As genetic tests for diagnosis of and predisposition to psychiatric disorders become more widely available, questions inevitably arise about regulatory and liability concerns. In the U.S., federal authorities have taken a relatively hands-off attitude toward genetic testing. Although tests performed for clinical purpose must be conducted in laboratories certified under the Clinical Laboratory Improvement Act (Rivers, et al., 2005), the federal government has not otherwise regulated the accessibility of genetic testing—in contrast to many European countries that have enacted tight restrictions (Grimaldi, 2010). At the moment, it is unclear whether the Food and Drug Administration will exert regulatory authority over direct-to-consumer testing, and if so, what limits it will impose (Vorhaus, 2011). However, it does seem clear that if testing for either diagnostic or predictive purposes advances to the point that it represents the standard of care in psychiatry, clinicians who fail to obtain such tests may be held liable for negligence (Molloy v. Meier, 2004). This underscores the importance of clinicians staying up-to-date on advances in genetic testing and the clinical use of such tests.
