance by both users and healthcare professionals needs validation. Regarding reliability, reproducibility of continuous measurements over weeks to months must be ensured to assess long-term blood pressure fluctuations. Current studies show mixed results, with some demonstrating significant differences between new cuffless devices and traditional devices [28,45-47], while others report acceptable consistency [48-50], possibly due to methodological differences (such as sample size), insufficient device capability to track 24-hour blood pressure changes, and individual blood pressure natural fluctuations. Nevertheless, the Position Paper emphasizes that current regulation of these new devices focuses primarily on safety and cannot guarantee rigorous validation of clinical accuracy, necessitating multidisciplinary collaboration during the design phase and establishment of a cooperative mechanism among regulatory agencies, scientists, manufacturers, and clinicians to unify validation concepts and protocols [51].

3 Benefits and Challenges

3.1 Benefits

New blood pressure monitoring technologies reduce data errors caused by cuff position, cuff tightness, and other factors through wearable or cuffless devices. Technologies such as PTT, PAT, and PPG enable more accurate blood pressure measurement in individuals with large arm circumference, atrial fibrillation patients, and those with extreme blood pressure values. By collecting multiple physiological signals from the human body, these technologies enable more comprehensive assessment of individual health status, and continuous blood pressure monitoring with minimal or no user perception can provide more extensive blood pressure data. Overall, new blood pressure monitoring technologies offer potential benefits including overcoming limitations of traditional cuff-based methods, more accurate blood pressure measurement in special populations, improved nocturnal blood pressure monitoring, and more comprehensive blood pressure data, which can help provide more complete information for community-based hypertension management and aid in understanding cardiovascular physiology and disease mechanisms.

3.2 Challenges

The Position Paper enumerates current challenges in the clinical application of new blood pressure monitoring devices (Table 3). Before these devices can be integrated into clinical use, especially for large-scale community applications, randomized controlled trials must provide evidence of accuracy, usability and acceptability, and reliability. In China, the clinical application of new blood pressure measurement devices also faces the challenges listed in Table 3. Future efforts should adopt comprehensive measures including improving validation systems, implementing tiered promotion strategies, strengthening physician-patient training, increasing government funding support, and enhancing public-private collaboration to promote the scientific popularization and standardized application of new devices.

4 Digital Interventions

Digital interventions involve the application of digital technologies to achieve specific health goals. According to the 2023 Italian Society of Hypertension Position Paper, digital technologies include three categories: first, mobile phone applications, smartphones, tablets, and more advanced wearable devices; second, medical technologies including telemedicine platforms and instruments that allow sharing of clinical data between patients and physicians; and third, innovative medical devices with high-quality hardware and software capable of integrated analysis of large datasets [52]. New blood pressure monitoring technologies basically belong to the first category. The Position Paper summarizes research evidence on digital interventions based on new blood pressure monitoring technologies and identifies their transformative potential and challenges.

4.1 Research Evidence

New blood pressure monitoring technologies can acquire and integrate multiple physiological signals from the human body, providing additional value for risk assessment and treatment monitoring. A 2023 study used a wireless, wearable, non-invasive reflective PPG chest patch monitor to conduct high-frequency intermittent monitoring in 521 participants. The monitor collected a set of physiological parameters every 5 minutes, including heart rate, blood oxygen saturation, respiratory rate, cuffless blood pressure, body temperature, cardiac output, and 8 total parameters. Based on these parameters, an expert panel developed a Multi-Parameter Real-Time Warning Score (MPRT-WS) for pre-symptomatic real-time monitoring and early warning of patient deterioration. Compared with the widely used National Early Warning Score (NEWS) in clinical practice, MPRT-WS issued "high-risk" or "urgent" alerts 42.7±49.1 hours earlier in 39 patients with deterioration, while NEWS identified only 6 high-risk cases [53]. One study analyzing wearable PAT found that the correlation coefficient between nighttime mean normalized PAT and arterial stiffness parameters reached 0.91, significantly higher than that of nighttime blood pressure [54]. Other research has found that nocturnal pulse wave surges may be associated with left ventricular hypertrophy [35]. Additional studies suggest that new blood pressure monitoring devices have advantages in various scenarios including heart failure patients, psychological stress patients, mountaineering and high-altitude environments, particularly in acute stress situations [7].

The Position Paper highlights the advantages of new blood pressure monitoring technologies in nocturnal home blood pressure monitoring. Among these, automated timed home blood pressure monitoring (HBPM) is currently the only emerging technology validated through large-scale cross-sectional and longitudinal clinical studies. Research findings indicate that obtaining at least 6 nocturnal blood pressure readings using dedicated home blood pressure monitors correlates with subclinical organ damage and cardiovascular event risk at least as strongly as ambulatory blood pressure monitoring, independent of office blood pressure and morning/evening home blood pressure [7]. In 2019, a Japanese research team published evidence from a study of 2,545 subjects, analyzing the association between nocturnal blood pressure measured by HBPM at 2:00, 3:00, and 4:00 daily and cardiovascular events, finding that each 10 mmHg increase in nocturnal systolic blood pressure increased cardiovascular event risk by 20.1% [55].

Additionally, regarding the role of digital interventions in managing resistant hypertension, some studies mention that digital interventions can improve patients' blood pressure, lifestyle, and adherence, though most of these studies have used traditional blood pressure monitoring methods. In the future, these could be combined with new blood pressure monitoring technologies to tailor blood pressure interventions [56].

