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Berichten met de tag Ethics and Responsible AI
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”.

Download the article here: Kop_EU AI 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.

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Suzan Slijpen Conference Speaker at the National University of Ireland

Legal Aspects of AI in Healthcare

On 16 August 2019, Suzan Slijpen LL.M. had the honour to speak about the legal aspects of the development and use of artificial intelligence (a disruptive technology) in healthcare, at the AI in Medicine Conference organized by the Irish Association of Physicists in Medicine (IAPM). The conference took place in Galway, at the National University of Ireland (School of Physics, NUI Galway/ OÉ Gaillimh). Suzan is a senior legal consultant at AIRecht.nl, and specializes in eHealth & medical devices, pharmaceutical law, European food law and contract law, from an AI helicopterview. She is also founder and lawyer at boutique law office Slijpen Legal.

Key topics of the Artificial Intelligence in Medicine lecture

Key legal topics that Suzan addressed in her Artificial Intelligence in Medicine lecture:

1. AI & Robotics: Disruptive Technologies: Synergetic effects of 4th Industrial Revolution technologies like robotics, big data, quantum computing, Blockchain, Virtual Reality (VR) and Internet of Things (IoT).

2. eHealth and medical devices: legal classification.

3. Fundamental Rights: Safeguarding of Fundamental Rights in AI applications, Rights of Patients.

4. Ethics and responsible AI: 1791 French Revolution Values, HLEG Concept of Trustworthy AI.

5. Intellectual Property on AI and Health Apps: Licensing your IP.

6. Liability for damages caused by smart robots: who is liable for misdiagnosis by an AI algorithm?

7. Legislation and Jurisprudence.

8. AI Impact Assessment: remove roadblocks for AI.

Legislation and regulations regarding AI in Healthcare

Do you want to know more about legislation and regulations regarding AI in Healthcare, or Legal aspects of disruptive tech in Medicine? Or do you want to organize a workshop or conference yourself and invite us as a speaker or teacher? Then please contact us about the possibilities!

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