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 met de tag Mauritz Kop
Mauritz Kop calls for a Quantum Governance Act at the University of Copenhagen, Faculty of Law

Much enjoyed giving a lecture titled ‘Quantum-ELSPI: A Call for a Quantum Governance Act’ on Thursday June 9, 2022 at the University of Copenhagen, Faculty of Law. This was an internal CeBiL event that took place before The Quantum Future symposium, organized by the Royal Danish Academy of Sciences and its newly established Committee for Quantum Information and Quantum Computing, together with the Niels Bohr Institute’s Quantum Life Centre.

EU Quantum Governance Act

With its own Copenhagen interpretation of quantum mechanics in which physical phenomena must be observed and measured to exist, the University of Copenhagen, Faculty of Law was the perfect place to propose an outline for a novel Quantum Governance Act on a European level, fostering open innovation while putting targeted, technology and industry specific risk based controls in place. The EU Quantum Act should jointly optimize advancing quantum technology (investment and innovation) with safeguaring quantum technology, society and humankind (guardrails, standards, values, IP protection and national security). For example, it could contain a product safety regime as found in the EU AI Act, combined with pro-innovation mechanisms as found in the US CHIPS Act. In addition, I connected regulating quantum to regulating general purpose technologies (GPT) like artificial intelligence (AI), but also to nanotechnology, biotechnology, semiconductors, and last not least to managing dual use fissionable materials such as nuclear isotopes and nuclear weapons, utilizing export and intellectual property controls.

The Law of Quantum: Quantum Regulatory Frameworks

The Quantum & Law lecture gave an overview of work done over the past 3 years on quantum regulatory frameworks, incentive and rewards systems, competition law, beyond intellectual property innovation law, ethics, national security policy, standardization, technology impact assessment, benchmarking and certification published or forthcoming in high impact journals at both sides of the Atlantic. My talk ended with discussing the latest research findings pertaining to the Law of Quantum, and Quantum-ELSPI academic disciplines. Thanks to the participants for their inspiring questions and comments!

Panel Debate about the Quantum Future at the Royal Danish Academy of Sciences

The brilliant lectures on atoms, photons, qubits, the nature of quantum information, the history of quantum physics, and current research into quantum computer paradigms -including combatting decoherence on both software and hardware levels- at The Quantum Future symposium where highly enjoyable. This fascinating program ended with a panel debate on how quantum technology will change our society, at the beautiful building of the Royal Danish Academy of Sciences, in attendance of fellow jurists Nicholson Price II, Louise C. Druedahl, Marcelo Corrales Compagnucci, and Agnieszka Radziwon.

Surfing the Waves of the Second Quantum Revolution

The panel debate at the Academy -superbly moderated by Nanna Bonde Thylstrup- gave a true, almost symptomatic picture of the various stakeholders' viewpoints and positions. But we are learning to speak each other's language better and better, a crucial and exciting step when it comes to balancing the societal impact of our mystical family of quantum technologies. Surfing the waves of the second quantum revolution requires building bridges between disciplines, beyond traditional research silos. Bringing together the humanities, social and natural sciences to spur sustainable innovation driven by a golden triangle of academia, government and industry is essential.

Thank you to Professor Timo Minssen and his team at CeBiL for the kind invite. https://jura.ku.dk/cebil/

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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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Mauritz Kop Visiting Quantum & Law Scholar at Stanford Law School

Mauritz Kop is Visiting Quantum & Law Scholar at Stanford Law School in 2022-2023. Kop was invited by Prof. Mark Lemley, the William H. Neukom Professor of Law at Stanford Law School and the Director of the Stanford Program in Law, Science and Technology.

Advanced legal research on Regulating Quantum technology at Stanford Law School

This Stanford Law School ‘Regulating Quantum Technology’ research project will perform a detailed study of how to sensibly regulate the suite of quantum technologies including computing, sensing and networking, unifying the world of the large with that of the small. It intends to answer questions on how our innovation architecture should be constructed, so that benefits of quantum computing, sensing, simulation, and communication -including quantum-AI hybrids- will be distributed equitably, and risks proportionally addressed. Building upon foundational work done on quantum and AI innovation policy mechanisms, national security strategy, standardization & certification, ethics, responsible quantum R&D, governance principles, technology impact assessments, data ownership and intellectual property in quantum software and hardware structures - published in flagship Journals at Stanford, Harvard, Yale, Berkeley, Physics World, Max Planck, Springer Nature, and Oxford - the transdisciplinary research aims to develop an integrated, holistic vision on smart governance and regulation of quantum & AI infused digital transformation.

Happy to speak at a number of in person events in the nexus of AI, Quantum & Law in the coming weeks:

Scarcity, Regulation and the Abundance Society Roundtable at Stanford

1. April 22, Scarcity, Regulation and the Abundance Society Roundtable at Stanford, where I will present a chapter titled ‘Abundance & Equality’ for the book project co-edited by Mark Lemley and Deven Desai. The chapter connects good governance to the end of scarcity and unifies equality with technology driven abundance, by introducing a novel Post-Rawlsian Equal Relative Abundance (ERA) principle of distributive justice. As befits tradition, we will insert musical interludes for piano, with me performing ‘Stanford Theme & Variations’ à l'improviste in the Stanford Law School Faculty Lounge. https://law.stanford.edu/publications/scarcity-regulation-and-the-abundance-society/

Patenting Quantum Computing Technologies talk at Quantum & Law Conference in Lund

2. April 29, presenting our 'Patenting Quantum Computing Technologies and Market Power: A Quantitative Analysis' research together with my academic friends Profs Mateo Aboy (Cambridge) and Timo Minssen (Copenhagen) at the Quantum & Law Conference in Lund. We wrote 2 papers focusing on IP portfolio strategies, trade & state secrets, and their interface with antitrust regulations, utilizing industry and quantum domain specific mixed theoretical & empirical research methods. http://quantum-law.org/conference/

EU AI Act Presentation at AI World Summit Americas in Montreal

3. May 4, I’ll present an overview of the EU AI Act with its ‘product safety framework’ and market entrance requirements, constructed around a set of 4 risk categories at the AI World Summit Americas in Montreal. We will discuss whether it provides a regulatory framework for AI that should be adopted globally during a Headline panel with Prof. Gillian Hadfield (Toronto) and Dr José-Marie Griffiths (President Dakota State), moderated by Meredith Broadbent (Washington). https://americas.worldsummit.ai/speakers/

Keynote Quantum Computing Ethics at IBM Research

4. May 17, I’ll give a keynote on Quantum Computing Ethics at IBM Research during their Tech for Racial and Social Justice Seminar (internal event), organized by Dr Aminat Adebiyi, moderated by Dr Mira Wolf-Bauwens, with whom I worked together on the WEF Quantum Computing Principles. https://www.weforum.org/publications/quantum-computing-governance-principles/

Quantum Impact Assessment (QIA)

5. We are creating a world’s first application-driven Quantum Impact Assessment (QIA) in The Netherlands -raising ELSA awareness and removing barriers for adoption of QT- with a diverse, multidisciplinary team lead by Prof. Bart Schermer (Leiden) and Daniël Frijters for the Centre for Quantum & Society, made possible by ECP and Quantum Delta NL. https://quantumdelta.nl/centre-for-quantum-and-society

Quantum-ELSPI special for Springer Nature with Luciano Floridi

6. Meanwhile I am editing the Quantum-ELSPI special for Springer Nature on the Ethical, Legal, Social and Policy Implications of Quantum Technology, together with EiC Prof. Luciano Floridi (Oxford). https://law.stanford.edu/publications/quantum-elspi-ethical-legal-social-and-policy-implications-of-quantum-technology/

More exciting projects soon ...

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World Economic Forum Quantum Computing Ethics & Governance Principles

During 2021, Mauritz Kop helped design the World Economic Forum Quantum Governance Principles. In January 2022, the World Economic Forum released its accompanying Quantum Computing Governance Principles Insight Report. The report and principles were developed as part of a co-design process over the course of 2021 with a diverse set of global quantum stakeholders from industry, academia and government.

Governance Principles for the Responsible Design and Adoption of Quantum Computing

In 2022, our multidisciplinary WEF expert group published the first set of governance principles for the responsible design and adoption of quantum computing technology. A global multi stakeholder initiative to create an ethical framework enabling the responsible design and adoption of quantum computing. Quantum computing, though at its early stages, will help provide very significant advances in our computing capabilities and will have a considerable impact on improving the state of the world in the coming years. It could have a revolutionary impact on human well-being, national security, and global society, along with potential commercial applications across industries.

The Quantum Computing Ethics project is part of the World Economic Forum’s Shaping the Future of Technology Governance: Artificial Intelligence and Machine Learning Platform.

