Updated April 24, 2020: The pressure that COVID-19 has placed on physicians, practices, and hospital systems to ramp up remote monitoring will no doubt accelerate the adoption of wearables into healthcare after this crisis passes. But at the same time, using data from wearables, especially those designed for consumer use rather than formal clinical monitoring, may bring liability risks.
Before the COVID-19 pandemic, an estimated 40 million people in the U.S. were using some type of smart watch or fitness tracker to monitor their health, a number that has more than doubled since 2013, according to the Deloitte 2018 Health Care Consumer Survey. Now with this public health emergency, these wearables are presenting benefits to individual and population health on two major fronts: by identifying those who are about to get sick—even before they feel unwell—and by preserving limited hospital resources for the sickest patients by monitoring some patients while they remain at home.
Potential to Predict COVID-19 Cases
Researchers at the University of California, San Francisco, are investigating whether Oura smart rings can help identify healthcare workers who may have been infected with COVID-19. An algorithm flags small upticks in temperature and heart rate, which can indicate immune response before people feel ill. To be effective, researchers will need to distinguish heart rate and temperature elevations indicating immune response from those due to other causes, and they’ll need to distinguish immune responses to COVID-19 from immune responses due to other germs—a tall order. But the ability to predict who will get sick would enable healthcare workers, who are among the most exposed, to seek care sooner, and would help prevent the virus’ spread.
Meanwhile, scientists at Stanford University and Scripps Research Translational Institute are recruiting users of many kinds of wearables in an attempt to predict regional outbreak clusters by tracking data on heart rate and temperature, plus activity levels vs. sleep levels. They hope to recruit at least a million participants.
Monitoring COVID-19 Patients to Preserve Hospital Resources
Hospital systems like the Mayo Clinic are talking with makers of existing remote monitoring tools about how clinical-grade wearables can be adapted to monitor confirmed COVID-19 patients while they are in isolation, whether at home or in a hospital. For instance, a wearable developed for opioid overdose patients is being retooled for use with COVID-19: It continuously monitors a patient’s pulse, breathing, and blood oxygen levels. If it detects shallow breathing or an unusually slow or accelerated pulse, it alerts caregivers and hospital staff.
Such measures help preserve limited hospital resources for the sickest patients. These innovative remote monitoring strategies may also benefit patients with chronic conditions, such as heart failure, who require careful management while minimizing infection exposure.
Preparing for Wider Adoption
Looking beyond the current pandemic, some new devices look promising, such as the AliveCor, which uses Bluetooth technology to send a single lead rhythm monitor to a smartphone or watch. Continuous glucose monitoring is another area in which wearables continue to make headway. Undoubtedly, this technology is going to continue advancing, and the medical community will find ways to apply it in the most effective way for patients.
Tips for Mitigating Potential Liability
As often is the case, these technological advances come with questions about potential liability. Many of the questions concern what a physician should do with the available data when a patient sends the physician data remotely or comes in and says, "Take a look at my watch. Here’s information about my health.” How much can you trust that information? At what level is it actionable? What do you need to document?
Making meaningful use of information from wearables means addressing a variety of concerns:
- Data quality: Researchers have determined that wearables can detect atrial fibrillation, but only at a fairly low incidence in the almost 500,000 people who were studied in an Apple Watch study. A high rate of false positives also brings into question the usefulness of those results. How can physicians determine when data from wearables is reliable?
- Data saturation: Wearables provide so much information that the physician may become overwhelmed and miss important information, compromising patient safety and possibly leading to malpractice liability.
- Interoperability: Patients are already texting, faxing, and emailing information from their wearables to their physicians, and it may soon be common for the devices to transmit data directly to the physician. But when wearables are not interoperable with electronic health records (EHRs), it is difficult or impossible for the physician to securely acquire the data. This leads to many questions about the physician’s obligations to protect and store that data. In addition, lack of interoperability may make finding relevant data a needle-in-the-haystack experience.
- Regulatory concerns: Even though HIPAA applies to patient data collected by healthcare providers, differing state laws mean that their specific responsibilities for monitoring and protecting patient data vary by location.
- Lack of legal clarity: Theoretical malpractice risks are abundant with wearables, but so far there is little guidance in case law. It is unclear, for instance, if and when the monitoring of a wearable medical device creates a physician-patient relationship that brings a duty of care. Does it matter if the physician provided the device, recommended it, or was merely made aware of the data by the patient? Once a wearable device is known to the physician, when and how often must the data be reviewed? When does a physician’s knowledge of data from a wearable device obligate the inclusion of that information in treatment decisions—and when does the failure to obtain or use data from a wearable constitute a breach of the duty of care? Once a wearable device is known to the physician, when and how often must the data be reviewed?
- Security: The security of wearable devices and apps cannot be controlled by the physician, and there is ample reason to question whether the data is safe. An app called MyFitnessPal suffered a breach in 2018 that affected 150 million people. If a physician has any hand in providing or managing wearables for patients, the practice could be held responsible for notifying consumers of a breach or a recall.
Navigating the Data Maze: Now and After COVID-19
The healthcare community will continue clarifying the role of wearable devices in improving patient health, as well as the responsibility of the healthcare provider in incorporating that data into treatment plans—particularly after COVID-19 applications show the value of data collected from wearables. As practices move forward in incorporating wearables into patient care—or as patients send practices unsolicited data from their devices—practices should develop written policies that state how the practice intends to use wearables and sets limitations on what data will be accepted.
Wearable devices are part of the data maze that healthcare professionals continue to struggle through. The potential for improvement in patient health makes it worthwhile to determine how we can best incorporate this technology in our practices—during this pandemic and beyond—without undue risk.
John P. Erwin, III, is a cardiologist at NorthShore University HealthSystem in Chicago, Illinois, and a member of the American College of Cardiology and Professional Liability Committee (ACC PLC). Debra Davidson is a senior patient safety risk manager with The Doctors Company in East Lansing, Michigan.