03 Jan, 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...
18 Oct, 2023 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...
26 Jul, 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...
17 Jul, 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...
25 Oct, 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...
03 Oct, 2022 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...
15 Sep, 2022 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...
12 Jul, 2022 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...