What is the impact of genetic testing on privacy?

"Genetic testing appears to exist in a regulatory vacuum," according to the policy director of the Genetics and Public Policy Center at Johns Hopkins. Because of the difficulty of performing and interpreting genetic tests, the labs which perform the approximately 1,000 tests currently available are not well (if at all) regulated at either the Federal or state level. Indeed, almost none have been reviewed by any government agency to ensure they do what they say they do. The FTC (Federal Trade Commission) regulates how genetic tests are advertised to consumers but none have been enforced yet with respect to the advertising of genetic tests. The FDA (Food and Drug Administration) regulates genetic test kits, but, according to Javitt, most gene testing labs develop their own in-house methods that are not currently reviewed by FDA. Even laboratories certified by CLIA (Clinical Laboratory Improvement Amendments) which covers basic and generic lab practice issues, does not provide information that is relevant to disease or future disease or condition.

With regard to privacy, there is no comprehensive federal protection in place. At the state level, privacy/discrimination legislation is variable, at best. For example, a consumer in Oregon purchases a genetic test from DNADirect (an online vendor based in San Francisco, CA). The consumer sends in their DNA sample to be tested. As soon as the sample leaves the state it is no longer protected under Oregon's genetic privacy laws. DNADirect sends the sample to Myriad Genetics, a laboratory in New Mexico, for testing. Since New Mexico currently does not have specific laws protecting the privacy of genetic information--and since the sample is no longer under Oregon jurisdiction--maintaining the privacy of the sample (and the donor) may be at-risk. At the present time, several other U.S. genetic testing labs, notably, Florida, California, and Ohio, also have no legislation which speaks directlly to protecting the privacy of genetic information.

For all of the above reasons, raising your awareness and understanding of the regulatory state of genetics and genetic testing in your state is important.

Consumer Considerations:

• Genetic tests ordered through a doctor provide for better privacy protection.
• Increasing the circulation of genetic and other health information through unregulated channels may increase the potential for unwarranted invasions of privacy and genetic discrimination.
• Policymakers have been slow to enact blanket genetic privacy protections and the protections currently in place provide no solid protection for individuals.