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  1. Advancing Regulatory Science

Post-Market Evaluation of Smartwatch Cardiovascular Notifications

CERSI Collaborators: Stanford University (Stanford): Mintu Turakhia, MD; Robert Harrington, MD; Nigam Shah, MBBS, PhD; Tina Hernandez-Boussard, PhD; Clark Seninger, MBA; Natasha Din, MD; Krishna Pundi, MD

FDA Collaborators: Center for Devices and Radiological Health (CDRH): Anindita Saha; MiRa Jacobs, PhD; Vinay Pai, PhD, MBA; Aubrey Shick, MS; Gloria Nyankima, PhD; Jessica Paulsen; Kan Fang, MD; Jacqueline Puigbo, PhD; Charlie Yongpravat, PhD; Mary Jung, PhD, MPH; Aneesh Deoras

Project Start Date: September 2021

Regulatory Science Challenge

Many wearables that can check physical activity, heart rate, and heart rhythm are available to consumers. Companies like Apple, Samsung, Fitbit, and others make wearable products and medical device software that can identify heart diseases or arrhythmias, like atrial fibrillation (Afib), and give people wearing them an alert when anomalies are detected. While these wearables are not meant to provide diagnoses, when problems are found and doctors and/or patients are notified, doctors can prescribe tests, drugs, or other treatments to prevent health problems like heart failure or stroke. The FDA has authorized the software functions used with these wearable products so that they can be legally marketed and sold without a prescription.

While these software functions have been reviewed by the FDA before they were legally marketed, it is also important to continue to monitor the performance of these wearables in the real world and to understand their usage by the general population. While a notification at the right time may lead to appropriate intervention, it is possible that sometimes a notification may be false and may lead to extra medical tests or drugs. Understanding real-world usage will help the FDA better understand the long-term, real-world performance of these devices.

Project Description and Goals

Researchers aim to identify the tests and drugs patients may receive after cardiovascular notifications are received. They will use data from the electronic patient charts at Stanford Health Care System and the entire Veterans Health Administration to determine when patients talked to their doctors about these notifications. Then, researchers will find out what tests or drugs these patients were prescribed. The number of heart attacks, strokes, or other health problems diagnosed following patient receipt of wearable device notifications will also be measured. This research will help the FDA better understand the extent to which wearable product notifications inform appropriate and needed medical care that may help prevent further health problems. Over time, this work will inform the development of a road map for interpreting and using digital health technologies.

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