The newly approved EU Artificial Intelligence Act is set to impact the life sciences sector, with significant implications for AI-driven technologies in healthcare. The legislation aims to harmonize AI regulations while safeguarding fundamental rights and promoting innovation.
New EU AI Act Set to Impact Life Sciences Sector
The European Parliament approved the EU Artificial Intelligence (AI) Act in March 2024. Negotiated with Member States in December 2023, the legislation seeks to harmonize AI regulations across the EU, promoting innovation while safeguarding fundamental rights, democracy, the rule of law, and environmental sustainability from high-risk AI applications.
The Act will affect various sectors, with significant implications for life sciences and healthcare. This includes AI-driven technologies such as telemonitoring tools, digital therapeutics, healthcare robots, and diagnostic algorithms. Life sciences companies utilizing AI in research, product development, clinical trials, and post-market surveillance must adhere to the Act’s requirements.
The regulation covers both embedded and non-embedded AI, aiming to ensure comprehensive oversight. Notably, it regulates machine-based systems with self-learning capabilities and the ability to generate outputs influencing physical or virtual environments.
The EU AI Act also addresses general-purpose AI models, which are defined by their ability to perform a wide range of tasks and adapt autonomously. These regulations intend to align with existing EU laws, minimizing duplication and ensuring seamless compliance for high-risk AI systems.
Pending final adoption by the Council of the EU and subsequent publication, the Act will be phased in over 24 months.
