EBOOK
About
"Humanity is about to be handed almost unimaginable power, and it is deeply unclear whether our social, political, and technological systems possess the maturity to wield it." - Dario Amodei, Anthropic CEO
The leaders of every regulated enterprise are being asked the same question: what does an AI-native future actually look like inside our walls? Human in the Core is the answer the regulators have already written down.
Every copy of this book is a donation. Human in the Core is written for the professionals who do this work, so its proceeds are theirs too. One hundred percent of the net proceeds from every sale are donated, in full, to the professional society or regionally accredited university that each reader chooses: the Regulatory Affairs Professionals Society (RAPS), The Organisation for Professionals in Regulatory Affairs (TOPRA), DIA, the International Society for Pharmaceutical Engineering (ISPE), the Parenteral Drug Association (PDA), SAE International, the American Institute of Aeronautics and Astronautics (AIAA), the International Council on Systems Engineering (INCOSE), or the Global Association of Risk Professionals (GARP). When you buy the book, you decide where your copy's proceeds go. Buy a copy and you fund the work. Recommend it to a colleague and you keep the giving going.
The regulations of ten regulatory regimes on three continents - U.S. FDA, EU AI Act, IMDRF, Health Canada, MHRA, EMA, EASA, ICH, ISO, IEC - describe between them the architecture of an AI-native enterprise. Read in isolation, each is a body of requirements. Read together, they describe one structural recipe. Article by article, principle by principle, the architectural commitments emerge. And they converge.
The convergence is not asserted; it is demonstrated, clause by clause. By the time the leader has watched the same architectural commitments emerge from independent regulatory traditions, they have the architectural literacy to lead all of it, the who, what, and why, to face the board and lead the people who build it, guide it, or design it, with the regulatory ground already walked.
Human in the Core represents years of regulatory reading already done: every relevant article, every regulation, every jurisdiction in scope, with the connections between them made plain.
The leaders of every regulated enterprise are being asked the same question: what does an AI-native future actually look like inside our walls? Human in the Core is the answer the regulators have already written down.
Every copy of this book is a donation. Human in the Core is written for the professionals who do this work, so its proceeds are theirs too. One hundred percent of the net proceeds from every sale are donated, in full, to the professional society or regionally accredited university that each reader chooses: the Regulatory Affairs Professionals Society (RAPS), The Organisation for Professionals in Regulatory Affairs (TOPRA), DIA, the International Society for Pharmaceutical Engineering (ISPE), the Parenteral Drug Association (PDA), SAE International, the American Institute of Aeronautics and Astronautics (AIAA), the International Council on Systems Engineering (INCOSE), or the Global Association of Risk Professionals (GARP). When you buy the book, you decide where your copy's proceeds go. Buy a copy and you fund the work. Recommend it to a colleague and you keep the giving going.
The regulations of ten regulatory regimes on three continents - U.S. FDA, EU AI Act, IMDRF, Health Canada, MHRA, EMA, EASA, ICH, ISO, IEC - describe between them the architecture of an AI-native enterprise. Read in isolation, each is a body of requirements. Read together, they describe one structural recipe. Article by article, principle by principle, the architectural commitments emerge. And they converge.
The convergence is not asserted; it is demonstrated, clause by clause. By the time the leader has watched the same architectural commitments emerge from independent regulatory traditions, they have the architectural literacy to lead all of it, the who, what, and why, to face the board and lead the people who build it, guide it, or design it, with the regulatory ground already walked.
Human in the Core represents years of regulatory reading already done: every relevant article, every regulation, every jurisdiction in scope, with the connections between them made plain.