In April 2003, the National Human Genome Research Institute, the Department of Energy and the International Human Genome Sequencing Consortium successfully completed the Human Genome Project (HGP). In the years following the HGP’s successful completion, technological innovation in genomic science continues, creating capabilities to more accurately and efficiently identify human genetic variation. This innovation has led to broader use of genomic technology in traditional clinical treatment settings, while also leading patients to direct-to-consumer genetic laboratory kits. While it is widely believed that genomic technology will allow for more precise and efficient patient care, there are corresponding concerns about how the rapid advancements in genomics, coupled with consumer expectations about the use of genomics in their treatment, could result in an “onslaught of expensive malpractice lawsuits against physicians in coming years,” see Turna Ray, “Study Finds Docs Could Face Greater Malpractice Risk in Personalized Rx Era,” Genomeweb (June 27, 2011).

The liability concerns for Pennsylvania health care providers regarding genomic testing technologies are varied. This article will address the medical practices and specialties that are most affected by the advances in genetic testing technologies and primary drivers of observed genetic malpractice suits. It will then examine potential emerging and novel areas of liability in genomic medicine before concluding with a brief section addressing practical tips.

Common Uses of Genomic Testing Technology