A recent journal article about wearable tech for infants pulls no punches: “There is no evidence that consumer infant physiologic monitors are life-saving, and there is potential for harm if parents choose to use them,” it states.
While the article is an opinion piece, it carries the weight of authority: It was published in the Journal of the American Medical Association and was authored by two pediatricians and an expert from the ECRI Institute, a nonprofit organization dedicated to the rigorous evaluation of medical procedures and devices.
The authors call out specific products that are marketed to nervous parents, including the $250 Owlet Smart Sock, which monitors a sleeping baby’s pulse and blood oxygen levels. There’s no need to monitor healthy infants so closely, the authors say, and doing so will likely cause false alarms and fear.
This analysis has implications for the larger field of mobile health. It’s been less than a decade since the “quantified self” craze began, but fitness trackers, wearable gadgets, and health-related apps have proliferated; for diabetes management alone, consumers can choose from more than 1500 apps.
Some experts believe that these products will provide useful streams of health data that will empower consumers to make better decisions and live healthier lives; for example, one Stanford professor credits his wearables for early detection of his Lyme disease.
But others say the flood of information can have the opposite effect by overwhelming consumers with information that may not be accurate or useful. To probe further, IEEE Spectrum spoke with David Jamison, coauthor of the JAMA article and executive director of ECRI Institute’s health devices group, as well as Priyanka Shah, a project officer in his group.
Spectrum: ECRI has a long tradition of testing medical devices for hospitals and doctors. How did you get involved with the mobile health apps and gadgets that are sold directly to consumers?
Jamison: Over the last couple of years, we’ve had a lot of hospitals and doctors telling us they’re interested in these kinds of products. For instance, the wearable baby monitor study came about when I was talking with a doctor at CHOP (Children’s Hospital of Philadelphia) about these products. He said parents and grandparents were asking him: “Is the use of this technology a good idea for our baby?”
These consumer products can impact a hospital in terms of giving care advice, liability, and cost of care. And smartphone apps are a similar story: We’re studying diabetes apps now. We’re focusing on products and apps that can have the most clinical impact, and things that might cost hospitals a lot of money.
We think it’s really important to get data about accuracy and safety. The public needs to be aware that many of these consumer products are not regulated as medical devices, so may not have the accuracy and safety they expect.
Spectrum: Your JAMA article about infant wearables argues that constantly monitoring things like a baby’s heart rate and respiration could actually lead to worse health outcomes. Can you give an example?
Jamison: The main problem is over-diagnosis. Parents are awakened by some nasty alarm in the middle of the night. They look at a number [on the device], but may not know how to deal with that number or what it means. So they go to the emergency room. The doctors look at the baby and want to be sure everything’s okay, so they do some blood tests. The blood stick causes pain, and the whole process causes stress.
And maybe the doctors make an error: There are normal variations in the human body in terms of temperature and pulse and blood oxygenation. If you look at a number from just one point in time, that creates problems.
Spectrum: Are infant wearable companies like Owlet capitalizing on parents’ fear of sudden infant death syndrome (SIDS), which is still pretty mysterious?
Jamison: It certainly seems that way. We’re not in the business of evaluating people’s advertising. But when you look at the videos on their website, especially if you’re a parent, you’re pretty affected by the things they say. [Jamison is referencing a CNBC video about the Owlet and SIDS that was prominently featured on the Owlet homepage until late last year.]
Spectrum: You’re planning to test some of these baby-monitoring devices, right? Which ones?
Jamison: We’re especially interested in testing the ones that measure blood oxygenation, because those are more like hospital devices. We want to compare their accuracy and ease of use to those of hospital devices.
Spectrum: Does the situation with infant wearables point to a larger problem with mobile health products?
Shah: Getting data is easy in this day and age, but getting meaningful data is what’s really valuable to consumers. If I’m the parent of a baby, I’m not really interested in gathering a repository of my child’s blood oxygenation data. But can the wearable technology help me come to a conclusion, or notify me before the occurrence of a declining health condition?
Spectrum: Let’s talk about the big data issue. A product called Fever Scout, which is a stick-on patch to continuously monitor a child’s temperature, just got FDA approval. Is this a case where more data isn’t necessarily better?
Jamison: It’s interesting that you bring that one up. We’ve been looking at it too, and we conferred with some pediatricians. They said that temperature is a pretty rough indicator, and many times it doesn’t mean much. But at certain specialized times, it does. You need to be a clinician to look at the data and understand what to do next: “Is this a problem, or should go we go back to bed?”
Spectrum: There have also been examples of mobile health apps and gadgets that are flat-out inaccurate. For example, the best-selling Instant Blood Pressure app that used the phone’s camera and microphone for its analysis was found to be very inaccurate in a study by doctors. And the FTC recently sued the company that made the Breathometer, a breathalyzer attachment for smartphones, saying that it dangerously overstated its accuracy. Do you expect to see a lot of cases like this?
Jamison: It’s buyer beware right now with some of these technologies. One of our role in this landscape is to help people find out if consumer products really work as advertised. That’s why we’re looking at these baby monitors, which aren’t regulated as medical devices. These companies have no reason to take all the validation steps that a company selling a regulated medical device would take, so we’re going to check these products out.