May 30, 2024

Wearable Device Technology in Health Care

By Sharon Hall, RN

Wearable technology has advanced beyond federal Food and Drug Administration-approved medical devices to monitor acute or chronic health conditions. Ask someone today if they are familiar with wearable health care technology and the chances are they'll think of wearable "smart" devices that are also capable of tracking wellness parameters.

A 2019 National Trends Survey of 4,100 participants revealed that about 30% of respondents used a wearable device, and of these adopters, 46% had shared the data with their physician or practitioner. While studies to validate the predictive quality of wearables are mostly lacking, that isn't stopping consumers from using wearables to track their wellness.

Should a physician or health care professional consider providing care to patients incorporating wearable data? Let's consider some of the benefits-and some of the risks.

About our smart devices

Common types of wearables today include smartwatches, smart bracelets, and smart glasses. They are not usually approved by the FDA. The data collected by wearables include metrics such as pulse, blood pressure, temperature, blood oxygenation, glucose levels, sleep patterns, and movement. Wearables often track identified metrics continuously to identify a baseline and reveal trends over time, with the resulting data potentially used by the individual's physician or health care practitioner to aid in diagnosis and treatment or changes in care.

Some examples: Continuous monitoring of glucose levels may allow a patient to adjust their diet and activity in real time, leading to more consistent blood-sugar levels and fewer in-person practitioner visits. Smart watches with EKG capabilities may lead to considering the diagnosis of atrial fibrillation. Pairing another application with a smartwatch may detect an infection such as the onset of COVID-19 before symptoms become obvious.

Other potential benefits of wearable technology include improved motivation in activities such as quitting smoking, managing diabetes, and exercising; higher patient activation as data demonstrates how choice influences health; better management of chronic diseases through shared decision-making; and improved patient engagement in preventative care, resulting in fewer office visits.

Practitioner risks and responsibilities

When patients share health data from wearables, questions arise about a physician's or health care practitioner's responsibility to accept this data, act on it, and incorporate it into the patient's medical record. Both patient and practitioner expectations for wearable use and monitoring should be clear from the outset.

Current resources do not suggest existing case law involving wearables, so it's not clear whether monitoring a patient's personal wearable device creates a physician- patient relationship requiring a duty of care. However, when wearables are part of the patient's plan of care, a duty may exist, and physicians and practices can minimize malpractice risks through planning and documentation. Risks include inappropriate patient selection, limited usability of the device to monitor selected parameters, failure to educate or train patients and staff, data management issues, communication issues, privacy, and security.

Choosing patient candidates

Patient selection is an important component when considering a plan of care that involves remote monitoring using a wearable. Not all individuals are appropriate candidates, nor do all medical conditions lend themselves to remote monitoring. Consider the following when determining if your patient is an appropriate candidate for remote monitoring using a wearable device:

• Equity and inclusion: If the patient's insurer does not pay for the wearable, can the patient afford to purchase the device and any necessary accessories?
• Accessibility: Does the patient have a smartphone if one is required by the wearable? Does the patient have internet access and sufficient internet speed to transmit data? If the objective is to monitor a health condition or well-being through the device and the patient cannot transmit the data, the device may not be helpful for that patient.
• Compliance: Is the patient comfortable and capable of operating the wearable correctly? Physicians and health care professionals recommending the wearable can improve patient compliance through a shared-decision- making informed-consent process. The informed consent should include an explanation of the wearable, patient responsibilities, benefits and risks of using the wearable, the technology's limitations, and possible alternatives. Consent should also address the rights of the practitioner and patient to discontinue use of the wearable. As with telehealth, confidentiality and potential security issues are also important to discuss.
• Service and support: Who maintains the device? How is troubleshooting conducted if the device fails to function properly? Who addresses potential device recalls?
• Usability: Since wearables are generally not FDA approved, they may not be as accurate or dependable as approved devices. Does the wearable have a good track record for safety and reliability, which impact data integrity? Can data easily be retrieved and transmitted? For non-FDA- approved devices, we recommend investigating the medical community's consensus and reviewing scientific evidence for the acceptance of the proposed off-label use for the patient's condition.

Training of staff and patients

Physicians and health care professionals must ensure they are trained in the use of any new technology and must be prepared to teach patients. For FDA-approved wearables, the manufacturer may offer or require training; otherwise, instruction may be offered in accompanying product materials. Designate staff experienced in the setup, use, and remote monitoring of security and privacy issues for wearables to provide patient training. Document the patient's training on the device in the patient record.

Patient training should include setup, use, maintaining, troubleshooting, and sending data from their wearable. Training should include scheduling and determining the frequency for review of data by the physician or office.

Be specific in documentation

Medical record documentation of the wearable technology should include the specific technology and model number, patient training, informed consent, plan of care to reflect use of the device, data transmitted, and any actions taken related to data transmission. Lack of adherence to the plan of care should be noted, as well. Device-specific informed consent should be obtained for wearable devices that generate real- time data. Patient responsibilities should be defined, including a responsibility to follow up after a data-point deviation has been transmitted and becomes known to the patient.

Administrative considerations

Remote-monitoring technology references should be added to your notice of privacy practices. Include wearables in the organization's security and product-recall procedures. Be aware of manufacturer warnings, FDA alerts (if applicable), or recalls of patient wearables. If you have any wearable vendor or subcontractor contracts, there may be a need for business- associate agreements. Recommendations for using specific wearables may fall under federal fraud and abuse guidelines. A health care practitioner cannot accept anything of value in exchange for recommending the use of a wearable medical device.

The future is wearable

Given the potential risks, why should a physician or health care professional consider providing care to patients incorporating wearable data? Because there are benefits for patient involvement in their care and compliance, and it's very likely that patients will be sharing their health data with you. Plus, more companies are seeking FDA approval for their wearable products.

While many health care practitioners consider wearables to be fun consumer gadgets, many are currently changing their viewpoint. Wearables can be used as a motivational tool to facilitate shared decision-making regarding a patient's condition and have the potential to be utilized as a predictor of health and even lead to improved health outcomes.

Sharon Hall, RN, MPH, ARM, is a senior clinical risk consultant with Physicians Insurance.

This article was featured in the May/June 2024 issue of WSMA Reports, WSMA's print magazine.