Key BCBS Official Asks Whether FDA's Software Precertification Will Gauge Clinical Safety, Effectiveness

Editor's Note: This story has been updated with the correct title for BCBSA's Naomi Aronson. The head of Blue Cross Blue Shield Association's clinical evaluation, innovation and policy shop questions whether FDA's proposed software precertification program -- which would allow certain companies to take new medical software to market more easily -- will offer adequate clinical evaluations of safety and effectiveness. The BCBSA official asked, during a two-day workshop held at the National Institutes of Health, how...