10 Guiding Principles for Quantum Computing published at Yale

The Principles build in part on the prior 10 Guiding Principles for Quantum Computing published March 30, 2021 in the Yale Journal of Law & Technology in my article titled: Establishing a Legal-Ethical Framework for Quantum Technology.

There, I argue that the unique physical characteristics of quantum mechanics demand universal guiding principles of responsible, human-centered quantum technology. To this end, the article proposes ten guiding principles for the development and application of quantum technology. These ground rules aim to put controls in place and integrate our common democratic norms, standards and values into the design of our future hi-tech systems as much as possible

Law and ethics frequently interrelate. Ethical standards for quantum should however be a supplementation to legal measures, and not a replacement. Ethics alone can never be enough when regulating high-risk technologies like dual use quantum tech and quantum artificial intelligence. To make sure all groups of society benefit from quantum and AI we have to put controls and guardrails in place that address identified risks and incentivise sustainable innovation.

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Quantum ELSPI: Ethical, Legal, Social and Policy Implications of Quantum Technology

Call for Papers Quantum ELSPI

Delighted to announce that the Quantum ELSPI call for papers is now open! AIRecht Director & Stanford Law School TTLF Fellow Mauritz Kop has the honor to guest-edit a Topical Collection for Digital Society, a new journal edited by Luciano Floridi (Oxford Internet Institute). This project is a Stanford/Oxford collaboration that aims to explore uncharted territories of Ethical, Legal, Social and Policy Implications of Quantum Technology. Articles should be submitted before 15 February 2022 and will be double blind peer reviewed. Accepted articles will be published by Springer Nature.

You can find the Quantum ELSPI collection page here: https://link.springer.com/collections/eiebhdhagd.

Download the Springer Nature Quantum-ELSPI Call for Papers here: TC_Quantum ELSPI_Call for papers

ELSPI stratagems for quantum technology

Anticipating spectacular advancements in real-world quantum driven products and services, the time is ripe for governments, academia and the market to prepare regulatory and business strategies that balance their societal impact. This topical collection seeks to provide informed suggestions on how to maximize benefits and mitigate risks of applied quantum technology. It intends to deliver insights and actionable recommendations on how and when to address identified opportunities and challenges, which can then be refined into plausible, evidence-based policy decisions by stakeholders across the world.

Special edition of Digital Society

In this special edition of Digital Society, we aim for scholars to reflect on the multifaceted questions associated with Quantum ELSPI. In addition to learning from history and connecting quantum to other big picture trends, quantum should be treated as something completely unique and unprecedented. We especially welcome cross-disciplinary contributions that look beyond research silos and integrate law, economic theory, ethics, sociology, philosophy of science, quantum information science, and sustainable innovation policy, and that consider how to improve ELSPI stratagems for quantum technology. We encourage authors to be pioneers in this complex, and at times counterintuitive field.

Multifaceted questions associated with Quantum ELSPI

Questions and topics that could be addressed by contributions in the topical collection are not restricted to, but could include the following:

-Potential strategies for industries facing disruption such as the cybersecurity industry and financial institutions. What role could antitrust law, intellectual property, prizes, fines, funding, taxes, lifelong learning and labor mobility play while incentivizing innovation?

-How should dual use applications be managed? How do we balance freedom with control? What role could a Quantum Treaty play to make our world a safer place?

-The creation of a list of quantum-specific themes, goals, benefits and risks that need to be addressed by universal, overarching principles of responsible quantum design and application, including a definition of hi-risk quantum-systems.

-How can policy makers learn from history and adjacent fields - such as AI, biotechnology, nanotechnology, semiconductors and nuclear - when regulating exponential innovation and ensuring equal access to quantum computing, sensing and the quantum internet? How can winner take all effects and a quantum divide be prevented? To what extent does governing digitization driven by classical computing paradigms (binary digits) differ from governing quantum computing (qubits)?

-It is not inconceivable that the development and uptake of transnational quantum principles will run along the lines of democratic and authoritarian tech governance models. Against that background, how can we embed cultural norms, liberal values, democratic principles, human rights and fundamental freedoms in globally accepted interoperability standards?

-How can we implement ethically aligned design into our quantum systems architecture and infrastructure? How can quantum technology impact assessments help achieve these goals?

