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.

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Mauritz Kop joins Expert Panel on Quantum Technologies of the Council of Canadian Academies (CCA)
Mauritz Kop joins Expert Panel on Quantum Technologies of the Council of Canadian Academies (CCA)

Mauritz Kop joins the multidisciplinary Expert Panel on Quantum Technologies of the Council of Canadian Academies (CCA) over 2022-2023, chaired by Professor Raymond Laflamme. In November 2023, The Expert Panel on the Responsible Adoption of Quantum Technologies published their final report titled Quantum Potential. https://cca-reports.ca/reports/quantum-technologies/

The Council of Canadian Academies (CCA) Investigates Future Impact of Quantum Technologies

As Chair, Dr. Raymond Laflamme will lead a multidisciplinary group with expertise in quantum technologies, economics, innovation, ethics, and legal and regulatory frameworks. The Panel will answer the following question:

In light of current trends affecting the evolution of quantum technologies, what opportunities and challenges do these present in Canada?

The Quantum Potential Report

Quantum technologies are poised to play a major role in Canada’s future, from its national security to its economic standing. While Canada is among the global leaders in quantum research, it nevertheless faces challenges in the adoption of these technologies as they approach market readiness. Quantum Potential, a new expert panel report from the Council of Canadian Academies (CCA), outlines a responsible approach to quantum-technology adoption — a critical step toward ensuring Canada’s global competitiveness in the decades ahead.

Quantum Computing, Sensing, and Communications

Quantum Potential considers quantum computing, sensing, and communications, three categories of quantum technology at varying levels of maturity. While these technologies may strengthen digital infrastructure, improve data security, and optimize processes across a range of economic sectors, they also pose significant risks, such as misuse by malicious actors. Risks associated with quantum technologies span ethical, legal, social, and policy realms; without sufficient consideration, they may compromise public trust in quantum technologies, limit research funding, and stifle innovation.

The Commercialization Potential of Quantum Technologies in Canada

Quantum Potential explores the commercialization potential of quantum technologies, articulates Canada’s position within the global quantum value chain, and examines those conditions and policy levers that might promote their responsible adoption. https://cca-reports.ca/reports/quantum-technologies/

Quantum technologies offer opportunities to harness the properties of quantum mechanics for a breadth of applications, many of them novel. Though many quantum technologies are several years away from reaching market, it is believed that they have the potential to revolutionize many industries as they reach widespread commercial availability. Domestic industries will need to adopt these technologies if they wish to remain globally competitive, as will governments hoping to ensure national and economic security, public safety, and the integrity of critical infrastructure. To date, Canada has made noteworthy investments in the research and development of quantum technologies but has focused less on mechanisms to stimulate their diffusion and adoption.

Ethical, Legal, Social, and Policy Implications (Quantum-ELSPI)

The adoption of quantum technologies also carries significant ethical, legal, social, and policy implications. These include potential threats to data security and digital infrastructure, anticompetitive pressures by market-dominant firms, mass surveillance and privacy loss, regulatory uncertainty, inequitable access to technology, and social challenges related to employment and public trust in science. However, there are many strategies that could help address these challenges and stimulate the responsible adoption of quantum technologies. These include public-private co-operation, pro-competition oversight and policies, industry-led initiatives, and the creation of a diverse quantum workforce. In order to maximize the benefits of quantum technologies while mitigating potential risks, responsible approaches to adoption should use state-sanctioned and self-regulating measures – including quantum impact assessments, soft-law mechanisms, and consultations with stakeholders – to anticipate the effects of technological change.

Thanks to the sponsors National Research Council Canada and Innovation; Science and Economic Development Canada for facilitating this Report.

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Quantum Technology, Quantum ELSPI, Quantum ComputingMauritz Kopresponsible quantum technology, Canada, Mauritz Kop, strategy, policy, law, ethics, regulation, Raymond Laflamme, Intellectual Property Law, Governance, innovation, fair competition
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
What are the main requirements for AI systems in Healthcare?
What are the main requirements for AI systems in Healthcare?

Main barriers to adoptation of Artificial Intelligence in healthcare.

Absence of a specific AI law, or clear legal framework from the perspective of both professional users (A) and patients (B).

When constructing such a framework, it is important to make a distinction between the various sub-areas of healthcare, such as research and development, professional care providers and recipients of care. Because each sub-area has different needs.

Barriers for professional users.

It is simply unclear for companies and private and academic research institutes in the medical sector what is and is not allowed in the field of AI, blockchain, computer & machine vision and robotics. Both at European level and at national level. This knowledge is important for the commodification of their inventions/creations. Two practical examples are permission from Farmatec and obtaining a CE-marking.

Requirements for sustained use of AI in healthcare.

Since traceability and transparency are key within any healthcare (and food-feed) system, blockchain could play an important role in sustained use of AI in healthcare.

A EU AI Directive or Regulation should be able to implement and/or adhere to principles of Eudralex (The body of European Union legislation in the pharmaceutical sector), Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in particular.

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Algoritmes, Artificiële Intelligentie, AVG / GDPR, Big data, Blockchain, Cognitive Computing, Computer Vision, Deep Learning, Europees recht, Europese Richtlijn, Ethiek, Farmaceutica, Grondrechten, Kunstmatige Intelligentie, Machine Learning, Privacywetgeving, Productontwikkeling, Robotica, Robotlaw, Tech Startups, Virtual Reality, Wetgeving, Healthcare, eHealth, Medical DevicesMauritz KopArtificiële Intelligentie & Rechthealthcare, Artificial Intelligence Impact Assessment, robotics, blockchain, intellectual property, insurance, liability, damages, AI, Farmatec, FDA, QAQC-systems, GMP, GDP, medicine, Eudralex, Medical Devices, eHealth, wearables, legislation, European Union, European AI Alliance, privacy, legal and ethical framework, CE-marking, pilots, computer vision, machine learning, virtual reality, Law School, Medical School, fundamental rights, copyrights, computer generated works, regulation, directive, Machinery, standards, path dependency, traceability, surgery, patients, big data, cognitive computing, knowledge, legal certainty, innovation, tech startups, incentive & reward