News Archive

Nicolas P. Terry, Hall Render Professor of Law and Executive Director of the Hall Center for Law and Health, was recently quoted in a Law.com article about possible Food and Drug Administration review of Apple’s new medical device-like health monitoring features for Apple Watch.

The online article, "Does Apple Need FDA Review to Add Medical Monitoring Features to Apple Watch?" published on September 28, was prompted by speculation building by the FDA’s recent announcement that Apple was one of nine companies the agency has approved for a pilot Digital Health Software Precertification program.

Professor Terry was quoted as saying that such a device "would likely fall squarely within [the] definition of medical device—both hardware and software aspects,” and explained that the “limited health and fitness aspects" of the watch were allowed by the FDA under a published regulatory guidance "under which [the] FDA exercised regulatory discretion for classes of mobile medical apps and devices."

Law.com also asked Professor Terry what traditional medical device manufacturers might think about Apple and the FDA. Professor Terry told the website that companies like Apple, Samsung and Fitbit are "not really disrupting [the] traditional medical device market," but that device manufacturers are "more likely keeping a watchful eye on Google Deep Mind or Verily."

Read the article at http://www.law.com/sites/almstaff/2017/09/28/does-apple-need-fda-review-to-add-medical-monitoring-features-to-apple-watch/?slreturn=20170909113642.