Digital health products (e.g., wearables, mobile medical applications or software, telehealth, and remote patient monitoring technologies) have played an important role and accelerated the advancement of the healthcare system during the COVID-19 pandemic. These products support not only public health surveillance, reduce the risk of infection but also reduce significant government healthcare burden. In this article, we discuss how The Food and Drug Administration (FDA) facilitated and made these advancements possible. Moreover, we will discuss some of the innovative examples that emerged during the COVID-19 pandemic and how these products made had revolutionized traditional routine healthcare and shed new light on digital health medicine.
FDA’s Digital Health Policies Support COVID-19 related Public Health Solutions
FDA has issued multiple temporary policies to support the implementation of these digital gadgets during public health emergencies (1). The FDA recognizes digital health technologies can provide powerful tools for public health officials and the public in the management of COVID-19 response and to reach out to a great number of people in a fast and effective manner. However, FDA does not consider the majority of apps and software systems for public health surveillance and communication to be devices regulated by the FDA. These technologies may mainly assist the public in retracing close contacts and documenting symptoms more efficiently. The FDA generally does not regulate products that are used mainly for tracking locations or contacts as these devices often do not meet the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA regulates digital health products, which are medical devices, according to the level of risk posed to users (2).
According to the policy for device software functions and mobile medical applications (MMA), FDA has identified several software functions that are not devices within the meaning of FD&C Act but showed useful applications during the COVID-19 pandemic:
- Software that provides educational information about COVID-19
- Software that provides patients with commonly used reference information related to COVID-19
- Software that provides patients or individuals who are self-quarantining with information about their health conditions or treatment
- Software for video conferencing and telemedicine
FDA is also interested in expanding its engagement with manufacturers in the development of medical products related to mental health during the COVID-19 pandemic.
Implementation of wearable devices to facilitate preventive measures during the COVID-19 pandemic
Given the encouraging involvement of the FDA in speeding up the usage of digital health products during the COVID-19 pandemic, innovative digital systems or wearable devices are vastly implemented to assist the treatment and diagnosis. We herein address some of the innovative strategies implemented globally using wearable devices.
Mass surveillance testing has been a hot implementation strategy to control outbreaks, reduce manpower and enable cost-effective management during COVID-19. While variants of COVID-19 continue to evolve rapidly, diagnostic test shortages are prevalent globally. Shandhi et al. tried to develop an intelligent testing allocation method to leverage data from existing studies (a total number of 15345 participants) with smartwatch data. They also collected clinical information such as COVID-19 results. By collecting data from various databases, they found that resting heart rate (RHR) is an important feature in distinguishing between COVID-19 positive and negative subjects. The detection can be up to 10 days before the diagnostic test for COVID-19-positive cases(3).
Addressing the side effects of COVID-19 vaccination was another important issue during the COVID-19 pandemic worldwide, Quer et al. explored the possibility of using a smartphone-app-based research platform, smartwatch data, and self-reported medical history (e.g., vaccination information, COVID-19 test results). The research group also found that in most individuals, RHR increased after vaccination, peaked on day 2, and returned to baseline by day 6. This RHR was generally one standard deviation above individuals’ normal daily pattern in almost half (47%) of the participants (n=7728) after their second vaccine dose. Young women (< 40 years old) also experienced a greater response. This study also elucidated the potential use of wearables even for vaccine-induced immune response monitoring (4).
A population-based study in the USA published by Radin et al., by leveraging of smartwatch or fitness tracker, connected participants’ sensor data and the medical history of 35842 participants. They passively collected participants’ daily RHR and step count during the study period and identified anomalous days with abnormal RHR and reduced step count. These results showed that real-time disease tracking and forecasting of COVID-19 infection is possible using wearable technologies, and it has the potential to serve as important biomarkers in viral surveillance programs (5).
How Belun® remoVital facilitates in healthcare management of COVID-19
Belun® remoVital is a vital sign real-time monitoring system composed of an FDA 510(k)- cleared Belun® Ring, a body temperature sensor Belun® COR and a communication hub. The system measures vital signs, including blood oxygen saturation, pulse rate, and body temperature. The installation is simple and user-friendly, and no pairing for Bluetooth or WiFi is required. The automatic connection with the cellular networks enables the system to run once it is turned on. It allows easy access to patients’ real-time measurements via the web portal. Besides, this real-time alarm customization alerts healthcare professionals if any measured vital sign exceeds the pre-set thresholds.
During the 5th wave of COVID-19 in Hong Kong, Belun® remoVital was widely implemented in quarantine centers, including the Asia World Expo; Belun® remoVital played a safe-guarding role, especially for elderly and vulnerable subjects during the COVID-19 infection. With the implementation of our system, Belun facilitated clinicians to manage 400 elderly patients with mild COVID-19 symptoms at the Asia World Expo. Our system not only significantly reduced manpower shortages during the COVID-19 pandemic but also reduced the risk of infection in our healthcare professionals.
Partnering with Belun :
Up to now, over a hundred organizations, including HK hospital authority hospitals, medical groups, clinic groups, dentists, and elderly centers selected to use the Belun Sleep System, Belun® Ring and Sleep App, and Belun® remoVital monitoring system. Many doctors read our medical journal papers, including:
1) “Belun® Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea” (https://jcsm.aasm.org/doi/10.5664/jcsm.8592),
2) “Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network based algorithm and its combined use with STOP-Bang questionnaire” (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258040),
3)Belun® Ring (Belun Sleep System BLS-100): Deep Learning-Facilitated Wearable Enables OSA Detection, Apnea Severity Categorization, and Sleep Stage Classification in Patients Suspected of OSA (https://journals.lww.com/jhypertension/Abstract/2023/06000/The_Belun_sleep_platform_to_diagnose_obstructive.16.aspx),
4) Correlation of Pulse Rate Variability(PRV) and Heart Rate Variability(HRV) Metrics During Sleep in Subjects Suspected of OSA (Accepted in SLEEP conference 2023, Abstract ID: 954).
If you would like to know more about how to adopt Belun’s solution in your organization or home use, please feel free to contact us to schedule a meeting by filling out the form below: