Personal Genome Medicine: The Legal and Regulatory Transformation of U.S. Medicine

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Personal Genome Medicine: The Legal and Regulatory Transformation of U.S. Medicine

By Michael J. Malinowski
Cambridge University Press August 2023

Specifications

ISBN-13
9781009293365
Publisher
Cambridge University Press
Publication
August 2023
Format
Paperback
Jurisdiction
U.K. ? Countri(es) for reference only

Details

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.

Table of Contents

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
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