Table 4.

A clinician’s ABCD guide to wearable device use in clinical practice

ABCD guide	Topics	Questions clinicians need to ask	Examples of how to answer these questions (based on an ECG smartwatch)
A	Assess the device Assess the literature Assess regulatory approvals Assess price Assess best practice guidelines for the use of these devices	What data (raw or processed) is generated by the device and what is its clinical utility? Are the hardware sensors accurate and clinically valid? Are the software algorithms accurate and clinically valid? What is the price of the device? Is the device FDA or CE approved for its specific indication? Is clinical evidence available to support the use of the device for a specific clinical application?	This device generates heart rate, physical activity and single-lead ECG data; the hardware has been clinically validated and FDA cleared; single-lead ECG has limitations compared with 12-lead ECGs such as the inability to diagnose acute coronary syndromes; the software algorithms for AF detection have been validated in some of the devices19,53; regulatory approval or clearance status can be found on each regulatory agency’s website or in press releases; no randomized clinical trials are available showing that ECG smartwatches improve outcomes; some trials, such as HEARTLINE54, are currently ongoing
B	Benefit to patients Benefit to clinical practice	Does the device help me with the patient’s clinical care or saves them money or inconvenience through remote monitoring? Does the device assist me with patient care by facilitating remote patient management and improving my clinical workflow and cost-effectiveness?	ECG-based devices can help me manage patients with established AF remotely, thereby improving convenience and reducing costs; I can use the device to assess AF burden in my patients; I might be able to use the device to manage anticoagulation if future trials show benefit; seeing stable patients with AF remotely while reviewing their recorded ECGs allows me to fit new patient consults within my schedule
C	Clinical workflow integration	What are the logistics of integrating the device in my clinic, such as consent or electronic health record integration? Who will teach patients how to use the device and link their data with the clinic? Who will teach the other health-care staff (such as nurses or assistants) how these devices work? What are my patients’ expectations for the frequency of reviewing wearable data? How will my patients be informed of abnormal findings and who will inform them? What parameter thresholds will be set to notify me or my patients? Can I bill for the device initial setup? Can I bill for reviewing the data? What data can I bill for and how frequently? What are the billing codes?	Reimbursement for virtual visits and remote monitoring requires patient consent; some smartwatches can share patient ECGs to electronic health records, for example, Apple Watch-derived ECGs can be shared to some electronic health records such as EPIC; if a patient has a smartwatch ECG, my trained assistant or myself will teach them how to acquire and transmit an ECG; I might invest in buying a model smartwatch for demonstration to my staff or medical trainees; if the patient records an ECG for a new episode, they will share the ECG with me through the electronic medical records and will notify my assistant about the episode; otherwise, we will review regularly acquired ECGs during our in-person or virtual visits; future software platforms might allow the clinician to set customizable alarms (for example, alert me if more than five episodes of AF per month or when episodes of rapid ventricular response occur); discuss with my billing department the codes that can be used to bill for remote monitoring set up and data review (for example, in the USA, CPT codes 99453, 99454, 99457 and 99091 can be used)115
D	Data rights and governance Data storage and privacy	Who owns the rights to the data? Can I use these data for research? Do I have data user agreements or privacy policies in place? Can I send these data to a third party and how does this affect patient care and trust? Where are these data being stored and are they HIPAA secured?	The patient must consent to the rights for using their data in research or sharing the data with third parties; the wearable ECG devices will be only accessible through HIPAA-compliant electronic medical records; the patient should be aware that cybersecurity breaches are a possibility, especially if non-secure platforms are used

AF, atrial fibrillation; ECG, electrocardiogram; HIPAA, The Health Insurance Portability and Accountability Act of 1996.