Life Sciences and AI - Shaping Digital Transition in the Pharma Sector

• Jurisdiction: European Union
• Year: 2024

Speaker

Miranda Cole is a partner at Norton Rose Fulbright LLP, based in the Brussels and London offices, specializing in antitrust and competition law. With over 20 years of experience, she focuses on the technology, life sciences and healthcare, transport, and energy sectors. Miranda is a trusted advisor to global life sciences and technology companies, offering strategic guidance on navigating complex regulatory landscapes.

Her expertise includes merger control, abuse of dominance, anticompetitive agreements, and compliance under Articles 101 and 102 TFEU. She also represents clients in proceedings before the European courts in Luxembourg. Miranda has extensive experience supporting businesses facing heightened regulatory scrutiny and aligning competition policies with emerging regulatory frameworks.

In addition to her practice, Miranda is deeply involved in helping clients adapt to new competition rules and policies globally, ensuring they remain compliant and competitive in rapidly evolving industries.

Topic

The presentation provides an analysis of the European Union's regulatory frameworks shaping the digital transition in the life sciences and pharmaceutical sectors, with a focus on artificial intelligence (AI) and data governance. Delivered by Miranda Cole of Norton Rose Fulbright LLP, it explores the implications of recent and upcoming EU legislation, including the AI Act, Data Act, and Digital Services Act, for stakeholders in the life sciences industry.

Key topics include the AI Act’s risk-based approach, which categorizes AI systems into prohibited, high-risk, and low-risk categories. The presentation emphasizes compliance requirements for high-risk AI systems, particularly in healthcare, where AI solutions may qualify as medical devices. These systems are subject to stringent obligations, such as transparency, data governance, human oversight, and conformity assessments aligned with the EU Medical Device Regulation...