Regulators around the world are increasingly starting to acknowledge that conventional approaches to regulation may act as an impediment to digital innovation in healthcare and are looking to modernise health regulation.
The Bill aims to protect patient safety from medical device cyber attacks and improve medical device security
On Wednesday, June 8, 2016, a bill was introduced in Congress that would, if passed, amend the Federal Food, Drug, and Cosmetic Act to require physicians and physicians’ offices to submit reports to FDA on hazards relating to medical devices.