Innovation, Quantum-AI 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 Artificial Intelligence
Hoover Institution Invites Mauritz Kop to Speak on Quantum, Democracy and Authoriarianism

Professor Mauritz Kop Addresses Quantum Technology's Role in the Era of Digital Repression at Hoover Institution Workshop

Palo Alto, CA – April 22, 2024 – Professor Mauritz Kop, Founding Director of the Stanford Center for Responsible Quantum Technology (RQT), delivered insightful opening remarks at a breakout session on Quantum Technology as part of the two-day closed door workshop, "Getting Ahead of Digital Repression: Authoritarian Innovation and Democratic Response." The workshop, held on April 22-23, 2024, at Hoover Institution, Stanford University, was a collaborative effort by the National Endowment for Democracy’s International Forum for Democratic Studies, Stanford University’s Global Digital Policy Incubator, and the Hoover Institution’s China’s Global Sharp Power Project.

The event convened leading researchers and advocates to map how digital authoritarians are innovating globally and to identify new strategies for ongoing knowledge-sharing and cooperation to confront this deepening challenge. The agenda focused on understanding how autocrats leverage emerging technologies—from AI and digital currencies to quantum technology—for social control, censorship, and to export their governance models.

Guardrails Against Digital Authoritarianism

Professor Kop's address served as a crucial discussion starter for the breakout session, which aimed to brainstorm how advances in quantum technology might alter the dynamics of the struggle against digital authoritarianism and to explore potential guardrails. His remarks underscored the profound societal impact of quantum technologies and the imperative for proactive, principles-based governance to ensure they are developed and deployed responsibly, safeguarding human rights and democratic values on a global scale.

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Harvard Petrie-Flom publishes EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Harvard Law School's Petrie-Flom Center has published EU and US Regulatory Challenges Facing AI Health Care Innovator Firms on its Bill of Health blog—an op-ed co-written by lead author Suzan Slijpen, Mauritz Kop (Founder of the Stanford Center for Responsible Quantum Technology), and senior author I. Glenn Cohen, who directs the Center. It examines why firms building artificial intelligence for medicine face such a tangled compliance map, and what a better one might look like.

Two regulatory philosophies, one transatlantic market

The piece sets Europe's cross-sectoral instinct against America's sectoral one. An AI medical product entering the EU must answer to the Medical Device Regulation, the GDPR, and a sweeping digital rulebook that now includes the EU AI Act and the coming European Health Data Space. In the United States, by contrast, coverage is patchy by design: HIPAA reaches only certain entities and data, and the FDA regulates medical AI only where it fits an existing category. Each model has genuine merits and genuine blind spots, and a firm selling on both shores must satisfy both at once.

Where the law strains hardest

The authors are clearest on the cases that resist tidy rules. Adaptive algorithms that keep learning after deployment make it hard to say when a model has changed enough to need fresh review—an area where the FDA's 2023 predetermined-change-control guidance points a constructive way forward. Generative AI overtook the EU AI Act mid-negotiation, unsettling how foundation models are treated under a rulebook drafted before they arrived. And at the material frontier sit quantum- and AI-driven devices, with their export controls, fragile supply chains, dual-use questions, and intellectual-property and security concerns—the bridge from this op-ed to Kop's broader work on the quantum technology governance frontier. The lesson the authors draw is procedural as much as substantive: regulators must understand the tempo of the technology they govern, or risk writing rules that are obsolete before they bind.

Toward a workable middle ground

Rather than crowning a winner, the authors propose a mixed horizontal-vertical approach: keep the precautionary care for patient safety, keep the permissionless capacity to innovate, and tailor the result to the economic realities of health care—from clinical-trial costs to market licenses. Regulation that is sensible, practical, and sector-specific, they argue, serves innovators and patients alike; anything less is rendered ineffective fast. Readers tracking Kop's longer arc on responsible technology can also follow his AIRecht scholar profile, where the through-line from AI in medicine to the law and ethics of the quantum age is laid out across a decade of work.

