By Sara Gerke and Chloe Reichel
According to one estimate, over 318,000 health apps are available in app stores, and over 200 health apps are added each day. Of these, only a fraction are regulated by the U.S. Food and Drug Administration (FDA); those classified as “medical devices,” which typically pose a moderate to high risk to user safety.
Specifically, we asked: How can/should regulators deal with the assessment of health apps? For apps not currently regulated by the FDA, should they undergo any kind of review, such as whether they are helpful for consumers?