Apple’s Digital Health Criteria May Have Bigger Impact Than FDA

A couple of months ago, the U.S. Food and Drug Administration acted to shore up criteria for digital health companies with final guidance articulating the difference between the “low-risk” digital health apps and devices for general health management and those apps and devices that needed FDA 510(k) clearance. Now Apple has set down some rules for digital health companies aspiring to use the technology giant's iOS network.