1/3/2024 1:43:30 PM 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...
10/18/2023 1:11:49 PM Announcing AI ChatRoom – conversational videos about the rapidly evolving legal landscape of AI - Episode 1: AI + Compliance + Litigation By Danny Tobey DLA Piper is pleased to present AI ChatRoom, a captivating series of conversational videos created to help businesses understand the...
7/26/2023 8:22:01 AM 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...
7/17/2023 12:50:11 PM 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...
10/25/2022 12:14:45 PM 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...
10/3/2022 2:20:32 PM Your clinical decision support software may now be regulated by FDA as a medical device By Bethany Hills Danny Tobey Dan Kagan Jianyuan Hua +1 more... Show less Clinical Decision Support (CDS) software is an area driven by innovative technologies that is often intertwined with traditional clinical...
9/15/2022 1:47:57 PM AI risk assessments: Future-proofing your innovation when rules can change mid-game - At the Intersection of Science and Law Podcast Series By Danny Tobey In this episode, DLA Piper partner Danny Tobey is joined by Aviva Wein, Assistant General Counsel at Johnson & Johnson, to discuss how...
7/12/2022 12:47:33 PM Coming EU legislation will change the AI regulatory environment for healthcare technology and life sciences companies By Coran Darling Mark O'Conor Danny Tobey The proposed EU AI Regulation, a comprehensive regime for the purposes of regulating AI in the EU, is set to impact organizations around...