Personal Genome Medicine
The Legal and Regulatory Transformation of US Medicine

Draws from the past and present of medicine in the U.S. to address the emerging future of personal genome medicine.

Michael J. Malinowski (Author)

9781009293327, Cambridge University Press

Hardback, published 31 August 2023

480 pages
28 x 19 x 2.9 cm, 0.896 kg

'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

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.

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.

Subject Areas: Medical & healthcare law [LNTM]