Managing Patient Concerns About Wearable Device Data
By Eric Zacharias, MD
COPIC Department of Patient Safety and Risk Management
An active 53-year-old patient came in to see her physician because she was worried about the rapid heart rates she saw when she downloaded the data from her fitness monitor (she used a high-tech watch to track physiological data on her daily runs). She told her physician that she had a strong family history of heart disease and an internet search revealed that a high heart rate can be the first sign of an impending heart attack. Her data downloads had never shown such high heart rates before. She brought in a year’s worth of heart rate data printouts to the appointment and asked the physician to put these in her medical record. What should this physician do?
There has been a significant increase in the use of consumer-marketed, wearable technologies that measure and report physiological data. As a consequence, physicians have noticed patients are starting to bring this information to appointments expecting something to be done with it. Understanding a few basic principles will help when seeing such patients.
First, it is useful to make it clear to patients who bring in data from consumer-grade monitoring devices that the information reported is designed for consumer use and not for medical care. For example, you may choose to tell patients that although you see and agree that the information from their wearable device is indeed abnormal/outside what may be expected, this information is not from a medical-grade, FDA-approved device.
Thus, you know neither its reliability nor necessarily how to interpret it. Furthermore, it may be useful to explain that any abnormal information from such a device is not a medical diagnosis, but perhaps may be a reason for a careful medical assessment.
Additionally, physicians should set expectations with patients who bring physiological data from consumer-grade wearable devices as to how this information may be documented and used. For example, you could tell them that, given its limitations, the information may be documented in a subjective way in your note and may help contribute to their care, but it will not be stored as part of the medical record as data from a physician-prescribed, medical-grade device would.
Another point to understand is that, although data from wearable devices is not medical grade, it probably should not be completely dismissed without at least looking at it. This may involve a follow-up office visit. In an established physician-patient relationship, it is reasonable for physicians to assume they have some responsibility to consider the data that a patient presents to them from wearable devices in their overall decision-making process.
However, as noted above, the actual data brought by the patient can be considered indeterminate due to the unclear reliability of the source. Some physicians report that they treat data from wearable devices in a fashion analogous to how they would treat a sheet of paper brought in by the patient with a list of questions or self-checked pulses on it: it informs the care during the visit, but is not put directly into the medical record.
Lastly, it should also be made clear and documented that any patient who believes she is having a medical emergency, no matter what information a wearable device is reporting, should immediately dial 911. So, for the case presented, here is a reasonable approach the physician might take once the presence of an emergency situation has been excluded:
Perform a thorough history and physical examination and let the patient know this is informed by her concerns as well as the information she brought from her wearable device. Determine appropriate near- and long-term testing, referrals, and follow-ups as for any evaluation.
Alert the patient as to the plan for further evaluation and management as well as signs and symptoms that would warrant re-evaluation or calling 911.
Tell the patient that although you appreciate the years' worth of fitness data, it is not appropriate for the medical record. Also, communicate that the device used is not medical-grade and the information may not be accurate or reliable.
Eric Zacharias, MD, is with the COPIC Department of Patient Safety and Risk Management.