Artificial Intelligence & Digital Health

Machine learning models (ML) including Large Language Models (LLMs), mHealth applications, wearable medical devices, Software as a Medical Device (SaMD), Medical Device Artificial Intelligence (MDAI), General Purpose AI systems, foundation models and conversational agents raise complex legal challenges. We deliver legal advice across the AI lifecycle. Our firm advises healthcare companies on Regulation (EU) 2024/1689 (EU AI Act) compliance, including AI system classification under Article 6, prohibited practices under Article 5, conformity assessment for high-risk AI systems, post market monitoring and substantial modification analysis under MDCG 2025-6 and AIB 2025-1. We advise on the European Health Data Space under Regulation (EU) 2025/327, on GDPR compliance for AI training datasets, on Data Act obligations under Regulation (EU) 2023/2854, on cybersecurity under NIS2 and CRA, on intellectual property protection for AI generated outputs, on product liability under the new Directive (EU) 2024/2853, on cloud computing arrangements and on the legal qualification of digital therapeutics (DTx). We support start ups on incorporation, funding rounds, IP licensing and regulatory market access.