European Commission launches brand-new AI package

On Wednesday 21 April, the European Commission published its long-awaited regulation package on artificial intelligence (AI), including new rules and actions to position Europe as a hub for trustworthy AI application. The package includes a Communication on Fostering a European approach to Artificial Intelligence, a new regulatory framework on AI, a 2021 Coordinated Plan on Artificial Intelligence, and a Proposal for a Regulation on Machinery Products.

The package includes a Communication on Fostering a European approach to Artificial Intelligence, a new regulatory framework on AI, a 2021 Coordinated Plan on Artificial Intelligence, and a Proposal for a Regulation on Machinery Products.

The Communication on Fostering a European approach to Artificial Intelligence overarches the Coordinated Plan and the Regulation proposal. It emphasises that the EU needs to thrive with global leadership in this area, while recognising its dual effect of risks and opportunities in sectors such as healthcare and education. Moreover, it draws attention to the aspect of trust in these technologies, which requires a proportionate and risk-based European regulatory approach.

The new regulatory framework consists of a proposal for a Regulation on a European approach for AI. This regulation aims to ensure trust in AI applications by means of setting high safety requirements and obligations for providers and users of those AI systems. More specifically, it aims to achieve following four objectives:

  1. Ensure that AI systems placed on the Union market and used are safe and respect existing law on fundamental rights and Union values; 
  2. Ensure legal certainty to facilitate investment and innovation in AI; 
  3. Enhance governance and effective enforcement of existing law on fundamental rights and safety requirements applicable to AI systems; 
  4. Facilitate the development of a single market for lawful, safe and trustworthy AI applications and prevent market fragmentation.

As previously announced, the Regulation proposes a single definition for AI and lays down a risk methodology to define “high-risk” AI systems that pose significant risks to the health and safety or fundamental rights of persons. 

As to health, the proposed Regulation notes that the application of AI can bring great value to the healthcare sector while acknowledging potential risks, particularly in terms of diagnostic systems, systems supporting human decisions, disease prevention and treatment.

The Coordinated Plan will be strengthening close collaboration between the Commission and Member States. It proposes the following four overarching goals:

  1. Set enabling conditions for AI development and uptake in the EU;
  2. Make the EU the place where excellence thrives from the lab to the market;
  3. Ensure that AI works for people and is a force for good in society;
  4. Build strategic leadership in high-impact sectors, including the health care sector.

In the area of health, the Coordinated Plan proposes, among others, the following objectives that will be undertaken by the Commission:

  • Evaluate and revise the general pharmaceutical legislation to adapt to cutting-edge products, scientific developments (e.g. personalised medicine) and technological transformation; 
  • Support the development and deployment of applications of the ‘digital twin in health and care’, where AI technologies will have a central role, through the promotion of a functional, inclusive EU system;
  • Invest in the development and clinical validation of robust, fair and trustworthy demand-driven AI-powered systems for treatment and care, including personalised prevention and risk prediction of diseases, with a particular focus on among others the use/re-use of unstructured health data.

The Proposal for a Regulation on Machinery Products, which will be replacing the Machinery Directive, will ensure that the new generation of machinery guarantees the safety of users and consumers as well as the safe integration of the AI system into the overall machinery, with the aim of innovation. As such, this Regulation will bring more legal clarity to the current provisions, simplifying the administrative burden and costs for companies by allowing digital formats for documentation and adapting conformity assessment fees for SMEs.

With respect to next steps, the European Parliament and the Member States in the Council will have to adopt their reports on these Commission proposals for regulation during the ordinary legislative procedure.

 

 

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