LUANN STOTTLEMYER has had diabetes for 23 years, but it was only in 2016 that her doctor prescribed a treatment that changed her life. It has allowed her to bring her blood-sugar levels under control and lose weight. Yet this miracle of modern science is not a new pill. It is a smartphone app called BlueStar.
The program is one of a growing number of apps that America’s Food and Drug Administration (FDA) has approved to treat everything from diabetes to substance abuse. The FDA has encouraged firms to join a scheme that aims to streamline the regulatory process for such treatments. There are many candidates: at least 150 firms globally are developing some form of “digital therapeutic” (“digiceutical” in the lingo), says Mark Sluijs, who advises Merck, a big American drugmaker.
Unlike other sorts of digital health apps, digiceuticals have been tested for efficacy, approved by regulatory agencies such as the FDA and are prescribed by a doctor. Most gather data, either by asking patients for information or by using sensors,…Continue reading