Medical DNA sequencing leads to lawsuits and legal questions
One of the biggest concerns is legal liability. Health care providers face a disconnect: Technology has outpaced their ability to interpret genetic results, such as a patient’s risk of breast cancer or heart attack from a particular mutation. Because of that, typical fallbacks including providing a rigorous standard of care—which can also act as a legal shield against malpractice claims—are becoming fuzzy. What is a doctor to do when a patient has results from a direct-to-consumer testing company like 23andMe and asks what implications they have for their health? Or when a lab notifies a doctor that a genetic variant their patient carries, thought meaningless 3 years ago, is now known to be harmful, but they can’t locate the patient? Can a testing lab be held liable for not regularly reviewing the scientific literature, to track science’s understanding of the gene variants it tests for?
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LawSeqSM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application
This innovative 3-year project, based cooperatively at the University of Minnesota and Vanderbilt University, has convened a national Working Group of top legal and scientific experts to analyze current US federal and state law and regulation on translational genomics and to generate consensus guidance on what the law should be.