Personal Genome Medicine

The Legal and Regulatory Transformation of US Medicine

Michael J. Malinowski (Louisiana State University)

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Hardback

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English

Cambridge University Press
31 August 2023

Ethical issues: scientific & technological developments; Intellectual property law; Regulation of medicines & medical devices; Medical ethics & professional conduct; Impact of science & technology on society

In the years following FDA approval of direct-to-consumer, genetic-health-risk testing, millions of people in the United States have sent their DNA to companies to receive personal genetic health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the U.S., Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of U.S. medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

By: Michael J. Malinowski (Louisiana State University)
Imprint: Cambridge University Press
Country of Publication: United Kingdom
Edition: New edition
Weight: 881g
ISBN: 9781009293327
ISBN 10: 100929332X
Pages: 480
Publication Date: 31 August 2023
Audience: General/trade , ELT Advanced
Format: Hardback
Publisher's Status: Active

Prologue: revolution, transition and transformation; 1. Medical profession sovereignty to protect and promote the science and evidence base of US medicine; 2. US integration of government, academia and industry: a catalyst for science-technology revolutions; 3. The proliferation of US Direct-to-Consumer (DTC) and Direct-to-Physician (DTP) biopharmaceutical marketing; 4. The evolution of consumer genetic testing services from Oncormed, Inc. to 23andMe Holding Co.; 5. Vulnerability of the science and evidence base of US medicine; 6. A warning label for commercial Direct-to-Consumer (DTC) genetics; 7. Protecting and promoting the evidentiary-science base of Personal Genome Medicine (PGM); Epilogue: the personal genome future of US medicine.

Michael J. Malinowski is the Ernest R. and Iris M. Eldred Endowed Professor of Law and the Lawrence B. Sandoz Jr. Endowed Professor of Law at the Paul M. Hebert Law Center, Louisiana State University. He has published extensively on biotechnology research and development (R&D), health care, and bioethics.

Reviews for Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine

'A critical analysis of the last century of informed consent, of current recreational genetics, and of the future of personalized genomic medicine. A meticulous and critical understanding of the novel ethical and legal issues. Personal Genome Medicine is a tour de force.' Bartha Maria Knoppers, McGill University