By Jessica Kim Cohen, Becker's Hospital Review | January 12, 2019 The FDA has drafted a new regulatory framework outlining how it wants to review digital health products, based on a pilot program the agency rolled out in 2017. Four things to know: 1. The FDA's pilot, dubbed the Digital [...]
By Diana Manos, Healthcare IT News | January 10, 2019 The new Digital Health Innovation Action Plan is part of the agency’s broader effort to improve oversight of technologies. The Food and Drug Administration (FDA) has released its first ever guidance on how it plans to work toward a more [...]
By Kevin Truong, MedCity News | January 8, 2019 A range of companies at the Digital Health showcase in San Francisco discussed how they view the changing regulatory environment within the category of software as a medical device. Traditional medical devices have a largely episodic regulatory process, with a major [...]
By Samara Rosenfeld, Healthcare Analytics News | November 20, 2018 The U.S. Food and Drug Administration (FDA) is creating a framework that could enable most prescription drug software developers to avoid formal review.The FDA said the rules will help guide the safe and effective use of medicines and help patients [...]
By Dave Muoio, MobiHealth News | November 15, 2018 As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals. Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to [...]
By Fred Donovan, HealthIT Security | September 28, 2018 The FDA’s proposed cybersecurity unit would help establish the public-private CyberMed Safety Board mentioned in the FDA's medical device safety action plan issued in April, FDA spokeswoman Stephanie Caccomo recently told HealthITSecurity.com. The cybersecurity unit would be part of a Center [...]
