When considering whether genetic testing is different from other laboratory tests, it is important to understand the viewpoint known as "genetic exceptionalism," the perspective that genetic information is unique among health-related information and therefore deserves special considerations and protections. Proponents of this perspective usually point to the following features of genetic information as being distinct from other types of health information:
• It can be used to make predictions about an individual’s health future.
• It does not change throughout a person’s lifetime.
• It has the potential to reveal information about family members.
• There are instances in which it has been used to discriminate against individuals or selected populations.
....... a nonexceptionalist approach has been taken with respect to Federal health privacy protections. The Federal Health Information Portability and Accountability Act Privacy Rule, which became effective in 2003, treats genetic information as equally sensitive as other medical information and provides the same level of protection to genetic and other types of personal health information. Recent policy recommendations encourage movement away from genetic exceptionalism.
The Committee is concerned by the gap in oversight related to clinical validity and believes that it is imperative to close this gap as expeditiously as possible. To this end, the Committee makes the following recommendations:
The Sherpa Says:
I will go into this report in more detail later. But If I was Google......This would be mandatory bed-time reading...Looking at these snippets it is clear. The barrier to entering the testing business is about to get MUCH, MUCH bigger. Playing nice with the government will only get you so far.