4.2 Impact on Healthcare Services

Digital interventions can break through barriers to health service coverage in resource-scarce regions while optimizing healthcare efficiency, improving self-efficacy and adherence in hypertensive patients, and reducing medical costs, particularly for resistant hypertension and high-risk populations. By integrating new blood pressure monitoring technologies, there is potential to achieve prediction of hypertension and related cardiovascular disease onset, optimization of personalized treatment pathways, and empowerment of primary care. Figure 1 [FIGURE:1] outlines digital interventions and technologies for hypertension. However, implementation still faces obstacles including the digital divide, usage barriers due to socio-cultural factors, and regional disparities, necessitating attention to localized adaptation of digital interventions [56-59].

In November 2017, the National Health Commission issued a document designating primary healthcare institutions as the first line of defense in hypertension management [60,61]. By 2022, primary care facilities nationwide were managing over 100 million hypertensive patients. How to standardize, efficiently, and precisely manage these patients, achieve cardiovascular disease early warning, and better reduce the burden of cardiovascular disease represents a major challenge and pain point in traditional primary care. Although new blood pressure monitoring technologies have not yet been formally adopted by clinical experts, they have the potential to transform current blood pressure prevention and control models. First, new devices such as smart rings and wrist-worn devices can simplify operational procedures, and continuous monitoring can improve detection rates of masked hypertension. Meanwhile, with the rapid development of internet information technology, blood pressure data and other real-time collected physiological signals can be directly uploaded to primary public health platforms, enabling remote blood pressure monitoring and remote medication adjustment, while automatically identifying abnormal signals to send alerts to physicians, thereby improving patient treatment adherence and optimizing long-term management. Additionally, through early intervention and timely complication management, complication-related expenses can be reduced. Some new blood pressure monitoring technologies are not costly, making them particularly suitable for township health centers with limited budgets. Finally, general practitioners can individualize patient treatment plans based on blood pressure trends and other physiological signals, while reducing human operation errors and improving blood pressure data reliability. However, integrating new blood pressure monitoring technologies into clinical decision-making still faces numerous challenges, requiring joint efforts from government regulators, scientists, clinicians, and commercial companies to achieve full-chain digitalization of "screening-diagnosis-management-intervention" at the primary care level in the near future, supporting the "Healthy China 2030" goals.

Table 1 Types and definitions of new blood pressure monitoring devices and technologies

Category Definition Wearable Devices Non-wearable Devices Continuous Monitoring Intermittent Monitoring Cuff-based technology Measures blood pressure via inflatable cuffs on upper arm, wrist, or finger (e.g., auscultatory, oscillometric methods) Wrist-worn devices Devices for static/limited scenarios (e.g., auscultatory, upper-arm devices) Applicable for some technologies Applicable for some technologies Cuffless technology Measures blood pressure via PPG, arterial tonometry, ECG, ballistocardiography, bioimpedance, seismocardiography, ultrasound, or combinations with AI algorithms Wearable devices (e.g., watch-type, ring-type, upper-arm type) Applicable for some technologies (portable but not wearable) Can monitor blood pressure continuously with readings ≤30s interval Monitors blood pressure at >30s intervals (e.g., oscillometric) Can detect beat-to-beat values (subset of continuous monitoring, e.g., tonometry, volume-clamp, or PTT methods) Applicable for some technologies

Table 2 Verification scheme of the new cuffless blood pressure monitoring device

Standard IEEE 2014-2019 [41] ISO 2022 [42] ESH 2023 [41,43] Study sample size ≥85 subjects 30-120 subjects 85-175 subjects Reference blood pressure Manual auscultation Invasive arterial pressure Manual auscultation / Ambulatory Calibration post-test Different postures test Blood pressure change tracking Pre-recalibration test Acute and long-term test / Allowable error (mmHg) ≤6±10 ≤5±8 Sequential/dynamic synchronous measurement

Table 3 Challenges faced by novel blood pressure measurement devices

• Lack or limited data to guide clinical decision-making
• Lack or limited data for hypertension prevention and detection
• Lack or limited data on blood pressure changes in medicated hypertensive adults
• Lack of validation data for elderly, non-white racial/ethnic groups, and special populations (obesity, pregnancy, etc.)
• Lack of data on reproducibility/reliability of blood pressure data
• Lack of data on tolerability of out-of-office devices
• Lack of data on patient adherence to new out-of-office devices
• Lack of data linking blood pressure measured by new devices to cardiovascular outcomes, and whether blood pressure reduction via new devices correlates with reduced cardiovascular risk
• Lack of blood pressure threshold data defining "hypertension" based on new device readings
• New devices may identify novel blood pressure phenotypes, but their clinical significance remains unclear
• Need for specially designed validation protocols for these devices (more stringent than cuff-based devices)
• New cuffless devices require repeated calibration
• Use of proprietary technology (unclear whether blood pressure recorded by different devices is consistent, especially affecting cuffless devices)
• "Black box" methods harder to understand than oscillometric methods (e.g., machine learning/deep learning/neural networks)
• Devices must have sufficient storage to record measurements or transmit data to applications
• Need for system alerts to avoid information overload risks for patients and/or healthcare teams
• Frequent out-of-office measurements (some values may be high) increase patient anxiety, leading to more frequent contact with clinicians
• Lack of trust from patients and clinicians in using new monitoring devices
• Complex regulatory approval processes
• Unclear reimbursement mechanisms for new monitoring devices
• Lack of electronic health record integration, incomplete feedback loops for clinical team decision-making

Author Contributions: ZHANG Ying was responsible for conceptualization and drafting; YANG Rong was responsible for quality control and review; LIAO Xiaoyang, YANG Hanfei, YU Yongjun, LIU Lidi, JIA Yu, SHEN Can, LI Xiao, and HUANG Chuanying were responsible for literature review, professional verification, and manuscript revision; all authors approved the final manuscript.

Conflict of Interest: This article has no conflicts of interest.

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