The Apple ECG App is Out: What Does it Mean?
This article was authored by John S. Rumsfeld, MD, PhD, FACC, chief innovation officer of the ACC, professor of medicine at the University of Colorado School of Medicine and a member of the Apple Heart Study Steering Committee. He can be reached at: email@example.com or firstname.lastname@example.org.
Apple recently released their highly anticipated ECG app for the Apple Watch. This joins AliveCor’s Kardia as a consumer digital health product that allows wearers to potentially detect atrial fibrillation from their wrist. The Apple ECG app includes two features: a 1-lead ECG and a ’tachometer’ feature that monitors heart rate and regularity in the background and notifies users of potential atrial fibrillation.
Given the massive reach of Apple products, this is a major event in consumer digital health. It could also end up being a notable event in the digital transformation of cardiovascular care (i.e., where digital health products provide data that could inform diagnosis and treatment outside of traditional clinical care settings). However, that depends on how good the digital health tools are, how they are used by consumers, and whether and how they are integrated into clinical care. In the case of the former, the initial data was good enough for U.S. Food and Drug Administration (FDA) clearance of the Apple ECG app features, and there is high anticipation for the results of the ongoing Apple Heart Study, which is being led by FACC investigators from Stanford University and has enrolled more than 400,000 people.
Regarding the potential impact this may have on clinical care, any assertion is speculative at this juncture. The goal behind the Apple ECG app features, according to Apple Vice President of Health Sumbul Desai, MD, is to, “help users have more informed-conversation with their physicians” and to “better understand aspects of their health in a more meaningful way.” These are obviously worthy goals – and more broadly, we can expect there to be continued rapid growth in the availability and use of digital health tools by patients, and more generally by consumers. However, some clinicians have raised notes of concern about data coming from consumer digital health products on clinical use and health care utilization.
Commenting on the Apple ECG app, ACC President C. Michael Valentine, MD, FACC, said, “The idea that wearables can be used by both patients and their health care providers to manage and improve heart health holds promise, but should also be approached with caution to ensure information and data are used responsibly and in concert with other evidence-based tools and guidelines.” His quote nicely encapsulates both the potential and challenge of digital health. It should be noted that patients with atrial fibrillation were excluded from the initial studies done by Apple leading to the FDA clearances for the ECG app, and were also excluded in the Apple Heart Study. Thus, Apple is careful to note that the ECG app is not intended for managing atrial fibrillation patients. However, as clinicians, we can easily extrapolate that in addition to potential new cases stemming from the use of the Apple Watch and/or Kardia, patients with atrial fibrillation may utilize these tools to monitor their rhythm and rate status.
All of this reinforces a new reality – a world in which digital health products will increasingly be used by consumers and patients and can potentially become part of cardiovascular care. In this new reality lies real opportunity for clinicians, researchers, and the ACC to guide the digital transformation of cardiovascular care. To that end, ACC’s Innovation staff and the new ACC Health Care Innovation Member Section are actively working with patients, health systems, and technology companies to co-develop, evaluate, and implement digital health tools. We are exploring ways that digital health data can be transformed into actionable clinical information, and that digital technologies like these can be used to optimize care and outcomes. That way, we can lead instead of follow innovation.
Keywords: Wrist, Research Personnel, Atrial Fibrillation, Heart Rate, United States Food and Drug Administration, Physicians, Wrist Joint, Health Personnel, Learning, Electrocardiography, Health Policy
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