Almost everyone has wearable tech - What's the risk?

Almost everyone has some form of wearable tech, from smartwatches to fitness trackers. Most people use them for personal tracking and entertainment. And as healthcare reimbursement moves toward a higher adoption of value-based care (VBC), more healthcare providers are considering integrating wearables into their practices to monitor data such as heart rate, blood pressure, body temperature, blood oxygen, and blood glucose levels in patients with chronic conditions.

Juniper Research revealed that the healthcare industry is expected to monitor the health of an estimated five million patients via wearable devices by 2023, driving $20 billion in annual spending on these devices. Providers see the promise of virtual care models paired with remote patient monitoring (RPM) technologies to help them deliver more efficient, safe, high quality, effective, and lower-cost care. And in so doing, minimize contact risk exposure.

For example, consider a use case for a type 2 diabetes patient with uncontrolled blood sugar levels who has been prescribed a continuous glucose monitoring (CGM) wearable device, with data inputs remotely relayed to their physician. The patient can now easily track their blood glucose, adjust their diet and activity accordingly, and prevent wide variations. This might lead to reducing the number of in-person doctor visits. Whereas before, when a physician may make diet or medication recommendations based on a single episode of data, the technology might offer a more holistic picture of an individual's wellbeing to make more informed clinical decisions.

To date, there have been no reported medical professional liability lawsuits involving wearables, but experts predict it is only a matter of time before losses could emerge. Consider the following areas of potential liability.

Not all wearable technologies are created equal, nor are all suitable for RPM

It is vital to distinguish medical-grade devices approved by the Food and Drug Administration (FDA) from consumer-grade wearables. Medical-grade wearables are subject to FDA approval if their purpose is to help with diagnosis or treatment. On the other hand, consumer-grade wearables are used primarily as a motivational tool for patients. Because medical-grade devices undergo rigorous testing, they are likely to be more accurate and dependable than consumer-grade devices. In addition, medical-grade devices may have features that consumer-grade devices do not, such as the ability to record and store data for extended periods. This is important for doctors who need to be able to track a patient's progress over time.

Brace for impact

Implementing platforms that integrate secure data transmission and alert systems into provider workflows and patient medical records is important. If your organization is not prepared to interact with this technology, it may lead to claims for failure to monitor, failure to detect, or missed diagnosis. It is just as important to plan for the impact continuous monitoring will have on your staffing model. Organizations should plan to staff to the levels required to monitor alerts effectively and respond promptly, and outline workflows and 'guardrails’ - guidelines, parameters, protocols, and policies - to ensure all staff and patients understand expectations.

Practices should consider who will be designated to monitor and quickly respond to incoming data. Will it be the provider? An allied health professional or nurse? Think about how often the data will be analyzed. Weekly? Daily? Guidelines should be made to determine what data might trigger the need to contact a patient and factor in steps to reduce 'alert fatigue' so that staff is not led to ignore or override an overwhelming number of incoming alerts.

Bringing the patient up to speed

With the right technology and staffing in place, RPM can be a valuable tool for better patient care. But it is essential for all parties, including patients, to understand the associated risks.

First, there is the challenge of patient selection. Not all patients are appropriate candidates for remote monitoring. Several factors should be considered, including how motivated patients are to manage their health and their ability to understand and use the technology.

Second, it is important to educate patients, obtain informed consent and set appropriate expectations. Patients should know how to use and maintain the device, when and how often to transmit data, what to do if the device malfunctions, and how the healthcare team will manage alerts. Providers should capture all expectations and a formal record of informed consent in the form of a written agreement and include this as part of the patient’s medical record.

Finally, to help guard against unauthorized individuals accessing patient data and to comply with Health Insurance Portability and Accountability Act (HIPAA) regulations, practices must properly encrypt data transmission. It is not advisable to rely only on wearable manufacturers to ensure security. Instead, providers must take steps to safeguard patient information within their own network.

With proper planning and by staying abreast of the latest FDA approvals, alerts, and recalls, providers can put themselves in a much better position to avoid potential liability and implement RPM programs successfully.

Judy L. Klein, PA, CPHRM, FASHRM, is manager of the risk management department for Coverys.