Samsung is introducing a new, wearable, all-in-one chip for monitoring and processing health data that has the potential to test for common medical laboratory test biomarkers
Leading the drive to create wearable diagnostic devices are companies manufacturing products designed to serve the markets for consumer fitness and consumer wellness. Now a major electronics company says it has a new chip that will redefine how consumers and patients use wearable monitoring and diagnostic devices.
Samsung Electronics has already begun production of this new chip. Its Bio-Processor chip is different from the chips contained in other wearable devices currently on the market in that it is an “all-in-one” chip that could alter how wearable technology functions. Therefore, this new product has the potential to do some diagnostic testing that is currently performed in medical laboratories.
Currently, most wearable devices marketed to consumers for improving health and fitness measure steps and heart rate. The new chip from Samsung is claimed to be capable of considerably more.
A Single Chip for Generating Copious Amounts of Big Data
• a microcontroller unit (MCU);
• a power management integrated circuit (PMIC);
• a digital signal processor (DSP); and
• flash memory, it is able to process the bio-signals it measures without the need of external processing parts.”
The company says the chip will measure:
• bioelectrical impedance analysis (BIA);
• photoplethysmogram (PPG);
• electrocardiogram (ECG);
• skin temperature; and
• galvanic skin response (GSR).
Thus, this one chip will monitor and provide readings on:
• body fat;
• skeletal muscle mass;
• heart rate;
• heart rhythm;
• skin temperature; and
• stress level.
The Samsung Bio-Processor chip’s capabilities exceed those of similar chips currently on the market. Big data enthusiasts should hail the chip as great news, as it is capable of generating copious, detailed data on individuals, which could then be compiled and used for any number of purposes that could well advance scientific knowledge and understanding.
The company says its Bio-Processor chip will drive new wearable health-monitoring devices that will come to market in 2016.
How Will Advancements in Technology Affect Clinical Laboratories?
The trend driving the popularity of wearable devices and health-related software does not show any signs of slowing down. Clinical laboratories can expect the surge in data generation to impact their operations sooner rather than later, and the role of wearables in healthcare may expand even further.
The automobile industry, for example, has collaborated with medical device designers in researching how medical technology could be used in the context of driving (See Dark Daily, “Why Your Ford Mustang or Toyota Prius Will Soon Test Drivers for Glucose Levels and Perform Other Medical Laboratory Tests,” February 27, 2012.)
The current sales numbers for wearables suggest there is consumer demand for such devices, and studies show that in some situations wearables can both help patients live healthier lifestyles as well as improve clinical outcomes. The Samsung Bio-Processor, which is the first device capable of measuring multiple bio-markers in addition to processing the information on the chip itself, seems poised to push consumers from simply monitoring fitness to monitoring their health status and chronic conditions.
How Useful is All This Information? The Debate Over Wearable Healthcare Devices
Wearables are increasingly being used in clinical trials and in other clinical applications. And, industry watchdogs have suggested that Samsung will “license out” this chip, which would likely expand the number of applications and settings in which it could be used.
Thus, the question facing the healthcare providers, clinical laboratories professionals, and consumers is: How useful is all this information?
As Samsung and other tech giants are demonstrating with each new health product launch, they believe health data is a safe financial bet. However, there is not yet consensus among the healthcare provider community. This fact was eloquently illustrated in an article published in The BMJ (formerly the British Medical Journal) in April 2015. It offers a glimpse of the debate by providing two MD viewpoints on the issue.
The Pro Argument
Iltifat Husain, MD, Director of Mobile App Curriculum and an Emergency Medicine Assistant Professor at Wake Forest University School of Medicine (WFSM) in Winston-Salem, North Carolina, says health apps and the data they generate will lead to a healthier populace.
“Health apps on smartphones are here to stay, and some at least have great potential to reduce morbidity and mortality by encouraging healthy behavior. They can help people to correlate personal decisions with health outcomes, and they can help doctors to hold patients accountable for their behavior. And their low cost and availability means that they have the potential to benefit broad demographics,” Husain stated in the conclusion of his argument in favor of healthy adults using wearable devices and apps to encourage healthy behavior.
The Con Argument
Des Spence, MD, a Glasgow, UK, GP and a former columnist for The BMJ, suggests that wearable health-monitoring devices result in unnecessary anxiety. His opposing viewpoint is that the people who purchase and use health-related wearable devices and software do not know how to interpret the data they collect, and so will be anxious, pushing their physicians to diagnose and over-prescribe.
“The truth is that these apps and devices are untested and unscientific, and they will open the door of uncertainty,” Spence stated in the BMJ article. “Make no mistake,” he continued, “diagnostic uncertainty ignites extreme anxiety in people. We must reflect on what we might lose here, rather than what we might gain. Will apps simply empower patients to over diagnosis and anxiety?”
What Does This Mean for Medical Laboratories?
For medical laboratory personnel, the questions raised by apps, devices, and Samsung’s new all-in-one chip are a bit different. Traditionally, test results have been the purview of the clinical laboratories conducting the tests. It’s widely accepted that as much as 80% of electronic health records (EHRs) are comprised of test results generated by labs. If the data that health apps and devices generate is channeled into EHRs, as some have suggested they should be, where does that leave labs? (See Dark Daily, “Wearable Health-Monitoring Devices Could Alter Traditional Role of Pathologists as Gatekeepers of Medical Laboratory Test Data,” July 1, 2015.)
It could offer an opportunity for labs to confirm results generated by wearable devices using traditional and reliable testing methods. It may also mean that physicians will be able to bypass some types of general screening lab tests and go directly to certain specialty medical lab tests in order to confirm the diagnosis or select appropriate therapies for the patient.