Guest-Editor Quantum ELSPI: Mauritz Kop (Stanford Law School, Stanford University)

Editor-in-Chief Digital Society: Luciano Floridi (Oxford Internet Institute, Oxford University)

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De Wet op de Artificiële Intelligentie

Een bewerkte versie van deze bijdrage 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/wet-artificiele-intelligentie-belangrijkste-punten/

Nieuwe regels voor AI gedreven producten, diensten en systemen

Op 21 april 2021 presenteerde de Europese Commissie haar langverwachte Wet op de Artificiële Intelligentie (AI). Deze concept Verordening geeft regels voor de ontwikkeling, commodificatie en gebruik van AI gedreven producten, diensten en systemen binnen het territorium van de Europese Unie. Het was bemoedigend te zien dat het team van President Ursula von der Leyen een belangrijk aantal van onze strategische aanbevelingen op het gebied van de regulering van AI heeft overgenomen, danwel zelfstandig tot dezelfde conclusies is gekomen.

Doelstellingen wettelijk kader voor AI

De concept Verordening biedt horizontale overkoepelende kernregels voor kunstmatige intelligentie die op alle industrieën (verticals) van toepassing zijn. De wet beoogt de hoge maatstaven van het EU Trustworthy AI paradigma te codificeren, dat voorschrijft dat AI wettig, ethisch en technisch robuust dient te zijn en daartoe 7 vereisten hanteert.

De Wet op de Artificiële Intelligentie heeft de volgende 4 doelstellingen:

1. ervoor zorgen dat AI-systemen die in de Unie in de handel worden gebracht en gebruikt, veilig zijn en de bestaande wetgeving inzake grondrechten en waarden van de Unie eerbiedigen;

2. rechtszekerheid garanderen om investeringen en innovatie in AI te vergemakkelijken;

3. het beheer en de doeltreffende handhaving van de bestaande wetgeving inzake grondrechten en veiligheidsvoorschriften die van toepassing zijn op AI-systemen, verbeteren;

4. de ontwikkeling van een eengemaakte markt voor wettige, veilige en betrouwbare AI-toepassingen vergemakkelijken en marktversnippering voorkomen.“

Risico gebaseerde aanpak kunstmatig intelligente applicaties

Om deze doelstellingen te realiseren combineert de concept Artificial Intelligence Act een risk-based approach op basis van de pyramid of criticality, met een modern, gelaagd handhavingsmechanisme. Dit houdt onder meer in dat er voor AI applicaties met een verwaarloosbaar risico een licht wettelijk regime geldt, en onacceptabel risico applicaties verboden worden. Tussen deze 2 uitersten gelden er naarmate het risico toeneemt strengere voorschriften. Deze variëren van vrijblijvende zelfregulerende soft law impact assessments met gedragscodes, tot zwaar, multidisciplinair extern geauditeerde compliance vereisten inzake kwaliteit, veiligheid en transparantie inclusief risicobeheer, monitoring, certificering, benchmarking, validatie, documentatieplicht en markttoezicht gedurende de levenscyclus van de toepassing.

Handhaving en governance

De definitie van hoog risico AI applicaties binnen de diverse industriële sectoren is nog niet in steen gehouwen. Een ondubbelzinnige risicotaxonomie zal bijdragen aan rechtszekerheid en biedt belanghebbenden een adequaat antwoord op vragen over aansprakelijkheid en verzekering. Om ruimte voor innovatie door SME’s waaronder tech-startups te waarborgen, worden er flexibele AI regulatory sandboxes geïntroduceerd en is er IP Action Plan opgesteld voor intellectueel eigendom. De concept Verordening voorziet tenslotte in de installatie van een nieuwe handhavende instantie op Unieniveau: het European Artificial Intelligence Board. De EAIB zal op lidstaatniveau worden geflankeerd door nationale toezichthouders.

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Quantum Computing and Intellectual Property Law

Berkeley Technology Law Journal, Vol. 35, No. 3, 2021

New Stanford University Beyond IP Innovation Law research article: “Quantum Computing and Intellectual Property Law”.

By Mauritz Kop

Citation: Kop, Mauritz, Quantum Computing and Intellectual Property Law (April 8, 2021). Berkeley Technology Law Journal 2021, Vol. 35, No. 3, pp 101-115, February 8, 2022, https://btlj.org/2022/02/quantum-computing-and-intellectual-property-law/

Download the article here: Kop_QC and IP Law BTLJ

Please find a short abstract below:

Intellectual property (IP) rights & the Quantum Computer

What types of intellectual property (IP) rights can be vested in the components of a scalable quantum computer? Are there sufficient market-set innovation incentives for the development and dissemination of quantum software and hardware structures? Or is there a need for open source ecosystems, enrichment of the public domain and even democratization of quantum technology? The article explores possible answers to these tantalizing questions.

