While wearables for audio streaming, augmented reality, data storage, drug delivery, enhanced hearing, and fitness may continue to enjoy upward growth in 2020, the Coronavirus Disease 2019 (COVID-19) pandemic has ushered in a new period of growth for other wearables — those focused on monitoring.1 In particular, the emergency is opening the door to enhanced patient monitoring, symptom monitoring, and location monitoring. Governments and regulators around the world are embracing this technology, loosening traditional oversight, and surprising the public.2 And wearables are playing a critical role in those efforts.

FDA-Regulated Wearables — Expansion of Remote Patient Monitoring During COVID-19 Emergency

On March 20, 2020, the United States Food and Drug Administration (FDA) seized on the possibility that wearables could bolster the efforts of first responders, healthcare providers, and public health officials:

SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the United States. To respond effectively to the COVID-19 outbreak, appropriate clinical management and infection control in conjunction with implementation of community mitigation efforts are critical. FDA…will help address these urgent public health concerns by helping to expand the availability of remote patient monitoring devices. Modified use of these devices may increase access to important patient physiological data without the need for in-office or in-hospital services during the COVID-19 public health emergency. Increased utilization of non-invasive remote patient monitoring may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure for patients and health care providers to SARS-CoV-2.3

Using a clinically accurate multi-vital sign wearable wristband and real-time analytics, the loop system is a game changing tool for providers serving COPD patient populations. (Credit: Spry)

To fight the spread of the virus, FDA decided that it would not require manufacturers to overcome the usual hurdles to modify certain indications, claims, functionality, or hardware or software of previously cleared non-invasive remote monitoring devices used to support patient monitoring.4

By reducing the regulatory burden in order to expedite enhanced patient monitoring, FDA is allowing devices, such as the wearable Loop Signal wearable by Spry Health, to make specific claims related to COVID-19, without going through the 510(k) process to receive clearance to target a new disease state. FDA’s decision eliminates the costs of both potential testing that could have been required and the months-long process of submitting and receiving FDA marketing authorization.

Additionally, it allows companies to put their products into immediate service in the fight against the pandemic. For example, Spry Health has been able to pivot from promoting the wearable as a system that measures and records arterial oxygen saturation, heart rate, and respiration rate for adult patients at home, to promoting it immediately for “reducing hospital visits and improving home monitoring of patients confirmed, suspected, or at-risk for COVID-19.”5,6

FDA has indicated that the new policy “is limited to the duration of the emergency.” 7 Companies moving forward with expanded uses can gather data during this emergency phase to support future 510(k) applications, to understand patient and healthcare provider preferences, and to evaluate market acceptance. When the emergency ends, companies may be able to use this data to stay on the market for the expanded use during the pendency of the 510(k) process.

Monitoring for Public Health and Welfare

FDA has been disinclined to exercise regulatory authority over a variety of apps, software, and wearables, noting that it generally does not regulate products that are intended to track locations or contacts associated with public health surveillance because these products generally do not meet the definition of a medical device in the Federal Food, Drug & Cosmetic Act…The FDA also does not regulate general purpose location tracking, contact tracking, journaling, scheduling, or related functions. By stepping back, FDA believes that it is allowing innovation to accelerate in the public health space.8

Innovators appear to agree. In March, Scripps Translational Research Institute, working with CareEvolution, launched the DETECT health study that is using wearables to track COVID-19, among other fast-spreading viral illnesses.9 In the study, subjects will allow their wearable devices, including an Apple Watch, Fitbit, or Garmin, to track heart rate, sleep, and activity levels and share that information with the investigators. These wearables are well-suited to measuring resting heart rate. While that information can help users understand fitness levels, it also provides critical data regarding infections. Specifically, “[w]hen your heart beats faster than usual, it can mean that you’re coming down with a cold, flu, coronavirus, or other viral infection.”9

The COVID-19 data that can be tracked on wearables is diminished if the users experience low satisfaction or compliance rates. Thus, related growth areas may include comfort and user interface improvements, and long-lasting wearables. Long-lasting wearables, in particular, is likely to encourage power innovations.10 Additionally, advances in geofencing could assist in pinpointing virus hot spots and, even, future patients zero.

