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No physician should indicate that wearable health devices are in any way a replacement of direct medical care by healthcare professionals or an equivalent of medical equipment available at hospitals.
The Apple Watch has taken the market by storm since its debut in 2015. Recently crowned as the top-selling watch in the world, Apple has latched onto the desires of consumers by linking their obsession of smartphone applications with a constant deluge of information. On Sept. 12, Apple presented its newest watch iteration, the Apple Watch Series 4, to the delight of ravenous fans worldwide. This year’s annual upgrade includes an electrocardiogram (ECG) capabilities built into the watch itself.
Heart monitors in fitness trackers and smart watches are expected by consumers nowadays, but the results are usually taken with a grain of salt. Currently, most wearable devices monitor heart rate through the use of green LED lights embedded in the back of the watch that lies against the wrist. As the light reflects on the skin, it detects the pulse and changes in blood volume to calculate heart rate. Even with this kind of breakthrough technology, Apple continues to set itself apart from the competition by emphasizing health and self-care in its products. The new technology behind the Series 4 is Apple’s next step.
Apple Watch Series 4 owners can use the ECG app and technology by simply putting their opposite finger on the digital crown while wearing the device. This action, in effect, closes the circuit and allows tracking of the electrical signals in the heart. The process takes 30 seconds and gives owners a heart rhythm classification: sinus rhythm or atrial fibrillation. As stated on Apple’s website, “Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram.” It is not the same as a 12-lead ECG performed in hospitals that detect and analyze the heart from multiple angles. The Series 4 is in no way a substitute for an emergency room ECG test.
Still, the new watch had to pass the Food and Drug Administration (FDA)’s rigorous regulatory process. The FDA approval deems the watch a medical device with the ability to monitor for atrial fibrillation and detect abnormally slow or fast heart rates. John J. Warner, president of the American Heart Association, expressed his support of Series 4 on stage at the unveiling, though he did not expressly endorse the new timepiece.
Heart disease is the No. 1 cause of death globally, according to the World Health Organization. It is easy to see how this technology could have an immense effect if used correctly, at least by those who can afford the device. With the ability to store data, and even email it in the form of a PDF, patients can present health information from outside the doctor’s office to their physicians. How much consideration should physicians place on the health information brought in from patients’ personal wearable devices? Are these devices a reliable way of keeping tabs on a patients’ health between visits?
Single-lead devices, such as the Series 4, have the potential to detect episodic rhythm disorders, including atrial fibrillation and ventricular tachycardia. These devices can encourage patients to go to the emergency room in situations where they may otherwise ignore an odd feeling masquerading as a heart disease symptom. The ECG is the golden standard for diagnosis, but a single-lead is limited in scope. It even has the potential for false negative test results, which could have the unintended effect of discouraging patients from going the hospital for necessary care.
While physicians could use the additional help in keeping track of patients’ health information, blindly agreeing to accept health data from wearable devices may cause more complications than solutions. Even though hospitals and healthcare workers are generally encouraged to keep up with advancing technology, it is no secret that many physicians still wage wars with the formidable fax machines. Forcing physicians to stay up to date with the ever-changing medical world, in addition to the newest technology, may simply be asking too much. Furthermore, accepting patient data in PDFs or other formats creates liability issues. HIPAA requires physicians to have an appropriate method for keeping such private health information safe. If the Series 4 health data fell into the wrong hands, physicians may be liable for HIPAA violation fines as well as civil and/or criminal litigation.
Beyond legal threats, relying entirely on patient-produced health information may not be within the standard of care. After all, do physicians normally rely entirely on what patients report? Of course not. They use their medical knowledge and experience to diagnose patients and develop a treatment plan. What if the Stage 4 ECG reports are found to be less than 100 percent reliable? Any failure on the part of the Apple or a third-party app to accurately monitor these vital signs could push physicians’ clinical decision making in the wrong direction. Such claims could be based on hardware and/or software failures onto medical professionals. By relying on a Series 4 ECG report, as opposed to ordering a 12-lead ECG, physicians could find themselves in a malpractice suit in a heartbeat. And sadly, Apple has yet to develop an app to make a medical malpractice suit disappear.
It is an unanswered question as to what extent providers are required to monitor the real time data produced by mHealth devices like the Series 4 ECG. If that data flows into the providers’ EHR, it could potentially create alerts for abnormal results. That raises the question of whether physicians then have a duty to respond to this potentially emergent situation. Physicians can encourage patients to self-monitor through their wearable devices, but they should not indicate that these devices are in any way a replacement of direct medical care from healthcare professionals or an equivalent of medical equipment available at hospitals. Contrary to apples keeping doctors away, physicians should continue to stay close and monitor patients, rather than solely relying on independent data to administer treatment.
Dennis Harms is a Shareholder with the firm Sandberg Phoenix & von Gontard P.C. where he serves as the Health Law Practice Group Leader. His legal education and experience, coupled with his education in the field of health management and informatics, allows him to provide an in-depth perspective into risk management and regulatory issues in the field of healthcare technology.
Kevin Peek is an associate in the St. Louis office of Sandberg Phoenix & von Gontard P.C. where he focuses on cases involving medical malpractice defense and the defense of providers in correctional healthcare.
Editor’s note: This story was updated Sept. 18, 2018.