The following are key points to remember from a science advisory on advancing wearable biosensors for patients with congenital heart disease:

1. Wearable biosensors (wearables) enable continuous, noninvasive physiologic and behavioral monitoring.
2. Various wearables are available, including medical grade devices used for at-home heart rhythm assessment, as well as non–medical grade devices. Devices incorporating photoplethysmography can be used to diagnose arrhythmias and monitor oxygen saturation levels.
3. Patients with congenital heart disease may have physiologic measures outside of the normal range. Wearables have generally been tested at the typical physiologic ranges of oxygen saturation of 90-100%, and heart rate <200 bpm.
4. Systems will need to be in place to integrate data obtained through wearable devices into the electronic medical record in a way such that there can be efficient evaluation by the treating care team.
5. Factors that may drive patients in caregiver adherence to wearable biosensors may vary by patient age. Requirements across age groups include comfort, utility, lack of interference with activities of daily living, and accuracy.
6. Health equity should be taken into account in the development and application of wearable devices. Devices should be developed and tested across the diversity of the population. Additional factors include access to broad band, socioeconomic status and cost of technology, literacy and education, cultural issues, digital literacy, and access to specialty health care.
7. Devices may fall into two regulatory categories. The first is medical grade, which is subject to regulatory oversight. The second category is health and wellness devices, which are not subject to Food and Drug Administration (FDA) clearance.
8. In the current state, the lack of standard regulation for establishing the validity of many commercial devices and the lack of clinical trials supporting their use, limit knowledge of their accuracy and efficacy.
9. In the future, wearable devices could help significantly in the management of patients with congenital heart disease. Continued improvement of the devices and vigorous testing, as well as a strong regulatory framework, will be required to secure widespread application of these technologies.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Congenital Heart Disease

Keywords: Heart Defects, Congenital, Wearable Electronic Devices

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