Artificiële Intelligentie & Recht
Innovation, Technology & Law

Blog over Kunstmatige Intelligentie, Quantum, Deep Learning, Blockchain en Big Data Law

Blog over juridische, sociale, ethische en policy aspecten van Kunstmatige Intelligentie, Quantum Computing, Sensing & Communication, Augmented Reality en Robotica, Big Data Wetgeving en Machine Learning Regelgeving. Kennisartikelen inzake de EU AI Act, de Data Governance Act, cloud computing, algoritmes, privacy, virtual reality, blockchain, robotlaw, smart contracts, informatierecht, ICT contracten, online platforms, apps en tools. Europese regels, auteursrecht, chipsrecht, databankrechten en juridische diensten AI recht.

Berichten in European Law
EU Artificial Intelligence Act: The European Approach to 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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Artificial Intelligence, Artificiële Intelligentie, Certification, European Law, Europees recht, Kunstmatige Intelligentie, Machine Learning, Stanford, WetgevingMauritz KopStanford Law SchoolEU Artificial Intelligence Act, regulatory framework, Pyramid of criticality, pre-market conformity, CE-marking, Certification, Risk-based approach, High-Risk AI Systems, Impact Assessment, Trustworthy AI by Design, life-cycle auditing, Ethics and Responsible AI, Worldwide standards, Extraterritorial effect, Fourth Industrial Revolution, Data Act, GDPR, FFD, MDR, Awareness, Stanford - Vienna Transatlantic Technology Law Forum, Stanford University, European Commission, Product safety regime, Machine learning trainingdatasets, Democratic values, human rights, rule of law, legal sandboxes, innovation, flourishing AI-ecosystem, Legal Compliance
Safeguards for accelerated market authorization of vaccines in Europe
Safeguards for accelerated market authorization of vaccines in Europe

by Suzan Slijpen & Mauritz Kop

This article has been published by the Stanford Law School ‘Center for Law and the Biosciences’, Stanford University, 15 March 2021. link to the full text: https://law.stanford.edu/2021/03/15/safeguards-for-accelerated-market-authorization-of-vaccines-in-europe/

Download the article here: Slijpen_Kop_Manufacturing Licenses and Market Authorization Vaccines EU-Stanford Law

The first COVID-19 vaccines have been approved

People around the globe are concerned about safety issues encircling the accelerated introduction of corona vaccines. In this article, we discuss the regulatory safeguards for fast-track market authorization of vaccines in Europe. In addition, we explain how the transmission of European Union law into national Member State legislation works. We then clarify what happens before a drug can be introduced into the European market. We conclude that governments should build bridges of mutual understanding between communities and increase trust in the safety of authorized vaccines across all population groups, using the right messengers.

Drug development normally takes several years

Drug development normally takes several years. The fact that it has been a few months now seems ridiculously short. How is the quality and integrity of the vaccine ensured? That people - on both sides of the Atlantic - are concerned about this is entirely understandable. How does one prevent citizens from being harmed by vaccines and medicines that do not work for everyone, because the admission procedures have been simplified too much?

The purpose of this article is to shed a little light upon the accelerated market authorization procedures on the European continent, with a focus on the situation in the Netherlands.

How a vaccine is introduced into the market

In June 2020, the Dutch government, in close cooperation with Germany, France and Italy, formed a Joint Negotiation Team which, under the watchful eye of the European Commission, has been negotiating with vaccine developers. Its objective: to conclude agreements with drug manufacturers at an early stage about the availability of vaccines for European countries. In case these manufacturers are to succeed in developing a successful vaccine for which the so-called Market Authorization (MA) is granted by EMA or CBG, this could lead to the availability of about 50 million vaccines (for the Netherlands alone).

Who is allowed to produce these vaccines?

Who is allowed to produce these vaccines? The Dutch Medicines Act is very clear about this. Only "market authorization holders" are allowed to manufacture medicines, including vaccines. These are parties that have gone through an extensive application procedure, who demonstrably have a solid pharmaceutical quality management system in place and have obtained a pharmaceutical manufacturing license (the MIA, short for Manufacturing and Importation Authorisation). This license is granted after assessment by the Health and Youth Care Inspectorate of the Ministry of Health, Welfare & Sport (IGJ) – by Farmatec. Farmatec is part of the CIBG, an implementing body of the Ministry of Health, Welfare and Sport (VWS). The M-license is mandatory for parties who prepare, or import medicines.

