Human in the Core: The Architecture of the Regulated AI-Native Enterprise

Mitchell L. Hayes, author
HITC Press, publisher

About the Book

Available formats: print and e-book

With unimaginable power, the dangers are as vast as the opportunities, and leaders in regulated industries must get AI right. Human in the Core: The Architecture of the Regulated AI-Native Enterprise lays out the commitments an AI-native organization must meet, drawn from AI-specific legislation (the EU AI Act), the major regulators (FDA, EMA), the harmonization forums (IMDRF, ICH), and the international standards bodies (ISO, IEC). The book shows that these regulators converge on one architecture, organized in five layers, so an enterprise can build once and satisfy all of them.

Who will benefit from this book?

Human in the Core: The Architecture of the Regulated AI-Native Enterprise is the ultimate guide for regulatory and quality executives and the professionals who advise them; it spans life sciences, automotive, aviation, nuclear and finance.

About the Author

Mitchell L. Hayes is a lifelong student of regulated industries and a pragmatic builder of the technology that serves them. He has spent 35 years building technology for the world's most regulated industries: pharma, medtech and, earlier, aerospace. A four-time founder and Six Sigma Black Belt, he has made a career of reading the regulations themselves, and his book, Human in the Core: The Architecture of the Regulated AI-Native Enterprise, gives that reading its name. It won the 2026 NYC Big Book Award in Technology.

Special Thanks to the Author

Hayes dedicates this book to the professionals who do the work, so has donated the proceeds from its sales to RAPS, which will use them to support education, professional development, and networking for regulatory and quality professionals. By purchasing this book, you’re not only gaining valuable resources, but you’re also contributing to a meaningful cause.

Purchasing Options

This book can be purchased in the following formats:

• Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
• Printed book.

This book can also be purchased as part of the following bundles:

• All Access Library (12-month digital subscription)

*All subscriptions listed above (excluding the All Access Library) are for three years. They grant you access to the products in the bundle. During this period, you can read the content online or download books as PDFs for offline use. You’ll also receive automatic updates to any new editions of the books and/or chapters included in your subscription. Learn more about subscriptions.

Published by HITC Press ©2026. Paperback. 276 pages. ISBN (print): 979-8-9962837-0-5. ISBN (digital) 979-8-9962837-1-2. Library of Congress Control Number: 2026913423.