As DNA testing gallops ahead, doctors face wrenching questions about legal risks, protecting patients’ privacy, and the quality of the genetic information they’re providing—and they need help. That was one message from a symposium yesterday at the University of Minnesota (UMN) in Minneapolis. Leaders of a $2 million project called LawSeq are wrestling with how to push the legal world to catch up to science.
“The genome is static, but our ability to analyze it and interpret it is undergoing dramatic change,” said James Evans, a geneticist at the University of North Carolina in Chapel Hill. “We don’t understand most of these variants, nor their potential impact on health and diseases … and we change our minds a lot, which is kind of frightening for patients.”
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?