Wearables at the Intersection of Monitoring, Privacy, and Security

Particularly in the context of wearables for monitoring, generational differences introduce different concerns and preferences. For example, Generation Z may demand more privacy protection than Millennials.11 These demands, along with concerns about protected health information stored on and transmitted from health monitoring wearables, may lead to device security and encryption technology innovations. Companies developing wearables for monitoring that will collect and share protected health information should consider potential issues concerning compliance with the HIPAA Security Rule.

For wearables subject to FDA regulatory oversight that add wireless and/or Bluetooth capability, FDA guidance directs manufacturers to develop controls that “assure device cybersecurity and maintain device functionality and safety.” To develop and maintain the cybersecurity controls, manufacturers may find helpful information in FDA’s “Content for Premarket Submissions for Management of Cybersecurity in Medical Devices” and “Postmarket Management of Cybersecurity in Medical Devices.”12, 13, 14

Fighting the Virus and Protecting What is Yours

Just because you may embrace the opportunity for your wearable to help fight COVID-19, that does not mean that you have to ignore the intellectual property related to your product. Wearables and the technology covering them are part of a crowded field. Do your research, including a clearance search, domestically and globally, to understand existing patent protections and to uncover gaps that your invention may fill. Determine whether your wearable will involve standard essential patents and licensing requirements on FRAND terms. Remember that design counts too, and explore the possibility of design patents, trademarks, and trade dress protection. Check to see whether copyright protection may cover software elements.

Conclusion

Wearables for monitoring are having a moment. During this period, patients, healthcare providers, public health professionals, researchers, and governments may become accustomed to having access to increased volume, velocity, and variety of data from wearables. After we move through the current COVID-19 reality, it will be interesting to see whether there is a consensus that the state of emergency has ended or if the desire to prevent the next pandemic, and retain access to all of the data generated by wearables, will cause the war against COVID-19 to continue long after the surge.

References

  1. See Cathy Russey, “Global Wearables Market Faces Short-Term Impact Before Recovery in 2020, Says IDC,” Wearable Technologies (March 26, 2020).
  2. See Charles Maynes, “Moscow to Launch New Surveillance App to Track Residents in Coronavirus Lockdown,” National Public Radio (April 1, 2020); Daniel Estrin, “Israel Begins Tracking Those Possibly Exposed to the Coronavirus,” National Public Radio (March 19, 2020).
  3. U.S. Food & Drug Administration, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” at 5 (March 2020).
  4. FDA News Release, “Coronavirus (COVID-10) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely” (March 20, 2020).
  5. 510(k) K181352, Decision Date 03/29/2019.
  6. Sam Draper, “Spry Health Launches ‘Loop Signal’ to Improve Remote Monitoring for COVID-19 Patients,” Wearable Technologies (March 27, 2020).
  7. FDA News Release, “Coronavirus (COVID-10) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely” (March 20, 2020).
  8. Digital Health Policies and Public Health Solutions for COVID-19, “FDA’s Digital Health Policies Allow Innovators to Create COVID-19 Related Public Health Solutions” (March 26, 2020).
  9. DETECT Health Study.
  10. See, e.g., Gigi Onag , “SMART’s new chips will power innovations in wearables,” FutureIoT (October 3, 2019).
  11. Astha Khanal, “Gen Z’ers Are More Cautious Online Than Previous Generations,” Pacific Standard (May 6, 2019).
  12. U.S. Food & Drug Administration, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” at 8 (March 2020).
  13. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” Guidance Document.
  14. Postmarket Management of Cybersecurity in Medical Devices,” Guidance Document.

This article was written by Jennifer L. Mallory, Partner at Nelson Mullins, Columbia, SC. For more information, visit here .


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This article first appeared in the March, 2021 issue of Medical Design Briefs Magazine.

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