The EU AI Act is a comprehensive regulation designed to ensure AI systems are safe, transparent, and respectful of fundamental rights. It categorises AI systems based on their risk levels—ranging from minimal risk to high risk—and establishes specific requirements for each category. For the pharmaceutical and healthcare industries, this means greater scrutiny, enhanced data quality, robust compliance frameworks, and significant operational adjustments. As the industry increasingly relies on AI for drug discovery, clinical trials, and patient care, understanding and adapting to the EU AI Act is crucial for compliance and innovation. This guide to the EU AI Act will ensure that you understand how to prepare for its full implementation while remaining at the forefront of innovation.

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Introduction:

The EU AI Act represents a significant regulatory development aimed at harmonising rules for Artificial Intelligence (AI) within the European Union. This legislation is designed to address the risks associated with AI, ensuring its safe and ethical deployment. For the pharmaceutical and healthcare sectors, understanding the implications of the AI Act is crucial, given the industry’s increasing reliance on AI for drug discovery, clinical trials, and patient care.

What is the EU AI Act?

The EU AI Act is a comprehensive regulation designed to ensure AI systems are safe, transparent, and respectful of fundamental rights. It categorises AI systems based on their risk levels—ranging from minimal risk to high risk—and establishes specific requirements for each category.

High-risk AI systems, such as those used in healthcare, must comply with stringent standards to mitigate potential harms and biases. AI systems that present unacceptable risks, such as real-time biometric identification in public spaces, are banned outright (DW, 2024) (Reed Smith LLP, 2024).

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