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Princeton University’s Liechtenstein Institute on Self-Determination’s visits Stanford Center for Responsible Quantum Technology

On Wednesday, January 22, 2024, the Stanford Center for Responsible Quantum Technology (RQT) had the distinct pleasure of hosting a delegation from Princeton University’s Liechtenstein Institute on Self-Determination (LISD) for a dynamic discussion on transatlantic technology policy at Stanford Law School. The event was marked by great energy and a profound exchange of ideas, reflecting the shared commitment of both institutions to navigating the complex intersection of emerging technology, global governance, and societal values.

Princeton LISD leadership and their talented International Policy Associates at Stanford RQT

As the host of the meeting, Professor Mauritz Kop had the opportunity to welcome the LISD leadership and their talented International Policy Associates. He provided an overview of the mission of the Stanford RQT, explaining our framework for ensuring that quantum technologies are developed and integrated into society in a manner that is safe, ethical, and equitable. This introduction served as a foundation for a rich and meaningful conversation, where the Princeton fellows posed insightful questions. The discussion traversed a wide spectrum of pressing topics, including the challenges of regulating the suite of quantum technologies, the discovery of quantum use cases in healthcare, the complexities of export controls and quantum materials supply chains, and the crucial interface between AI and quantum computing. Furthermore, we explored the application of universal democratic values and culturally sensitive ethics to these new domains, comparing the innovation systems of the US, EU, and China, and considering the potential for technology to drive both scarcity and abundance on a planetary scale.

Freeman Spogli Institute for International Studies (FSI) and Stanford Graduate School of Business (GSB)

The engagement at the RQT was a cornerstone of the LISD delegation's broader visit to Northern California, which included several high-level meetings across Stanford University. The group’s thank-you message noted their "incredibly enriching visit" and the comprehensive nature of their discussions. Their agenda also included conversations with preeminent scholars Professor Francis Fukuyama and Professor Michael McFaul at the Freeman Spogli Institute for International Studies (FSI), and a meeting with Dean Jon Levin of the Stanford Graduate School of Business (GSB). According to the delegation, these dialogues covered a range of vital geopolitical issues, from the war in Ukraine and a possible attack on Taiwan to Stanford's pivotal role in innovation, highlighting the "multifaceted impact of technology on democracy." The visit also provided an opportunity for the delegation to connect with Princeton alumni in the region.

Collaborating on global challenges and opportunities presented by quantum technologies

The esteemed LISD delegation was led by its senior leadership, including Sophie Meunier, the Acting Director of LISD and a Senior Research Scholar at the Princeton School of Public and International Affairs; Nadia Crisan, the Executive Director of LISD; Jonathan Fredman, a Non-Resident Fellow and former senior leader at the Central Intelligence Agency; and Jana-Alessa Peper, the Institute Assistant who coordinates the IPA program. They were accompanied by the LISD’s International Policy Associates, a cohort of students pursuing careers in foreign policy and international business, who brought a diverse array of academic and professional interests to the discussion.

The dialogue reinforced the critical importance of building bridges between institutions and disciplines. The exchange of perspectives between Stanford’s technology and policy experts and Princeton’s specialists in international affairs and self-determination created a unique and valuable synergy. We extend our sincere thanks to the entire LISD delegation for a stimulating and productive session that has undoubtedly planted the seeds for future collaboration in addressing the global governance challenges and opportunities presented by quantum and other advanced technologies.

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CQ Researcher Interviews Mauritz Kop on Regulating Artificial Intelligence and Quantum Computing

In late 2022, journalist Sarah Glazer interviewed Mauritz Kop—Founder of the Stanford Center for Responsible Quantum Technology (Stanford RQT)—for a CQ Researcher report, The Future of Artificial Intelligence — Can it be successfully regulated?, published under the lineage of Congressional Quarterly. Her questions ranged across the whole governance agenda: the regulatory gaps for artificial intelligence in the United States and Europe, the reach of the EU AI Act, the timing and skepticism around quantum computing, China and defense, and whether a machine could ever be sentient. Kop's written responses offer a compact statement of his position just before the field's law caught up with its technology.

