Practice Area

We advise life sciences clients on the legal and regulatory aspects of integrating artificial intelligence solutions into their business.

Our work involves advising on the application of AI across a broad range of operations, from drug discovery and diagnostics to clinical trials and digital health. We also provide advice on the impact of existing EU medical device laws on AI systems and general-purpose AI systems.

Our cross-disciplinary team helps clients navigate evolving frameworks, including the EU AI Act, GDPR and medical device regulations, ensuring their use of AI is compliant, ethical and commercially sound. We provide strategic guidance on risk allocation, liability, IP and data governance, empowering clients to innovate with confidence. Our unrivalled sectoral knowledge means we understand how AI is reshaping business models, and how to turn regulatory complexity into a competitive advantage.

Recent Work

  • Providing EU regulatory advice to a global pharmaceutical company on the application of the AI Act to the regulation of drug development and clinical research.

  • Advising some of the world’s leading GenAI providers on the application of EU medical device law to their general-purpose AI systems.

  • Providing EU regulatory advice to a global consumer electronics and fitness company on the application of the AI Act to its health products.

  • Advising a provider of a conversational AI assistant on the impact of EU medical device law on its services.

  • Providing EU regulatory advice to a Fortune 100 Global healthcare company on the application of the AI Act to their products.

Dedicated Team

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Brian McElligott

Brian McElligott

Partner

Head of Artificial Intelligence

+353 86 150 4771 brianmcelligott@mhc.ie View Profile on MHC.ie
Michaela Herron

Michaela Herron

Partner

Head of Life Sciences Regulatory, Product Liability

+353 86 607 6005 mherron@mhc.ie View Profile on MHC.ie
Jamie Gallagher

Jamie Gallagher

Partner

Regulatory, Product Liability

+353 86 068 9361 jamesgallagher@mhc.ie View Profile on MHC.ie