By: Samantha Palladino
As we are approaching a year in quarantine due to the COVID-19 pandemic, ways to detect and limit the spread of the deadly virus have been on the rise, especially since the number of cases continue to skyrocket due to the spread of the virus from individuals with limited to no symptoms. It has been estimated, although hard to accurately depict due to the exhibition of no symptoms, through numerous studies that anywhere up to 70% of COVID-19 cases arise in individuals who exhibit no symptoms at all.[1] And a detection solution may be closer to home than many of us even realize.
We live in a constantly developing technological landscape where wearable devices can track our steps, heart-rate, temperature, and even our sleeping patterns. Can these devices be used to track COVID-19 in individuals with asymptomatic and pre-symptomatic cases? Can utilizing data drawn from wearables limit or even greatly eliminate the spread of COVID-19 and other future viruses? Are these methods of detection even legal for researchers to use? The answer to these questions, and others, may shock individuals who wake up every morning, grab their smart watch from its charger, and set out to start their days with a wealth of information flowing from their wrists.
Let’s start with the value of using wearable devices to detect COVID-19 indicators in the individuals who wear them. Unlike conventional testing methods for COVID-19, i.e. PCR tests, rapid tests, and antibody testing, which offer a time-sensitive window of potentially infected individuals, wearable devices offer a continuous flow of real-time physiological data which can be monitored for the development of COVID-19 symptoms.[2] This method of observational testing tracks the difference in physiological symptoms to that person’s baseline measurements whereas conventional methods of testing compares information gathered to population statistics.[3] Therefore, wearable devices offer a much more personal analysis into the detection of even slight deviations from the individual’s normal baseline physiological data.[4] This information can be utilized to increase early-stage COVID-19 case detection and therefore greatly reduce the amount of exposure an individual infected with COVID-19 interacts with non-infected individuals.[5]
A study conducted by colleagues at Stanford University School of Medicine and Case Western University analyzed the data of 32 infected individuals, which were identified from a pool of over 5,000 participants and tracked certain physiological metrics to see if any correlations existed between the changes in their data that help in the detection of a positive COVID-19 diagnosis.[6] They looked specifically at the change in heart rate in connection to the number of steps they took and 81% of the positive COVID-19 cases showed discrepancies, an increased heart rate, 4 to 7 days before the onset of their COVID-19 symptoms.[7] From this, the researchers were able to develop an algorithm that could detect the beginning stages of infection from monitoring this change of heart rate in conjunction with the number of steps taken.[8]
However, other studies indicate that heart rate and step monitoring alone were insufficient in clearly identifying positive COVID-19 cases, due to other factors like age and exposure to other viral infections.[9] When added to sleep metrics and self-reporting of noticeable symptoms, the rate of proper detection increases.[10] Additionally, there is a smart ring available on the commercial market that has been proven to identify the higher temperature reading in people with even slight symptoms of COVID-19.[11] This shows that while wearable devices are not the end all of detection, their useful collection of data, coupled with the improvement to the ever-evolving wearable technology field, and self-reporting of symptoms can be a huge help in the early detection and slowing of the spread of COVID-19 and other harmful viruses that could arise in the future.
Is the collection of this data legal? According to FDA regulations, wearable devices are classified as a general wellness device which means they are subject to less stringent and lower standards of regulation as they are generally accepted as “low risk” devices that do not collect data for the purpose of treating patients.[12] However, looking solely at the FDA does not give us the whole picture as the FDA regulates safety and efficiency but not privacy standards.[13] When we look towards laws that regulate the privacy of the collection of medical information, we look towards the Health Insurance Portability and Accountability Act, otherwise known as HIPAA laws.[14] These devices are considered outside of the scope of protection under HIPAA as they do not engage directly with healthcare service providers.[15] Looking towards the Federal Trade Commission Act, otherwise known as the FTC, might give us a little more insight as to the privacy regulations surrounding wearable devices provided to the consumer public because the FTC prohibits companies from engaging in deceptive or unfair acts and from failing to comply with the company’s privacy policies by allowing legal actions against companies that fail to maintain security of sensitive data collected.[16] However, many of these companies allow for third party cross-device tracking without explicitly mentioning this within their privacy policies.[17] If companies that allow cross-device tracking do not make this clear and transparent within their statements to their consumers, there is a possibility they could face legal repercussions.[18] In addition to the FTC, companies that sell wearable devices need to be cognizant of the particular restrictions imposed within specific states as there is a possibility for higher levels of privacy protection under individual state laws.[19] The main takeaway from all of this information would be to be aware of what privacy protections the device you want to buy affords you and what level of transparency you feel comfortable with.
Wearable technology devices offer a multitude of benefits to society and those who choose to implement them within their daily lives. They allow people to track their health and identify ways in which they can implement positive change into their routine in order to see themselves attain goals anywhere from being more active to instituting better sleeping habits. The research world also sees a benefit from the access to continuous monitoring of physiological metrics and that has recently been seen through the use of metric data in tracking and preventing the spread of COVID-19 cases. While these metrics are not definitive of a positive COVID-19 case, and the sharing of data has the potential to cross the line into privacy law issues, recognizing the data limitations and companies remaining transparent with how their consumers’ data is being utilized can lead to positive consequences such as the minimization of the spread of the COVID-19 pandemic.
[1] Sarah Fisher, Anoushka Chowdhary, Karena Puldon, Adam Rao & Frederick Hecht, Wearable Sensor May Signal You’re Developing COVID-19 – Even If Your Symptoms Are Subtle, Univ. of Cal. S.F. (Dec. 14, 2020), https://www.ucsf.edu/news/2020/12/419271/wearable-sensor-may-signal-youre-developing-covid-19-even-if-your-symptoms-are.
[2] H. Ceren Ates, Ali K. Yetisen, Firat Güder & Can Dincer, Wearable Devices for the Detection of COVID-19, Nature Electronics (Jan. 25 2021), https://www.nature.com/articles/s41928-020-00533-1.
[3] Id.
[4] Id.
[5] Id.
[6] Id.
[7] Ates et. al., supra note 2.
[8] Id.
[9] Id.
[10] Id.
[11] Fisher et. al., supra note 1.
[12] Gicel Tomimbang, Wearable: Where do they fall within the regulatory landscape, Int’l Ass’n of Priv. Pros. (Jan. 22, 2018), https://iapp.org/news/a/wearables-where-do-they-fall-within-the-regulatory-landscape/.
[13] Id.
[14] Id.
[15] Id.
[16] Id.
[17] Tomimbang, supra note 12.
[18] Id.
[19] Id.