Read more at the Stanford Center for Law and the Biosciences!

Read more on manufacturing licenses, fast track procedures and market authorization by the European Medicines Agency (EMA) and the EC, harmonisation and unification of EU law, CE-markings, antigenic testing kits, mutations, reinfection, multivalent vaccines, mucosal immunity, Good Manufacturing Practices (GMP), pharmacovigilance, the HERA Incubator, clinical trials, compulsory vaccination regimes and continuous quality control at Stanford!

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Ethics, European Law, Farmaceutica, Healthcare, Grondrechten, Innovation, Licenties, Medicine, Medische Producten, Stanford, VaccinsMauritz KopAIRechtVaccines, Corona, COVID-19, SARS-CoV-2, Medication, Law and Biosciences, Stanford Law School, Suzan Slijpen, Mauritz Kop, Stanford University, Marked Authorization, RIVM, Europe, USA, Pharmaceutical Manufacturing License, Dutch Medicines Act, Slijpen Legal, AIRecht, CIBG, Farmatec, EudraGMDP, IGJ, CBG, EMA, FDA, Warp Speed, EUA, fast-track, herd immunity, CHMP, GMP, quality management system, pharmacovigilance, Healthcare, Intellectual Property, Artificial Intelligence, clinical trials, innovation, democracy, ethics, fundamental rights, technology transfer, HERA Incubator, harmonisation, unification, reception, EU law, compulsory vaccination regimes, multivalent vaccines, CE-marking, mutations, reinfection, antigenic testing kits, nasal spray, mucosal immunity
Shaping the Law of AI: Transatlantic Perspectives
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”.

Download the article here: Kop_Shaping the Law of AI-Stanford Law

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
Artificial Intelligence, Big data, Data processing, Ethics, European Law, Innovation, Intellectual Property, Machine Learning, Research, University, Law of AIMauritz KopStanford Law SchoolLaw of AI, Legal-Ethical Framework, Regulation, European Commission, Trustworthy AI, Risks, Data Act, Access, Machine Learning, Overarching Core AI Rules, Interoperability, Legal Transplant, United States, Impact Assessment, Comparative Law, Values, Ethically Aligned Design, IP, Incentives, Innovation, Mauritz Kop, Stanford-Vienna Transatlantic Technology Law Forum, Stanford Law School
We hebben dringend een recht op dataprocessing nodig
We hebben dringend een recht op dataprocessing nodig

Deze column is gepubliceerd op platform VerderDenken.nl van het Centrum voor Postacademisch Juridisch Onderwijs (CPO) van de Radboud Universiteit Nijmegen. https://www.ru.nl/cpo/verderdenken/columns/we-dringend-recht-dataprocessing-nodig/

5 juridische obstakels voor een succesvol AI-ecosysteem

Eerder schreef ik dat vraagstukken over het (intellectueel) eigendom van data, databescherming en privacy een belemmering vormen voor het (her)gebruiken en delen van hoge kwaliteit data tussen burgers, bedrijven, onderzoeksinstellingen en de overheid. Er bestaat in Europa nog geen goed functionerend juridisch-technisch systeem dat rechtszekerheid en een gunstig investeringsklimaat biedt en bovenal is gemaakt met de datagedreven economie in het achterhoofd. We hebben hier te maken met een complex probleem dat in de weg staat aan exponentiële innovatie.

Auteursrechten, Privacy en Rechtsonzekerheid over eigendom van data

De eerste juridische horde bij datadelen is auteursrechtelijk van aard. Ten tweede kunnen er (sui generis) databankenrechten van derden rusten op (delen van) de training-, testing- of validatiedataset. Ten derde zullen bedrijven na een strategische afweging kiezen voor geheimhouding, en niet voor het patenteren van hun technische vondst. Het vierde probleempunt is rechtsonzekerheid over juridisch eigendom van data. Een vijfde belemmering is de vrees voor de Algemene verordening gegevensbescherming (AVG). Onwetendheid en rechtsonzekerheid resulteert hier in risicomijdend gedrag. Het leidt niet tot spectaculaire Europese unicorns die de concurrentie aankunnen met Amerika en China.

Wat is machine learning eigenlijk?

Vertrouwdheid met technische aspecten van data in machine learning geeft juristen, datawetenschappers en beleidsmakers de mogelijkheid om effectiever te communiceren over toekomstige regelgeving voor AI en het delen van data.

