AI-by-Design
Artificial intelligence, large language models, chatbots, extended reality, and other emerging technologies are becoming central to modern healthcare, industry, and society. They offer major benefits, from faster diagnoses and personalized medicine to immersive collaboration and new ways of protecting information. At the same time, they create new risks for privacy, cybersecurity, fairness, and accountability, all of which are important for maintaining public trust in technology.
AI-by-Design: Integrating Privacy, Security, and Ethical Governance in Health, Industry, and Society starts from a simple idea: good governance should be built into technology from the beginning, rather than added later when problems arise. Privacy, security, and ethical safeguards should therefore be part of the design and development of AI systems from their earliest stages. The book explores how privacy-by-design, security-by-design, and ethics-by-design can be brought together into a single approach for developing AI and other technologies that people can trust.
This is particularly important because the rules governing AI are changing quickly. AI governance is not a fixed set of requirements that organizations can follow once and then forget. Laws, technologies, political priorities, and public expectations continue to change. The AI-by-Design approach helps address this challenge because it does not depend on any single law or regulatory framework. Instead, key principles such as data minimization, transparency, security, human oversight, explainability and accountability are built directly into the technology and the way it is developed and used. In this sense, design choices are also governance choices. They shape how data is collected and used, how cybersecurity risks are managed, how individual rights are protected, and how the benefits and risks of new technologies are shared across society.
The book brings together contributions from areas such as healthcare, industry, and society. In healthcare, the authors examine AI-supported diagnostics, mental health chatbots, mobile health applications, and other technologies that are changing how care is provided while raising concerns about transparency, bias, privacy, and cybersecurity. In industry, the book looks at the growing use of AI, data infrastructures, and extended reality and considers how legal requirements can be put into practice through technical standards and concrete safeguards. At the broader societal level, the contributors examine AI reasoning, explainability, accountability, and the need for governance approaches that can respond to rapid technological change.
Throughout the volume, the contributors connect legal and ethical principles with practical solutions. The book shows how privacy, security, fairness, transparency, and accountability can move beyond general principles and become part of the technical, organizational, and legal choices made throughout the design and use of AI systems.
Marcelo Corrales Compagnucci is Associate Professor and Associate Director at the Center for Advanced Studies in Bioscience Innovation Law (CeBIL), Faculty of Law, University of Copenhagen, Denmark, and an Inter-CeBIL Research Affiliate at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. His research focuses on information technology, AI, privacy, data protection, cybersecurity, and digital regulation. He is also an Attorney at Law, CIPP/E certified, and the founder of CORCOM ApS, a consultancy specializing in compliance with the GDPR, the AI Act, and cybersecurity regulations. He has previously worked as a lawyer and consultant for law firms and IT companies, and has been a research associate at the Institute for Legal Informatics (IRI), Leibniz Universität Hannover, as well as a visiting research fellow at institutions including Harvard Law School, the University of Cambridge, the Max Planck Institute, the University of Edinburgh, the University of Turin, and Academia Sinica in Taiwan. He has a Doctor of Laws (LL.D.) degree from Kyushu University in Japan. He also holds a Master of Laws (LL.M.) in international economics and business law from Kyushu University, and an LL.M. in law and information technology and an LL.M. in European intellectual property law, both from the University of Stockholm in Sweden. He has published more than 120 scholarly works, including three monographs and twelve edited books on information technology law and other fields.
Timo Minssen is Professor of Law at the University of Copenhagen (UCPH). He holds the UNESCO Co-Chair in the Right to Science and is the Director of UCPH's Center for Advanced Studies in Bioscience Innovation Law (CeBIL). He is also an Inter-CeBIL Research Affiliate at Harvard Law School and at the University of Cambridge. His research and practice concentrate on IP-, Competition & Regulatory Law in emerging technologies, including the law and ethics of AI, quantum technologies, and health & life science innovation. Timo holds a German law degree from the University of Göttingen, and biotech & IP -related LL.M. M.I.C.L., LL.Lic. and LL.D. degrees from Lund & Uppsala University. He had been an Epigenetics fellow at the Pufendorf Institute for Advanced Studies, and a Visiting Professor at the Technical University of Munich, the Universities of Cambridge and Oxford, Waseda Law School, Harvard Law School, the Max Planck Institute for Innovation & Competition, and at the Chicago-Kent College of Law. Moreover, he was trained in the German Court system, the European Patent Office, law firms & start-ups. Timo serves as an advisor to the WHO, WIPO, OECD, the EU Commission, companies, national governments, and law firms. At UCPH he leads several interdisciplinary research projects on legal issues in emerging biotechnologies, precision medicine, ATMPs, antimicrobial resistance, pandemic preparedness, advanced medical computing, medical devices, and in sustainable innovation.
Mark Fenwick is a professor of international business law at Kyushu University in Fukuoka, Japan. His primary research interests are in business regulation in a digital age. Recent publications include Smart Contracts: Business, Legal & Technological Perspectives (Hart, 2021: co-edited with M. Corrales Compagnucci and S. Wrbka); Organising-for-Innovation: Corporate Governance in a Digital Age (Springer, 2023: co-authored with E.P.M. Vermeulen and T. Kono); and The Law & Ethics of Data-Sharing in Health Sciences (Springer, 2024; co-edited with M. Corrales Compagnucci, T. Minssen, M. Aboy, and K. Liddell). He has conducted research on these and related issues for the EU, the OECD, and the World Bank. He has also been a visiting professor at Hong Kong University, the National University of Singapore, Tilbury University, Thammassat University, Chulalongkorn University and Duke University.