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

The United States' decentralized, largely privatized, and commerce-driven healthcare system is undergoing a shift to personal genome medicine. This change is charged by ongoing progress in biotech and genomic research and development. This book draws from U.S. medicine's past and present to address its emerging personal genome medicine future.

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.