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The EU Artificial Intelligence Act: An Overview (EN)

The European Union’s groundbreaking AI legislation, known as the EU Artificial Intelligence Act, is a comprehensive regulatory framework designed to govern the use and development of artificial intelligence technology. This article explores its significance and implications for some healthcare stakeholders.

Introduction: The EU Artificial Intelligence Act represents a significant milestone in the world of technology regulation. This article delves into the purpose, scope, and potential impact of this pioneering legislation on healthcare startups, investors, and the broader AI landscape.

Why the EU Artificial Intelligence Act?

  1. Regulating AI: The primary objective of the EU Artificial Intelligence Act is to establish regulatory control over artificial intelligence, ensuring that this innovative technology is used and developed under certain guidelines.
  2. Safety and Transparency: It seeks to make AI usage safe by ensuring human oversight, transparency, traceability, non-discrimination, and environmental friendliness.
  3. Defining AI Systems: One of its core objectives is to provide a technology-neutral definition of AI systems, addressing the current lack of consensus within the scientific community.

Classification of AI Systems:

The legislation proposes a classification system based on the level of risk posed by AI systems:

  1. Unacceptable Risk: AI systems that pose a direct threat to individuals, such as those involved in cognitive behavioural manipulation, are banned.
  2. High Risk: AI systems that could negatively impact safety or fundamental rights, like medical devices, fall into this category. They are subject to rigorous assessment prior to being introduced to the European market and throughout their lifecycle
  3. Limited Risk: AI systems with less risk, such as those generating images, must comply with minimal transparency requirements.
  4. Low or Minimal Risk: AI systems with low or no risk are not subject to specific obligations.

Stringent Requirements for High-Risk AI Systems:

High-risk AI systems must adhere to a set of requirements, including registration in an EU-wide database and compliance with risk management measures like technical documentation, data training, and cybersecurity.

Timeline and Implications:

Negotiations on the final form of the law are ongoing, with the aim of concluding by the end of the year. This legislation will most certainly have implications for healthcare startups and investors:

  • Streamlined Compliance: It can simplify data privacy compliance and security measures.
  • Increased Costs: However, it may lead to extra expenses, including compliance costs, external audits, insurance costs, and potential fines for non-compliance.
  • Impact on Investment and Innovation: There may be concerns about reduced AI investment and stifled innovation, as well as potential competition challenges for EU companies compared to unregulated foreign counterparts.

Unanswered questions

The EU Artificial Intelligence Act raises several important questions :

  • Should AI Remain Unbridled? What is the balance between regulation and innovation in AI development?
  • Cross-Border AI Operation: How can AI be effectively operated across borders while adhering to diverse regulations?
  • Comprehensive Framework: Can a single framework cover the myriad aspects of AI, from ethics to technology?
  • Agility in Regulation: How can Europe maintain agility in developing regulated AI systems while keeping pace with rapid technological advancements and non-regulated foreign markets?
  • What will the enforcement mechanisms be ?

These questions highlight the complex nature of AI regulation and its broader implications.

In conclusion, the EU Artificial Intelligence Act represents a pioneering step toward regulating AI systems in the European Union. Its impact on healthcare startups, investors, and the broader AI ecosystem will become clearer as negotiations progress, offering both opportunities and challenges for stakeholders in this dynamic field.

Being aware of all future implications will be essential for our promising startups.

Written by Caroline Sai

Angels Santé & the European Health Investor Network