In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome 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 US, 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 US 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.

The rise and ease of genome-editing technologies, like CRISPR, has ushered in communities of “biohackers,” do-it-yourself enthusiasts for molecular genetics who perform experiments outside traditional institutional laboratory settings. Conventional wisdom posits that such research is beyond traditional modes of regulation or legal enforcement and that new biohacking laws are needed. This view, however, is incorrect; both public and private regulators currently possess–and in other contexts, use–many of the tools needed to regulate the safety and ethics of biohacking. The U.S. Food and Drug Administration, for example, has expansive authority over “biologics,” which includes many of the biohacking kits currently in use. Patent holders and community laboratories similarly have the power to impose ethical and safety restrictions on biohacking activities. Rather than new laws or stiffer enforcement, regulators should do what they do for other industries: actively engage with the community to educate and promote the advancement of technology.