The highly anticipated unveiling of the Apple Watch Series 4 caused a news and social media sensation. Apple coined the iconic timepiece as the “guardian of your health”, with health tracking functionalities such as the ability to detect atrial fibrillation (AFib) by a self-performed electrocardiogram (ECG). But from patients’ and carepartners’ perspectives, there is a long road to a universally accessible, seamlessly implemented, mass-adoption, and meaningful use for this wearable technology.
Many experts, such as Dr. Eric Topol a cardiologist at the Scripps Research Institute, and other reports, were quick to highlight concerns about the consequences of false positives. The Apple Watch was criticized as a source for unnecessary anxiety. A letter from the Center for Devices and Radiological Health (CDRH) of the FDA, which cleared the ECG app as a class II over-the-counter (OTC) device, highlighted the risks to health and potential mitigation measures that the Apple Watch posed. Unfortunately, the vast majority of concerns in the public domain haven’t emphasized the risks to health due to poor implementation, integration, and adoption strategies of digital tools and wearables.
The current health care system needs to be significantly refreshed as it is not positioned to simply drop in advancements, such as those offered by the Apple Watch Series 4, into everyday patient care. Having Dr. Ivor Benjamin, president of the American Heart Association (AHA), endorse the Apple Watch at the Apple Keynote Event did wonders for the mass marketing appeal. It would’ve have been more credible and demonstrated more value if he stated that the AHA devised a strategic clinical practice implementation guide for cardiologists, created patient education materials for using the Apple Watch, partnered with payers to incentivize doctors to adopt the technology, and reimburse for virtual consults to support remote patient monitoring (RPM).
Let’s talk about the real-world use of the Apple Watch Series 4. Imagine I receive an alert from my Apple Watch that AFib has been detected. Here’s the cascade of questions that follow:
- Who do I call: my primary care physician (PCP), cardiologist, or 911?
- When do I confidently ignore, act upon, or wait to make actionable decisions about alerts I’ve received?
- What do I do if I don’t have a PCP or cardiologist and I need to wait 3 – 4 weeks for a new patient appointment?
- What if my care team doesn’t use this wearable technology in their practice or recognize the value of the data that is generated?
- Does Apple have a national registry of physicians by zip code that I may call for a virtual consult?
These are only a few questions that come to mind. From a patient’s perspective, the vastness of the uncertainties can be overwhelming. As a patient, if I can’t get answers for my urgent questions, I’ll just stop wearing the watch so I don’t have to deal with the alerts. Cue the discussion on what the industry calls “poor patient engagement”, “patient non-compliance”, and “difficult to change behaviors”.
There isn’t a switch that can be flipped for mass adoption of this technology by all physicians. Currently, digital tools can’t be dropped into traditional patient care workflows and operations. Seamless implementation requires proactive methodical planning to identify barriers that will be encountered both internally from a workflow and operations standpoint, as well as externally by patients using the technology. As more digital technologies become available for RPM and digitization of the patient experience, strategic support tools must be provided to physicians and health care organizations to properly plan and prepare for the implementation of these technologies into their workflows and daily operations. If data is collected by RPM technologies, such as the Apple Watch, but there is no standardized process in place for reviewing that data and making it actionable, we have failed patients and simply created another data silo.
The readings obtained by the Apple Watch are not a substitute for professional medical advice or traditional clinical ECGs but serve as a screening tool. Alerts and symptoms will need follow-ups and medical attention. There are grave concerns in mass marketing this technology via direct-to-consumer (DTC) and over-the-counter (OTC) in a fee-for-service ecosystem. Poor health literacy, lack of patient education materials, fear, anxiety, lack of real-time medical support, and poor coordination of care may lead to significant overdiagnosis, overtreatment, potential increases in emergency room use, and increased costs incurred without evidence-based benefits to the end users.
With the digitization of the patient and point-of-care, we must address concerns about privacy and health data use. At the Apple keynote event, Apple CEO Tim Cook said “At Apple, we believe your personal information belongs to you. You should decide who you share it with and who gets to see it. Period. All your health and fitness data are encrypted on the device and in the cloud.”
But what about de-identified data? While Apple states it safeguards patient data privacy and has gone to great measures to implement differential privacy, will this new watch functionality become an underground pipeline for access to mass quantities of health data that may be de-identified, aggregated, and sold for commercial purposes to third-party vendors? The genomic testing company, 23andMe, created a DTC genomic test, built up a customer databank of over four million participants that consented to research, and sold access to that databank in an exclusive partnership with pharma company GlaxoSmithKline (GSK).
It is well known that vast quantities of patient data are needed to power machine learning algorithms to advance AI-based platforms. Medical data trading is a multi-billion-dollar industry, unbeknownst to patients and the general public. Patients want to partner to advance human data science and should be offered transparent opportunities to do so as well as informed ways to opt-out. Access to one’s health data, even if it’s been anonymized, should be compensated. There are great opportunities to elevate industry standards on data privacy and transparency with the launch of wearable technologies. As the self-proclaimed guardian of people’s health and one of the world’s most powerful and influential companies, Apple is perfectly positioned to disrupt the way we imagine healthcare of the future and the way we advance human data science: inauthentic, transparent partnership with patients.
There is a significant difference in disrupting to be the first-in-class for a designated technology and disrupting to authentically improve patient care and the patient experience. The two are not synonymous. The creation of a digital technology alone is not disruption. The seamless implementation and universal adoption of a digital technology, deeply rooted in transparency and partnership with patients, is what leads to not only disruption but rather an enhancement of care as we know it. No single entity alone can disrupt healthcare. It must be a non-siloed, collaborative approach with every stakeholder working together.
Grace Cordovano, Ph.D., BCPA is a board-certified patient advocate and patient experience enhancer, who blogs at Enlightening Results and is passionate about elevating the patient’s and carepartner’s voice.