“The problem with these apps is they’re so new and novel; it’s probably going to be hard establishing a standard of care, or what a reasonable doctor would, and would not do when using these products,” says Nathan Cortez, a professor and associate dean for research at SMU Dedman School of Law, who recently published a paper about the necessities of clearer mHealth regulations.
Eventually, he says we’re going to see lawsuits concerning this. Until then, it’s up to hospitals and professional medical societies to establish standards of how doctors should use and recommend mHealth products—a conversation that should take place sooner rather than later.
Let’s say in our arrhythmia example the app or device itself is deemed the guilty party, not your doctor, then state law gives you three ways to seek legal ramifications.
The most common tort case will likely be about a “design defect” that caused your injury, Cortez says. Another option is a “breach of warranty claim”, where the developer warranted that the product would work a specific way but failed to keep its promises and that led to your injury. Lastly, he says there is a “failure to warn” claim, in which the developer didn’t warn you that the app may not work, or maybe you weren’t told about an updated version and got injured using an older version of the app.
There are two big roadblocks when trying to sue a developer or manufacturer using any of the above three claims: FDA regulations and developer/manufacturer liability agreements.
When it comes to mHealth, the FDA’s guidelines are a bit vague and leave a lot open to interpretation, says Glenn Cohen, a Harvard Law School professor, and the faculty director at Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics.
Unlike traditional medical devices, the FDA does not usually use a full-blown premarket approval procedure for mHealth.