13 Dec, 2024 The EU Updates its Products Liability Directive to Include AI By Zach Harned On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This...
19 Nov, 2024 Upcoming FDA Meeting Focuses on Generative AI in Medical Devices By Jefferson Lin The U.S. Food and Drug Administration will focus on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices” during its...
06 Nov, 2024 We're Back from The 2024 Digital Health Counsel AI Summit! By Jennifer Yoo Jefferson Lin Zach Harned After attending the 2024 Digital Health Counsel AI Summit, the transformative impact of AI and data-driven innovation on healthcare is...
01 Oct, 2024 California Gov. Vetoes Bill Seeking to Regulate Private Equity Healthcare Transactions By Jennifer Yoo On Saturday, September 28, California Gov. Gavin Newsom vetoed a controversial bill that would have restricted private equity and hedge...
09 Sep, 2024 The Interplay of Appeals to the Federal Circuit from Both District Court and the PTAB By Jennifer Bush The recent case involving United Therapeutics' patent on Tyvaso and Liquidia's Yutrepia sheds light on the complexities of patent law....
27 Jun, 2024 Change Breach Results in Notification Clarity By Sari Heller Ratican Jennifer Yoo On May 31, 2024, more than four months after the February 2024 Change Healthcare ransomware attack, the U.S. Department of Health and...
14 Jun, 2024 SCOTUS Unanimously Preserves Access to Abortion Pill By Jennifer Yoo On Thursday, June 13, the Supreme Court maintained access to the abortion pill, mifepristone. This medication, in conjunction with...
06 Jun, 2024 Entities Big and Small Must Soon Comply with Washington's My Health My Data Act By Sari Heller Ratican The deadline is fast approaching for Washington “small businesses” to comply with the state's My Health My Data Act (MHMDA). The MHMDA,...