What You Need to Know About EU AI Act

The EU’s Artificial Intelligence Act mandates a human-centric approach, emphasising risk-based regulation, data governance, and accountability hopefully to foster innovation. But what does the mean for labs?

The European Union’s Artificial Intelligence Act (AI Act) marks a pivotal moment in the regulation of Artificial Intelligence and not just within the EU. It is the first harmonised global attempt to put into place guidance and safeguards for the development and deployment of AI technologies. This transformative legislation, adopted by the European Parliament in December 2023 introduces a comprehensive legal framework that aims to foster innovation while ensuring AI technologies are developed and used in a responsible and ethical manner.

For laboratories and research institutions, this act delineates clear regulatory obligations and opportunities for innovation, presenting what should be a shift in how AI is developed and utilised in the scientific community.

A fundamental aspect of the AI Act is its risk-based approach to regulation. The Act states:

“The purpose of this Regulation is to promote the uptake of human centric and trustworthy artificial intelligence and to ensure a high level of protection of health safety fundamental rights democracy and rule of law and the environment from harmful effects of artificial intelligence systems in the Union while supporting innovation and improving the functioning of the internal market”​​

Artificial Intelligence Act (P9_TA(2023)0236)

For laboratories engaged in the development or deployment of AI systems, this classification necessitates a thorough assessment of the potential risks associated with their AI technologies. Laboratories must now ensure that their AI systems meet specific requirements regarding transparency, data governance, and accountability before they can be introduced to the market or utilised in research activities

One of the key implications of the AI Act for laboratories is the heightened emphasis on data governance and privacy. AI systems often rely on large datasets for training and operation, raising concerns about data protection and the ethical use of personal information. The legislation aligns with the European Union’s robust data protection framework, reinforcing the importance of safeguarding personal data and ensuring transparency in AI system operations. Laboratories must adopt rigorous data management practices, ensuring that the datasets used in AI applications comply with the EU’s data protection standards.

The AI Act also mandates transparency and accountability for AI systems, particularly those identified as high risk. This is critical in fields such as healthcare and pharmaceuticals, where AI systems are increasingly employed for diagnostics and treatment. The Act underscores that “

High-risk AI systems should only be placed on the Union market or put into service if they comply with certain mandatory requirements.

Artificial Intelligence Act (P9_TA(2023)0236)

These requirements are designed to ensure that AI systems are not only technologically advanced but also operable in a transparent and accountable manner, thereby fostering public trust in AI applications.

Furthermore, the AI Act provides a stable regulatory environment that encourages innovation and research in AI technologies. By clarifying the legal framework for AI, the Act enables laboratories and research institutions to explore new AI applications with the assurance that their developments are in line with European values and legal standards. This supportive environment is anticipated to accelerate technological advancements, contributing to the development of AI solutions that can address societal challenges effectively.

Additionally, the Act places a strong emphasis on ethical considerations in the development and deployment of AI systems. It mandates a human-centric approach to AI, where ethical principles are integrated into the research and development process. This approach is vital for ensuring that AI technologies are developed with a focus on respecting human dignity, privacy, and fundamental rights, enhancing the societal acceptance and responsible use of AI.

If your lab is currently developing an AI system then in order to comply with the EU AI Act it can be summarised that there are 5 key areas that you need to think about.

  • Assess AI System Risks: Determine whether your AI systems are classified as high-risk under the EU Act.
  • Implement Data Protection Measures: Adhere to GDPR standards by ensuring data used in AI systems is handled transparently and securely.
  • Document AI Decisions: Maintain clear records of how AI systems make decisions, readying them for review and explanation.
  • Embed Ethical Principles: Integrate ethics from the outset, designing AI systems to be fair, accountable, and non-discriminatory.
  • Leverage Regulatory Framework for Innovation: Use the Act’s guidelines as a foundation to innovate responsibly and develop new AI technologies.

The European Union’s Artificial Intelligence Act represents a significant step forward in the regulation of AI, and certainly a first step that will be followed by other governments. AI technologies are developing fast and this act certainly tries to allow for that change and growth but only time will tell if it can achieve its impressive goals.


Matthew has been writing and cartooning since 2005 and working in science communication his whole career. Matthew has a BSc in Biochemistry and a PhD in Fibre Optic Molecular Sensors and has spent around 16 years working in research, 5 of which were in industry and 12 in the ever-wonderful academia.

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