Does Digital Health Help Patients Learn?

So much information. So little understanding. How else are we to interpret a landmark 2006 report noting that only about 12% of US adults had a proficient state of health literacy whereby “individuals can obtain, process and understand the basic health information and services they need to make appropriate health decisions,” as recently reported in JAMA.

Digital health products and services come in two basic flavors. They are either medical devices, subject to regulation by the FDA, or they are not. In most cases, the latter are intended to provide information and education to patients, like how to manage their chronic disease or when is the best time of the month to try to get pregnant. If you want to know which is which, read this guidance document.

Whether your digital health product is one or the other, they both should be clinically effective. In other words, they should do what you say they are supposed to do, or, what is their digital intended use? In the case of devices, you need to do clinical trials to demonstrate they are safe and effective. In the case of informational and educational products, you should somehow demonstrate that users increase their health literacy as an endpoint. Few digital health products do either.

Doctors and patients are confused about apps to recommend and there is a lack of clear and convincing evidence that using them increases heath understanding or changes behavior. Until and unless we demand more rigor from vendors, they are just pushing digital snake oil.