Should additional processes be in place to enhance the confidentiality of certain genetic test information and results?
The current CLIA requirements for protecting the confidentiality of laboratory test results, including genetic testing, are sufficient. Further, the Department of Health and Human Services (HHS) is currently working on its own comprehensive privacy standards and, therefore, any effort by CDC to develop separate confidentiality standards would be redundant. And, finally, there is no need to provide explicit protection for genetic testing. All laboratory testing results should remain confidential. Any limitations placed on the use of such data, such as barring health insurance and employment discrimination, are outside the scope of this regulation. Assuming that a genetic specialty under CLIA is defined and recognized, should a laboratory covered under this specialty be required to provide genetic counseling to their clients (including medical care providers and patients) for the tests they offer? AACC agrees that laboratories offering genetic services must employ someone who can assist