IP overprotection leads to exclusive exploitation rights for first movers

The article demonstrates that strategically using a mixture of IP rights to maximize the value of the IP portfolio of the quantum computer’s owner, potentially leads to IP protection in perpetuity. Overlapping IP protection regimes can result in unlimited duration of global exclusive exploitation rights for first movers, being a handful of universities and large corporations. The ensuing IP overprotection in the field of quantum computing leads to an unwanted concentration of market power. Overprotection of information causes market barriers and hinders both healthy competition and industry-specific innovation. In this particular case it slows down progress in an important application area of quantum technology, namely quantum computing.

Fair competition and antitrust laws for quantum technology

In general, our current IP framework is not written with quantum technology in mind. IP should be an exception -limited in time and scope- to the rule that information goods can be used for the common good without restraint. IP law cannot incentivize creation, prevent market failure, fix winner-takes-all effects, eliminate free riding and prohibit predatory market behavior at the same time. To encourage fair competition and correct market skewness, antitrust law is the instrument of choice.

Towards an innovation architecture that mixes freedom and control

The article proposes a solution tailored to the exponential pace of innovation in The Quantum Age, by introducing shorter IP protection durations of 3 to 10 years for Quantum and AI infused creations and inventions. These shorter terms could be made applicable to both the software and the hardware side of things. Clarity about the recommended limited durations of exclusive rights -in combination with compulsory licenses or fixed prized statutory licenses- encourages legal certainty, knowledge dissemination and follow on innovation within the quantum domain. In this light, policy makers should build an innovation architecture that mixes freedom (e.g. access, public domain) and control (e.g. incentive & reward mechanisms).

Creating a thriving global quantum ecosystem

The article concludes that anticipating spectacular advancements in quantum technology, the time is now ripe for governments, research institutions and the markets to prepare regulatory and IP strategies that strike the right balance between safeguarding our fundamental rights & freedoms, our democratic norms & standards, and pursued policy goals that include rapid technology transfer, the free flow of information and the creation of a thriving global quantum ecosystem, whilst encouraging healthy competition and incentivizing sustainable innovation.

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Establishing a Legal-Ethical Framework for Quantum Technology

Yale Law School, Yale Journal of Law & Technology (YJoLT) The Record 2021

New peer reviewed cross-disciplinary Stanford University Quantum & Law research article: “Establishing a Legal-Ethical Framework for Quantum Technology”.

By Mauritz Kop

Citation: Kop, Mauritz, Establishing a Legal-Ethical Framework for Quantum Technology (March 2, 2021). Yale J.L. & Tech. The Record 2021, https://yjolt.org/blog/establishing-legal-ethical-framework-quantum-technology

Download the article here: Kop_Legal-Ethical Framework for Quantum Tech-Yale

Please find a short abstract below:

What is quantum technology?

Quantum technology is founded on general principles of quantum mechanics and combines the counterintuitive physics of the very small with engineering. Particles and energy at the smallest scale do not follow the same rules as the objects we can detect around us in our everyday lives. The general principles, or properties, of quantum mechanics are superposition, entanglement, and tunnelling. Quantum mechanics aims to clarify the relationship between matter and energy, and it describes the building blocks of atoms at the subatomic level.

Raising Quantum Awareness

Quantum technologies are rapidly evolving from hypothetical ideas to commercial realities. As the world prepares for these tangible applications, the quantum community issued an urgent call for action to design solutions that can balance their transformational impact. An important first step to encourage the debate is raising quantum awareness. We have to put controls in place that address identified risks and incentivise sustainable innovation.

Connecting AI and Nanotechnology to Quantum

Establishing a culturally sensitive legal-ethical framework for applied quantum technologies can help to accomplish these goals. This framework can be built on existing rules and requirements for AI. We can enrich this framework further by integrating ethical, legal and social issues (ELSI) associated with nanotechnology. In addition, the unique physical characteristics of quantum mechanics demand universal guiding principles of responsible, human-centered quantum technology. To this end, the article proposes ten guiding principles for the development and application of quantum technology.

