MedTech Dive October 15, 2018
Dive Brief:
- Medical apps have enormous potential to improve healthcare outcomes and lower costs but will need a regulatory framework that encourages rigorous evaluation of which apps can make a difference, asserts a Viewpoint article published on JAMA online.
- The FDA recently announced a precertification program for mobile apps, but as currently designed it doesn’t require evaluation of whether the products improve patient health outcomes before they are introduced to the marketplace, the authors said. Their concerns over the so-called Pre-Cert program echo those raised by Senate Democrats last week.
- In addition to a set of robust tools to objectively assess the merits of health apps, the policy approach should require the FDA to review the apps for...