Direct to Consumer Wearables For Children: Who, What, When and How?

Expert Analysis

Lisa Roelle, PA-C; Tracy M Conner, MD; Jennifer A Silva, MD, FACC


November 16, 2022


Miniaturization of electronics and sensors has led to increased direct to consumer wearable (D2CW) technologies initially designed for wellness assessment and fitness tracking.[1,2] Photoplethysmography (PPG) technology paved the way for arrhythmia monitoring in wearable electrocardiograms (ECGs),[3] pulse oximetry assessments,[4] and sleep apnea monitoring.[5] Continued development of algorithms has increased clinician and patient use of D2CWs for cardiovascular care[6] and has also emerged as an important tool in the pediatric population.[7,8]

We explore D2CWs and their use in pediatric and congenital heart disease patients — identifying for whom these tools are appropriate, what tools should be considered, how to implement device use, and how to manage acquired data. (Figure 1).

Figure 1.

Figure 1: Considerations for device choice. Courtesy of Roelle L, Conner T, Silva JA.

Current Landscape

Approximately 20% of United States (US) residents own a smart wearable device[9] and 86% of patients say their device improves their quality of life.[10] Large quantities of data are generated from these D2CWs2 in various formats, including HR/pulse tracking, ECG tracings, and activity sensors (Table 1).

Overall, the older pediatric population has a high level of technology savviness, making adoption of these technologies easier in this patient group.

Who May Benefit from D2CWs?

Patients of all ages may benefit from D2CWs[11,12,13,14,15,16] and careful consideration of device type is necessary by age. Assessment of patient/family values about the use of technology by children, including the connected nature of these devices and potential data privacy issues, may impact the types of devices considered.

Appropriate Device Selection

When discussing D2CWs with patients, the clinical question must be identified, and the patient paired with the appropriate technology. Often, patients who ask about D2CWs are acutely aware of their symptoms and desire to understand them better. Empowering patients to have control over their personal data may be useful for promoting behavioral changes and improve overall health.[1]

Patients and families often look to clinicians for guidance regarding D2CWs.[2] Clinicians should engage in shared decision making with patients/families for their specific needs. For instance, when assessing supraventricular tachycardia (SVT) burden in symptomatic teenagers, ECG based technologies may be ideal, allowing discernment between sinus tachycardia versus supraventricular tachycardia. For newborns with documented SVT, simple HR monitors may best help assess arrhythmia burden.

Cost must be considered with device prices ranging from <$100 to >$600. Certain US Food and Drug Administration (FDA) approved devices may be reimbursable through flexible spending accounts (FSAs) or health savings accounts (HSAs).

Other considerations include ease of use, portability, and smartphone connectivity.[17] Because the use of D2CWs require an individualized approach, a concise guide would be helpful when determining best fit. One such tool, the ABCD guide is as follows:[1] A=assessment of price, regulatory approvals, best practice guidelines, B=benefits to patient/clinical practice, C=clinical workflow, D=data rights, storage, governance, privacy.

Practical Implementation

Once the patient/family decide to move forward with a D2CW, clinicians help them understand data transmission workflow and set expectations for receiving results, with a trial practice of data acquisition. A clinician will walk through the process of transmitting data to the health care team and provide feedback when information is received. Patients are made to understand that this mode of communication is for routine tracings and should never be used in an emergency.

By practicing the patient workflow during "normal" circumstances, the aim is for the patient/family to be familiar with data acquisition and transmission in advance of a clinical event. (Figure 2).

Figure 2.

Courtesy of Roelle L, Conner T, Silva JA.

Patient acquired real world data are uploaded and transmitted. Cloud computing with both edge and cloud-based artificial intelligence will allow not only data aggregation, but also higher order interpretation, processing, and event prediction. These data points are ideally entered into the electronic medical record (EMR) and transmitted to the health care team who will develop a patient specific plan which is then communicated back to the patient. The circle is completed when new data points are acquired under new conditions and data is then collected and transmitted, allowing not only for remote monitoring, but remote management as well. Clinicians spend time with patients to help them distinguish between a normal versus abnormal tracing, reinforcing this at each clinic visit, empowering them to be engaged partners and minimizing "worried well" behaviors.

Data Integration to the EMR

It is important to consider EMR integration of data generated by D2CWs. Patient portals are one way that this can be achieved in a safe, HIPAA-compliant format. Clinicians use the patient portal MyChart (Epic Systems, Verona, WI), where patients upload recorded data and send it via secure messaging into their EMR.[8] The clinician then determines if additional testing is needed or a change in plan is required. Return communication is also performed through the patient portal, allowing other health care team members to remain in the loop on patient management and communication.

Future Directions

Pediatric cardiac electrophysiology patients are well-suited for the expansion of digital health and D2CWs focusing on identification, management, and screening of arrhythmias. Continued publication of high-quality clinical data is essential for integration into the traditional clinic workflow.[18]

Emerging technologies include integration of blockchain[19] and non-fungible tokens[20] to provide greater levels of data encryption, storage, and patient privacy/data ownership. Expanding and securing artificial intelligence systems will aid in diagnosis and management of arrhythmias given the increased data generation. Finally, involvement of digital health companies with cloud-based storage will allow for increased data accessibility for patients receiving care in multiple hospital systems.


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