EU Artificial Intelligence Act

The European Union recently became the first body to significantly regulate artificial intelligence, with its parliament overwhelmingly approving the EU AI Act (523 in favor, 46 against, 49 votes not cast).

The Act, which was initially conceived in 2021, categorizes AI technology into four levels of risk: minimal, limited, high, and unacceptable, and outlines how these levels will be assessed. The Act is expected to have a global impact, much like the EU's General Data Protection Regulation (GDPR), and could serve as a guideline for organizations aiming to become AI-responsible.

The Act applies to any AI systems where the output is intended to be used in the EU, regardless of where they originate. It does not regulate the development of the technology, but rather its application. The Act also includes a process to address unforeseen consequences through continuous monitoring. The impact of the Act on businesses, competition, and AI investment is yet to be seen.

The definition of an AI system is located on Chapter I, article 3: ‘AI system’ means a machine-based system designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;

• Access full text here (PDF in english): Artificial Intelligence Act
• Acces the High-level summary of the AI Act
• Access the AI Act Explorer here (the AI Act Explorer is currently being updated to reflect the texts adopted by the European Parliament on 13 March 2024)
• Access the EU AI Act Compliance Checker: so you can answer the question How will the EU AI Act affect my AI system?

After a long conversation with several key opinion leaders, industry experts and SMEs, here are the questions that were raised and we need to work on:

1. How will the EU AI Act impact the use of AI in our healthcare services?
2. What measures do we need to take to ensure our AI systems comply with the new regulations?
3. How will the four levels of risk outlined in the Act affect our current and future AI projects?
4. How can we prepare for the continuous monitoring and assessment process included in the Act?
5. What are the potential consequences for our organization if we fail to comply with the Act?
6. How does the definition of an AI system in the Act align with our current use of AI in healthcare?
7. How might this Act influence our AI investment decisions?
8. How can we use the Act as a guideline to become more AI-responsible in our healthcare practices?
9. How will the Act affect our partnerships with AI developers outside the EU?
10. How can we ensure that our AI systems, regardless of where they originate, are compliant when their output is intended to be used in the EU?

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