Voeding, Pharma & Recht

Blog over Voedingsmiddelenwetgeving, cosmeticaregels, Europese wetgeving en geneesmiddelenrecht

Blog met kennisartikelen inzake het levensmiddelenrecht. Aandacht voor cosmeticawetgeving, Europese Regelgeving en juridisch advies farmaceutisch recht. Daarnaast juridische wetenswaardigheden en kantoorupdates van Slijpen Legal BV!

Berichten met de tag European Commission
EU Artificial Intelligence Act: The European Approach to AI

Stanford - Vienna Transatlantic Technology Law Forum, Transatlantic Antitrust and IPR Developments, Stanford University, Issue No. 2/2021

New Stanford tech policy research: “EU Artificial Intelligence Act: The European Approach to AI”.

EU regulatory framework for AI

On 21 April 2021, the European Commission presented the Artificial Intelligence Act. This Stanford Law School contribution lists the main points of the proposed regulatory framework for AI.

The Act seeks to codify the high standards of the EU trustworthy AI paradigm, which requires AI to be legally, ethically and technically robust, while respecting democratic values, human rights and the rule of law. The draft regulation sets out core horizontal rules for the development, commodification and use of AI-driven products, services and systems within the territory of the EU, that apply to all industries.

Legal sandboxes fostering innovation

The EC aims to prevent the rules from stifling innovation and hindering the creation of a flourishing AI ecosystem in Europe. This is ensured by introducing various flexibilities, including the application of legal sandboxes that afford breathing room to AI developers.

Sophisticated ‘product safety regime’

The EU AI Act introduces a sophisticated ‘product safety framework’ constructed around a set of 4 risk categories. It imposes requirements for market entrance and certification of High-Risk AI Systems through a mandatory CE-marking procedure. To ensure equitable outcomes, this pre-market conformity regime also applies to machine learning training, testing and validation datasets.

Pyramid of criticality

The AI Act draft combines a risk-based approach based on the pyramid of criticality, with a modern, layered enforcement mechanism. This means, among other things, that a lighter legal regime applies to AI applications with a negligible risk, and that applications with an unacceptable risk are banned. Stricter regulations apply as risk increases.

Enforcement at both Union and Member State level

The draft regulation provides for the installation of a new enforcement body at Union level: the European Artificial Intelligence Board (EAIB). At Member State level, the EAIB will be flanked by national supervisors, similar to the GDPR’s oversight mechanism. Fines for violation of the rules can be up to 6% of global turnover, or 30 million euros for private entities.

CE-marking for High-Risk AI Systems

In line with my recommendations, Article 49 of the Act requires high-risk AI and data-driven systems, products and services to comply with EU benchmarks, including safety and compliance assessments. This is crucial because it requires AI infused products and services to meet the high technical, legal and ethical standards that reflect the core values of trustworthy AI. Only then will they receive a CE marking that allows them to enter the European markets. This pre-market conformity mechanism works in the same manner as the existing CE marking: as safety certification for products traded in the European Economic Area (EEA).

Trustworthy AI by Design: ex ante and life-cycle auditing

Responsible, trustworthy AI by design requires awareness from all parties involved, from the first line of code. Indispensable tools to facilitate this awareness process are AI impact and conformity assessments, best practices, technology roadmaps and codes of conduct. These tools are executed by inclusive, multidisciplinary teams, that use them to monitor, validate and benchmark AI systems. It will all come down to ex ante and life-cycle auditing.

The new European rules will forever change the way AI is formed. Pursuing trustworthy AI by design seems like a sensible strategy, wherever you are in the world.

Meer lezen
Shaping the Law of AI: Transatlantic Perspectives

Stanford-Vienna Transatlantic Technology Law Forum, TTLF Working Papers No. 65, Stanford University (2020).

New Stanford innovation policy research: “Shaping the Law of AI: Transatlantic Perspectives”.

The race for AI dominance

The race for AI dominance is a competition in values, as much as a competition in technology. In light of global power shifts and altering geopolitical relations, it is indispensable for the EU and the U.S to build a transatlantic sustainable innovation ecosystem together, based on both strategic autonomy, mutual economic interests and shared democratic & constitutional values. Discussing available informed policy variations to achieve this ecosystem, will contribute to the establishment of an underlying unified innovation friendly regulatory framework for AI & data. In such a unified framework, the rights and freedoms we cherish, play a central role. Designing joint, flexible governance solutions that can deal with rapidly changing exponential innovation challenges, can assist in bringing back harmony, confidence, competitiveness and resilience to the various areas of the transatlantic markets.

25 AI & data regulatory recommendations

Currently, the European Commission (EC) is drafting its Law of AI. This article gives 25 AI & data regulatory recommendations to the EC, in response to its Inception Impact Assessment on the “Artificial intelligence – ethical and legal requirements” legislative proposal. In addition to a set of fundamental, overarching core AI rules, the article suggests a differentiated industry-specific approach regarding incentives and risks.

European AI legal-ethical framework

Lastly, the article explores how the upcoming European AI legal-ethical framework’s norms, standards, principles and values can be connected to the United States, from a transatlantic, comparative law perspective. When shaping the Law of AI, we should have a clear vision in our minds of the type of society we want, and the things we care so deeply about in the Information Age, at both sides of the Ocean.

Meer lezen