I mused while staring blankly towards the electronic tracking board, where I foresee reading the triage call “My tracker said, I have AFib.” I delved into what is in my armamentarium to handle this crisis of the digital age. The stethoscope around my neck suddenly seemed archaic.
We the physicians have resigned to the redundant clicks on the electronic medical records (EMR). While still recovering from this inescapable occupational hazard of the new digital documentation, a technological surge of broadband-enabled technology has inundated us. These have surfaced as ingestible, wearable and embeddable based on the route of placement. Are, we physicians, labeling the data provided by them as patient health information (PHI)?
The consumer benefits from the tracking devices in making healthy lifestyle changes and goal setting like stress, weight loss, and activity management. Physicians are still at the crossroads of the accuracy of these data analytics in specific disease management. Health care startups are marketing explicit claims about wearable technology in diagnosing clinical conditions. Most of these devices infuse the merits of predictive analytics geared at consumer wellness and, more recently, disease diagnosis. Have we, physicians, questioned the actual utilization of the wearable tools in health care delivery? How do we intend to incorporate this information?
Fitness trackers hit markets in 2007 and also started a new trend in health consumerism. End-users of the wearables have access to health-related metrics. The wearables are programmed to collect and analyze continuous consumer health and activity parameters. The pertinent question is: as physicians, are we ready to use this information for clinical decision making?
As a fitness enthusiast, a simplistic example of real-world data is at an athletic center. Many of us might have noticed the heart rates of members on a monitor as they work out, after synchronizing the wearable to the center platform? Can this, however, be used when a patient is recovering from a heart attack or starts retraining on an exercise plan? Can the consumer of this device utilize this information in his next doctor visit as unbiased information?
Ronald Coase states: “Torture the data, and it will confess to anything.” Data surplus is an ongoing problem with health information obtained from health records as well as other resources. After several initial speculations, the global community shelved discussions on data from wearables. The aforementioned emerged from a lack of immediate use and regulatory oversight. However, it is imperative that physicians are aware of the real-world data and its infiltration in every facet of the health care delivery tool.
Physicians are amidst a power struggle within the interoperable interphase between human clinical decision making and algorithm-driven machine intelligence. Real-world data incorporates other facets of health care delivery that are in secure data silos unavailable to a physician. These are data derived from patient registries, claims, billing, and electronic health records. The clinical evidence generated from the analysis of this data is real-world evidence.
A practicing physician corroborates evidence-based medicine as the standard of care. The optimized data from wearable technologies is currently missing a standardized reference. Medical devices have a rigorous Food and Drug Administration (FDA) approval process. All wearables are not subject to the same standards which include clinical trials and post-marketing surveillance.4
In 2016, FDA issued a guidance on medical devices requiring specific approvals. To have a streamlined process FDA announced the Digital Innovation Action Plan. The FDA regulatory standards are not a requirement for all the wearable technologies. The fitness trackers, of the first generation, were introduced as “wellness ” devices. They did not make claims to diagnose the medical condition with ICD-10 codes. The trend has changed.
One of the first FDA approved smart watch accessories is KardiaBrand which records a medical grade 30 seconds long electrocardiogram. So, while the fitness tracker can prompt the consumer to a rising heart rate, KardiaBrand, a wearable can diagnose atrial fibrillation. The Omron Heart Guide is another such wearable awaiting FDA approval with an inflatable wristband to record blood pressure. Clinical Research from the University of California at San Francisco (UCSF) and third-party healthcare startups are investigating through clinical trials correlation between the data collected by fitness trackers and their ability to diagnose health conditions: sleep apnea, hypertension, atrial fibrillation. What about the pre-owned fitness trackers? Health eHeart was one such study in collaboration with the Cardiogram app for Apple Watch, which has paved the way for prediction of hypertension and sleep apnea using the fitness wearables.
The industry is actively deploying strategies to procure clinical evidence from the devices. There is ongoing contemporary peer-reviewed research involving clinical data, deep neural networks, medical mining, and its applications. The idea of real-world evidence in health care has gained an active interest from all health sectors and stakeholders. The FDA has implemented a Software Pre-Certification Pilot Program to ensure an efficient regulatory oversight.
Neuroscientists are exploring options to measure the neurotransmitters in the brain using sensors to deliver selective stimulation. Diabetic patients finally have a no fingerstick device for monitoring blood sugars, Dexcom, which is an FDA-permitted wearable for a continuous glucose monitoring. In the foreseeable future, hospital systems can have telemonitoring of vital health parameters after discharge using the wearables. The intake time before physician visits can be cut short by monitoring the vitals before arrival. One can use the activity parameters to follow up on quality of life statistics after surgery. The analytical data-driven quality of life tool is a more reliable objective assessment at follow up to prescribe pain medications, in the thick of the opioid crisis. Sleep activity parameters are currently being standardized in the pediatric age groups to diagnose sleep apnea.
Physicians are at an inevitable crossroad to share the platform with the machine. The trackers are here to stay, and the miners will mine the data. While the stethoscope has its infinite acoustic charm, it is prime time to engage with the tracker.
Nita K. Thingalaya is an internal medicine physician.
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