Medical Device Legal News with Sam Bernstein: Episode 11
Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
The U.S. National Institute of Standards and Technology (NIST) is seeking comment on four draft publications meant to promote safe, secure, and trustworthy artificial intelligence (AI) systems. Two drafts provide guidance to...more
Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more