The diagnosis: rules without teeth

Kop's opening line to Glazer was unsparing: "On both sides of the Atlantic, AI regulation is virtually nonexistent at the moment." The EU Artificial Intelligence Act, he explained, would change that—and not only in Europe. Because it is a Regulation rather than a Directive, it binds all Member States directly; and through the Brussels effect it sets a de facto global standard, exporting a risk-tiered, conformity-and-certification approach to AI well beyond the EU's borders.

Quantum is not "twenty years away"

The interview's sharpest thread was Kop's rebuttal to the familiar claim that quantum computing is perpetually two decades off. The framing, he argued, confuses engineering milestones with physical reality. Adversaries can harvest encrypted data now and decrypt it later once a capable machine exists, so the migration clock is already running. The physics is unforgiving: because qubits exploit superposition and entanglement, a quantum register explores an exponentially large state space, and an algorithm like Shor's turns that into the ability to break the assumptions behind today's public-key encryption. The argument echoes the warning in the Foreign Policy op-ed that drew Glazer to him in the first place.

Govern the systems we have

On machine sentience, Kop kept capability and consciousness apart: quantum effects make hard computations tractable, but they do not manufacture an inner life, and nothing in the physics confers rights on a model. The serious work is to govern the AI and quantum systems already in deployment—an interdisciplinary, standards-first program Kop has carried into venues from the U.S. Senate to his scholar profile. Read in 2026, after the EU AI Act's adoption and NIST's finalization of its first three post-quantum cryptography standards, the 2022 conversation looks less like commentary than like an early reading of developments now settled in law.

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Why Quantum Computing Is Even More Dangerous Than Artificial Intelligence (Foreign Policy)

Washington DC, August 21, 2022. Foreign Policy just published an article about regulating quantum technology authored by Vivek Wadhwa and Mauritz Kop. https://foreignpolicy.com/2022/08/21/quantum-computing-artificial-intelligence-ai-technology-regulation/

United States and other democratic nations must prepare for tomorrow's quantum era today

To avoid the ethical problems that went so horribly wrong with AI and machine learning, democratic nations need to institute controls that both correspond to the predicted power of the emerging suite of second generation quantum technologies, and respect & reinforce democratic values, human rights, and fundamental freedoms. In fact, the quantum community itself has issued a call for action to immediately address these matters. We argue that governments must urgently begin to think about regulation, standards, and responsible use—and learn from the way countries handled or mishandled other revolutionary technologies, including AI, nanotechnology, biotechnology, semiconductors, and nuclear fission. Benefits and increased quantum driven prosperity should be equitably shared among members of society, and risks equally distributed. The United States and other democratic nations must not make the same mistake they made with AI—and prepare for tomorrow's quantum era today.

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Intellectual Property in Quantum Computing and Market Power: A Theoretical Discussion and Empirical Analysis (Oxford University Press)

Delighted to see our article ‘Intellectual Property in Quantum Computing and Market Power: A Theoretical Discussion and Empirical Analysis’ -co-authored with my talented friends Prof. Mateo Aboy, PhD, SJD, FIT and Prof. Timo Minssen- published in the Journal of Intellectual Property Law & Practice (Oxford University Press), the flagship IP peer-reviewed OUP Journal, edited by Prof. Eleonora Rosati. Thanks to the JIPLP team for excellent editorial support! Our article: https://academic.oup.com/jiplp/article/17/8/613/6646536

This piece is the sisterpaper of our Max Planck @ Springer Nature published article titled ‘Mapping the Patent Landscape of Quantum Technologies: Patenting Trends, Innovation and Policy Implications’, which we wrote in parallel. The IIC quantum-patent study can be found here: https://link.springer.com/article/10.1007/s40319-022-01209-3. Our teamwork was absolutely gratifying and we hope it will inform strategic, evidence based transatlantic policy making.

IP and Antitrust Law

Please find a short synopsis of our work below:

We are on the verge of a technological revolution associated with quantum technologies, including quantum computing and quantum/artificial intelligence hybrids. Its complexity and global significance are creating potential innovation distortions, which could not have been foreseen when current IP and antitrust systems where developed.

