Skip to main content
Elsevier

Responsible AI in Healthcare

Navigating the EU AI Act and Global Regulatory Frameworks

  • 1st Edition - January 1, 2027
  • Latest edition
  • Editors: Miltiadis D. Lytras, Foteini (Fani) Koutroumpa, Akila Sarirete, Afnan Alkhaldi, Miltiadis Lytras
  • Language: English

Responsible AI in Healthcare: Navigating the EU AI Act and Global Regulatory Frameworks examines how health systems design, deploy, and oversee AI under evolving legal and ethica… Read more

Back to School

Start strong. Study with purpose.

Save up to 25% on trusted learning resources

Shop now

Description

Responsible AI in Healthcare: Navigating the EU AI Act and Global Regulatory Frameworks examines how health systems design, deploy, and oversee AI under evolving legal and ethical mandates. It provides an integrated, practice‑oriented roadmap for compliance and responsible innovation. This book offers the first integrated, comparative treatment of the EU AI Act and global regulatory frameworks for healthcare, translating ethics and law into operational evaluation, governance, and value assessment. Through structured cases, decision tools, and stakeholder methods, it equips researchers and clinicians to design, validate, and deploy AI responsibly—and to keep learning as regulations evolve. Readers gain actionable tools, checklists, and frameworks to operationalize ethical AI, prepare for audits and certifications, and anticipate global convergence (“Brussels Effect”) shaping digital health. The volume serves clinicians, administrators, developers, policy and legal experts seeking rigorous yet accessible guidance.

Key features

  • Maps global health‑AI regulation (EU AI Act, GDPR, HIPAA, WHO) into clear organizational requirements and governance models
  • Demonstrates compliance in practice through hospital and public‑health case studies, checklists, and implementation guidance
  • Operationalizes ethics‑to‑action via explainability, bias mitigation, and privacy‑preserving methods (e.g., federated learning, differential privacy)
  • Demonstrates compliance in practice through hospital and public‑health case studies, checklists, and implementation guidance

Readership

Healthcare professionals and hospital administrators; digital‑health strategists, compliance officers, legal/regulatory experts, and AI researchers directly involved in developing, implementing, and overseeing healthcare AI systems, senior public‑health policymakers and advisors

Table of contents

1. The EU AI Act and Its Implications for Healthcare

2. Navigating GDPR and Data Privacy in AI Applications

3. International AI Regulation: U.S., Japan, Australia, and Beyond

4. WHO Guidance on Ethics & Governance of AI in Health

5. Cross Jurisdictional Challenges and Global Harmonization

6. Building Trustworthy and Explainable AI for Clinical Use

7. Privacy Preserving AI in Healthcare: Techniques and Tools

8. From Principles to Practice: Ethics by Design in AI Development

9. Institutional Governance and Risk Management Models

10. Implementing AI Compliance in Healthcare Organizations

11. AI in Radiology and Diagnostics: From Deployment to Regulation

12. AI for Mental Health and Predictive Interventions

13. Cross Border Data Exchange and Compliance: The MyHealth@EU Case

14. AI Driven Public Health Surveillance and Epidemic Prediction

15. Responsible AI Startups: Innovation Within Regulatory Boundaries

Product details

  • Edition: 1
  • Latest edition
  • Published: January 1, 2027
  • Language: English

About the editors

ML

Miltiadis D. Lytras

Miltiadis D. Lytras is an expert in advanced computer science and management, with extensive experience in academia and the business sector in Europe and Asia. He is a Research Professor at Deree College—The American College of Greece and a Distinguished Scientist at King Abdulaziz University, Saudi Arabia. Dr. Lytras specializes in cognitive computing, information systems, technology-enabled innovation, social networks, and knowledge management. He has coedited over 110 high-impact special issues in ISI/Scopus-indexed journals and authored more than 80 books with international publishers. Additionally, he has published over 120 high-impact papers in top-tier journals such as IEEE Transactions on Knowledge and Data Engineering and the Journal of Business Research. With 25 years of experience in Research and Development projects, Dr. Lytras has been involved in more than 70 R&D projects globally. He holds senior editorial positions in prestigious journals and is the Founding Editor and Editor in Chief of the International Journal on Semantic Web and Information Systems.

Affiliations and expertise
Effat University, Computer Science Department, College of Engineering, Jeddah, Saudi Arabia

FK

Foteini (Fani) Koutroumpa

Ms. Foteini Koutroumpa is a legal professional with over 20 years of experience in private law practice and active litigation. She is a specialist in AI compliance and regulation, with deep knowledge of the EU AI Act and a strong research focus on Responsible AI systems in the Government, Healthcare, and Energy sectors. Ms. Koutroumpa currently teaches Business Legal Issues at The American College of Greece and has previously taught courses in International Business Law and Management Principles. A Barrister of the Supreme Court of Greece, she has maintained her own law practice since 2003 and held advisory roles in major public and private sector projects. Her legal expertise spans commercial law, environmental law, contracts, and public procurement. She previously served as Legal Advisor for Ellaktor S.A. and worked with the Organizing Committee of the Athens 2004 Olympic Games on complex regulatory and contract matters.

Affiliations and expertise
The American College of Greece, Greece

AS

Akila Sarirete

Dr. Akila Sarirete is Dean of Graduate Studies and Research at Effat University. She received her PhD degree in Computer Science and Knowledge Management. Her main research interests are in artificial intelligence, knowledge management, communities of practice, machine learning, big data, and service-oriented architectures. She presented her research work in several conferences in different countries. Dr. Sarirete has a vast experience in software development industry and software engineering. She is interested in engineering education, innovation, smart cities and villages especially, the human aspect and the collaborative work.
Affiliations and expertise
The American College of Greece, Greece and Dean of Graduate Studies and Research, Effat University, Kingdom of Saudi Arabia

AA

Afnan Alkhaldi

Dr. Afnan Alkhaldi is Vice Rector for Academic Affairs and Research at the Arab Open University-Kuwait Branch. She holds a PhD in Operations and Information Management and specializes in smart cities, digital transformation, and e-government. She has served as a consultant in economic urban planning and smart city initiatives, supporting public-sector digital transformation, policy development, and data-driven decision-making. Dr. Alkhaldi is an active contributor to research on public sector innovation, healthcare digital ecosystems, and sustainable urban infrastructure. With a strong background in policy and systems thinking, she has supported national initiatives in Kuwait and across the GCC. Her work bridges academic insight and real-world transformation, emphasizing inclusive, efficient, and technologically advanced public services.
Affiliations and expertise
Open University Kuwait, Kuwait