Have you read it? Come on.....You didn't. Well, you are missing out. Back in 2004 I started watching the Secretary's Advisory Committee on Health, Genetics and Society. But even more importantly I began watching back meetings that were webcast, including the SACGT. I studied the players in the field, the advisors, the government. I began to notice trends and agendas.
This is why I saw all of the regulations coming. I began emailing members, speaking with advisors, and learning how and when all of the issues would arise and then be solved. Then in 2005 I began to develop the business plan for Helix Health of Connecticut.
The safest climb to the summit is with trained genetics professionals like the ones we have. The riskiest is D-I-Y. The SACGHS is against D-I-Y...notably this 276 page report goes into this in fine detail.
Highlights include
Are Genetic Tests Special?
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.
But.....
....... 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.
That Being Said....
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:
A. FDA should address all laboratory tests in a manner that takes advantage of its current experience in evaluating laboratory tests.
B. This step by FDA will require the commitment of significance resources to optimize the time and cost of review without compromising the quality of assessment.
C. The Committee recommends that HHS convene a multistakeholder public and private sector group to determine the criteria for risk stratification and a process for systematically applying these criteria. This group should consider new and existing regulatory models and data sources (e.g., New York State Department of Health Clinical Laboratory Evaluation Program). The multistakeholder group should also explicitly address and eliminate duplicative oversight procedures.
D. To expedite and facilitate the review process, the Committee recommends the establishment of a mandatory test registry as noted in the following recommendation.
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.
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