Risk-based Quantum Technology Impact Assessment Tools

Lastly, how can we monitor and validate that real world quantum tech-driven implementations remain legal, ethical, social and technically robust during their life cycle? Developing concrete tools that address these challenges might be the answer. Raising quantum awareness can be accomplished by discussing a legal-ethical framework and by utilizing risk-based technology impact assessment tools in the form of best practices and moral guides.

Mauritz Kop is a Stanford Law School TTLF Fellow, Founder of MusicaJuridica and strategic intellectual property lawyer at AIRecht, a leading 4th Industrial Revolution technology consultancy firm based in Amsterdam, The Netherlands. The author is grateful to Mark Brongersma (Department of Materials Science and Engineering at Stanford University), Mark Lemley (Stanford Law School), and Suzan Slijpen (Slijpen Legal) for valuable cross-disciplinary comments on an earlier version of this article. Thank you Ben Rashkovich and the Yale Journal of Law & Technology for excellent suggestions and editorial support. This article benefitted from comments at the World Economic Forum Quantum Computing Ethics Workshop.

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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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Workshop Juridische Aspecten AI & Data bij TNO - NL AIC Startups & Scaleups TekDelta Event

Op 24 september 2020 gaf Stanford Law School Fellow Mauritz Kop een masterclass over de juridische dimensie van kunstmatige intelligentie en informatie aan de getalenteerde deelnemers van de Werkgroep Startups & Scaleups van de Nederlandse AI Coalitie (NL AIC), in het kantoor van TNO Research in Den Haag. De workshop maakte onderdeel uit van het TekDelta | NL AIC startup accelerator event, met als centraal thema het versnellen en faciliteren van innovatie door het verbinden van startende ondernemingen met bestaande leading organisaties met slagkracht: het samen bouwen aan een succesvol high tech ecosysteem in Nederland.

Masterclass 'Juridische Aspecten van AI & Data’

De 2,5 uur durende masterclass 'Juridische Aspecten van AI & Data' bij TNO verschafte de cursisten duidelijkheid over de regels voor data delen, privacy en gegevensbescherming, alsmede juridisch en economisch eigendom van informatie. We behandelden onderwerpen variërend van de bescherming van intellectueel eigendom op het AI-systeem, de software, hardware en apps, clearance van data tot het anticiperen op de aanstaande AI & Data Governance wetten van de Europese Commissie.

Multidisciplinair Panel voor Verantwoord Data Delen

Dezelfde middag vond er vanuit het TNO gebouw een online seminar plaats speciaal voor startups, onder leiding van Anita Lieverdink, Senior Orchestrator of Innovation at TNO, Directeur van TekDelta en Program Manager van de Werkgroep Startps & Scaleups van de Nederlandse AI Coalitie.

AIRecht managing partner Mr. Kop nam als juridisch expert deel in het panel dat ging over verantwoord data delen. Het was goed om deel te nemen aan dit multidisciplinaire panel en samen met onze collega's oplossingen te verkennen voor het versneld en verantwoord delen van gegevens. Het is cruciaal en urgent om belemmeringen voor de inzet van benevolente AI weg te nemen en organisaties begeleiding te bieden die rechtszekerheid en vertrouwen in de snelle introductie van deze veelbelovende transformatieve technologie aanmoedigt!

Juridische Cursussen van AIRecht

Onze cursussen ‘AI en Recht – Juridische aspecten van AI, Machine Learning en Data’ bieden een compleet overzicht van de juridische facetten van kunstmatige intelligentie, big (structured/labelled en unstructured, raw) data en de verschillende typen machine learning (supervised, unsupervised, deep reinforcement, transfer, federated). De invalshoek is breed: van beschermen idee tot en met marktintroductie van het product. Cursusdoel is het wegnemen van juridische obstakels voor innovatie. Onderwerpen die hierbij aan de orde komen zijn privacywetgeving, het maximaliseren van uw IP-portfolio (intellectueel eigendom), normering, standaardisering (interoperabiliteit) en certificering (CE mark, keurmerken, conformiteit), het stimuleren van internationaal zakendoen, en het realiseren van (training)data delen op basis van EU regelgeving, licenties, toestemmingen en rechtsgeldige contracten. Maatwerk is mogelijk.

De workshops en masterclasses zijn cross-disciplinair en verbinden de ontwikkeling en toepassing van technologie met geldend nationaal en EU recht.

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