Enforcement Trends for Genetic Testing and Potential Implications for Telehealth and Pharmacogenetic Companies

The genetic testing industry has continued to grow in size and scope in recent years, but with this success comes increased regulatory scrutiny and potential liability, particularly during and after the COVID-19 pandemic. This article addresses the current civil and criminal enforcement climate, surveys the applicable statutes used by the Department of Justice (DOJ) and recent cases, and concludes with helpful tips about how health care professionals and genetic testing labs can prepare for the increased scrutiny announced by the Attorney General for this area.