Potential IP Overprotection

Using quantitative methods, we investigated our hypothesis that IP overprotection requires a reform of existing IP regimes for quantum tech, to avoid or repair IP thickets, fragmented exclusionary rights and anticommons concerns, lost opportunity costs, and an unwanted concentration of market power.

Perhaps counter-intuitively, we found that there appear to be (at least so far) no such overprotection problems in the real-world quantum computing field to the extent that their consequences would hinder exponential innovation in this specific branch of applied quantum technology, as more and more quantum patent information enters the public domain.

Patents versus Trade Secrets and State Secrets

However, developments taking place in secrecy, either by trade secrets or state secrets, remains the Achilles heel of our empirical approach, as information about these innovations is not represented by our dataset, and thus cannot be observed, replicated or generalized.

Interplay between IP and Antitrust Law: Open or Closed Innovation Systems

Policy makers should urgently answer questions regarding pushing for open or closed innovation systems including the interplay between IP and antitrust law, taking into account dilemma’s pertaining to equal/equitable access to benefits, risk control, ethics, and overall societal impact. Crucially, intellectual property in quantum technology has a national safety and (cyber)security dimension, often beyond the IP toolkit.

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Morning Brew and Dark Reading Interview Mauritz Kop on Quantum Ethics and the EU AI Act

Within the same fortnight in June 2022, two technology outlets sought out Mauritz Kop on the two governance questions that run through his scholarship: the ethics of quantum computing, and Europe's proposed AI Act. Emerging Tech Brew, Morning Brew's technology vertical, featured him in "As quantum computing advances, who's thinking about ethics?"; Dark Reading featured him in "EU Debates AI Act to Protect Human Rights, Define High-Risk Uses." In both, Kop is identified as a Transatlantic Technology Law Forum fellow at Stanford University and a strategic intellectual property lawyer at AIRecht.

Quantum ethics: act before the technology locks in

To Emerging Tech Brew, Kop's central message was about timing. "We were obviously too late for AI, and now, [for quantum computing], we still have the chance to be in time before the technology gets locked in," he said—invoking the Collingridge dilemma, in which a technology is easiest to steer precisely when its risks are hardest to see. The urgency is rooted in physics: superposition and entanglement give quantum machines a categorically different kind of power, including the eventual ability to break the public-key cryptography that protects today's communications—one reason the World Economic Forum's quantum governance principles name "non-maleficence" as a core value. Kop paired a call for transparency about present capability with a warning about a "Pandora's Box of unknown risks," and likened the field's duty of care to the Hippocratic Oath—"in this case, our society is the patient."

The EU AI Act: a product-safety regime for AI

To Dark Reading, Kop framed the EU AI Act as a product-safety regime that closes the gaps left by an otherwise unregulated field. "The risks are too high for nonbinding self-regulation by companies alone," he said, describing the act as "a human centric legal-ethical framework that intends to safeguard and protect human rights and fundamental freedoms from violations of these rights and freedoms by algorithms and smart machines." High-risk classification, he explained, scales obligations to danger—stricter rules for AI in healthcare and defense than for AI in tourism—through a dynamic, evolving list.

One conviction, two technologies

Both interviews express a single idea: that governance works best when embedded early, by design, and grounded in human rights rather than retrofitted after harm. Kop did not minimize the compliance burden on startups, nor the legal uncertainty that surrounds early regulation; his answer is "Trustworthy AI by Design," built in from the first line of code, and regulatory sandboxes that give responsible innovation room to breathe. More on the author's work is available via his scholar profile.

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Montreal World Summit AI 2022 Features Mauritz Kop Keynote on EU AI Act

Montreal, Canada – May 4, 2022 – Today, at the prestigious World Summit AI Americas held at the Palais des congrès, Mauritz Kop, TTLF Fellow at Stanford Law School and Director of AIRecht, provided a concise overview of the proposed EU Artificial Intelligence Act. He was a featured panellist in a critical discussion titled, "Does the proposed EU Artificial Intelligence Act provide a regulatory framework for AI that should be adopted globally?". The summit, themed "AI with impact: for crisis response and business continuity and recovery," brings together leading AI brains and enterprise leaders.

