During a recent webinar, Of Counsel Benjamin Zegarelli and Associate Pat Ouellete discussed the regulations surrounding medical devices and software in the healthcare industry. They emphasized the importance of staying informed and being able to navigate the ever-changing landscape of healthcare regulations. The session covered topics such as the FDA’s approach to regulating AI/ML devices, including recent marketing authorization decisions and enforcement actions, as well as other healthcare applications of AI/ML and the associated regulatory challenges. The speakers also highlighted potential pitfalls and emerging regulations, new regulations for EMR developers, and proposed non-discrimination requirements related to healthcare providers’ use of AI by the Office for Civil Rights.
Additionally, they touched on the recent White House AI Executive Order and the sections that are relevant to the use of AI in healthcare, as well as recent proposed legislation at both the state and federal levels. The webinar ended with a preview of the next session in the AI webinar series, which will focus on employment and is scheduled for May 23rd. This webinar series aims to provide valuable insights into the use of AI in various aspects of healthcare and the legal implications that come with it. Subscribe to stay informed about future sessions and learn more about this important topic.
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