Machine learning en datadelen zijn van elementair belang voor de geboorte en de evolutie van AI. En daarmee voor het behoud van onze democratische waarden, welvaart en welzijn. Een machine learning-systeem wordt niet geprogrammeerd, maar getraind. Tijdens het leerproces ontvangt een computer uitgerust met kustmatige intelligentie zowel invoergegevens (trainingdata), als de verwachte, bij deze inputdata behorende antwoorden. Het AI-systeem moet zelf de bijpassende regels en wetmatigheden formuleren met een kunstmatig brein. Algoritmische, voorspellende modellen kunnen vervolgens worden toegepast op nieuwe datasets om nieuwe, correcte antwoorden te produceren.

Dringend nodig: het recht op dataprocessing

De Europese Commissie heeft de ambitie om datasoevereiniteit terug te winnen. Europa moet een internationale datahub worden. Dit vereist een modern juridisch raamwerk in de vorm van de Europese Data Act, die in de loop van 2021 wordt verwacht. Het is naar mijn idee cruciaal dat de Data Act een expliciet recht op dataprocessing bevat.

Technologie is niet neutraal

Tegelijkertijd kan de architectuur van digitale systemen de sociaal-maatschappelijke impact van digitale transformatie reguleren. Een digitaal inclusieve samenleving moet technologie actief vormgeven. Technologie an sich is namelijk nooit neutraal. Maatschappelijke waarden zoals transparantie, vertrouwen, rechtvaardigheid, controle en cybersecurity moeten worden ingebouwd in het design van AI-systemen en de benodigde trainingdatasets, vanaf de eerste regel code.

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Artificial Intelligence, Data delen, Data processing, Privacywetgeving, Machine Learning, Kunstmatige Intelligentie, Intellectueel Eigendom, Innovation, Informatierecht, Europees recht, Europese Richtlijn, European Law, Ethics, Cloud Computing, Big data, AuteursrechtMauritz KopAIRecht recht op dataprocessing, data delen, machine learning, Kunstmatige Intelligentie, artificial intelligence, juridisch, wetgeving, Europees recht, privacy, rechtszekerheid, intellectueel eigendom, economisch eigendom, trainingsdatasets, bedrijfsgeheim, federated learning, blockchain, technologie, exponentiele innovatie, CPO, Radboud Universiteit, VerderDenken, Mauritz Kop, Stanford University, Harvard, EU Data Act, Open Data, Digitaal DNA, Unicorns
Mauritz Kop becomes TTLF Fellow at Stanford University
Mauritz Kop becomes TTLF Fellow at Stanford University

AIRecht Partner joins Stanford Law School’s Transatlantic Thinktank

Honoured and thrilled to join Stanford Law School’s Transatlantic Thinktank and become TTLF Fellow at Stanford University. It is the Silicon Valley, California based Transatlantic Technology Law Forum’s objective to raise professional understanding and public awareness of transatlantic challenges in the field of law, science and technology, as well as to support policy-oriented research on transatlantic issues in the field.

Human Centred AI & IPR policy

My comparative, interdisciplinary research project focuses on Human Centred AI & IPR policy. How to realize an impactful transformative tech related IP (intellectual property) policy that facilitates an innovation optimum and protects our common Humanist moral values at the same time?

Focus beyond Intellectual Property Law

With an additional focus beyond IP, the research shall present ideas on how Europe and The United States could apply sustainable disruptive innovation policy pluralism (i.e. mix, match and layer IP alternatives such as competition law and government-market hybrids) to enable fair-trading conditions and balance the effects of exponential innovation within the Transatlantic markets. The research envisages that the presented ideas and viewpoints will be refined towards more actual policies in Brussels and Washington.

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Amerikaans recht, Artificial Intelligence, Europees recht, European Law, University, IPR, Intellectual Property, Research, InnovationMauritz KopAIRechtMauritz Kop, TTLF Fellow, Stanford University, Stanford Law School, Silicon Valley, Research, European Law, artificial intelligence, Intellectual Property Law, Innovation, Policy, Legislators, Lawmakers, Disruption, Emerging Tech, 4th Industrial Revolution, Humanist moral values, Sustainable Disruptive Innovation Policy Pluralism, Public Domain, Res Publicae ex Machina, Pareto improvement, strategy, Amsterdam, Netherlands, USA, AIRecht, Law, Science & Technology (LST)