FDA Hearts Apple's New Watch
On September 11, 2018, FDA granted a De Novo application for electrocardiograph software to operate on the Apple Watch platform. Apple’s over-the-counter app is intended to create, analyze, and display electrocardiograph data, and provide information for identifying cardiac arrhythmias (irregular heartbeats). Although the device is explicitly not intended to provide a diagnosis, some clinicians are expressing concern that patients are scheduling unnecessary medical visits based on the app’s false positives.
However, FDA was aware of this risk, which it described as “false positive resulting in additional unnecessary medical procedures” in its letter to Apple authorizing the functionality and classifying the device as Class II (moderate to high risk). False positives are a common risk of many devices used to help diagnose health conditions and is, therefore, a concept with which the agency is very familiar. In its authorization letter, the FDA indicated that this risk can be mitigated though clinical performance testing; software verification, validation, and hazard analysis; non-clinical performance testing; and labeling. In light of these comprehensive mitigation measures, FDA found the app’s benefits outweighed its risks, including the risk of false positives.
In particular, the labeling mitigation measure is intended to educate users on how to interpret the app’s results. This guidance is important because an irregular heart rate can increase a person’s risk of stroke, heart failure and other heart-related complications. Providers are trained extensively to appropriately weigh the value and limitations of result data but patients, on the other hand, would understandably be concerned if they believed their Apple Watch signaled a potential cardiac health issue.
At this time, it does not appear that FDA will take any regulatory action in response to the clinicians’ potentially self-serving assertions. Rather, the FDA has been favoring collaborative approaches to innovate solutions for medical device software. For example, just last year, FDA selected nine companies (including Apple) to participate in its Digital Health Pre-Certification Pilot Program, which is intended to help inform the development of a better mobile medical app regulatory model. Mirroring this cooperative approach, it is possible that FDA could work with physician groups to develop tools for clinicians to make better use of data from wearable mobile medical apps to complement the technology’s growing capabilities. Without a concerted healthcare system in which health clinicians and FDA share perspectives, patients may be receiving conflicting messages regarding wearable technology that marginalize the public health benefits anticipated from the app.
FDA’s digital health policies are continuously evolving so it remains to be seen if and how the agency responds to the patient education concern voiced by clinicians. CDRH has been taking steps to empower consumers with their patient preference initiative to incorporate patient preference information into regulatory decision-making. Following FDA’s authorization of the app, FDA Commissioner Scott Gottlieb issued a statement emphasizing the promise of mobile medical apps in which he stated, “[h]ealth care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health….” We believe this trend of patient participation in health management is a capacity that FDA will continue to encourage in order to promote public health. But in order to realize its potential, clinicians must be prepared to embrace and help overcome consumer education challenges that accompany the implementation of innovative technology.
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