But out of the spotlight, the FDA has been doing away with regulatory action altogether on many diagnostic health apps targeting consumers, seeking to accelerate digital health adoption by defining many of these as “low risk” medical devices.
As the number of mobile health apps surged to a record 325,000 in 2017, app performance is going largely unpoliced, leading to what’s been dubbed a “Wild West” situation. Unfortunately for health consumers, the public can’t rely on the research community to play the role of sheriff.
When colleagues and I recently examined the medical literature on direct-to-consumer diagnostic apps in a study published in Diagnosis, we repeatedly found studies marred by bias, technological naïveté or a failure to provide crucial information for consumers. There was also a glaring lack of studies with actual consumers to see how they use these apps and what the impact on individual health, whether for better or worse, might be.
