A brief article in the Journal of the American Medical Association raises a significant issue related to app-enabled baby monitors.  Bonafide et al. draw attention to the increasing popularity of wearables for infants that supposedly monitor their health status and report it to parents via their smartphones.

For example, Owlet Baby Care offers socks containing sensors that monitor a baby's pulse rate and blood oxygen levels.  In a clinical setting, this data could be used to check for onset of Sudden Infant Death Syndrome. 

Like most such gear, the manufacturer makes no medical claims for it, marketing it solely as something that may "help" parents.

The article points out the fairness implications of this sort of gear.  First of all, there have been no studies to ascertain the accuracy or even "helpfulness" of these devices.  Thus, it is unclear what it means for the device to set off an alarm, or not.

One potential problem is underdiagnosis. That is, the app might assure parents that nothing is wrong when something is, in fact, wrong.  Clearly, this event would be bad for parents and their children.

The complementary problem is overdiagnosis.  That is, the app might set off an alarm when nothing is wrong.  This event would likely lead to hospital visits involving unnecessary tests and procedures.  Also, such events could well make parents more anxious instead of reassuring them that their children are well.

The fairness problem consists in deciding the proportion of underdiagnosis to overdiagnosis that would best serve the interests of all parties concerned.  Of course, parents have a legitimate interest in the health of their children.  At the same time, the public has a legitimate interest in avoiding unneccesary use of hospital resources.

Beyond fairness, there is also what I would call a progress problem: How should such gear be regulated?  The US Food and Drug Administration has fairly stringent standards for medical appliances, which would include medical apps.  However, the gear in question is being sold as recreational equipment, purely for people's personal enjoyment with no medical claims officially attached. 

However, given that people will likely draw medical conclusions from the data they get, is that form of regulation adequate?

The situation is yet more complex.  As the article points out, even data obtained from bona fide medical equipment must be interpreted with care.  In the case of blood oxygen, "Healthy infants have occasional oxygen desaturations to less than 80% without consequence..."

So, even if the Owlet Baby Care monitor could mimic hospital equipment, it could still be problematic to set off an alarm solely on a tripwire basis.

On this basis, it seems clear that this sort of gear does not belong on the marketplace.  That is, a precautionary strategy to regulation is to be followed. 

Yet, a broad ban on this technology could stifle innovation in designs that could prove to be helpful.  A permissive strategy to regulation may produce a win, at least in some cases.

Such is the dilemma of progress.

Baby Colt 3

Courtesy of Christopher Lance/Flickr.

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