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AI: Towards A Harmonised Regulatory Framework?

Authors: Christiana Aristidou, Antria Christodoulou


The European Commission is about to release a significant set of policies, in which a proposal for a “Regulation on a European Approach for Artificial intelligence” will be included, establishing rules for the development, placement on the market and use of AI systems in the EU, implementing a proportionate risk-based approach. In particular, it intends to address the risks caused by particular uses of AI through a set of complementary, proportionate as well as flexible rules.

This will be the first time trying to define a comprehensive regulatory framework for AI in the European Union, focusing on important aspects such as the definition of high-risk applications, regulatory obligations for providers of AI systems, the post-market surveillance of AI, the conformity assessment of high-risk AI applications and the possible creation of a new AI Board.

Moreover, it prohibits certain AI practices considered as harmful, while particular restrictions and safeguards are proposed in relation to certain uses of remote biometric identification systems. Importantly, these rules will give Europe a major role in setting the global gold standard, while AI developers, deployers and users will be given the clarity they require by intervening merely in those cases that existing national and EU legislations do not include.

In fact, the legal framework for AI suggests a clear, easy to comprehend approach, based on four distinct levels of risk: unacceptable risk, high risk, limited risk and minimal risk.

A European approach to Artificial intelligence.

Context of the proposal (Summary)

1.1 Reasons for and objectives of the proposal

  • Proposal for a Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act).
  • AI can bring a broad array of economic and societal benefits across the whole spectrum of industries and social activities. It can also support socially and environmentally advantageous effects and offer significant competitive benefits to companies and the European economy. On the other hand, it can also generate new risks or negative consequences for individuals or the society.
  • The EU is committed to strive for a balanced approach, due to the speed of technological transformation and possible challenges.
  • The Union intends to maintain the EU’s technological leading role and to secure that Europeans can take advantage from new technologies developed and functioning according to Union values, fundamental rights and principles.
  • On 19 February 2020 the Commission released the White Paper on AI – A European approach to excellence and trust, which intends to boost research and industrial capacity and ensure fundamental rights.
  • The proposal is based on EU values and fundamental rights and purporting to provide people and other users the confidence to welcome AI-based solutions, while inviting businesses to develop them.
  • AI should be a tool for people and be a force for societal good with the ultimate goal to increase human well-being.
  • The AI rules available in the Union market or otherwise affecting people in the Union should therefore be human-centric, in order for people to trust that the technology is used in a safe manner that is compliant with the law, including the respect of fundamental rights.
  • The proposal responds to clearly expressed requests from the European Parliament (EP) and the European Council, which have constantly expressed calls for legislative action to secure a well-functioning internal market for artificial intelligence systems (‘AI systems’) where both benefits and risks of AI are sufficiently addressed at Union level.
  • The Commission presents the proposed regulatory framework on Artificial Intelligence with the following particular objectives:

o  ensure that AI systems placed on the Union market and used are safe and respect existing law on fundamental rights and Union values;

o  ensure legal certainty to facilitate investment and innovation in AI;

o  enhance governance and effective enforcement of existing law on fundamental rights and safety requirements applicable to AI systems;

o  facilitate the development of a single market for lawful, safe and trustworthy AI applications and prevent market fragmentation.

  • In order for those objectives to be succeeded, this proposal introduces “a balanced and proportionate horizontal regulatory approach to AI” that is restricted to the minimum necessary requirements to address the risks and issues came with AI, without excessively constraining or hindering technological development or otherwise inappropriately increasing the cost of placing AI solutions on the market.
  • Harmonised rules for the development, placement on the market and use of AI systems in the Union are set by the proposal using a proportionate risk-based approach.
  • A governance system at Member States level will impose the suggested rules, developing on existing structures, while a cooperation mechanism at Union level will set-up a European Artificial Intelligence Board.
  • Further measures are also suggested to support innovation, specifically through AI regulatory sandboxes as well as other measures to minimize the burden of regulation and to support Small and Medium-Sized Enterprises (‘SMEs’) and start-ups.

Proposal for a Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act).

  1. The purpose of this Regulation is to enhance the operation of the internal market by laying down a uniform legal framework especially for the development, marketing and use of artificial intelligence in conformity with the values of the Union.
  2. The existence of a variety of national rules may cause fragmentation of the internal market and reduce legal certainty for operators that either develop or use AI systems. As a result, a consistent and high level of protection throughout the Union should be secured, while divergences impeding the free circulation of AI systems and associated products and services within the internal market should be prevented.
  3. Artificial intelligence can help to a broad range of economic and societal advantages across the whole spectrum of industries and social activities.
  4. AI may also create risks and give rise to harm towards the public interests and rights that are protected by Union law.

Title I: General provisions

Title II: Prohibited artificial intelligence practices

Title III: High-risk AI systems

Title IV: Transparency obligations for certain AI systems

Title V: Measures in support of innovation

Title VI: Governance

Title VII: EU database for stand-alone high-risk AI systems

Title VIII: Post-market monitoring, information sharing, market surveillance

Title IX: Codes of conduct

Title X: Confidentiality and penalties

Title XI: Delegation of power and committee procedure

Title XII: Final provisions