Mr. Kop joined fellow distinguished panellists Professor Gillian Hadfield from the University of Toronto and José-Marie Griffiths, President of Dakota State University and former NSCAI Commissioner. The session was moderated by Meredith Broadbent, Former Chairman of the U.S. International Trade Commission and Senior Adviser at CSIS.

Novel Legal Framework for AI

During the panel, Mr. Kop outlined the main points of the novel legal framework for AI presented by the European Commission on April 21, 2021. He explained that the EU AI Act sets out horizontal rules applicable to all industries for the development, commodification, and use of AI-driven products, services, and systems within the EU's territory.

A core component of the Act is its sophisticated ‘product safety framework’, which is constructed around four distinct risk categories in a "pyramid of criticality". This risk-based approach dictates that AI applications with unacceptable risks are banned, while lighter legal regimes apply to low-risk applications. As the risk level increases, so do the stringency of the rules, ranging from non-binding self-regulation and impact assessments for lower-risk systems to potentially heavy, externally audited compliance requirements throughout the lifecycle of high-risk AI systems.

EU "Trustworthy AI" Paradigm

Mr. Kop emphasized that the Act aims to codify the high standards of the EU’s "trustworthy AI" paradigm, which mandates that AI systems must be legal, ethical, and technically robust, all while respecting democratic values, human rights, and the rule of law. A crucial aspect highlighted was the requirement for market entrance and certification of High-Risk AI Systems through a mandatory CE-marking procedure. This pre-market conformity regime also extends to the machine learning training, testing, and validation datasets used by these systems. Only after a declaration of conformity is signed and the CE marking is affixed can these high-risk systems enter and be traded on the European markets.

Enforcement will be managed by a new Union-level body, the European Artificial Intelligence Board (EAIB), supported by national supervisors in each Member State, similar to the GDPR's oversight structure. Mr. Kop noted the seriousness of non-compliance, with potential fines reaching up to 6% of a company's global turnover.

Balancing regulation with innovation, the EU AI Act also introduces legal sandboxes. These are designed to provide AI developers with "breathing room" to test new inventions and foster a flourishing AI ecosystem in Europe.

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Mauritz Kop Lecturer AI Regulation and Intellectual Property Law at CEIPI, University of Strasbourg

Strasbourg, France – We are pleased to feature insights from a lecture on "Intellectual Property and Ownership of AI Input and Output Data" delivered by Professor Mauritz Kop at the Centre for International Intellectual Property Studies (CEIPI), University of Strasbourg. This session was part of the University Diploma in Artificial Intelligence and Intellectual Property.

Rights and responsibilities pertaining to AI and data

Professor Kop, a Fellow at Stanford University and a strategic IP lawyer, shared his expertise on the rights and responsibilities pertaining to AI and data, offering both theoretical perspectives and practical tips at the current state of technological and legal development. The lecture aimed to equip attendees with a bird's-eye view of the intertwined key elements of this multidimensional topic.

AI, data governance, and intellectual property law

Professor Kop's session underscored the dynamic interplay between AI advancement, data governance, and intellectual property law. It highlighted the necessity for legal professionals to be "double or triple educated" to navigate this complex field and for ongoing efforts to create legal frameworks that foster responsible innovation while addressing societal and ethical considerations.

The lecture concluded by stressing that AI literacy and awareness, continuous learning, and proactive legal strategies are essential for all stakeholders in the AI ecosystem.

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Mauritz Kop Consults Senator Mark Warner on AI & Quantum Technology Policy

Washington D.C., January 4, 2022—As the United States Congress grapples with the complex challenges of regulating artificial intelligence and quantum technology, leading policymakers are seeking expert guidance to inform a robust and forward-thinking national strategy. On January 4, 2022, Mauritz Kop, a distinguished scholar in the field of technology law and governance, was consulted by the legal team of U.S. Senator Mark Warner (D-VA) to provide strategic insights on both AI and quantum technology policy.

