Jan 03, 2024 European Medicines Agency publishes five-year AI workplan By Coran Darling Keo Shaw Danny Tobey Marco de Morpurgo +1 more... Show less On December 18, 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published their 2023-2028...
Nov 01, 2023 AI Chatroom – conversational videos about the rapidly evolving legal landscape of AI By Kristi Kung Keo Shaw In this episode of DLA Piper’s video series AI ChatRoom, we focus on emerging issues in artificial intelligence and digital health. This...
Jul 26, 2023 European Medicines Agency opens dialogue on use of AI in pharmaceutical life cycle By Danny Tobey Keo Shaw Marco de Morpurgo To open a dialogue with developers, academics, and regulators, the European Medicines Agency (EMA) recently published a draft Reflection...
Jul 17, 2023 Industry organizations establish practical frameworks for digital health and healthcare AI tools By Dan Kagan Keo Shaw Rachel Ludwig Kristi Kung Danny Tobey +2 more... Show less Digital health tools have proliferated in recent years, particularly during the exponential adoption of telehealth and remote care during...
Mar 17, 2023 FDA calls for comments on artificial intelligence in drug manufacturing By Keo Shaw Bethany Hills Daniel Tobey Geoffrey Levitt +1 more... Show less On March 1, 2023, FDA’s Center for Drug Evaluation and Research (CDER) published a discussion paper on artificial intelligence (AI) in...
Dec 19, 2022 FDA Denies Requests for Revocation of EUA for Covid Vaccine for Use in Individuals 5-11 and 12-17 Years of Age By Melissa Gilmore Jarred Reiling Keo Shaw The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
Oct 25, 2022 Your clinical decision support software may now be regulated by FDA as a medical device: 4 key takeaways from FDA’s webinar on the Final CDS Guidance By Keo Shaw Bethany Hills Danny Tobey In the wake of FDA’s long-awaited final guidance for the regulation of Clinical Decision Support Software, many software developers and...
Sep 23, 2022 Regulate your thoughts: the age of brain-machine interfaces and the neural lace is almost here By Coran Darling Keo Shaw Gareth Stokes You wake up early to the sound of an alarm that only exists inside your own head, and it is silenced automatically as soon as you’re...