This is a topic that we’ve been watching with growing concern, and are glad to have the opportunity to shed some light on the subject. Wearable and proximity health tech for children and infants is a rapidly growing business. In recent months, we have covered several of these products. Even though most health tech products for home use disclaim any medical diagnostic, prevention, or treatment capabilities, some experts in the medical community say that’s not sufficient.
Three experts have published a paper in a Journal of the American Medical Association to air their concerns in this area. Two of the authors are pediatricians from Children’s Hospital of Philadelphia. The third is an expert from the ECRI Institute, a nonprofit organization dedicated to the rigorous evaluation of medical procedures and devices. They take a strong stance against the use of smartphone apps with infant monitors that track physiological data. They raise concerns about the potential harm that could come from the use of these systems, calling out oxygenation monitors in particular (but not limiting their warnings to that class of device).
The authors specifically mentioned the Owlet smart sock monitor sold by Owlet Baby Care, which we wrote about in 2015. They state that the company had recently reported selling 40,000 of the $250 oxygenation monitors. The article mentions the company disclaimers but then quotes the Owlet website’s statement that, “We can’t promise to prevent Sudden Infant Death Syndrome (SIDS) right now, it’s an unknown issue but … we believe notifying parents when something is wrong maybe can help.” Saying that such statements and others may “stimulate unnecessary fear, uncertainty, and self-doubt in parents about their abilities to keep their infants safe,” the authors of the article call out a lack of evidence that commercial oxygenation monitors reduce the risk of SIDS. They also quote an American Academy of Pediatrics policy statement, “Do not use home cardiorespiratory monitors as a strategy to reduce the risk of SIDS.”
The article further points out that parents lack medical training to interpret biometric readings, generating undue alarms for apnea, tachycardia, bradycardia, and desaturation. One-time readings that result in unnecessary — and expensive — trips to the emergency room that could result in extensive tests that could cause stress for both parents and child. Referring to a lack of controls, the authors point out that some health tech devices for home tech have been found to be grossly inaccurate.
Looking for a solution, the authors state the first step would be for the FDA to provide regulatory oversight and include “apps that transform a mobile platform into a regulated class medical device.” They also suggest the clinical research community activity evaluate and publish their findings with smartphone-based health tech devices and applications.
The point of wearable technology is to improve health outcomes and reduce healthcare costs, but this paper raises valid concerns that they could end up having precisely the opposite effect. This JAMA article serves as an early warning shot over the bow, putting the wearable and health tech markets on notice.