This consultation highlights the growing recognition in Washington of the need for deep, interdisciplinary expertise to navigate the geopolitical, economic, and security dimensions of these transformative technologies. Senator Warner's team reached out to Kop based on his influential scholarship, including his extensive work at Stanford on the EU AI Act and the need for a strategic democratic tech alliance, his advisory role for the European Commission led by Ursula von der Leyen on the AI Act and Data Act, and his foundational article in the Yale Journal of Law & Technology proposing a comprehensive legal-ethical framework for quantum technology.

Senator Mark Warner: A Leader on Technology and National Security

Senator Mark Warner's engagement on these issues is both significant and timely. As the Chairman of the Senate Select Committee on Intelligence, he is at the forefront of addressing the national security implications of emerging technologies. His work involves overseeing the U.S. Intelligence Community and ensuring it is equipped to handle the threats and opportunities of the 21st century, where technological competition with nations like China is a central concern.

The Senate Select Committee on Intelligence has a broad mandate that includes analyzing intelligence on the technological capabilities of foreign powers and assessing the vulnerabilities of U.S. critical infrastructure. Senator Warner has been a vocal proponent of developing a national strategy for AI and quantum to maintain the United States' competitive edge and to ensure that these technologies are developed and deployed in a manner consistent with democratic values. This consultation with Mauritz Kop reflects the Senator's commitment to drawing on leading academic research to shape sound, bipartisan policy.

AI Policy: A Transatlantic, Risk-Based Approach that Lets Innovation Breathe

A key focus of the consultation was Kop's analysis of the European Union's AI Act. His Stanford publications argue for a balanced, pro-innovation regulatory model that can serve as a blueprint for international cooperation. Good governance and sensible legislation should incentivize desired behavior and simultaneously create breathing room for sustainable, beneficial innovation to flourish.

Quantum Governance: Establishing a Legal-Ethical Framework

The discussion also delved into the governance of quantum technology, drawing on Kop's seminal work in the Yale Journal of Law & Technology. Recognizing that quantum is rapidly moving from the theoretical to the practical, he stressed the urgency of establishing a legal-ethical framework before the technology is widely deployed and locked-in.

The consultation with Senator Warner's office represents a critical intersection of academic scholarship and high-level policymaking. As the United States charts its course in the era of AI and quantum, the insights provided by experts like Mauritz Kop are invaluable in ensuring that the nation's strategy is not only competitive but also responsible, ethical, and firmly rooted in democratic principles.

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Een IPCC voor AI en opkomende technologie: het IPREDICT-voorstel aan de VN

IPREDICT is de oproep aan de Secretaris-Generaal van de Verenigde Naties om een internationaal panel voor verantwoorde ontwikkeling van opkomende technologie op te richten — naar het model van het klimaatpanel IPCC. AIRecht-oprichter Mauritz Kop behoorde tot de internationale experts die het voorstel voorbereidden en leverde de inbreng over quantumtechnologie.

Een IPCC voor opkomende technologie

De kern is coördinatie: één onafhankelijke, interdisciplinaire bron die kunstmatige intelligentie, robotica, biotechnologie en quantumtechnologie beoordeelt vóórdat de gevolgen onomkeerbaar zijn. Het voorgestelde mandaat omvat betrouwbare informatie, expert-aanbevelingen, het aanmoedigen van verantwoorde innovatie in alle ontwikkelfasen en publieke betrokkenheid via een tweejaarlijks World Forum.

Internationale participanten

Het initiatief werd voorbereid door een breed gezelschap van wetenschappers uit recht, ethiek, robotica, AI en biotechnologie — van Princeton en Yale tot UNESCO-bioethici en SIPRI. Het is precies die multidisciplinaire mengeling die een panel als IPREDICT beoogt.

De bijdrage van AIRecht

Mauritz Kop leverde de quantum-expertise, in lijn met zijn werk aan een juridisch-ethisch kader voor verantwoorde quantumtechnologie. De achterliggende gedachte is dat anticiperende governance past bij technologie die met sprongen arriveert. Verder lezen over dat kader kan in Establishing a Legal-Ethical Framework for Quantum Technology.

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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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